chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Four hours after ingesting first Vivotif typhoid pill, began to experience abdominal pain.  Pain persisted for several hours, acute for about one hour.  About 7 hours after ingesting pill, experienced diarrhea.
Age: 16.0
Sex: M
Vaccine: FLUN4, MNQ
Symptoms: Expired drug administered
Clinical narrative: Expired LAIV Flumist administered to patient. LAIV expired 12/15/2014.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: Fever of 103; large area of redness on arm (all the way around arm, from shoulder to elbow); skin became very hot to touch.
Age: 23.0
Sex: M
Vaccine: TYP
Symptoms: Erythema, Oedema, Pain, Pruritus
Clinical narrative: Erythema, edema, pruritis, and pain.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Patient called and reported redness and a knot at injection site. Also states that it feels warm.
Age: 0.41
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: 3 1/2 in induration with redness and warmth. Painful to touch.
Age: 0.17
Sex: F
Vaccine: 6VAX-F, PPV
Symptoms: Body temperature increased, Skin warm
Clinical narrative: She got the vaccines around 3:15pm and slept until 6 when I woke her to nurse. She slept afterwards until I woke her at 10 to nurse. I realized she felt hot and checked her temperature. It was 102.6.
Age: 23.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site pruritus, Injection site reaction, Pyrexia
Clinical narrative: Pt. says that night after getting vaccine; (L) deltoid was sore and soreness increased throughout the day. Saturday 12/20 increased (L) deltoid pain and hard to move (L) arm and felt feverish. Sunday c/o red rash around injection site and at 3-4 inches in diameter with slight itchiness. The rash spread to elbow and patient described it as patches down arm. Pt took BENADRYL over the weekend. Today, 12/23 pt is 95% better. (Denied shortness of breath, no cough, no swelling of lips, tongue or throat).
Age: 23.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash erythematous
Clinical narrative: Pt. says that night after getting vaccine; (L) deltoid was sore and soreness increased throughout the day. Saturday 12/20 increased (L) deltoid pain and hard to move (L) arm and felt feverish. Sunday c/o red rash around injection site and at 3-4 inches in diameter with slight itchiness. The rash spread to elbow and patient described it as patches down arm. Pt took BENADRYL over the weekend. Today, 12/23 pt is 95% better. (Denied shortness of breath, no cough, no swelling of lips, tongue or throat).
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: DTaP administered to 12 yr old outside of maximum age.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Developed wamth, redness, swelling and itching 3" x 5" around shot site. No resp. prob. nl pulse and HR; no sweating.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Balance disorder, Chills, Confusional state, Hypersomnia, Injection site erythema
Clinical narrative: Weakness and pain in (R) arm, shaky, chills, confusion, unstable on feet slept for 24 hours after injection that night. By the 21st arm was red from elbow to 4 inches above injection site.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscular weakness, Pain in extremity, Tremor
Clinical narrative: Weakness and pain in (R) arm, shaky, chills, confusion, unstable on feet slept for 24 hours after injection that night. By the 21st arm was red from elbow to 4 inches above injection site.
Age: 5.0
Sex: F
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 5 year old given HIB. Max age for HIB is 4 years old.
Age: 80.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Amnesia, Chills, Gait disturbance, Pyrexia, Vomiting
Clinical narrative: 103 degree fever, trouble walking, chills, vomiting, memory loss.
Age: 1.79
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Rotavirus given to 21 month old child.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Eyelid oedema, Lip swelling, Oropharyngeal pain, Wheezing
Clinical narrative: Patient started to c/o throat hurting within 10 mins administering VARIVAX and MMR vacc then started to cough and wheeze. Eyes puffy and lips swelling.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US150856, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542837) website on 13 Nov 2014, with the follow-up information received from Quality Assurance Department (reference number: 339018) on 18 Dec 2014. This report refers to a 60-year-old female patient. She had no known allergies. Her medical history included COPD (chronic obstructive pulmonary disease). Concomitant drugs included clonazepam and PROAIR. On 30 Aug 2014, she was vaccinated with FLUVIRIN (batch number: 145225) in the right arm along with ZOSTAVAX (batch number: K000995) in the left arm. On 01 Sep 2014, she experienced injection site reactions which were reported as hot to touch, itchy, painful, red, raised and rash about 6 inches in diameter. She visited the emergency room and diagnosed with cellulitis. She received BACTRIM DS and PERCOCET. The final outcome of the events was unknown. The events reported as non-serious. Seriousness assessment of the events (vaccination site cellulitis and its symptoms) was upgraded based on the available information in the source document. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 145225) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 339018) on 24 Nov 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 339018) on 18 Dec 2014: Updated FLUVIRIN batch review report.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Case number PHHY2014US150856, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542837) website on 13 Nov 2014, with the follow-up information received from Quality Assurance Department (reference number: 339018) on 18 Dec 2014. This report refers to a 60-year-old female patient. She had no known allergies. Her medical history included COPD (chronic obstructive pulmonary disease). Concomitant drugs included clonazepam and PROAIR. On 30 Aug 2014, she was vaccinated with FLUVIRIN (batch number: 145225) in the right arm along with ZOSTAVAX (batch number: K000995) in the left arm. On 01 Sep 2014, she experienced injection site reactions which were reported as hot to touch, itchy, painful, red, raised and rash about 6 inches in diameter. She visited the emergency room and diagnosed with cellulitis. She received BACTRIM DS and PERCOCET. The final outcome of the events was unknown. The events reported as non-serious. Seriousness assessment of the events (vaccination site cellulitis and its symptoms) was upgraded based on the available information in the source document. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 145225) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 339018) on 24 Nov 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 339018) on 18 Dec 2014: Updated FLUVIRIN batch review report.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US150856, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542837) website on 13 Nov 2014, with the follow-up information received from Quality Assurance Department (reference number: 339018) on 18 Dec 2014. This report refers to a 60-year-old female patient. She had no known allergies. Her medical history included COPD (chronic obstructive pulmonary disease). Concomitant drugs included clonazepam and PROAIR. On 30 Aug 2014, she was vaccinated with FLUVIRIN (batch number: 145225) in the right arm along with ZOSTAVAX (batch number: K000995) in the left arm. On 01 Sep 2014, she experienced injection site reactions which were reported as hot to touch, itchy, painful, red, raised and rash about 6 inches in diameter. She visited the emergency room and diagnosed with cellulitis. She received BACTRIM DS and PERCOCET. The final outcome of the events was unknown. The events reported as non-serious. Seriousness assessment of the events (vaccination site cellulitis and its symptoms) was upgraded based on the available information in the source document. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 145225) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 339018) on 24 Nov 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 339018) on 18 Dec 2014: Updated FLUVIRIN batch review report.
Age: 57.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Bursa injury, Mobility decreased
Clinical narrative: Left arm got bursitis in joint from shot. Cant move my arm around like other arm. Pain can wake me up at night. Sometimes have to move it with other hand. Dont have strength in my arm.
Age: 57.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Asthenia, Bursitis, Mobility decreased, Pain, Poor quality sleep
Clinical narrative: Left arm got bursitis in joint from shot. Cant move my arm around like other arm. Pain can wake me up at night. Sometimes have to move it with other hand. Dont have strength in my arm.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site bruising, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: A spontaneous report was received from a pharmacist concerning a 61 year old female who on 28-NOV-2014 received ZOSTAVAX 0.65 ml subcutaneously in the right arm. Lot number K003602; expiration 30-MAR-2015. Concurrent conditions included diabetes and aspirin allergy. It was not specified whether the patient was taking any concomitant medications. On 29-NOV-2014, the patient experienced a hard, hot, inflamed lump, "like a nodule", about one inch above the injection site. This then spread to the back of the arm to the elbow and was very red, like shingles. It was difficult to determine if there were any vesicles. The patient went to see the pharmacist. No treatment was given for the events. The outcomes of the events were unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling
Clinical narrative: A spontaneous report was received from a pharmacist concerning a 61 year old female who on 28-NOV-2014 received ZOSTAVAX 0.65 ml subcutaneously in the right arm. Lot number K003602; expiration 30-MAR-2015. Concurrent conditions included diabetes and aspirin allergy. It was not specified whether the patient was taking any concomitant medications. On 29-NOV-2014, the patient experienced a hard, hot, inflamed lump, "like a nodule", about one inch above the injection site. This then spread to the back of the arm to the elbow and was very red, like shingles. It was difficult to determine if there were any vesicles. The patient went to see the pharmacist. No treatment was given for the events. The outcomes of the events were unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site nodule, Injection site reaction
Clinical narrative: A spontaneous report was received from a pharmacist concerning a 61 year old female who on 28-NOV-2014 received ZOSTAVAX 0.65 ml subcutaneously in the right arm. Lot number K003602; expiration 30-MAR-2015. Concurrent conditions included diabetes and aspirin allergy. It was not specified whether the patient was taking any concomitant medications. On 29-NOV-2014, the patient experienced a hard, hot, inflamed lump, "like a nodule", about one inch above the injection site. This then spread to the back of the arm to the elbow and was very red, like shingles. It was difficult to determine if there were any vesicles. The patient went to see the pharmacist. No treatment was given for the events. The outcomes of the events were unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Rash vesicular
Clinical narrative: A spontaneous report was received from a pharmacist concerning a 61 year old female who on 28-NOV-2014 received ZOSTAVAX 0.65 ml subcutaneously in the right arm. Lot number K003602; expiration 30-MAR-2015. Concurrent conditions included diabetes and aspirin allergy. It was not specified whether the patient was taking any concomitant medications. On 29-NOV-2014, the patient experienced a hard, hot, inflamed lump, "like a nodule", about one inch above the injection site. This then spread to the back of the arm to the elbow and was very red, like shingles. It was difficult to determine if there were any vesicles. The patient went to see the pharmacist. No treatment was given for the events. The outcomes of the events were unknown. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPH, MEN
Symptoms: Screaming
Clinical narrative: Screaming which lasted 48 hours.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Nervousness, Pruritus, Rash macular, Urticaria
Clinical narrative: Participant had flu shot @ 12:03 pm. 12:40 pm stated she has been itching and getting blotchy for about 10 minutes (12:30 pm). Patient was nervous, but stated she was okay. By 12:57 pm, increased itching and hives. 1:00 pm- epinephrine 0.3cc given SQ in right arm. Patient declined calling 911. Patient was advised to go to the hospital. Patient was wheeled out after second dose of epinephrine 0.3 cc in right thigh. This was the first flu shot for the patient. Participant sent to emergency room via private car.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Lip swelling, Pruritus
Clinical narrative: Participant stated his symptoms began yesterday at 12:00 noon. His wife noticed his lips swelling. Got worse throughout the day by the evening his lip was 3x the normal size and both palms itched and stated he had a mild headache. The swelling in his lip went down by the morning, but not to normal. Was instructed to be seen by his physician. 11:15 AM, follow-up with phone call from participant. He was seen by his physician and given prednisone. His lip continued to improve.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Nausea, Pallor
Clinical narrative: Participant complained of "funny feeling", light-headed, and nausea. BP and P 136/88, P72. Sat in chair w/legs lifted and given ice pack, face pale, pulse strong. 12:45 BP 118/78, P 64 strong. Stated at 12:40 that she felt like she did when she had anaphylactic shock before- carries epi w/her. 1:00 BP 110/78, P 64, color still somewhat pale. Said she felt better, insisted she go "2 doors down" for a mtg but would check back in an hour and also would take her benedryl. 1:40 color had completely returned and pulse strong. Said she felt completely better.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Depressed level of consciousness, Hyperhidrosis, Pallor, Unresponsive to stimuli
Clinical narrative: Participant started becoming diaphoretic and pale in color at 15:00. Participant began to lose consciousness, at which point his feet were elevated. Participant was at a decreased level of consciousness with difficulty responding to his name for approximately two minutes. Participant became more diaphoretic BP 102/54, HR 42. After two minutes participant was able to respond to his name, answer what day it was and where he was at correctly. Participant was given a glass of water to drink. At 15:09, BP 104/42. At 15:29, BP 110/62 HR 48. Pt stood reported no dizziness and stated he would have a snack once returned to his desk. Participant was pink in color and stated feeling good enough to return to desk. Participant was allowed to leave at 15:37.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: Localized pain at site of injection with difficulty lifting arm. Also, 2 week myalgias and arthralgias throughout body. Symptoms resolved after 2 weeks.
Age: 1.16
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB, HEPA, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Child presented with foster mom on December 23, 2014 for shots.  Child was behind on vaccines.  The nurse adminstering vaccines had intended to adminster Pediarix, Hep A, Varicella, and Hib. However, in error the child received Pediarix, Pentacel, Hep A and Varicella. Contact was made with primary care provider and child's guardian.  Spoke with guardian this AM (8:00; denies any signs of adverse reaction.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No date or time onset for adverse reaction. Under-dose possible second dose was given. Vaccination error.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Drug administration error, Injected limb mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: On 11/19/2014 pt recieved afluria flu vaccine. When administering the vaccine and depressing the plunger, I felt like the plunger had stopped, so I withdrew the needle. Realized when the needle was withdrawn, the total volume of the shot had not been delievered. Knowing that multiple injections can be given in the same arm as long as spaced out by 1 inch or more (per the APhA Immunization Certification program), I gave the remaining volume in same arm spaced out at least an inch from the first shot. Informed the patient of what I was doing prior to giving second shot. Counseled pt she would probably be more sore b/c of the extra shot. Followed up with pt the next day. She said her arm was sore, counseled to take Tylenol or ice pack for the soreness and to call if any issues.... Pt came by the pharmacy on 12/23/14, to pick up a prescription and said the arm was still weak from the shot, sometimes hard lifting arm or putting on clothes. First time she had reported this to the pharmacy. Said her arm started getting weak about 6 days after the shot. Advised her to see her physician to make sure nothing serious and I contacted the manufacturer to see if any other recommendations. Manufacturer said pt should be seen by physician as soon as possible. Said the arm weakness could be cause by a number of things, not necessarily the shot. Pt was not upset and said would follup up with physician, but probably not until after Christmas.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No date or time onset for adverse reaction. Under-dose or possible second dose was given. Vaccination error.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Local reaction, Local swelling
Clinical narrative: (forearm/elbow) L arm redness/swelling not near injection site, c/o "felt hot". Benadryl provided per fellow employee, advised to apply ice pack, no c/o SOB. 10:00 AM- HR sent email to employee and employee states "she is feeling fine." 11:10 AM- per employee, "I feel fine," local reaction resolved with Benadryl and fluids.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Dizziness, Nausea, Oropharyngeal pain, Pallor
Clinical narrative: Nausea, light-headedness, sore throat, pale in appearance.  Pt's feet were elevated and vitals monitered.  Gradual return to normal VS and feeling back to usual within around 15 minutes.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Aprox 5-10 min after giving injection, client states she felt a "little lightheaded and dizzy." She stated she never had this happen before. Feet were elevated (She did not want to lie down as suggested). Drank sips of water and observed for aprox. 40 min. Cold compress applied to forehead and neck. BP 140/80, P 72, R 16. BP 138/78, P 72, R 16. Returned to work- appeared and stated she is felt better. C/C'd several times with her vital 3PM.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to a patient of unknown age and unknown gender. On 16-OCT-2014 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dosage information and lot number were unknown) and a dose of (Oka-Merck) PROQUAD (dosage information and lot number were unknown) (dose, frequency and route not reported). No adverse effect reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 79 year old female patient. On 10-DEC-2014 the patient was in error vaccinated with a pediatric dose of VAQTA injection, 25/0.5 (units not provided) (lot # K005323, expiry date: 10-FEB-2017, route of administration, anatomical location were not reported). No adverse experience had been observed or reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 13 year old female patient. The patient's drug allergies were none and pertinent medical history included asthma. Approximately in 2013 (reported as a year ago), the patient was vaccinated with first dose of GARDASIL (dose and frequency unknown, route: in the arm) for vaccination. Concomitant medications included unspecified breathing treatments. Approximately on an unknown date in 2013 (reported as after first dose), the patient experienced hair loss. The patient was vaccinated with second dose on an unspecified date and on 15-DEC-2014, the patient was vaccinated with third dose of GARDASIL.  The patient's hair loss gotten progressively worse since her last vaccination on 15-DEC-2014. The mother of the patient also reported that the patient was receiving unspecified steroid treatments to treat the adverse experience. The patient sought medical attention with a dermatologist. It was also reported that the therapy with GARDASIL was continued. The outcome of hair loss has gotten progressively worse since her last vaccination was reported as not recovered/not resolved. No product complaint was repotted for GARDASIL. Additional information is not expected as the reporter did not wish to contact.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: First time flu shot- prior to giving shot, stayed in observation area. IM administration to left deltoid, client c/o headache. BP taken, 118/76, pulse 58. No c/o SOB or itching. Continued to monitor, no distress noted or SOB. Asked if he wanted 911 to be called, return to work, or go home. Called his boss about going home.  11:15 continued sitting with his boss, being observed. 11:30 condition unchanged- remain sitting with his boss. 11:55 returned to work, his boss stated he was fine.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Possible allergic reaction reported @ 11:30 AM. Hive on bilateral arms, neck, chin. Advised Pt to seek medical attention and to not take flu vaccine next year. She stated that she is allergic to many things and was dignosed last week with allergy to Angmention.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reports a 3 inch red, swollen area around the injection site.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea, Syncope, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old, non pregnant female patient. On 18-AUG-2014 the patient was vaccinated with second dose of GARDASIL (dose and route of administration were not reported). Date of administration first dose of GARDASIL was unknown. A patient experienced fainting after an initial GARDASIL administration and then dizziness, nausea, vomiting and headache following a second GARDASIL administration on 18-AUG-2014. No treatment was given for adverse events. Patient sought medical attention. The outcome of headache, vomiting, nausea and dizziness was reported as recovered/resolved on 19-AUG-2014. The outcome of fainting was reported as recovered/resolved on unknown date in 2014. Relatedness between evens and vaccination was not reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Heart rate increased, Lip swelling, Malaise, Nausea
Clinical narrative: Participant requested to be looked as she was not feeling well. Stated her heart was beating fast. Felt a little tight around her throat and her lips felt a little swollen. She felt nauseous.According to the participant she had been feeling like this since about noon. Temp was 100 degrees Fahrenheit otic, pulse 81 via pulse oximeter, respiratory rate 20, and  O2 saturation 98-99% on room air. Participant refused epinephrine. Participant refused for emergency to be called. Continuously monitoring her for any worsening symptoms. Participant reported feeling better. Advised to see physician.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Participant requested to be looked as she was not feeling well. Stated her heart was beating fast. Felt a little tight around her throat and her lips felt a little swollen. She felt nauseous.According to the participant she had been feeling like this since about noon. Temp was 100 degrees Fahrenheit otic, pulse 81 via pulse oximeter, respiratory rate 20, and  O2 saturation 98-99% on room air. Participant refused epinephrine. Participant refused for emergency to be called. Continuously monitoring her for any worsening symptoms. Participant reported feeling better. Advised to see physician.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: 1705, Immunization shot was given to minor participant. Participant had flu in the past no problems. He was advised to get the flu shot.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Gait disturbance, Hypoaesthesia
Clinical narrative: Employee did not provide another date or time of onset to: "Started tripping at work and couldn't feel my feet."
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Paraesthesia oral, Tongue disorder
Clinical narrative: Participant stated she did not feel well, stated her tongue felt funny, thick, color was good, not short of breath, no throat swelling. Participant stated she had similar incident 10 yrs ago. BP 102/78 Pulse 78. Participant refused EPI injection. Was given BENADRYL.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Headache, Heart rate increased, Nausea
Clinical narrative: Headache, nausea, dizziness, weakness, fast heartbeat.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Hypoaesthesia oral, Lip pruritus, Paraesthesia oral
Clinical narrative: 45 minutes after receiving vaccine lips went numb, started to itch and tingle.
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site rash, Injection site swelling, Rash papular
Clinical narrative: Red raised rash (R) upper arm. Cellulitis. Papular rash occurred day after shots.
Age: 6.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Dyspnoea, Eye swelling
Clinical narrative: Bilateral eye swelling. Difficulty breathing through nose. BENADRYL at 2:40 pm (5mL PO).
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients. On unknown dates the patients were vaccinated with doses of improperly stored of RECOMBIVAX HB (lot #, expiration date, dose and route unspecified). No adverse events were reported. No additional information was available at that time. This is one of several reports received from same source. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, Injection site erythema
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 26 year old male patient. There was no pertinent medical history and drug reactions or allergies provided. On 04-DEC-2014 the patient was vaccinated with a dose of expired (Oka/Merck) VARIVAX lot # H020587, expiration date 13-NOV-2014, 0.5 ml, subcutaneous. No concomitant medications were reported. On 04-DEC-2014, while patient was still in the office, he experienced mild redness at the injection site. There was no lab diagnostics studies performed. Treatment was given with diphenhydramine hydrochloride. The outcome of adverse event was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unknown age and gender. The nurse reported that an unknown number of doses of MMR II (dose, lot# and route not reported) that were improperly stored (outside of the range specified in the prescribing information) might have been administered. MMR II was exposed to 30F then 48F for 72 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 3 unspecified patients of unknown age and unknown gender. The 3 unspecified patients pertinent medical history was not reported. On 16-DEC-2014, the 3 unspecified patients were vaccinated with 3 doses of GARDASIL (dose/frequency: 0.5 ml) intramuscularly that underwent a temperature excursion. No adverse effect reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 25 year old female patient with no pertinent medication and drug reactions/allergies. On 15-DEC-2014 the patient was inadvertently vaccinated with one dose of (Oka/Merck) VARIVAX (lot # K003422, expiration date 06-MAR-2016, subcutaneous, dose not reported) as vaccination. Initial exposure to (Oka/Merck) VARIVAX was at 7 weeks which calculated that last menstrual period (LMP) on 27-OCT-2014 and estimated due date (EDD) of 03-AUG-2015. The patient took no concomitant medication. The pregnancy outcome was outcome pending. No adverse effects reported at the time of report (on 16-DEC-2014). No treatment was given for the event. The patient did not seek medical attention. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Ear infection, Erythema, Injection site reaction, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to an one year old male patient. None pertinent medical history and drug reactions or allergies were reported. On 28-NOV-2014, the patient was vaccinated subcutaneously with one dose of (Oka/Merck) VARIVAX, (frequency and anatomical location were not reported) (lot # was reported as K005426, expiration date: 15-APR-2016) as routine vaccination. Concomitant medication was not reported. On 05-DEC-2014 after receiving (Oka/Merck) VARIVAX, the patient experienced fever of 102 F, cough, and congestion. This was diagnosed as an unspecified ear infection. Patient also developed a "chickenpox-like" rash at the injection site, described as a lesion which "started off as a red disc for the first few days, then developed a white bump." Patient received cefdinir (dose and frequency were unspecified) for treatment. No laboratory test were performed. The patient sought medical attention (office visit) (exact date was not provided). No product quality complaint was reported. The outcome of unspecified ear infection and "chickenpox-like" rash at the injection site was reported as recovering at the time of the report. The relatedness between the events and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Respiratory tract congestion, Skin lesion
Clinical narrative: This spontaneous report as received from a physician refers to an one year old male patient. None pertinent medical history and drug reactions or allergies were reported. On 28-NOV-2014, the patient was vaccinated subcutaneously with one dose of (Oka/Merck) VARIVAX, (frequency and anatomical location were not reported) (lot # was reported as K005426, expiration date: 15-APR-2016) as routine vaccination. Concomitant medication was not reported. On 05-DEC-2014 after receiving (Oka/Merck) VARIVAX, the patient experienced fever of 102 F, cough, and congestion. This was diagnosed as an unspecified ear infection. Patient also developed a "chickenpox-like" rash at the injection site, described as a lesion which "started off as a red disc for the first few days, then developed a white bump." Patient received cefdinir (dose and frequency were unspecified) for treatment. No laboratory test were performed. The patient sought medical attention (office visit) (exact date was not provided). No product quality complaint was reported. The outcome of unspecified ear infection and "chickenpox-like" rash at the injection site was reported as recovering at the time of the report. The relatedness between the events and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Local swelling, Pain
Clinical narrative: This spontaneous report as received from a pharmacy intern student refers to a 60 year old male patient with penicillin allergy and no medical history. On 09-DEC-2014 the patient was vaccinated with ZOSTAVAX lot # K014734 expiration date 14-DEC-2015 for prevention of shingles (dose and frequency were not provided). There was no concomitant medication reported. On 11-DEC-2014 the patient presented back to the pharmacy with a reaction that included a "raised red patch" about two inches by four inches and the area was oblong in shape. The patient experienced warmth and pain. The patient applied ice to the reaction area and the reaction had started to clear up. The patient did not seek medical attention and no treatment was given for the adverse events. There was no lab diagnostics studies performed. The relationship between ZOSTAVAX and the events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to six adult patients of unknown age and gender. The reporter stated that she administered (Merck) PROQUAD, (0.5 ml, subcutaneous, frequency was reported as once, lot# not reported) on an unspecified date to the six adult patients (inappropriate schedule). No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 17-DEC-2014 the patient was inadvertently vaccinated with expired dose of ZOSTAVAX (dose and frequency not reported) (lot # J011337 and expiry date: 13-DEC-2014). No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with unspecified number of improperly stored VAQTA (dose, route of administration, lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown ages. On an unknown date the unknown number of patients were vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date, strength, dose and frequency were not reported) which were improperly stored. No adverse effects were reported. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with unspecified number of improperly stored (Oka/Merck) VARIVAX (dose, route of administration, lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Double stranded DNA antibody positive, Laboratory test normal
Clinical narrative: This spontaneous report as received from a 29 year old male physician (who is also a patient) with asthma and with no drug reactions or allergies, refers to himself. On 21-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot # K009105 with expiry date: 21-JAN-2016; strength, dose and route of administration unspecified). Concomitant therapies included ADVAIR and corticosteroids (unspecified). It was reported the patient subsequently had a positive anti-double-stranded DNA (anti-dsDNA) test for auto-immune disease on an unspecified date in 2014. His anti-dsDNA titer was originally 24 and then was 26 (units not provided) upon re-testing. The physician stated all other unspecified testing had been normal. The patient sought medical attention (unknown type) but no treatment was given. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. medical history was not reported.  The reporter stated that M-M-R II underwent a temperature excursion. It was reported that on 13-NOV-2014 the patient was vaccinated with the improperly stored M-M-R II, 0.5 ml, subcutaneous injection, lot number reported K007107, expiration date 16-MAY-2016. Concomitant medication was not reported. No adverse effect was reported at the time of the report. The outcome of improperly stored M-M-R II was administered was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Medical history was not reported. The reporter stated that M-M-R II underwent a temperature excursion. It was reported that on 21-NOV-2014 the patient was vaccinated with the improperly stored M-M-R II, 0.5 ml, subcutaneous injection, lot number J016232, expiration date 19-DEC-2015. Concomitant medication was not reported. No adverse effect was reported at the time of the report. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant concerning an unspecified amount of patients. The reporter stated that on an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, dosage schedule, route, lot number and expiry date not provided). There was no concomitant medication reported. No adverse effects were reported at the time of the report. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age or gender. On an unknown date the patient was vaccinated with VAQTA, (0.5 ml, intramuscular, dose number and lot number unknown). The healthcare worker reported that a dose of VAQTA that underwent a temperature excursion was administered to one unspecified patient. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patients of unknown age and gender. 14 doses of VARIVAX (Merck) (Lot number, dose and frequency was unknown) were improperly stored and administered to patients. After 25-NOV-2014. Temperature range was 10/8 Fahrenheit degrees Celsius (F). The time frame was 48 minutes. No adverse events were reported. The outcome of the event was not reported. Follow up information has been received from the same nurse on 17-DEC-2014. The nurse reported that "several" doses (unspecified of how many doses and unspecified if it was the VARIVAX (Merck) or ZOSTAVAX or both) were administered after the temperature excursion. No adverse effect reported. No further information was provided. This is one of several reports received from the same reporter. Additional information is not expected because the nurse requested not to receive any additional follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: A spontaneous report was received from both a physchian and helathcare worker (on the same phone call) concerning a patient (age and gender unknown). On 01-DEC-2014, the patient was inadvertently administered ZOSTAVAX instead of their first dose of (Oka/Merck). No adverse effect was reported. The outcome was unknown. Additional infromation has been requested.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a 47 year old female patient who was reporting on herself. On 30-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX (vial, dose, route of administration, lot number and expiration date were not reported). The patient was outside of the age indication for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 01-DEC-2014 the patient was vaccinated with ROTATEQ (oral dose, frequency, lot number and expiration date were not reported) which had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date in approximately November 2014 (approximately one year and one month ago), the patient had a previous administration of ZOSTAVAX (dose, route and lot# not reported). On 15-DEC-2014 the patient was inadvertently vaccinated with a second dose of ZOSTAVAX (dose, route and lot# not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Medical history was not reported. The reporter stated that M-M-R II underwent a temperature excursion. It was reported that on 25-NOV-2014 the patient was vaccinated with the improperly stored M-M-R II, 0.5 ml, subcutaneous injection, lot number K007107, expiration date 16-MAY-2016. Concomitant medication was not reported. No adverse effect was reported at the time of the report. This is one of several reports received from the same source. Additional information has been requested.
Age: 72.0
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a 72 year old patient of unknown gender. The patient was vaccinated with PNEUMOVAX 23 injection, 25/.025 Y (dose, route and lot@ were unknown) on 08-OCT-2014 and 29-OCT-2014 respectively. No adverse symptoms reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an adult 15 year old female patient. On 16-DEC-2014 the patient was vaccinated with VAQTA (dosing regimen unspecified). No concomitant therapy was reported. On 16-DEC-2014 the patient inadvertently received adult doses of VAQTA, instead of pediatric doses. Nurse reports that the two patients are sisters. No adverse effect reported and there was no product quality complaint involved. The outcome of inadvertently received adult doses of VAQTA was unknown. This case is linked to: 1412USA009309 (same reporter). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history was reported. On 15-NOV-2013, the patient was vaccinated with VAQTA strength 25/0.5 (unspecified units) dose 1, 0.5 ml, intramuscular. Concomitant therapy was not reported. On 02-MAY-2014, the patient was vaccinated with second dose of VAQTA. No adverse effects reported. No Product Quality Complaint was involved. Additional information has been requested.