chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.12
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: Increasing redness, warmth, tenderness to area no fever. Upper (rt) thigh with 3 cm circular erythematous lesion. Tx Cellulitis - BACTRIM susp 1 tsp po BID x 7 days.
Age: 1.12
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Skin warm, Tenderness
Clinical narrative: Increasing redness, warmth, tenderness to area no fever. Upper (rt) thigh with 3 cm circular erythematous lesion. Tx Cellulitis - BACTRIM susp 1 tsp po BID x 7 days.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pt. developed erythema, st swelling and pain at injection site on day following injection. Noted pain with movement of (L) arm.
Age: 0.76
Sex: M
Vaccine: HIBV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever 1 day after vaccine, to 104 degrees F resulting in febrile seizure. Treated & released from ER.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Crying, Dizziness, Erythema, Fall, Laceration
Clinical narrative: 13 yo male healthy moved 1 week prior. Seen at the clinic for vaccinations. Patient received Tdap, HAV, HPV#1. MCV vaccines. Within a few minutes after receiving vaccines. Patient was standing up in room. Patient per sister patient complained of feeling dizzy (said in a different language). Then fell forward and landed in prone position on floor. No loss of consciousness was turned over & noted to have about 1 cm chin laceration. Crying EMS was called and pt taken to ER for further evaluation. Pt was awake, alert, crying but able to follow commands. PARRL chest CTA, RRR with BP 120/80 was noted to have erythema on (L) side of chest and (L) arm much improved without intervention. No urticaria.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 3 patients of unknown age and gender. On an unknown date, the patient were vaccinated with a 0.65 ml dose of ZOSTAVAX, (route not reported) lot # (670754/0621AA). The pharmacist reported that on an unknown date all 3 patients experienced more of a localized reaction with the injection site. At the time of the report the patients status was unknown. Lot check requested. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 25-JUN-2012 was inadvertently vaccinated with a dose of VARIVAX (Merck) (Lot #, dose and route not reported) instead of ZOSTAVAX (Merck). No symptoms reported. It was not known if the patient sought medical attention. Follow-up information has been received from a pharmacist stated that she was told by the assistant that the patient came in to the office stating the physician told her she needed the "chicken pox vaccine" so the patient was vaccinated with (Merck) VARIVAX. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination/therapy, dose number. lot number, date of event, and recovery status. Additional information is not expected.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Scab, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 21 month old male who on 20-SEP-2011 was vaccinated with a dose of VARIVAX (Merck) (Lot# 670102/0605AA), (0.5mL, Subcutaneously). In around June 2012, the patient experienced chicken-pox and the physician believes the child got chicken-pox from his grandmother, who received ZOSTAVAX (Merck) (Lot#, dose and route not reported). The patient sought medical attention by an unspecified way. The adverse event was improving. At the time of reporting, the patient was recovering. Follow up information has been received from the physician concerning the 22 month (previous reported as 21 month) old male patient with no pre-existing allergies, birth defects, medical conditions and no illness at time of vaccination who on 20-SEP-2011 at 11:12 was vaccinated with the first dose of VARIVAX (Merck) (Lot# 670102/0605AA), IM (previously reported as subcutaneously) into the right thigh. The physician stated that patient experienced rash for 15 days and itchy started on shoulder and spread scabbed over. No relevant diagnostic tests were performed. At the time of the report, the patient had recovered from rash and itchy. Outcome of chicken pox was unknown. The physician also stated that the patient's grandmother had shingles (MARRS case #1207USA005119). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient who on 16-APR-2012 was vaccinated with a dose of RECOMBIVAX HB (lot# 665622/1023Y, expire date 18-JUN-2012) that was stored at colder than recommended temperature. No adverse symptoms noted. It was unknown if the patient had sought medical attention. This is one of three reports received from the same source. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pseudofolliculitis barbae, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 72 years old female patient with hypertension, arthritis and high cholesterol. The patient has no drug reactions or allergies. The patient was vaccinated was 0.65 ml ZOSTAVAX (lot number 672478/1603AA, expire date 13-JAN-2012) subcutaneously on 27-JUN-2012. No other co-suspects were reported. Concomitant medications included MOBIC, CRESTOR, potassium chloride - USP, furosemide, lisinopril, generic bisoprolol fumarate, ZIAC and tramadol hydrochloride. On unknown date the patient who received ZOSTAVAX had developed a rash on both legs. The patient described as a "shaving" type of rash. The patient was starting to develop a rash on both arms as well at the time of report. No treatment was given for adverse event and no laboratory diagnostics studies were performed. The patient was not recovered by the time of report. The patient had visited the pharmacy for medical attention. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a male patient who on 07-JUL-2008 was vaccinated with his first dose of VARIVAX (Merck) (lot # not reported). On 16-AUG-2011, the patient was vaccinated with his second dose of VARIVAX (Merck) (lot # not reported). On 22-MAY-2012 the patient was diagnosed with breakthrough varicella with less than 50 lesions. The patient had sought medical attention by visiting the physician's office. At the time of this report, the patient was recovering from the event. Follow up information has been received from an other health professional who concerning a 4 year old male patient with siblings of 2 who on 16-AUG-2011 (at 09:45 am) was vaccinated SC on right arm with the second dose of VARIVAX (Merck) (lot # 670180/0435AA). Other suspect therapy included MMR II, which was vaccinated SC on left arm with the second dose on 16-AUG-2011 (at 09:45 am). Concomitant therapy included KINRIX which was vaccinated IM on left arm with the first dose; and influenza virus vaccine (unspecified) which was vaccinated intranasally with the first dose. The concomitant therapies were vaccinated on 16-AUG-2011 (at 09:45 am). The reporter stated that the patient had breakthrough varicella with less than 50 minutes. There was no illness at time of vaccination. The patient required doctor visit. The patient was recovered from the event on an unspecified date. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Product packaging issue, Product quality issue
Clinical narrative: This spontaneous report as received from a Medical Assistant. Medical Assistant mentioned an unknown number of patients have received ROTATEQ (route, dose, lot# and expired date were not reported) from the office's private stock and VFC stock that were contained in the foil wrap in which the glue is disintegrating and detaching of the foil wrap. PQC filed. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Hypoaesthesia, Intervertebral disc protrusion, Nuclear magnetic resonance imaging abnormal, Paraesthesia
Clinical narrative: Initial report was received from a health care professional, who was also the patient, on 16 July 2012. A 34-year-old female patient had received an injection of MENACTRA (lot number, route and site not reported) in January of 2012. On 10 July 2012, the patient developed back pain, ascending paresthesias and numbness in both legs, saddle area, right hand and arm. The patient was seen in the emergency room (ER) and had an MRI on 10 July 2012 that revealed herniation of S1 without nerve involvement. The patient was started on MEDROL dose pack that was discontinued after two days. The patient was seen again in the ER on 16 July 2012 with no change to symptoms and was to see a neurologist. Past medical history and concomitant medications were unknown. The patient's outcome was not recovered. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Patient presents with (L) arm swelling, redness & some itching on 7/25/12 - that developed after getting Tdap on 7-20-12. Patient tried ice & BENADRYL with no relief. Patient was advised to ice twice a day, TYLENOL as needed and given a prescription of prednisone 20 mg x 5 days.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site urticaria
Clinical narrative: Red/white welt on side of both legs where vaccines were administered.
Age: 1.06
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Conjunctivitis, Rash vesicular
Clinical narrative: Vesicular lesions, on buttock, one lesion with conjunctivitis. Possible onset 7/18/2012 treated with mupirocin ointment outcome about 10 vesicular lesion at varying stage of healing.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Patient received ADACEL 7-18-12. States the next day it started swelling - the pain & swelling was described and gradual and persistent. When seen the (L) deltoid was red, warm to the touch with a hard knot.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient received ADACEL 7-18-12. States the next day it started swelling - the pain & swelling was described and gradual and persistent. When seen the (L) deltoid was red, warm to the touch with a hard knot.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dyspnoea, Electrocardiogram normal, Erythema, Feeling hot, Nausea
Clinical narrative: Both arms swelling and red - feels hot, nausea, difficulty breathing, red macula rash 3cm (R) arm 4cm (L) arm. Gave DECADRON 8 mg IM BENADRYL/25 mg IM BENADRYL 25 mg 1-2 caps Q4-6 degrees Kenalol cream 0.1% 2-3 times PRN return 7/21/12 or to ER if worse, also done EKG, pt in no distress.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Oedema peripheral, Rash macular
Clinical narrative: Both arms swelling and red - feels hot, nausea, difficulty breathing, red macula rash 3cm (R) arm 4cm (L) arm. Gave DECADRON 8 mg IM BENADRYL/25 mg IM BENADRYL 25 mg 1-2 caps Q4-6 degrees Kenalol cream 0.1% 2-3 times PRN return 7/21/12 or to ER if worse, also done EKG, pt in no distress.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Dysphagia, Ear discomfort, Head discomfort, Injection site pain, Swelling face
Clinical narrative: Vaccine was administer at 1600 with mild c/o of pain at site at 1615 mom called us stating that pt c/o "Head & ears feeling funny" since mom was driving she was around the corner from home. I called her back at 1617 to check how pt was doing. Pt state "my throat feels funny" per dr mom was to take pr to ED. By the time pt was ED there were facial swelling & difficulty swallowing.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Throat irritation
Clinical narrative: Vaccine was administer at 1600 with mild c/o of pain at site at 1615 mom called us stating that pt c/o "Head & ears feeling funny" since mom was driving she was around the corner from home. I called her back at 1617 to check how pt was doing. Pt state "my throat feels funny" per dr mom was to take pr to ED. By the time pt was ED there were facial swelling & difficulty swallowing.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, PNC13, VARCEL
Symptoms: Gastroenteritis viral, Pyrexia, Vomiting
Clinical narrative: (Per mom) Fever started between 7-8 pm on 7/11/12 and lasted 3 days. Got as high as 103 degrees. Was given TYLENOL and Ibuprofen !4-6 hrs. Started vomiting at 11pm that same evening. Vomited 6-7 times. Vomiting ended at noon on 7/12/12. Mom called doctor's office and was told patient probably had the stomach flu.
Age: 50.0
Sex: F
Vaccine: IPV, MNQ, TDAP, YF
Symptoms: Rash generalised
Clinical narrative: Generalized non-pruritic skin eruption. 7/25/12 - > pt reports rash has resolved.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Wrong drug administered
Clinical narrative: Hep B vaccine ordered = Hep A vaccine given.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling on left leg on vaccine site.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: Pt. describes discomfort across the shoulders at base of neck that radiates down both arms.  Describes pain down the arms as equal in intensity.  Pt. took an aspirin and stated the pain improved.  Encouraged pt. to seek medical attention if the pain returned was more intense than previous.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: C3-C6 Varicella-type rash.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Frequent bowel movements, Muscle spasms
Clinical narrative: Abdominal pain in the upper middle section near stomach, cramping, many bowel movements, some diarrhea, pain still exists today, 07/25/2012 along with diarrhea.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus generalised, Rash, Rash erythematous
Clinical narrative: First noticed at 09:00 AM legs and feet had rash that resembles razor burn.  Red spots are not raised.  Rest of body has a stinging itch. On 07/24/2012 primary doctor gave me a steroid shot & Benadryl.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Cough, Headache, Hyperhidrosis, Migraine
Clinical narrative: Beginning around 12 noon 7/24/12 after Tdap vaccine administered began with headache, body aches and nausea with slight fever. Began taking Tylenol every 4 hours. Symptoms intensified over the course of the evening to include "severe" headache, dry cough, scratchy throat, fever 101.2, increased nausea, with no vomiting, body aches, chills and sweats. At 4:00 AM awoke to feel as if she had a migraine headache. Felt as if running a higher fever than earlier. (did not take temperature with thermometer), hard chills and sweating. Some relief with Tylenol. Was able to go to work today, but still has headache, feels feverish, non- productive cough, nauseous and scratchy throat. Continuing to take Tylenol every 4 hours.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pyrexia, Throat irritation
Clinical narrative: Beginning around 12 noon 7/24/12 after Tdap vaccine administered began with headache, body aches and nausea with slight fever. Began taking Tylenol every 4 hours. Symptoms intensified over the course of the evening to include "severe" headache, dry cough, scratchy throat, fever 101.2, increased nausea, with no vomiting, body aches, chills and sweats. At 4:00 AM awoke to feel as if she had a migraine headache. Felt as if running a higher fever than earlier. (did not take temperature with thermometer), hard chills and sweating. Some relief with Tylenol. Was able to go to work today, but still has headache, feels feverish, non- productive cough, nauseous and scratchy throat. Continuing to take Tylenol every 4 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash
Clinical narrative: Rash on left arm and abdomen (not site of vaccination). Four days later, rash on right arm, hip, and right inner thigh. Slight headache.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Night sweats, Pyrexia
Clinical narrative: Recurrent weekly fevers; Night sweats; Muscle aches.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Expired drug administered
Clinical narrative: Client was administered vaccine that was expired by two and a half months. Client was re-immunized as advised by medical director to make sure valid dose was administered.
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, RV5
Symptoms: Wrong drug administered
Clinical narrative: Pt was given vaccine Hep A in error. PCV13 was the vaccine ordered Pt still will need to receive PCV13 and Hep A at the required scheduled time. Dr and Pt parents were notified.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.06
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Pruritus, Rash erythematous
Clinical narrative: Pt woke with temp max of 100.9r and rash on trunk and back and neck red and raised. Pt treated in office and to be treated every 6 hours at home with Benadryl for itching.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Crying, Rash erythematous
Clinical narrative: Mother called health center stating eating lunch and child developed red rash over legs, arm and neck and crying.  States had a reaction to vaccine last time received and had to go to ER.  Forgot to report this during today's visit.  Advised to see ER or PCP asap.  Mom called back and stated child saw PCP and was given prednisone and epinephrine.  States this event was worse than last one.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Swelling, Red, Hot.
Age: 1.55
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Rash, Varicella virus test positive
Clinical narrative: Focal rash, Left leg by day 3 in definite L3 dermatomal distribution, ie shingles. No clinical history of prior case of varicella disease.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Hypersensitivity, Lip swelling
Clinical narrative: Pt. returned to clinic with swollen right side of lip. NO respiratory distress. Sent to urgent care for higher level of care.
Age: 30.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Oropharyngeal pain, Pyrexia, Rash morbilliform, Rhinorrhoea
Clinical narrative: Extensive Measles-like rash 20 days after MMR and Tdap vaccine with prodromal symptoms of runny nose, fever, sore throat. Reported from patient's health care provider in doctor's office.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Joint swelling, Oedema peripheral
Clinical narrative: Swelling and redness to Left arm and right knee. Treatment: Benadryl and Ibuprofen were prescribed. Patient to return to clinic in 2 days if not better.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Influenza like illness, Injection site erythema, Injection site pruritus
Clinical narrative: Itching in throat, slight dizziness.  Next day, flu like symptoms--aches, fatigue, dizziness, large red itching whelp at injection site. Became more severe on the 25th.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Pain, Throat irritation
Clinical narrative: Itching in throat, slight dizziness.  Next day, flu like symptoms--aches, fatigue, dizziness, large red itching whelp at injection site. Became more severe on the 25th.
Age: 1.7
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Erythematous urticarial rash on the body and extremities.
Age: 22.0
Sex: F
Vaccine: DTAP
Symptoms: Activities of daily living impaired, Arthralgia, Dizziness, Fatigue, Immediate post-injection reaction
Clinical narrative: Became very dizzy, light-headed, and nauseous immediately after receiving the vaccine. Nurse was VERY sweet and helpful and had me lie down and slowly work up to standing up over a long period of time and sip some juice. The following day, I am experiencing achy joints, fatigue, a mild fever, and pain at the injection site. These symptoms are bothersome and are making normal activities difficult.
Age: 22.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: Became very dizzy, light-headed, and nauseous immediately after receiving the vaccine. Nurse was VERY sweet and helpful and had me lie down and slowly work up to standing up over a long period of time and sip some juice. The following day, I am experiencing achy joints, fatigue, a mild fever, and pain at the injection site. These symptoms are bothersome and are making normal activities difficult.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Local swelling
Clinical narrative: Localized swelling, redness and pain at site of injection, about 60 cm diameter.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Swelling, redness - Ice BENADRYL.
Age: 29.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Joint stiffness, Lymphadenopathy, Musculoskeletal stiffness, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, fever, stiff muscles and joints. Swollen glands and swelling of free on cheeks. She now has a rash on cheeks, arms, and back.
Age: 29.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Rash, Swelling
Clinical narrative: Sore throat, fever, stiff muscles and joints. Swollen glands and swelling of free on cheeks. She now has a rash on cheeks, arms, and back.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site reaction, Nodule, Skin warm
Clinical narrative: Pt received vaccine on Saturday (7/21) - Came into pharmacy whit large rxn site. Redness measure - 6 in x 2 in. Red area was warm to the touch & had large knot in the center. Called pt. PCP. Set up MD appt for today (7/25) at 2 pm. MD stated this was a normal rxn. Called Merck rep. who also greed this was not normal.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: Pt received vaccine on Saturday (7/21) - Came into pharmacy whit large rxn site. Redness measure - 6 in x 2 in. Red area was warm to the touch & had large knot in the center. Called pt. PCP. Set up MD appt for today (7/25) at 2 pm. MD stated this was a normal rxn. Called Merck rep. who also greed this was not normal.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site of injection, swollen and red, at times itches and minor pain.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Cardioversion, Electrocardiogram abnormal, Heart rate increased, No therapeutic response, Supraventricular tachycardia
Clinical narrative: Developed heart rate of 260 bpm; unresponsive to medication or cardioversion. Required placement on 2 long term cardiac medications.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersensitivity, Rash erythematous
Clinical narrative: Patient was vaccinated 7-16-12. She came back to Pharmacy on 7-18-12, complaining of rash & headache. Rash was red & raised approximately 1 1/4 inch circle. I immediately call manufacturer, Merck conferred with RPh. He recommended patient see her PCP. I advised her. She did see doctor who said she had allergic reaction.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 12 x 13 cm area around injection site of swelling, redness & warmth. Pt. was instructed to use BENADRYL & ice. Symptoms were resolved by 7/24/12.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site rash, Injection site swelling, Pain
Clinical narrative: Pt. had rash/swelling to (L) thigh and pain with ambulation. After 1 dose of BENADRYL symptoms started resolving.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm and headache. Tx: Drink water, apply heat or ice and take TYLENOL P.R.N.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Gaze palsy, Muscle twitching
Clinical narrative: Vaccine was given approximately 13:00 on 7/23/12. Mother of child states the patients right eye began to deviate to the right with twitching to the right eye brow at approx. 19:00 that evening, lasting for approximately 10 minutes.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered
Clinical narrative: Immunization documents not available before physical exam (7/23/12). Later that evening documents showed patient had received a previous dose of MENACTRA in 2009.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt. developed a rash over the trunk of her body.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 years old patient with no pertinent medical history and drug reactions or allergies. The patient was vaccinated with dose 1 of MMR II (Lot # 0134AE expiration date 10-OCT-2014) on 10-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on 10-JUL-2012, the patient had an injection site reaction described as a large white area (seemed to be fluid filled) formed immediately after the vaccination was given and then became a 2 by 2 inch area of redness, 1 day after onset of therapy. The injection site reaction was resolved within 30 minutes of vaccination. The patient was treated with arnica gel and ibuprofen. There were no Lab diagnosis or studies performed. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Fevering x 2 days with rash x 1 week that started on right thigh (RVL) where PCV-13 vaccines was administered. Mom notified us of event on 7/17/12, she monitored.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a 50 year old female patient who on 24-APR-2012 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # and route not reported). Concomitant therapy included FLONASE and JUNEL FE. The pharmacist reported that the patient got a rash in the injection site every time she went to the tanning bed. It was unknown if the patient sought medical attention. At the time of the report the patient was recovering from the event. Follow-up information has been received from a pharmacist concerning a patient with no illness at time of vaccination who on 24-APR-2012 at 15:30, was vaccinated with the first dose of ZOSTAVAX (Merck), left back arm (lot # 671144/1269AA, exp. 05-NOV-2012). The pharmacist reported that the patient stated rash around injection site was worsened and reappeared after tanning in tanning bed. The patient did not seek medical attention. The patient recovered on an unknown date. Additional information is not expected.
Age: 33.0
Sex: M
Vaccine: RAB
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: 4th Rabies vaccine administered at 1615. Pt. c/o ringing in (R) ear with 50% hearing loss after 7 minutes. Provider to room to examine. VSS with no significant change from baseline. Pt. denied any other symptoms.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: (L) thigh with induration & approximately 6 cm swelling & erythema at site. Resolved all erythema & swelling with BENADRYL 125 mg and TYLENOL 80 mg - Pt recovered.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Crohn's disease, Endoscopy gastrointestinal
Clinical narrative: Pt developed Crohn's Disease shortly after receiving HPV vaccine.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: 15 month 3 day old male presents with c/o Concerns and questions for 1 day redness right thigh at the area of injection site for DTaP; started today at 12 PM; area getting a little bigger since then, in the past 4 hours; also rash on the back since this afternoon. C/O rash for 1 day non-pruriginous on right thigh and back as above.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Incorrect route of drug administration, Injection site pain, Injection site swelling, Laboratory test
Clinical narrative: This spontaneous report as received from a registered nurse refers to her daughter a 32 years old patient with diabetes and unspecified narcotics allergy. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot number not provided) intravenous or intradermal on 17-JUL-2012. No other co-suspects were reported. Concomitant medications included unspecified insulin and LEXAPRO. On 17-JUL-2012 the patient developed pain and swelling which expanded 3 to 4 inches below injection site area within 1 to 2 hours after administration. The nurse believed that the PNEUMOVAX 23 injection may have been inadvertently administered by intravenous or intradermal route rather than by intramuscular route which may have contributed to the adverse events. The patient had sought medical attention via go to the emergency room and unspecified antibiotics was given for the adverse events. The patient performed hormone and blood tests with no results provided. The patient was recovering from the adverse events. Additional information is not expected.
Age: 33.0
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a physician refers to a 33 years old nurse student. The nurse student was vaccinated with two dose of MMR II on an unspecified date (Lot #, dose, route unknown). It was reported that at the time of reporting, on 20-JUL-2012, the patient has a low antibody titer to mumps. At the time of reporting, the outcome of low antibody titer to mumps was unknown. It was unspecified whether the patient sought medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning about 5 patients who on an unknown date were vaccinated with improperly stored GARDASIL (dose, route and lot number were not reported). The vaccines were exposed to 30 degrees F over the 16 day period. There were no adverse effects reported. Follow up information was received from the office. The reporter indicated that there is no additional information for these patients. None reported any adverse effects other than that was provided initially. Follow up information was received from administering healthcare professional. It was reported that a 11 year old female patient with no pre-existing allergies, birth defects or medical conditions and no illness at time of vaccination, on 20-DEC-2011 at 09:30 A.M., was vaccinated with the third dose of GARDASIL (lot number 671006/1291AA) I.M., left deltoid (dose not reported) at private doctor's office/hospital. It was also reported that on 11-FEB-2012 the patient was reimmunized with GARDASIL (lot number 672193/154AA, expiry date 25-AUG-2014), I.M., right deltoid (dose not reported). There was no reaction to reimmunization. The patient did not seek medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. No further information is available.
Age: 1.68
Sex: M
Vaccine: MMR
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M, Pyrexia, Swelling face
Clinical narrative: This spontaneous report as received from a physician refers to a 20 month old (now 3 years old) male patient. The patient was intramuscularly vaccinated with 0.5 ml of MMR II (lot number unspecified) on 13-APR-2010. No other co-suspects or concomitant medications were reported. A couple of years after vaccination "within the last couple of weeks" approximately in July 2012, the patient had fever and facial swelling. The doctor further stated that immunoglobulin G (IGG) and immunoglobulin M (IGM) were drawn and that IGG came back negative. The patient had sought unspecified medical attention. Unspecified treatment was given. The outcome was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Decreased appetite, Maternal exposure during pregnancy, Nausea, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse, for GARDASIL, a Pregnancy Registry product, refers to a 19 years old female patient with penicillin allergy. The patient was vaccinated with first, second and third dose of GARDASIL 0.5ml IM on 31-AUG-2007, 14-MAY-2010 and 17-JUL-2012. The third dose of vaccine's Lot number was 672233/1561AA. No other co-suspects were reported. No concomitant medications were reported. The patient became pregnant with an LMP on 25-MAY-2012 and an EDD of 01-MAR-13. The patient was exposed to GARDASIL during trimester 1. The patient has been having loss of appetite, stomach pain, nausea, and vomiting "for the past two weeks". The patient has been taking OTC antacid with no relief. The outcome of the events was reported as not recovered at time of the report. Urine pregnancy test was performed. The patient had sought medical attention via seeing the physician. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse, for GARDASIL, a Pregnancy Registry product, refers to a 19 years old female patient with penicillin allergy. The patient was vaccinated with first, second and third dose of GARDASIL 0.5ml IM on 31-AUG-2007, 14-MAY-2010 and 17-JUL-2012. The third dose of vaccine's Lot number was 672233/1561AA. No other co-suspects were reported. No concomitant medications were reported. The patient became pregnant with an LMP on 25-MAY-2012 and an EDD of 01-MAR-13. The patient was exposed to GARDASIL during trimester 1. The patient has been having loss of appetite, stomach pain, nausea, and vomiting "for the past two weeks". The patient has been taking OTC antacid with no relief. The outcome of the events was reported as not recovered at time of the report. Urine pregnancy test was performed. The patient had sought medical attention via seeing the physician. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Local reaction, Pain, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old male patient with diabetes. hypertension and hyperlipidaemia and with no drug reactions/allergies who on 01-MAY-2012, was vaccinated IM with 0.5 ml dose of PNEUMOVAX 23 (lot number 672962/0025AE, expiration date: 18-OCT-2012). On approximately 01-MAY-2012, 5 hours after vaccination, the patient developed a localized reaction after receiving PNEUMOVAX 23. It was also reported that the patient developed severe, almost paralyzing pain of his arm. The patient called the office. The patient was treated with TYLENOL and ice to be placed on the patient's arm. No lab diagnostic studies were performed. At the time of the report the patient was recovering. Follow-up information has been received from the medical assistant concerning a 65 year old male who on 01-MAY-2012, 14:30 was vaccinated with a dose of PNEUMOVAX 23, I.M. on right deltoid. On 01-MAY-2012, 17:30, the patient developed pain radiating from shoulder down arm and into hand. No numbness or tingling. Unable to left arm without severe pain. Patient recovered on 03-MAY-2012. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring to an unknown gender patient of unknown age who was vaccinated with a 1 ml (Merck) VARIVAX (Route and lot # not reported) on 18-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse stated that on 18-JUL-2012, the patient received a double dose of (Merck) VARIVAX, no medication confusion discovered. The nurse also reported that a medical assistant reconstituted two vials of (Merck) VARIVAX. No adverse event reported. No treatment was reported. The outcome of patient received a double dose of (Merck) VARIVAX and no adverse event was unknown. Patient received a double dose of (Merck) VARIVAX was not related to (Merck) VARIVAX. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 years old patient with no pertinent medical history and drug reactions or allergies. The patient was vaccinated with dose 1 MMR II (Lot # not reported) on 18-MAR-20122 (no adverse events reported) and 2 of MMR II (Lot # 0134AE expiration date 10-OCT-2014) on 10-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on 10-JUL-2012, the patient had an injection site reaction described as a large white area (seemed to be fluid filled) formed immediately after the vaccination was given and then became a 2 by 2 inch area of redness, 1 day after onset of therapy. The injection site reaction was resolved within 30 minutes of vaccination. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Malaise, Oedema peripheral, Pain
Clinical narrative: Information has been received from a registered nurse (R.N.) reported that there had been several instances of local site reactions like warmth, hardness of skin and redness when patients had received injections of PNEUMOVAX 23 (lot # not reported). At the time of reporting, the outcome of the patients was unknown. It was unknown if patients sought medical attention. Follow-up information was received from a doctor of pharmacist who stated that the 65 year old female patient came in for redness and swelling in her right arm after receiving IM in a PNEUMOVAX 23 (lot # 1852AA,exp 05-AUG-2013) on 11-JUN-2012. She reported that within a few hours of taking the vaccine, she began to felt achy and unwell. The patient denied chills, fever or sweats. Area medial aspect of the right upper arm. The injection was given in the right deltoid. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Product reconstitution issue
Clinical narrative: This spontaneous report as received from a registered pharmacist who reported that expired diluents (lot# 0762Z, exp January 2012) may had been used to reconstitute some doses of (Merck) VARIVAX (lot# 669346/0030AA, exp 18-DEC-2012) and ZOSTAVAX (lot # 0421E is an invalid lot number for ZOSTAVAX. Some of doses may had been administered to patients. Specific number of patients were unknown. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV1
Symptoms: Autopsy, Eye haemorrhage, Foaming at mouth, Mouth haemorrhage, Respiratory arrest
Clinical narrative: Information regarding PREVNAR was received from a newspaper article regarding a 4-month-old male patient who experienced sudden infant death syndrome. The patient received a dose on 12Sep2007. The patient also received a dose of PEDIARIX (GlaxoSmithKline) and ROTARIX on 12Sep2007. The patient experienced sudden infant death syndrome on 15Sep2007. The mother reported that she woke up at 5:15 am on 15Sep2007 and noted that the baby was not making any noise. The baby was warm and his lips were still pink, but he was not moving. Blood was crusted beneath his eyes, and his clothes and toys were covered with a bloody froth. Emergency Rescue (911) was called, and the parents tried to resuscitate him. In the Emergency Room, the baby was pronounced dead. The autopsy failed to detect any specific vaccine reactions forcing a determination of sudden infant death syndrome. Cause of death was reported as sudden infant death syndrome. No additional information was available at the time of this report. Follow-up(16Jul2012): Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database in the current safety database for processing follow-up information. As consequence of this migration, the follow up CIOMS 1 or Medwatch report any indicate in the appropriate field that it is an initial report. A non-contactable female reported via an article that two days after the little 4 month "well baby" visit in Sep2007 where he received all the routine inoculations, he was found by his mother not breathing in his crib. Blood was crusted under his eyes and a dark bloody foam was coming out of his mouth. There was so much bloody foam coming out of his mouth that his clothes and teddy bear were soaked with it. An autopsy pronounced his death as SIDS, but his mother knew better. She knew it was the vaccines. She had worked for several years at a local health food store and had been exposed to the vaccine controversy by many customers hoping to convince her of the danger. It had never occurred to her, however, that vaccines could actually kill her child. In a true SIDS death, a child inexplicably stop breathing with no sort of trauma, but in this baby case, there was blood coming out of his eyes and mouth. Clearly, there was some sort of internal bleeding and damage that occurred prior to baby death. This death was much more than just SIDS, and such a backhanded autopsy report seems an insult to anyone with a shred of intelligence. Here's what baby received 2 days before his death at the pediatrician's office: A shot of PEDIARIX, a-5-in-1 shot, a shot of PREVNAR, and ROTATEQ, given orally which contains four viruses associated with infant diarrhea. In less than 15 minutes, baby had been injected with or taken orally 19 different pathogens.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV1
Symptoms: Resuscitation, Sudden infant death syndrome
Clinical narrative: Information regarding PREVNAR was received from a newspaper article regarding a 4-month-old male patient who experienced sudden infant death syndrome. The patient received a dose on 12Sep2007. The patient also received a dose of PEDIARIX (GlaxoSmithKline) and ROTARIX on 12Sep2007. The patient experienced sudden infant death syndrome on 15Sep2007. The mother reported that she woke up at 5:15 am on 15Sep2007 and noted that the baby was not making any noise. The baby was warm and his lips were still pink, but he was not moving. Blood was crusted beneath his eyes, and his clothes and toys were covered with a bloody froth. Emergency Rescue (911) was called, and the parents tried to resuscitate him. In the Emergency Room, the baby was pronounced dead. The autopsy failed to detect any specific vaccine reactions forcing a determination of sudden infant death syndrome. Cause of death was reported as sudden infant death syndrome. No additional information was available at the time of this report. Follow-up(16Jul2012): Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database in the current safety database for processing follow-up information. As consequence of this migration, the follow up CIOMS 1 or Medwatch report any indicate in the appropriate field that it is an initial report. A non-contactable female reported via an article that two days after the little 4 month "well baby" visit in Sep2007 where he received all the routine inoculations, he was found by his mother not breathing in his crib. Blood was crusted under his eyes and a dark bloody foam was coming out of his mouth. There was so much bloody foam coming out of his mouth that his clothes and teddy bear were soaked with it. An autopsy pronounced his death as SIDS, but his mother knew better. She knew it was the vaccines. She had worked for several years at a local health food store and had been exposed to the vaccine controversy by many customers hoping to convince her of the danger. It had never occurred to her, however, that vaccines could actually kill her child. In a true SIDS death, a child inexplicably stop breathing with no sort of trauma, but in this baby case, there was blood coming out of his eyes and mouth. Clearly, there was some sort of internal bleeding and damage that occurred prior to baby death. This death was much more than just SIDS, and such a backhanded autopsy report seems an insult to anyone with a shred of intelligence. Here's what baby received 2 days before his death at the pediatrician's office: A shot of PEDIARIX, a-5-in-1 shot, a shot of PREVNAR, and ROTATEQ, given orally which contains four viruses associated with infant diarrhea. In less than 15 minutes, baby had been injected with or taken orally 19 different pathogens.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Insomnia, Pain, Rash
Clinical narrative: This spontaneous report as received from a nurse refers to a 87 years old male patient. The patient was subcutaneously vaccinated with 0.65 ml ZOSTAVAX (lot # 669864/0359AA) on 19-OCT-2011. On 05-JUL-2012 the patient experienced shingles located on left flank side (disability) and "causing patient severe pain, uncomfortable rash and severe discomfort in which patient is unable to rest and sleep". The patient sought medical attention through contacting the physician. The patient got Acyclovir 800 mg four times a day for 7 days (manufacturer were unknown) to treat the AEs. The outcome of shingles located on left flank side, unable to rest or sleep and severe discomfort were reported as not recovered/not resolved. The relatedness for shingles located on left flank side, unable to rest or sleep, severe discomfort and uncomfortable rash were unknown for ZOSTAVAX, "lot check request" from the nurse. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Restlessness
Clinical narrative: This spontaneous report as received from a nurse refers to a 87 years old male patient. The patient was subcutaneously vaccinated with 0.65 ml ZOSTAVAX (lot # 669864/0359AA) on 19-OCT-2011. On 05-JUL-2012 the patient experienced shingles located on left flank side (disability) and "causing patient severe pain, uncomfortable rash and severe discomfort in which patient is unable to rest and sleep". The patient sought medical attention through contacting the physician. The patient got Acyclovir 800 mg four times a day for 7 days (manufacturer were unknown) to treat the AEs. The outcome of shingles located on left flank side, unable to rest or sleep and severe discomfort were reported as not recovered/not resolved. The relatedness for shingles located on left flank side, unable to rest or sleep, severe discomfort and uncomfortable rash were unknown for ZOSTAVAX, "lot check request" from the nurse. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain in the upper arm where vaccine was given, not necessarily on the injection site, whole upper arm up to shoulder area. Patient experienced pain one week after receiving the vaccine.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in the upper arm where vaccine was given, not necessarily on the injection site, whole upper arm up to shoulder area. Patient experienced pain one week after receiving the vaccine.