chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Fatigue, Lacrimation disorder, Pyrexia
Clinical narrative: Patient claims to have felt dizziness, extreme fatigue, chills blurred vision, had extreme thick lacrimation. Felt faint and slight fever 99F. Family members wanted to take him to the hospital. Took Tylenol and felt better next day. Four days later still complaining of vision problems.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Patient claims to have felt dizziness, extreme fatigue, chills blurred vision, had extreme thick lacrimation. Felt faint and slight fever 99F. Family members wanted to take him to the hospital. Took Tylenol and felt better next day. Four days later still complaining of vision problems.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swollen raised warm area at injection site. Measured about 1 1/2 inch diameter.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Large area of swelling, red, firm to touch and warm. 3" by 5" initially, increased to whole underside of left upper arm by morning.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Hyperaesthesia, Paraesthesia, Pruritus
Clinical narrative: EXPERIENCED TINGLING, ITCHING AND BURNING IN A LINE ALONG RIGHT THORAX, APPROX AT T-7 OR 8.   SENSITIVE WHEN CLOTHES TOUCH AREA, AND NO SIGNS EXTERNALLY OF RASH AT THIS TIME. WENT TO MD, PRESCRIBED ACYCLOVIR 800 MG 5X/DAY X7 DAYS.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: pt denied adverse reaction at time of vaccination- she returned to clinic approx 7:35 and was waiting outside clinic, she states that she has severe pain in right deltoid - site without redness or swelling, pt has sensation and mobility right arm, I spoke with Dr. and he advised pt to go to ER pt had pneumovax in the past without reaction. she states vaccination must be given right deltoid due to lymphedema
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Tremor
Clinical narrative: Dizziness, nausea, and shakes for about an hour until they stopped.  Patient thought about going to the ER until it stopped.
Age: 0.54
Sex: F
Vaccine: IPV, RV5
Symptoms: Cough, Crying, Diarrhoea, Flatulence, Gastrooesophageal reflux disease
Clinical narrative: Started with gas and some diarrhea.  Progressed by 9/15 to extreme fussiness, more frequent diarrhea, and lack of sleep.  (Baby was up the entire night.) By 9/16, diarrhea was more frequent, and baby also had reflux-like symptoms.  Another night of no sleep and lots of crying.  9/17, baby still has diarrhea and has also developed coughing and a mild rash on her back and chest.  Still extremely irritable.  Calling doctor tomorrow.
Age: 0.54
Sex: F
Vaccine: IPV, RV5
Symptoms: Insomnia, Irritability, Rash
Clinical narrative: Started with gas and some diarrhea.  Progressed by 9/15 to extreme fussiness, more frequent diarrhea, and lack of sleep.  (Baby was up the entire night.) By 9/16, diarrhea was more frequent, and baby also had reflux-like symptoms.  Another night of no sleep and lots of crying.  9/17, baby still has diarrhea and has also developed coughing and a mild rash on her back and chest.  Still extremely irritable.  Calling doctor tomorrow.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Blood potassium decreased, Blood urea decreased, CSF culture, Hypoaesthesia, Nasopharyngitis
Clinical narrative: Had a severe cold the first of May then starting Tuesday morning 5/19/09 I started losing feeling in my feet and by afternoon on 19th my left hand, then right hand became numb.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: White blood cell count increased
Clinical narrative: Had a severe cold the first of May then starting Tuesday morning 5/19/09 I started losing feeling in my feet and by afternoon on 19th my left hand, then right hand became numb.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypersensitivity, Nausea, Palpitations
Clinical narrative: Patient was given FLUZONE HD, about 3 hrs after she experienced palpitation and nausea and difficulty in breathing. Ambulance was called (911), she was taken to hospital. She was admitted with possibility of allergic reaction to the flu vaccine.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to a patient of unknown age and gender. On an unknown date (reported as quite a few years ago) the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) (dose, strength, route and site of administration not reported) for prevention of hepatitis B. When serological testing was completed on this unspecified patient, on an unspecified date, the titers came back as negative. The outcome of the titers came back as negative was unknown. The relatedness between titers came back as negative and hepatitis b vaccine (manufacturer unknown) was not reported. Additional information is not expected, because the reporter did not want to be contacted.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, C-reactive protein, Erythema, Fatigue, Full blood count
Clinical narrative: Faitgue, malaise, fever, joint pain, arm is red, swollen, and painful to touch.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Faitgue, malaise, fever, joint pain, arm is red, swollen, and painful to touch.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. On 10-SEP-2014 the patient was vaccinated with PROQUAD INJ (route, dose no, dosage and lot number unknown). The healthcare student reported that the patient received improperly stored PROQUAD instead of M-M-R. PROQUAD was found to be unsupported by in-house stability data. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Urticaria
Clinical narrative: A couple of hours after shots Hep A and B, I was covered in welts, then mouth, face went numb. Rushed to Dr was put on steroids as the BENADRYL I had taken didn't work. Steroid did not last 24 hours and had to take pill early in the middle of the night after emergency call to Dr. 3 days of severe welts etc.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash, Rash papular, Rash vesicular
Clinical narrative: Erythematous papular/vesicular rash over trunk, arms.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia, Upper respiratory tract congestion
Clinical narrative: Pt reported fever (temperature unknown), chills, body aches, upper respiratory congestion. More severe than with any regular flu shot in the past.
Age: 58.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash pustular
Clinical narrative: Redness, pus, itching reported 9/11/14 8 days after getting. Responded to hydrogen peroxide/NEOSPORIN and just red/itching now.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth reaction at site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with allergy to penicillin (PCN), sulfa and other antibiotics. Pertinent medical history was not specified. On 03-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (route, anatomical location and lot number were not reported). Concomitant medications were not specified. On an unspecified date in September 2014, the patient experienced injection site reaction. This was further clarified as warmth, white blisters and golf size raised area. The patient did not seek medical attention. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected because there is no consent for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to one of the two patients of unkonwn age and gender. Patient medical history and historical conditions were not reported. On 12-SEP-2014, the patient inadvertently administered ZOSTAVAX single dose, subcutaneous (dose was not reported) (lot # J004599 and expiration date was 18-JUL-2014), that had expired in 18-JUL-2014. Concomitant therapy was not reported. No adverse effects reported. No PQC was involved. The outcome of inadvertently administered ZOSTAVAX that had expired in 18-JUL-2014 was unknown. The reporter considered inadvertently administered ZOSTAVAX that had expired in 18-JUL-2014 to be not related to ZOSTAVAX. This case was linked to MARRS# 1409USA007128 (same patient link). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to one of the two patients of unknown age and gender. Patient medical history and historical conditions were not reported. On 12-SEP-2014, the patient inadvertently administered ZOSTAVAX VIAL single dose, subcutaneous (dose was not reported) (lot # J004599 and expiration date was 18-JUL-2014), that had expired in 18-JUL-2014. Concomitant therapy was not reported. No adverse effects reported. No PQC was involved. The outcome of inadvertently administered ZOSTAVAX VIAL that had expired in 18-JUL-2014 was unknown. The reporter considered inadvertently administered ZOSTAVAX VIAL that had expired in 18-JUL-2014 to be not related to ZOSTAVAX. This case was linked to MARRS# 1409USA008025 (same patient link). Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from an unspecified provider at a conference via a company representative, refers to a 68 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. The reporter stated that on an unknown date the patient was administered ZOSTAVAX (dose, route and lot number not provided), and experienced three shingles outbreaks in the hip area (dates unspecified). At the time of the report, the outcome of the event was unkown. Additional information is not expected because the reporter details were not provided.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from an unspecified provider at a conference via a company representative, refers to a 70 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. The reporter stated that on an unknown date the patient was administered ZOSTAVAX VIAL (dose, route and lot number not provided), and was diagnosed with shingles (date unspecified). At the time of the report, the outcome of the event was unknown. Additional information is not expected because the reporter details were not provided.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site cellulitis, Insomnia, Limb discomfort
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknown demographics. No relevant medical history of the patient was reported. On 28-AUG-2014, the patient was vaccinated with PNEUMOVAX23 (lot # J014399, expiry date: 20-NOV-2014) (strength, dose and route of administration were not reported). Other suspect  therapies included FLUZONE (strength, dose and route of administration, lot number and expiry date were not reported), administered on the same day. Concomitant medications were not reported. On an unknown date in 2014 the patient experienced flu like symptoms and could not sleep on his or her side because of the discomfort in the arm in which they received the PNEUMOVAX23. The patient came to the pharmacy on 02-SEP-2014, and the reporting pharmacist diagnosed the patients injection site reaction as cellulitis. It was unspecified whether the patient had received any treatment for the events. There was no product quality complaint involved. The outcome of flu like symptoms, injection site reaction cellulitis and could not sleep on his or her side because of the discomfort in the arm in which they received the PNEUMOVAX23 was unknown. The causality of the events was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknown demographics. No relevant medical history of the patient was reported. On 12-AUG-2014, the patient was vaccinated with PNEUMOVAX23 (lot #J014399, expiry date: 20-NOV-2014 (strength, dose, route of administration were not reported). Concomitant therapies included FLUVIRIN administered on the same day. On an unknown date in 2014 the patient was diagnosed with cellulitis near the injection site of the PNEUMOVAX23. It was unspecified if any treatment was given for th event. There was no product quality complaint involved. The outcome of cellulitis near the injection site of the PNEUMOVAX23 was unknown. The causality of the event was not provided.  This is one of several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: 9/14-1 hive. 9/15-2 more hives. 9/16-3 or more hives.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, VARCEL
Symptoms: Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Patient was given the Varicella vaccine in right lower vastus lateralis subq. within 1-2 mins. after injection, complained of itch, red rash noted around injection site, given liquid BENADRYL for treatment.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Therapeutic response decreased
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 19 year old (also reported as 20 year old) male patient. Medical history and drug reactions or allergies were not specified. In 1995 and 2008, the patient was vaccinated with the first and the second dose of (Oka/Merck) VARIVAX injection (route, dose and lot number were not reported) for prevention of varicella. Concomitant medications were not specified. On 21-AUG-2013, the patient had a titer drawn and results were equivalent. This was clarified to be subtherapeutic (exact results and units were not provided). The patient did not seek medical attention. The outcome of had a titer drawn and results were equivalent, this was clarified to be subtherapeutic was unknown. The relatedness between the event of had a titer drawn and results were equivalent, this was clarified to be subtherapeutic was not reported. Additional information is not expected because there is no permission to contact.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 17 year old patient of an unknown age. Medical history and concurrent conditions were not reported. On 05-SEP-2014 the patient was vaccinated with a dose of PROQUAD (Merck) (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. Medical assistant reproted that a 17 year old patient received a dose of PROQUAD (Merck) on 05-SEP-2014. No symptoms reported. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMRV, VARCEL
Symptoms: Incorrect dose administered, Irritability
Clinical narrative: Matched the Lt# written on the clients service slip at that point I realized I had given a VZV (LUT) and MMRV (RUT). Printed 3231 form and gave to MGM. Then explained to MGM that child received a single dose chickenpox vaccine and another dose of chickenpox vaccine combined with MMR. Reinforced what to look for that's considered severe problems such as high fever (102 degrees and above), swelling of face and throat, difficulty breathing etc on V15 statement. Informed MGM should any of these problems occur to call 911 or take child to the nearest ER. MGM voiced understanding. Child remained in clinic 15-20 minutes after shots for observation, no s/s of any reaction. Again reinforced importance of watching for severe problems; if any call 911 or take child to nearest ER. Followed up with home phone provided in client's record at 11:45 AM. No answer, left voice message, again at 1:45 pm no answer left message; no response back. Phoned MGM again at 3:15 pm, spoke with MGM and she reported that child was fussier than usual but denied that child had fever, swelling pr difficulty breathing or any other reaction, Explained to MGM that child may be fussy due to ache or pain in the legs where shots were given. Acetaminophen can be given for pain or fever but read carefully before giving.  MGM voice understanding.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: 1 hour after shot given pt experienced redness and swelling at injection site. Side effects peaked at day 8. Pt reports no pain at any point. There is still internal swelling that feels like a lump. Slight redness still visible.
Age: 21.0
Sex: F
Vaccine: HEPA, TDAP, YF
Symptoms: Convulsion, Vomiting
Clinical narrative: Patient received three vaccines on date of visit Tdap (ADACEL), Hep A and Yellow Fever (YF-Vac). Pre-vaccination, patient mentions has fainted with shots - asked patient to lay down on exam table but she declined preferring to sit in chair - after 3rd injection patient slumped, then had seizure. Medics called and also checked by ARNP - discharged with mother who later called to report pt vomited x 3 on way home - will go to ED if worsens and FU with PCP.
Age: 33.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Erythema, Local swelling, Pain, Skin warm
Clinical narrative: Pain, swelling and redness (three inches by four inches). Hot to the touch.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vaccination site inflammation, White blood cell count increased
Clinical narrative: Patient had fever, elevated white blood cell count and inflammation at the site of vaccination.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Heart rate increased, Hypertension, Paraesthesia, Rash
Clinical narrative: 9/15/14 tingly feeling arms, body, headache. 9/16/14 rash, increased heart rate. 9/17/14 hypertension (high) - never issue previously.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) upper arm slightly swollen and bright red, no pain or itchy. Presented 9/17/14. PNEUMOVAX administered 9/15/14.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypotonia, Pallor
Clinical narrative: Approx within 1-2 min of receiving vaccines he became very pale and decreased muscle tone. No apnea no cyanosis - VS nl. Observed to recover w/in approx 5 minutes.
Age: 14.0
Sex: F
Vaccine: HPV2
Symptoms: Dizziness, Erythema, Headache, Local swelling, Pain in extremity
Clinical narrative: Pt received vaccine 9-16-14. We received a call (9/17/14) from pts mother stating the pt's right arm was swollen, red and painful. Mother stated pt had a fever and a headache on 9/17/14. Patient also felt dizzy.
Age: 14.0
Sex: F
Vaccine: HPV2
Symptoms: Pyrexia
Clinical narrative: Pt received vaccine 9-16-14. We received a call (9/17/14) from pts mother stating the pt's right arm was swollen, red and painful. Mother stated pt had a fever and a headache on 9/17/14. Patient also felt dizzy.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Vaccination site reaction
Clinical narrative: Pt presented with red rash on upper arm, where vaccination adminsitered day before (2" x 5"). Pt was advised to seek MD help if any symptoms of SOB, increased rash, increased T or other S/E.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Deep vein thrombosis
Clinical narrative: 2 days after receiving FLUZONE High Dose and ZOSTAVAX immunizations patient had DVT in (L) upper leg.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Patient came to pharmacy one day after vaccine administration showing right arm with inflammation and red. It was counseled to visit her doctor.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large, painful lump at injection site size of an orange, raised, warm, very painful, small red area also located above large area.
Age: 1.83
Sex: F
Vaccine: MMRV, PNC13
Symptoms: Injection site rash
Clinical narrative: Small rash around administered vaccine.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Pt showed vasovagal syncope episode. I had her lay down on the floor with fully covered blanket and provided water little by little when she was able to upright position. She was alert all the time and didn't hit any place since I was catching her when laying her down.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an 11 year old female patient. Concomitant conditions and other relevant medical history were not reported. The physician informed that the patient was vaccinated on an unspecified date in approximately 2011 (also reported as "when she was 9 years old") with the first dose of GARDASIL (intramuscular injection, dose 1, 1 DF, route, lot #, anatomical location not reported). Then the patient presented herself in office, on 08-SEP-2014, and received the second dose of GARDASIL (Intramuscular injection, dose 2, 1 DF, route, lot #, anatomical location not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a expired dose of PNEUMOVAX 23 (route, lot number# and expiration date unspecified). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative, referred to a currently 65 year old female patient. On an unknown date, the patient was vaccinated with one injection of PNEUMOVAX 23 (lot # K004930 with expiry date: 16-MAR-2015; dose and route of administration unspecified) for prevention of pneumonia. On an unknown date, after receiving the PNEUMOVAX 23, the patient developed severe injection site reactions including redness and hardness at the injection site. The patient sought medical attention via calling the office. The outcome of the events was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. This is one of several reports received from the same source. Additional information is not expected as the reporter did not grant permission to be contacted.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old female patient. On 23-JUN-2014 the patient was vaccinated with the first dose of ROTATEQ (lot#, expiration date, dose were unknown) oral. On 25-AUG-2014, the patient was vaccinated with the second dose of ROTATEQ (lot#J003813, expiration date: 10-AUG-2014, dose was unknown) oral. No adverse effects were reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative, referred to a currently 69 year old female patient. On an unknown date, the patient was vaccinated with one injection of PNEUMOVAX 23 (lot # K004930 with expiry date: 16-MAR-2015; dose and route of administration unspecified). On an unknown date, after receiving PNEUMOVAX 23, the patient called into he office and stated that she developed severe injection site reactions including redness and hardness at the injection site. The patient sought medical attention via calling the office. The outcome of the events was unknown. The relatedness between the event and PNEUNOVAX 23 was not reported. This is one of several reports received from the same source. Additional information is not expected as the reporter did not grant permission to be contacted.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a male patient of unknown age. In July 2013 the patient was vaccinated with a single dose of ZOSTAVAX (lot#, strength, dosage and route unknown). In January 2014, 6 months later, he was diagnosed with shingles. The patient had sought medical attention. The outcome of the event was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient with none pertinent medical history and none drug allergies. On 27-AUG-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml/ once, subcutaneous, (lot#, expiration date not reported) (reported as "she requested it and her doctor wrote a prescription"). The patient called in to the pharmacy "today" (29-AUG-2014), stating she developed redness at the injection site that "looks like a big mosquito bite". No treatment was given for the event. None lab diagnostics studies were performed. The outcome of the event was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a healthcare student concerning a 20 year old female patient with no pertinent medical history or drug reaction/allergies. On 04-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose number not reported) lot #K000996, expiration date 13-MAR-2015, 0.65ml in the left upper arm. Other suspect therapies included PNEUMOVAX23 on left upper arm and FLUVIRIN on right upper arm. Patient sought medical attention at the pharmacy on 10-SEP-2014 for an injection site reaction at the site of ZOSTAVAX administration. A description of the injection site reaction was unspecified. At the time of the report the outcome was reported as not recovered. Patient did not received treatment or performed any lab diagnostics studies for the adverse event. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with an expired vial PNEUMOVAX 23, route and lot number not provided. No adverse reactions were reported. There was a product quality issue involved. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Redness, heat, swelling, soreness.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Large rash, as big as a baseball. Fever in it, and itching.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Nodule, Pruritus, Skin warm
Clinical narrative: Redness, swelling, itching, hot to the touch, hard knot subQ. Ibuprofen.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Redness, swelling, itching, hot to the touch, hard knot subQ. Ibuprofen.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling, soreness, red, warm to touch.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Pain, Pruritus
Clinical narrative: Inflammation, soreness, redness, itched.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, heat, redness, pain and itching at injection site. Fatigue.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Redness, heat, swelling, soreness.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling, redness (1/2 dollar size), itching.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling, redness, hot to the touch. Soreness. Hydrocortisone cream.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Paraesthesia, Pruritus, Skin warm
Clinical narrative: After vaccination, area where vaccinated started to slightly tingle. Later, I experienced swelling, redness, itchiness. Area was also warm to the touch and sore. Today, area is slightly sore and still itches occasionally.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: After vaccination, area where vaccinated started to slightly tingle. Later, I experienced swelling, redness, itchiness. Area was also warm to the touch and sore. Today, area is slightly sore and still itches occasionally.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling, itching. Ibuprofen.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Induration, Local reaction, Pruritus, Tenderness
Clinical narrative: Case number PHHY2014US098896, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 531969) web site on 08 Aug 2014, with the follow-up information received from Quality Assurance Department (reference number: 318406) on 10 Sep 2014. This report refers to a 10 year old female patient. Her medical history was not reported. Concomitant medications included BENADRYL, Cephalexin and TYLENOL. She was vaccinated with MENVEO (batch number: M13046 and expiry date: May 2015), intramuscularly into left arm on 20 May 2014. On the same day she received GARDASIL (batch number: J012435, other manufacturer), intramuscularly into right arm and BOOSTRIX (batch number: N435Z, other manufacturer), intramuscularly into left arm. On 22 May 2014, she developed local reaction described as induration and surrounding erythema, pruritus and tenderness. She was treated with antihistamine, cold packs, per oral antibiotics to cover possible cellulitis of left arm. The final outcome of the events was recovered. Causality of the events was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Based on the investigation performed, the QA department stated that, MENVEO (batch number: M13046) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 318406) on 12 Aug 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 318406) on 10 Sep 2014: Updated MENVEO expiry date and batch review report.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Convulsion, Dizziness, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Case number PHHY2014US112572 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 534781) website on 03 Sep 2014, with the follow-up information received from the Quality Assurance Department (reference number: 324360) on 11 Sep 2014. This report refers to an 18 years old male patient. His medical history included amoxicillin allergy. He did not have any history of seizures. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M13064) and HAVRIX (other manufacturer, batch number: 4A53K); both vaccines administered in the right arm on 17 Jun 2014. He also received GARDASIL (other manufacturer, batch number: J015378) in the left arm on 17 Jun 2014. On 17 Jun 2014, he stated that he felt dizzy and he turned pale and lost consciousness. He began to convulse for 3 seconds and he lay back on to the bed and began snoring. He became conscious for about 20 seconds later. He sweated profusely and stated that he was extremely sleepy. The final outcome was reported as complete recovery. The event was reported non-serious, but was internally upgraded by the agency. The causality of the event was not reported. Follow-up information received from the Quality Assurance Department (reference number: 324360) on 11 Sep 2014: Updated correct MENVEO batch number and QA reference number.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Snoring, Somnolence
Clinical narrative: Case number PHHY2014US112572 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 534781) website on 03 Sep 2014, with the follow-up information received from the Quality Assurance Department (reference number: 324360) on 11 Sep 2014. This report refers to an 18 years old male patient. His medical history included amoxicillin allergy. He did not have any history of seizures. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M13064) and HAVRIX (other manufacturer, batch number: 4A53K); both vaccines administered in the right arm on 17 Jun 2014. He also received GARDASIL (other manufacturer, batch number: J015378) in the left arm on 17 Jun 2014. On 17 Jun 2014, he stated that he felt dizzy and he turned pale and lost consciousness. He began to convulse for 3 seconds and he lay back on to the bed and began snoring. He became conscious for about 20 seconds later. He sweated profusely and stated that he was extremely sleepy. The final outcome was reported as complete recovery. The event was reported non-serious, but was internally upgraded by the agency. The causality of the event was not reported. Follow-up information received from the Quality Assurance Department (reference number: 324360) on 11 Sep 2014: Updated correct MENVEO batch number and QA reference number.
Age: 19.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a male patient of unknown age. On 12-AUG-2014 the patient was vaccinated with a dose of GARDASIL (lot#, route unspecified, dose/frequency reported as directed in the prescribing information). Concomitant medications were unspecified. On 12-AUG-2014 the patient fainted after receiving GARDASIL. No treatment was given for the adverse event. The patient had sought medical attention by office visit on an unspecified date. Outcome of the event was not reported. Follow up information has been received from a nurse refers to a 19 year old male patient with tonsil stone and allergy to amoxicillin (hives), not ill at the time of vaccination. On 12-AUG-2014 11:15 am the patient was vaccinated with the first dose of GARDASIL lot#K008335, expiration date: 23-JUN-2016, intramuscular in the right arm (dose was not reported). The nurse reported that on 12-AUG-2014 at 11:20 am several minutes after received GARDASIL injection the patient stood up, became pale and lost consciousness for approximately 20 seconds, he hit the head on wall as he was eased to the floor. No apparent injury. Upon regaining consciousness was assisted to exam table and allowed to rest, the food and drink were given as the patient had not eaten that morning. Blood pressure was 110/80 (units not provided). The patient recovered on 12-AUG-2014 and was driven to his home by parent. Upon internal review loss of consciousness was determined to be medically significant. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 19.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Head injury, Loss of consciousness, Pallor, Syncope
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a male patient of unknown age. On 12-AUG-2014 the patient was vaccinated with a dose of GARDASIL (lot#, route unspecified, dose/frequency reported as directed in the prescribing information). Concomitant medications were unspecified. On 12-AUG-2014 the patient fainted after receiving GARDASIL. No treatment was given for the adverse event. The patient had sought medical attention by office visit on an unspecified date. Outcome of the event was not reported. Follow up information has been received from a nurse refers to a 19 year old male patient with tonsil stone and allergy to amoxicillin (hives), not ill at the time of vaccination. On 12-AUG-2014 11:15 am the patient was vaccinated with the first dose of GARDASIL lot#K008335, expiration date: 23-JUN-2016, intramuscular in the right arm (dose was not reported). The nurse reported that on 12-AUG-2014 at 11:20 am several minutes after received GARDASIL injection the patient stood up, became pale and lost consciousness for approximately 20 seconds, he hit the head on wall as he was eased to the floor. No apparent injury. Upon regaining consciousness was assisted to exam table and allowed to rest, the food and drink were given as the patient had not eaten that morning. Blood pressure was 110/80 (units not provided). The patient recovered on 12-AUG-2014 and was driven to his home by parent. Upon internal review loss of consciousness was determined to be medically significant. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 49.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, White blood cell count normal
Clinical narrative: This spontaneous report as received from a 49 year old female patient refers to herself. The patient's medical history included lupus and drug reaction/allergies penicillin. On 26-AUG-2014 the patient was vaccinated with ZOSTAVAX in the right arm, route of administration and dose were not provided. Reporter explained that her rheumatologist (unspecified) felt she should receive the vaccine due to having lupus. Concomitant therapies included PLAQUENIL, EVISTA tramadol hydrochloride and pravastatin. Blood work was performed, but result was not reported. On 27-AUG-2014, the patient developed injection site reaction after ZOSTAVAX. Reporter stated that the following day (on 27-AUG-2014) the injection site became hard, bumpy and the size of quarter. Caller stated she visited a local Urgent Care facility on 29-AUG-2014, which at that time the reaction developed into red, hot streaking which spread down to her elbow and that her lymph nodes were swollen, as well. Patient sought medical attention and received ROCEPHIN (injection, one dose in office) as a treatment for adverse events. The outcome of events was reported as recovering. Relatedness between events and vaccination was not reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Injection site erythema, Injection site induration, Injection site reaction, Injection site streaking
Clinical narrative: This spontaneous report as received from a 49 year old female patient refers to herself. The patient's medical history included lupus and drug reaction/allergies penicillin. On 26-AUG-2014 the patient was vaccinated with ZOSTAVAX in the right arm, route of administration and dose were not provided. Reporter explained that her rheumatologist (unspecified) felt she should receive the vaccine due to having lupus. Concomitant therapies included PLAQUENIL, EVISTA tramadol hydrochloride and pravastatin. Blood work was performed, but result was not reported. On 27-AUG-2014, the patient developed injection site reaction after ZOSTAVAX. Reporter stated that the following day (on 27-AUG-2014) the injection site became hard, bumpy and the size of quarter. Caller stated she visited a local Urgent Care facility on 29-AUG-2014, which at that time the reaction developed into red, hot streaking which spread down to her elbow and that her lymph nodes were swollen, as well. Patient sought medical attention and received ROCEPHIN (injection, one dose in office) as a treatment for adverse events. The outcome of events was reported as recovering. Relatedness between events and vaccination was not reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a 49 year old female patient refers to herself. The patient's medical history included lupus and drug reaction/allergies penicillin. On 26-AUG-2014 the patient was vaccinated with ZOSTAVAX in the right arm, route of administration and dose were not provided. Reporter explained that her rheumatologist (unspecified) felt she should receive the vaccine due to having lupus. Concomitant therapies included PLAQUENIL, EVISTA tramadol hydrochloride and pravastatin. Blood work was performed, but result was not reported. On 27-AUG-2014, the patient developed injection site reaction after ZOSTAVAX. Reporter stated that the following day (on 27-AUG-2014) the injection site became hard, bumpy and the size of quarter. Caller stated she visited a local Urgent Care facility on 29-AUG-2014, which at that time the reaction developed into red, hot streaking which spread down to her elbow and that her lymph nodes were swollen, as well. Patient sought medical attention and received ROCEPHIN (injection, one dose in office) as a treatment for adverse events. The outcome of events was reported as recovering. Relatedness between events and vaccination was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS, FLU3, VARZOS
Symptoms: Blood test normal, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given shot on 8/14. She reports redness and swelling on 8/15. Blisters were observed on 8/16. Patient went to the hospital on 8/17. Diagnosed with cellulitis and given antibiotics.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS, FLU3, VARZOS
Symptoms: Local swelling, VIIth nerve paralysis
Clinical narrative: Patient was given shot on 8/14. She reports redness and swelling on 8/15. Blisters were observed on 8/16. Patient went to the hospital on 8/17. Diagnosed with cellulitis and given antibiotics.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS, FLU3, VARZOS
Symptoms: Blood test normal, Drug administered at inappropriate site, Feeling hot, Headache, Injection site erythema
Clinical narrative: Patient was given shot on 8/14. She reports redness and swelling on 8/15. Blisters were observed on 8/16. Patient went to the hospital on 8/17. Diagnosed with cellulitis and given antibiotics.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS, FLU3, VARZOS
Symptoms: Injection site swelling, VIIth nerve paralysis
Clinical narrative: Patient was given shot on 8/14. She reports redness and swelling on 8/15. Blisters were observed on 8/16. Patient went to the hospital on 8/17. Diagnosed with cellulitis and given antibiotics.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS, FLU3, VARZOS
Symptoms: Blister, Cellulitis, Erythema, Swelling
Clinical narrative: Patient was given shot on 8/14. She reports redness and swelling on 8/15. Blisters were observed on 8/16. Patient went to the hospital on 8/17. Diagnosed with cellulitis and given antibiotics.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Eye haemorrhage, Rash macular
Clinical narrative: This spontaneous report was received from approximately a 71 year old male patient, regarding himself. The patient had no pertinent medical history, drug reactions and allergies. On 29-JUL-2014 the patient was vaccinated with ZOSTAVAX (dose, lot # and other details unspecified). No concomitant therapy was reported. On 30-JUL-2014, the patient experienced big-red blotches on his legs, popped eye vessels and bleeding from his eyes after receiving ZOSTAVAX. The consumer also stated that he was seen and released, the same day (30-JUL-2014), from an unspecified emergency room, on an unspecified date. The consumer stated that, he received treatment for events with antibiotic (unspecified name, dose/frequency and manufacturer), allergy medication (unspecified name, dose/frequency and manufacturer) and steroids (unspecified name, dose/frequency and manufacturer). No product quality complaint was filed. The action taken was assessed as not applicable. The outcome of events was reported as recovered on 13-AUG-2014. The causality was unspecified in the report. Follow-up information was received on 15-SEP-2014 from consumer. The patient's concomitant medications included, acetaminophen (manufacturer unknown) 325 mg tablet, 2 tablets every 6 hours orally for pain-mild 1-3, aspirin 81 mg daily, KEFLEX 500 mg capsule, 1 capsule every 12 hours for 10 days, metoprolol tartrate (manufacturer unknown) 1 tablet every 12 hours, prednisone (manufacturer unknown) 20 mg, 2 tablets daily for 2 days then 1 tablet daily total 5 days and simvastatin (manufacturer unknown) 20 mg, 1 tablet orally at bedtime. On an unknown date in 2014, the patient experienced swelling of hand and infection of skin. The patient was asked to contact primary care physician in order to re-evaluate the condition and overall health of the patient. Approximately on an unknown date in 2014, the patient was laid up for three weeks (disability) because of this bad batch. The outcome of laid up for three weeks, hand swelling and skin infection was unknown. The causality was unknown. Additional information has been requested.