chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were unspecified. On an unknown date an unspecified number of patients were vaccinated with improperly stored LIQUID PEDVAXHIB, exposed to 33 F for 6 days (144 hours) (dose, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were reported. No concomitant therapies were reported. The outcome of the event was unknown. This is one of several reports received from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were unspecified. On an unknown date an unspecified number of patients were vaccinated with improperly stored M-M-R II, exposed to 33 F for 6 days (144 hours), (dose, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were reported. No concomitant therapies were reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were unspecified. On an unknown date an unspecified number of patients were vaccinated with improperly stored ROTATEQ, exposed to 33 F for 6 days (144 hours), (dose, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were reported. No concomitant therapies were reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were unspecified. On an unknown date an unspecified number of patients were vaccinated with improperly stored GARDASIL, exposed to 33 F for 6 days (144 hours), (dose, dose schedule, route, anatomical location, lot  number and expiration date were unspecified). No adverse effects were reported. No concomitant therapies were reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 2 month old patient of unspecified gender. On 04-SEP-2014, the patient was vaccinated with a pediatric dose of VAQTA, 0.5 ml, intramuscular (lot # and expiration date were not provided). On 04-SEP-2014, the 2 month old patient accidentally received pediatric VAQTA dose. No adverse effects were noted. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information is not expected.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 month old patient of unknown gender. No medical history or concurrent conditions were reported. On 04-SEP-2014, the patient was vaccinated with a fourth dose of ROTATEQ, oral (dose, strength and lot number not reported) after patient received a third dose of ROTATEQ on 25-AUG-2014. No adverse effects were reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Oedema mouth, Rash, Swelling face
Clinical narrative: Swelling of mouth and side of face 3 days after administration. Rash comes and goes. Significant swelling and redness at injection site. Pt went to clinic for symptoms.
Age: 27.0
Sex: M
Vaccine: HEPA, IPV, TDAP
Symptoms: Arthralgia, Back pain, Chills, Migraine, Pain
Clinical narrative: 24 hrs after immunizations pt developed migraine type headache (3-4 PM) then 6 P fever, chills, body aches. At 9 PM fever increased 101.8 F - took TYLENOL and went to sleep. Also had joint pain of knees, elbows and lower back pain. All resolved within 48 hrs. No residual effects.
Age: 27.0
Sex: M
Vaccine: HEPA, IPV, TDAP
Symptoms: Pyrexia
Clinical narrative: 24 hrs after immunizations pt developed migraine type headache (3-4 PM) then 6 P fever, chills, body aches. At 9 PM fever increased 101.8 F - took TYLENOL and went to sleep. Also had joint pain of knees, elbows and lower back pain. All resolved within 48 hrs. No residual effects.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pronounced redness, heat at site of injection.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: Patient received ADACEL vaccine on 8/2/14. She said she has had shoulder pain since she received the shot. She notified us on 8/25/14.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Vaccination error
Clinical narrative: Patient was given dose #3 of Hep A in error.
Age: 72.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chest discomfort, Dizziness, Hypoaesthesia oral
Clinical narrative: Administered FLUZONE HD and ADACEL. Patient waiting in lobby, complained of numbness around mouth, dizziness, and tightness in chest. No difficulty swallowing or breathing. No treatment administered. After about 20 minutes patient left pharmacy with husband.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased
Clinical narrative: Mother called and reported approximately 102 degree F. Reported 17 hours after immunization administration. No local reaction visible at site of inj. Taking NSAID and water.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with a single dose of PNEUMOVAX 23 (dose, lot# and route of administration were not reported) that was exposed to 23F for unknown period of time. It was unable to determine how long the vaccine was exposed to this low temperature since the facility did not clear the minimum-maximum thermometer daily. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with a single dose of RECOMBIVAX HB (dose, lot# and route of administration were not reported) that was exposed to 23F for unknown period of time. It was unable to determine how long the vaccine was exposed to this low temperature since the facility did not clear the minimum-maximum thermometer daily. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with a single dose vial of GARDASIL (dose, lot # and route of administration were not reported) that was exposed to 23F for unknown period of time. It was unable to determine how long the vaccine was exposed to this low temperature since the facility did not clear the minimum-maximum thermometer daily. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Cough, Nasopharyngitis, Pyrexia, Viral titre increased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient, pharmacist's nephew, of unknown age. None pertinent medical history, drug reactions or allergies were reported. On an unknown date (reported as as a baby) the patiens was vaccinated with M-M-R II (dose, dose schedule, route, anatomical location, lot number and expiration date were not reported). None concomitant therapies were reported. On an unknown date (reported as college age) the patient went on a trip, and, when he went back to his country, experienced cold with fever and a "lingering cough". The patient sought medical attention by office visit. The pharmacist stated that the patient was treated by his physician with amoxicillin (unspecified). The reporter also stated that the patient had MMR titers drawn for entrance into a college program, and that the result was 150 (units not provided); reporter was concerned because that was a high value, but stated the laboratory did not provide an acceptable range for their testing. The outcome of "lingering cough", fever and cold was reported as recovering. The outcome of the increased titers was not reported. The relatedness between M-M-R II and the events were not reported. Additional information is not expected because the reporter refused additional contact.
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient. On 02-SEP-2014 the patient was vaccinated with (Oka/Merck) PROQUAD (lot #, expiration date, dose and route unspecified). No adverse effects reported. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patient of unknown gender and age. It was reported that since 24-JUL-2014, improperly stored doses of ZOSTAVAX (dose, dose number, route, lot/batch number, expiration date were not reported) were administered to unknown number of patients in approximately 2014. No adverse effects were noted. No product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to an unspecified number of patients of unkonwn age and gender. On unkonwn date the patients were vaccinated with a single dose of PEDVAXHIB (dose, lot# and route of administration were not reported) that was exposed to 23F for unspecified period of time. It was unable to determine how long the vaccine was exposed to this low temperature since the facility did not clear the minimum-maximum thermometer daily. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEP, IPV, MMR, HEP, IPV, MMR, TD
Symptoms: Lymphadenopathy, Swelling face
Clinical narrative: 2001 I had swelling of gland on my face; 07 I went to Emergency Room. I have the same problem on my face till this days. Swelling of face etc.
Age: 18.0
Sex: M
Vaccine: HEP, IPV, MMR, HEP, IPV, MMR, TD
Symptoms: Dyspnoea, Salivary gland enlargement
Clinical narrative: 2001 I had swelling of gland on my face; 07 I went to Emergency Room. I have the same problem on my face till this days. Swelling of face etc.
Age: 47.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Local swelling, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a 47-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 18 June 2014 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm). In June 2014, less than one week after vaccination with BOOSTRIX, the subject experienced fever and swelling, pain and tenderness at injection site. The subject visited the physician who performed an urine test and a blood test. The results showed a low infection. The subject was treated with antibiotics. At the time of reporting the events were improved. This case was associated to a product complaint. Follow-up information received on 2 September 2014: This case was upgraded to serious. In June 2014, within 48 hours after vaccination with BOOSTRIX, the subject experienced the above mentioned events. The pharmacist considered the events were clinically significant (or requiring intervention).
Age: 47.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Blood test abnormal, Infection, Injection site pain, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a 47-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 18 June 2014 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm). In June 2014, less than one week after vaccination with BOOSTRIX, the subject experienced fever and swelling, pain and tenderness at injection site. The subject visited the physician who performed an urine test and a blood test. The results showed a low infection. The subject was treated with antibiotics. At the time of reporting the events were improved. This case was associated to a product complaint. Follow-up information received on 2 September 2014: This case was upgraded to serious. In June 2014, within 48 hours after vaccination with BOOSTRIX, the subject experienced the above mentioned events. The pharmacist considered the events were clinically significant (or requiring intervention).
Age: 47.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Pyrexia, Urine analysis abnormal
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a 47-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 18 June 2014 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm). In June 2014, less than one week after vaccination with BOOSTRIX, the subject experienced fever and swelling, pain and tenderness at injection site. The subject visited the physician who performed an urine test and a blood test. The results showed a low infection. The subject was treated with antibiotics. At the time of reporting the events were improved. This case was associated to a product complaint. Follow-up information received on 2 September 2014: This case was upgraded to serious. In June 2014, within 48 hours after vaccination with BOOSTRIX, the subject experienced the above mentioned events. The pharmacist considered the events were clinically significant (or requiring intervention).
Age: 47.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Blood test abnormal, Injection site pain, Injection site swelling, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a 47-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 18 June 2014 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm). In June 2014, less than one week after vaccination with BOOSTRIX, the subject experienced fever and swelling, pain and tenderness at injection site. The subject visited the physician who performed an urine test and a blood test. The results showed a low infection. The subject was treated with antibiotics. At the time of reporting the events were improved. This case was associated to a product complaint. Follow-up information received on 2 September 2014: This case was upgraded to serious. In June 2014, within 48 hours after vaccination with BOOSTRIX, the subject experienced the above mentioned events. The pharmacist considered the events were clinically significant (or requiring intervention).
Age: 47.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Urine analysis abnormal
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a 47-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 18 June 2014 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm). In June 2014, less than one week after vaccination with BOOSTRIX, the subject experienced fever and swelling, pain and tenderness at injection site. The subject visited the physician who performed an urine test and a blood test. The results showed a low infection. The subject was treated with antibiotics. At the time of reporting the events were improved. This case was associated to a product complaint. Follow-up information received on 2 September 2014: This case was upgraded to serious. In June 2014, within 48 hours after vaccination with BOOSTRIX, the subject experienced the above mentioned events. The pharmacist considered the events were clinically significant (or requiring intervention).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Injection site erythema, Injection site swelling
Clinical narrative: Pt states that she has a red spot at the site of the injection as well as a bump.  Pt also reports being hoarse.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Pyrexia
Clinical narrative: Pt reported a very large red, hot and inflamed area at the injection site.  Pt is also running fever.  Pt was also given the influenza vaccine at the same time in a different arm.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Injection site inflammation, Injection site swelling, Pyrexia
Clinical narrative: Inflammation and swelling on 5 inch diameter surrounding injection site. Mild fever, chest tightness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pruritus, Injection site swelling, Nasopharyngitis
Clinical narrative: 1. Injection (right tricep) site red, swelling, itchy, increased over several days then subsided after a week (have pictures if needed). 2. Right side below waist - itchy and big hive-like eruptions; LEFT forearm - two itchy red swollen spots that either came to a head or were scratched to crust. 3. Sensitivity to heat and sweat - hives or rash like eruptions on right side of neck 9/6 - 9/9.  Relief found by applying Ammen's medicated powder. 4. On Tuesday, 9/2/14 woke up at 2am with a bad sore throat - took Zicam which I have taken in the past with no ill effects.  Became a 'cold' - taking Mucinex DM extra strength 12 hr and Sudafed 12 hr and advil.  Cold is finally resolving as of 9/9/14 and hives have not increased.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pruritus, Rash erythematous, Rash pruritic, Scab
Clinical narrative: 1. Injection (right tricep) site red, swelling, itchy, increased over several days then subsided after a week (have pictures if needed). 2. Right side below waist - itchy and big hive-like eruptions; LEFT forearm - two itchy red swollen spots that either came to a head or were scratched to crust. 3. Sensitivity to heat and sweat - hives or rash like eruptions on right side of neck 9/6 - 9/9.  Relief found by applying Ammen's medicated powder. 4. On Tuesday, 9/2/14 woke up at 2am with a bad sore throat - took Zicam which I have taken in the past with no ill effects.  Became a 'cold' - taking Mucinex DM extra strength 12 hr and Sudafed 12 hr and advil.  Cold is finally resolving as of 9/9/14 and hives have not increased.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Temperature intolerance, Urticaria
Clinical narrative: 1. Injection (right tricep) site red, swelling, itchy, increased over several days then subsided after a week (have pictures if needed). 2. Right side below waist - itchy and big hive-like eruptions; LEFT forearm - two itchy red swollen spots that either came to a head or were scratched to crust. 3. Sensitivity to heat and sweat - hives or rash like eruptions on right side of neck 9/6 - 9/9.  Relief found by applying Ammen's medicated powder. 4. On Tuesday, 9/2/14 woke up at 2am with a bad sore throat - took Zicam which I have taken in the past with no ill effects.  Became a 'cold' - taking Mucinex DM extra strength 12 hr and Sudafed 12 hr and advil.  Cold is finally resolving as of 9/9/14 and hives have not increased.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Loss of consciousness
Clinical narrative: Started blacking out at the gym.  Thought perhaps blood pressure was high but it was extremely low. 70 over 45.  Stayed with nurses and they had me eat packets of sugar and got me to eat some food in cafeteria.  I am not certain the shot caused the black outs or low blood pressure,  but the gym thought the shot did factor into what happened.  Perhaps a combination of coming off Agumentin for the dog bites, Tetanus shot, and then the flu shot. I have had a flu shot every year without any issues. Pressure came back up later in the day.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Cough, Heart rate increased, Oedema mouth, Urticaria
Clinical narrative: HIVES, INSIDE MOUTH SWELLING, COUGHING, TOOK BENADRYL, HIVES, SUBSIDED, COUGHING CONTINUED, HEART RATE INCREASED LATER IN EARLY HOURS OF 09/07/2014, HIVES STILL PRESENT CALLED 911.
Age: 53.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Muscle atrophy, Muscle fatigue, Muscle spasms, Myalgia
Clinical narrative: On day three after received Varivax vaccine, pt started to have muscle ache from shoulder region down to his left arm, he also had lots of spasm to his left shoulder blade. He went to his PCP for evaluation since OTC NSAIDs didn't help him with his discomfort. He also reported some muscle atrophy and fatigue experience with the same arm. He was treated with Flexeril by his PCP. His symptoms' went away about 4 weeks after he received his vaccination.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse via company representative refers to a 70 year old female patient. There were not pertinent medical history or drug allergies reported. On an unspecified date of February 2014, the patient was vaccinated with ZOSTAVAX. The Nurse reported that the patient was diagnosed with Bell's Palsy (medically significant) 14 days after receiving ZOSTAVAX (onset considered approximately on February 2014). The nurse stated that Computerized Tomography (CT) scan was done and ruled out in a stroke in the patient. The reporter reported that there were no other vaccines administered with the ZOSTAVAX. Patient sought medical attention by visiting the office. The patient's present status was reported as recovered (date unspecified). The causality was not reported. No product quality complaint (PQC) was reported. Upon internal review, bell's palsy was determined to be medically significant. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Incisional drainage, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling/redness at injection site. Fever 102.7. Headache. Required incision and drainage of soft tissue.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warm to the touch at injection site.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired driving ability, Injection site haematoma, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Severe pain at injection site and symptom of rotator cuff injury, decreased active and passive range of motion; symptoms worsened overnight and following day resulting in inability to drive or use left upper extremity; symptoms now persistent with decreased but moderate pain and severe pain with abduction greater than 30 degrees even one week after vaccine administration; small hematoma at injection site which is near the top of the shoulder.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Rotator cuff syndrome
Clinical narrative: Severe pain at injection site and symptom of rotator cuff injury, decreased active and passive range of motion; symptoms worsened overnight and following day resulting in inability to drive or use left upper extremity; symptoms now persistent with decreased but moderate pain and severe pain with abduction greater than 30 degrees even one week after vaccine administration; small hematoma at injection site which is near the top of the shoulder.
Age: 0.31
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting projectile
Clinical narrative: Per mom, patient developed a low grade fever which progressed to diarrhea and projectile vomiting after a few days.  Per mom, patient taken to an emergency room where they tried to hydrate, but could not get an IV in place, patient given Zofran which helped control the vomiting.  Mom states today, 09/09/14, is the first day patient is able to keep food down and appears to be doing better.  She strongly feels like it is a reaction to the immunizations, specifically Rotavirus vaccine.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Hive, burning, itching, redness, warmth in L arm from site of injection (L Deltoid) to L FA.
Age: 1.2
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Rash generalised
Clinical narrative: Rash all over body with swelling at injection site.
Age: 50.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Headache, Injected limb mobility decreased, Injection site joint pain, Injection site pain, Oedema
Clinical narrative: Client reports edema, decreased ROM (unable to raise arm greater than 45 degrees), pain at injection site and in shoulder joint lasting 3-4 weeks.  Reports fever and headache after administration.
Age: 50.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Pyrexia
Clinical narrative: Client reports edema, decreased ROM (unable to raise arm greater than 45 degrees), pain at injection site and in shoulder joint lasting 3-4 weeks.  Reports fever and headache after administration.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Oropharyngeal pain
Clinical narrative: Patient described severe throat soreness.  Experienced trouble swallowing, could not eat for the remainder of day.
Age: 38.0
Sex: F
Vaccine: HEPAB, MMR, MNQ
Symptoms: Chills, Headache, Nausea, Neck pain, Pyrexia
Clinical narrative: NAUSEA, HEADACHE, FEVER, CHILLS AND NECK PAIN.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a Medical assistant refers to a 4 year old male patient without pertinent medical history or drug reactions/allergies. On 04-SEP-2014, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # J013555, expiration date 02-MAY-2014) injection, 0.5 ml, subcutaneous There was no concomitant medication. The Medical assistant reported that the patient received a dose of PNEUMOVAX23 on 04-SEP-2014. While he was still in the office he developed a fever and a rash on his cheeks. The physician directed his parents to take him to the emergency room. The patient was observed at the emergency room and released. No lab diagnostics studies was performed. Currently the patient was recovering and has soreness at the injection site. The outcome of the events was recovering. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Medication error, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old patient of unknown gender. The reporter stated that it was discovered on 12-AUG-2014 that a patient who was outside of the age indication for PROQUAD (Merck) on 11-AUG-2014 received a dose of PROQUAD (Merck) (0.54 ml, subcutaneous, lot# J009048, expiration date: 31-JAN-2015, anatomical location was not reported). The reporter stated that another nurse saw that the patient was intended to receive M-M-R II and VARIVAX (Merck), and she administered a dose of PROQUAD to the patient without consideration of the age indications. It was reported that this error was not a result of medication confusion. It was a healthcare professional error. No adverse effect had been observed or reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 19 year old male patient. On 09-JUL-2014, the patient was vaccinaed with GARDASIL (dose, Lot# and route of administration not reported). Since vaccination on 09-JUL-2014, reported as for the past 2 months, the patient has been experiencing welts on his face on and off. The severity of the welts fluctuated for unspecified time periods. The patient sought medical attention by visiting the emergency room as a result of welts being so bad. The patient was not admitted to the hospital. The outcome of welts on face was reported as not recovered. Relatedness between welts on face and therapy with GARDASIL was not provided. 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 and gender. Information about concurrent medical conditions, concomitant medication and medical history was not provided. On 21-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # J009827, expiration date 10-AUG-2014, dose and frequency were not provided) intramuscularly. No known adverse effect was reported. All of the data was reconfirmed with the reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a patient of unknown age. On an unknown date in July 2014 (2 months ago), the patient was vaccinated with ZOSTAVAX single dose, subcutaneous. The nurse reported that the patient was inadvertently vaccinated with a second dose of ZOSTAVAX on 05-SEP-2014. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers a patient of unknown age. On an unknown date, patient was vaccinated with LIQUID PEDVAXHIB (lot #, expiry date unknown) exposed to 32F for 33 days. There was no product quality complaint. No adverse effects were reported. Outcome of the reported event was unknown. This case related to 1409USA001456 (same reporter link). Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure within 48 hrs of vaccine.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Pt complained of pain in shoulder hours after injection (IM, left arm). I informed her it was likely not an ADR d/t location.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Hyperaesthesia, Myalgia, Nausea, Pain in extremity
Clinical narrative: Around dinner time patient started feeling soreness in his arm that was sensitive to temp and touch (day of vaccination). Next day patient's arm get worse with pain radiating all the way down hi arm. Also experienced nausea and terrible muscle pains. No treatment needed. Patient recovered after 1-2 days.
Age: 23.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Administered MMR and Varicella around 3:30 PM in patients left arm per mothers request to have both in 1 arm to avoid right arm being sore.  Immediately upon administration, there was redness and swelling. No pain. MD evaluated patient and rec cool compress, ibuprofen. Follow up call 5 PM - patient is doing well. No increased swelling.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient presented with swelling, redness and fever at injection site that began approx. 1 day after vaccination. Patient stated that shoulder and arm were very sore. Patient also had a rash on the same arm. I recommended BENADRYL and acetaminophen but patient did not want take BENADRYL. I referred her to MD to prescribed a steroid (per patient).
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient presented with swelling, redness and fever at injection site that began approx. 1 day after vaccination. Patient stated that shoulder and arm were very sore. Patient also had a rash on the same arm. I recommended BENADRYL and acetaminophen but patient did not want take BENADRYL. I referred her to MD to prescribed a steroid (per patient).
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site rash
Clinical narrative: Inflammation and rash (raised) about 2-3 inches below injection site. Tx: prednisone 50mg tablets qd x2 days.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Local swelling
Clinical narrative: Mother called 2 days after vaccine given. States arm is swollen the size of a soft ball.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Hep A vaccine administered to early.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Local swelling, Pain
Clinical narrative: Swelling of RA, chills, pain developed on 9-1, got Rx for Amoxicillin (cellulitis).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chills, Feeling hot, Heart rate increased, Myalgia, Throat irritation
Clinical narrative: Throat - burning, hot, heart beat - faster, chills, Muscle pain - around rib cage, legs, No fever. 4PM Meningococcal vaccines administered. After 6PM he started complaining, lastt 4-5 days
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a patient's friend refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX (dose, lot # and route of administration not reported). On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) were not known. The pregnancy outcome was pending. The trimester of exposure was unknown. No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. It was reported that in August 2009 (also reported as "5 years ago") the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not reported). On 20-AUG-2014 the patient was vaccinated with a second dose of GARDASIL (dose, route and lot number were not reported). No adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. The patient thought she was exposed to the chicken pox in the past but was not sure. On 27-MAY-2014 the patient was vaccinated with 2 injections of ZOSTAVAX (strength, dose, route and lot # not reported), injection, both in her left arm, one right after another, as she was told by the unspecified health care professional that ZOSTAVAX was administered in two doses. "Within 48 hours", on approximately 29-MAY-2014, the patient had a red lump about 2 inches long at the injection site. On an unspecified date in 2014, the patient continued to have swelling, and a radiating, burning hot pain that stretched from the injection site (in her left arm) to her left breast. However, she stated that there was no rash. The patient also mentioned she was noticing a minor version of the same symptoms on her "right side'. She did visit an unspecified urgent care center and was checked for a chest wall though she did not have any breathing problems. The outcome of the adverse events was unknown. Additional information is not expected as no physician contact information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. The patient thought she was exposed to the chicken pox in the past but was not sure. On 27-MAY-2014 the patient was vaccinated with 2 injections of ZOSTAVAX (strength, dose, route and lot # not reported), injection, both in her left arm, one right after another, as she was told by the unspecified health care professional that ZOSTAVAX was administered in two doses. "Within 48 hours", on approximately 29-MAY-2014, the patient had a red lump about 2 inches long at the injection site. On an unspecified date in 2014, the patient continued to have swelling, and a radiating, burning hot pain that stretched from the injection site (in her left arm) to her left breast. However, she stated that there was no rash. The patient also mentioned she was noticing a minor version of the same symptoms on her "right side'. She did visit an unspecified urgent care center and was checked for a chest wall though she did not have any breathing problems. The outcome of the adverse events was unknown. Additional information is not expected as no physician contact information was provided.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Morning after patient received vaccine she states she was itchy all over (mentioned face and arms). Later in the day she states she developed hives on face. No trouble breathing/swelling of tongue/throat. Advised BENADRYL, and cool compresses on facial hives.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 19-AUG-2014, the patient was vaccinated with an expired dose of M-M-R II (lot # H014989, expired date: 10-AUG-2014), (dose and route were not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information is not expected since no consent to follow up.
Age: 63.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient without drug reactions/allergies. ON 28-AUG-2014, the patient was vaccinated with the first dose of PNEUMOVAX23 (lot # K004148, expiration date 10-MAY-2015) injection (dose and strength not reported). Concomitant therapies included BENTYL, PROTONIX, cholestyramine resin and SYMIBCORT. The pharmacist reported that on 28-AUG-2014 the patient developed redness and swelling "the size of a half of a boiled egg" at the injection site within 45 minutes to 1 hour after receiving the vaccine. The patient was seen in the emergency room due to the redness and swelling. NARCO was given to treat the adverse events. At the time of this report, the outcome of the events was recovering.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a approximately 64 year old female patient. On 04-SEP-2014, the patient was vaccinated with expired dose ZOSTAVAX (lot # J011211, expiry date: 31-JUL-2014) 0.65 ml, subcutaneous in the left upper arm. No adverse effects reported. No product quality complaint. No further details provided. Outcome of the event was unknown. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given Pneumoccal Polysaccharide (Adult) rather then the PREVNAR 13. -No adverse events occured.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 70 year old female patient. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # and expiry date unknown) injection, one shot. There was no concomitant medication. On an unknown date, the patient experienced shingles within a couple of weeks after receiving ZOSTAVAX. Patient sought medical attention and visited office. There was no product quality complaint. Treatment information was unspecified by the reporter. The patient recovered from the event after stopping the therapy. Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood cholesterol, Hepatic enzyme, Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a consumer's wife refers to a 74 year old male patient. The patient's medical history included hardening of the arteries (2 stents put in). Drug reactions or allergies was reported as none. Approximately on an unknown date in 2007 (also reported as 7 years ago) the patient was vaccinated with ZOSTAVAX dose 1, one time vaccine. Concomitant therapies included statin for cholesterol, Metoprolol (for blood pressure). On 25-AUG-2014 the patient experienced shingles with very little pain. The primary reporter was a consumer. She stated that she and her husband (patient) both got the vaccine 7 years ago, but the husband developed Shingles last week which was very mild with very little pain. Patient was prescribed anti virus medicine, and oral tablet for reduction of inflammation. A month ago blood test for cholesterol and liver enzymes was done (details unspecified). Patient sought medical attention. There was no product quality complaint (PQC) involved. The outcome of shingles with very little pain was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 2 month old patient. On 19-AUG-2014 the patient ws vaccinated with a dose of PNEUMOVAX23 (0.5 ml, intramuscular, lot number was not reported) accidentally at the age of 2 months old instead of PREVNAR. No adverse effect reported. Additional information has been requested.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) reporting on unspecified number of patients of unknown age and genders. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of (Oka/Merck) VARIVAX that underwent a temperature excursion (dose number, lot number and expiration date were not reported), 0.5 ml, subcutaneous. Co-suspect and concomitant therapies were not reported.   Follow up information has been received from a medical assistant who stated that on 19-AUG-2014 a 14 month old patient received (Oka/Merck) VARIVAX (lot # J014402, expiration date 13-NOV-2015). No further information was available at the time of the report. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Tuberculin test positive
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old patient. On 13-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (route of administration, lot # and dose were not reported). Concomitant therapies included unspecified LIQUID PEDVAXHIB. On 15-MAY-2014, the patient experienced positive Tuberculosis Skin Test (PPD). Another two PPD tests were performed on (13-MAY-2014 and 20-AUG-2014) but results were not reported. No treatment was given for adverse event. Patient sought medical attention on follow-up visit. The outcome of the event was unknown. Relatedness between event and vaccination was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a father refers to his son of unknown age. On unknown date in May 2012 the patient was vaccinated with a first dose of GARDASIL (dose, route and lot # not reported). On an unknown date the patient missed a second dose of GARDASIL, because the reporter did not keep up with his son's follow up appointment (date unknown). By the time of the report, the father was trying to get his son back on track with the three doses of GARDASIL as recommended. Additional information is not expected as the reporter did not provide contact details.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a currently 13 year old male patient. On 14-JUL-2005, the patient was vaccinated with a first dose of (Oka/Merck) VARIVAX (lot number reported as 0895P, dose, units, route of administration, anatomical location, expiration date were not reported). On an unknown date (also reported as some time after receiving (Oka/Merck) VARIVAX the patient developed shingles. The reporter stated that the patient was seen by this unspecified healthcare provider (date unspecified) regarding this event.The outcome of developed shingles ws not reported. The relatedness between event and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Computerised tomogram, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 67 year old female patient. There were no drug reactions/allergies. On 19-JUL-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency and lot # unspecified) in the left arm. Other suspect therapies included prednisone (manufacturer unknown). Concomitant therapies included SYMBICORT. On 20-JUL-2014, about 24 hours after vaccination, the patient experienced hard, arm tender knot at the injection site. She stated that her arm was tender for about 2 weeks. On 28-JUL-2014, patient had to have a CAT scan. On approximately 25-JUL-2014 (also reported as 3 days prior to CAT scan), she had to take prednisone (manufacturer unknown. On 04-AUG-2014 the patient experienced rash developed at injection site and on the back of her legs. Rash was only on left side of her body. On an date in 2014, patient had back pain as well, the patient was concerned that prednisone (manufacturer unknown) could have caused this reaction, since she had to take this so shortly after ZOSTAVAX vaccination. No lab diagnostics were performed. The outcome of events was unknown. The patient did not receive any treatment for the events. The patient did not seek medical attention. Product quality complaint was not involved. The reporter considered hard, warm tender knot at the injection site, arm was tender, rash developed at injection site and on the back of her legs with ZOSTAVAX was unknown. Additional information has been requested.