chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Arthropod bite, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site was warm, erythematous and mildly tender. + pruritus. Some improvement over the next day. Did also get several scattered mosquito bites the evening of 8/30/16 prior to noticing this reaction. No other symptoms. Was seen in clinic on 8/31/16 ~3:00 PM. Area of swelling, erythema and warmth on left upper arm at site of previous injection measuring ~15.5x12.5 cm. Subsequently saw an allergist - no workup done.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site warmth
Clinical narrative: Injection site was warm, erythematous and mildly tender. + pruritus. Some improvement over the next day. Did also get several scattered mosquito bites the evening of 8/30/16 prior to noticing this reaction. No other symptoms. Was seen in clinic on 8/31/16 ~3:00 PM. Area of swelling, erythema and warmth on left upper arm at site of previous injection measuring ~15.5x12.5 cm. Subsequently saw an allergist - no workup done.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient reported that there was swelling at injection site and arm was very sore. Some redness at injection site. No treatment that I know of.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Pruritus, Urticaria
Clinical narrative: Patient states he experienced itching, whelps, and a rapid heart beat.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles occurred occurred several months after receiving vaccine. Resolved in December 2016.  MD wanted to report.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Gait disturbance, Myalgia
Clinical narrative: Pain attack muscles and joints still suffering with pain and walking.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No Adverse reaction FLUZONE QUADRIVALENT dose of 0.5ml was administered (discovered on 12/22/2016).
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, HEP, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Left arm swelling that is from the forearm distal part of the arm to the end where elbow is.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Oral herpes
Clinical narrative: This spontaneous report was received from a pharmacist of unknown age reporting on herself. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, some ZOSTAVAX vaccines splashed on the patient's skin of her hands (accidental exposure to product). Then, on an unspecified date (reported as: "a few days later"), the patient developed a cold sore on her lips (oral herpes). On an unknown date, the patient recovered from the oral herpes. The reporter did not assess the relatedness between the event and suspect therapy. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005477: US-009507513-1612USA004758: US-009507513-1612USA005476: US-009507513-1612USA005473: US-009507513-1612USA005474.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Impaired work ability, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist of unknown age reporting on herself. The patient's concurrent conditions included hypercholesterolaemia, Sarcoidosis, sleep apnoea syndrome, hypertension, glucose tolerance impaired and hypothyroidism. On an unspecified date in 2005, the patient was vaccinated with PNEUMOVAX 23, intramuscularly (strength, dose number, lot number and expiration date were not provided) for prophylaxis. Then, on an unknown date in 2013 (reported as: "about 3 years ago"), she received a dose of ZOSTAVAX subcutaneously (strength, dose number, lot number and expiration date were not provided) for prophylaxis. Then, on an unknown date in August 2015, she received a dose of PREVNAR intramuscularly (strength, dose number, lot number and expiration date were not provided) for prophylaxis. On an unknown date in October 2016, the patient received a second dose of PNEUMOVAX 23.  Concomitant therapies included losartan potassium (manufacturer unknown), CRESTOR, LEVOXYL, liotrix, metoprolol and metformin. On an unspecified date in October 2016 (reported as: "On the same night that she received the most recent dose of PNEUMOVAX"), the patient experienced sore, painful, 2 inches diameter, raised, hard area at the site of the injection (Injection site pain and Injection site induration). It was reported that it made her miss work the next day. The patient took ibuprofen and TYLENOL for the pain on unspecified dates. On an unspecified date in 2016 (reported as: "About 2 to 3 days" after receiving this most recent PNEUMOVAX injection"), the patient recovered from the adverse events. The reporter did not assess the relatedness between the event and suspect therapy. Additional information has been requested. Sender's Comments: US-009507513-1612USA004758: US-009507513-1612USA005475: US-009507513-1612USA005476: US-009507513-1612USA005473: US-009507513-1612USA005474.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient received flu vaccine 11/14/16 and has ad extreme pain in her right arm for 3 weeks.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Patient reported red rash on upper arm(Left) 12-14hours after PNEUMOVAX administered. Patient states Rash is not itchy, or painful; not warm to the touch; He is not allergic to any vaccines/drugs or foods; takes a baby aspirin daily will monitor.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue
Clinical narrative: Extreme fatigue.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Influenza like illness, Ocular hyperaemia, Productive cough, Pyrexia
Clinical narrative: Flu vaccine was administered on 11/23/16. Employee came to clinic for 1st time on (12/14/16). Patient stated that he experienced flu like symptoms (cough, increased phlegm, congestion red eyes as well a initial low grade temp. No rash, no SOB. Symptoms lasted 6 days. The symptoms began day after vaccine.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Respiratory tract congestion
Clinical narrative: Flu vaccine was administered on 11/23/16. Employee came to clinic for 1st time on (12/14/16). Patient stated that he experienced flu like symptoms (cough, increased phlegm, congestion red eyes as well a initial low grade temp. No rash, no SOB. Symptoms lasted 6 days. The symptoms began day after vaccine.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Discomfort, Headache, Immunodeficiency, Injection site discomfort, Swelling
Clinical narrative: Pt complained of discomfort at site we medicine. The next day she reported to her mom discomfort, swelling and mild headache. Reported SX to HD on 12/12/16. States no HA but mild discomfort and swelling. Counseled to try cold compress for a couple of hours and apply heat. Counseled that this has been reported day 1-5. Pt is immunosuppressed.
Age: 67.0
Sex: F
Vaccine: PPV, TD
Symptoms: Cellulitis, Local reaction
Clinical narrative: Within 1 day a local reaction and progressed to cellulitis the day after. Treated with antibiotics - clindamycin 300mg TID.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Possible allergic reaction to vaccines he received in left arm 3 days ago. The area is red, hot and firm to touch. No fever reported. Prescribed cephalexin 500 mg capsule.
Age: 77.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site discomfort, Musculoskeletal pain
Clinical narrative: Reported local injection discomfort that went away, shoulder pain returned on 12/14 and has not improved to date although will improve throughout day.
Age: 77.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Injection site discomfort
Clinical narrative: Reported local injection discomfort that went away, shoulder pain returned on 12/14 and has not improved to date although will improve throughout day.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Injection site discomfort, Joint range of motion decreased
Clinical narrative: Reported local injection discomfort then went away, shoulder joint pain returned on 12/15. This has slowly improved, but pt still has limited range of motion to date.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain
Clinical narrative: Reported local injection discomfort then went away, shoulder joint pain returned on 12/15. This has slowly improved, but pt still has limited range of motion to date.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 102.4 R after imms no soreness, fussiness, or redness at site.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, VARCEL
Symptoms: Vomiting
Clinical narrative: Vomiting after imms. No fever or other reactions.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased
Clinical narrative: Flu shot 12-21-16-Temp to 100.6. No other sx.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Patient had shortness of breath/wheezing about 3.5 hours after administration of vaccine that lasted 3 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Redness at injection site, spreading to back in the next few days. Patient reports itching, redness and warmth of rash.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Body temperature increased, Eye movement disorder, Febrile convulsion, Postictal state, Tonic clonic movements
Clinical narrative: Child experienced a seizure (eye's rolled back in head, tonic clonic movements, postictal period). Temperature of 102 F. No history of seizures. Fire department paramedics dispatched to home, child was transported by parents to Hospital ER. Diagnosed as febrile seizure, ibuprofen administered.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen area around inj site after imms. Afebrile left thigh.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Rash generalised
Clinical narrative: The pt had a rash all over body about 4 weeks after shot was light red and itchy for pt-seen my MD.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Significant pain in left arm, lifting in air, hard to lift arm in air.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching on the site of injection.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling, painful, warm to the touch. Defined area. Worsening throughout the day. Approximately 2" in diameter. Recommended ice, ibuprofen, benadryl. We have had multiple patients with similar adverse reactions following pneumonia vaccine.
Age: 53.0
Sex: M
Vaccine: FLUC4, PPV, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: On 12/19/2016 patient received PNEUMOVAX23 and FLUCELVAX immunizations in his left arm. Received BOOSTRIX in his right arm. Patient's wife called 12/22/16 stating that he was having a fever ranging from 99-100.8. And his left arm was feeling sore, along with redness and swelling on the front side of the arm. She said he was feeling better today than yesterday, but wanted to check in. I told her that these are typical side effects of vaccinations and I recommended taking ibuprofen to help with symptoms. If the symptoms did not get better then he could come in and we could look at his arm, or he could go to the doctor.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm reddened, swollen, painful. We have had multiple patients with similar reactions after PNEUMOVAX.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Joint and arm pain.  Pt claims to be unable to move his arm past shoulder length.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Injection site redness about the size of a quarter. Still red 2 days after immunization.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Hypoaesthesia, Rash, Rash pruritic, Scab
Clinical narrative: Felt Numbness in left arm and leg (same side as vaccination given on) several minutes after the injection, lasted 2 days. Blurry Vision set in about 1 day after vaccination and lasted several weeks. Skin rash that itched and had scabbing and bleeding and has persisted for several months.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Felt Numbness in left arm and leg (same side as vaccination given on) several minutes after the injection, lasted 2 days. Blurry Vision set in about 1 day after vaccination and lasted several weeks. Skin rash that itched and had scabbing and bleeding and has persisted for several months.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pruritus, Rash
Clinical narrative: Pt. received PREVNAR and FLUZONE on 12/16/16, he came in on 12/22 and said the PREVNAR site has been itchy since Monday and noticed today that there was a rash spread over the area the size of a baseball. I recommended he take BENADRYL and apply hydrocortisone and call MD if not improved tomorrow.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, MMR, VARZOS, UNK, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: None, Patient was given ZOSTAVAX instead of Varicella. According to MMWR, this will count as Varicella dose.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, MMR, VARZOS, UNK, VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None, Patient was given ZOSTAVAX instead of Varicella. According to MMWR, this will count as Varicella dose.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Red, sore, swollen arm at the site of the injection, mild body aches. Site is warm to touch with a 4" diameter erythema around injection site. Suggested ice to site and ibuprofen or other NSAID.
Age: 70.0
Sex: F
Vaccine: HEP, TYP
Symptoms: Cheilitis, Exfoliative rash, Eyelid rash, Lip pain, Lip swelling
Clinical narrative: Pt. had scaly rash develop around lips, on chest, on upper eye lids and below eyes. Lips were painful with some swelling. Rash resolving after finishing last dose of vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: None stated.
Age: 74.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Sore, swollen arm with a 4-5" inch diameter erythema around injection site. Warm to touch. Mild body aches lasting 3 days. TX included cold packs to site, an NSAID prn for pain and swelling.
Age: 67.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Swelling in right arm, redness and sore to touch.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Pain, Sleep disorder
Clinical narrative: Very sore top of Deltoid, can't move without sharp pain or extreme weakness across body, backwards, or laterally up in left shoulder. Can't sleep on left side. Very sore all the time always feels like it needs to be messaged.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Inflammation
Clinical narrative: Inflamed and red in large area; we told pt. to go to MD; MD diagnosed him with cellulitis and prescribed LEVAQUIN.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain started upper extremities and has gradually worsened over the months so painful I can't use them.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Activities of daily living impaired, Arthralgia, Groin pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non HCP. A 72-years-old female patient received PREVNAR 13, via an unspecified route of administration in the left arm on 20Jan2016 at 3:30pm at single dose. Medical history included ongoing hypertension diagnosed age 33 years old, ongoing hypothyroidism since 12 years before. Concomitant medication included ongoing quinapril (unknown manufacturer, tablet) at 40 mg 1x/day for hypertension, ongoing hydrochlorothiazide (unknown manufacturer, tablet) at 25 mg 1x/day for hypertension and diuretic therapy and ongoing levothyroxine (unknown manufacturer) at 100 ug 1x/day for hypothyroidism. The patient previously took influenza vaccine on 01Oct2015. The patient experienced left arm soreness and a little knot on 21Jan2016 with outcome of recovered, sore throat on an unspecified date in Jan2016 with outcome of recovered, swollen glands on an unspecified date in Jan2016 with outcome of recovering, extreme muscle and joint pain on 30Jan2016 with outcome of not recovered; all she can do to get out of bed in the morning; actually got down to the floor and crawled to do things on an unspecified date with outcome of unknown. About 30Jan2016, developed extreme muscle and joint pain from her neck all the way down to her legs: neck, shoulder, arms, lower back, hips, buttocks, legs and groin, knees. Further clarified the only muscles that don't hurt were the muscles that move her eyes and stomach muscles. It was all she could do to get out of bed in the morning. Actually got down to the floor and crawled to do things. Cried when turning over in bed. Therapeutic measures were taken as a result of extreme muscle and joint pain included Ibuprofen which helped a little bit. Follow-up (08JUN2016): Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Neck pain, Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non HCP. A 72-years-old female patient received PREVNAR 13, via an unspecified route of administration in the left arm on 20Jan2016 at 3:30pm at single dose. Medical history included ongoing hypertension diagnosed age 33 years old, ongoing hypothyroidism since 12 years before. Concomitant medication included ongoing quinapril (unknown manufacturer, tablet) at 40 mg 1x/day for hypertension, ongoing hydrochlorothiazide (unknown manufacturer, tablet) at 25 mg 1x/day for hypertension and diuretic therapy and ongoing levothyroxine (unknown manufacturer) at 100 ug 1x/day for hypothyroidism. The patient previously took influenza vaccine on 01Oct2015. The patient experienced left arm soreness and a little knot on 21Jan2016 with outcome of recovered, sore throat on an unspecified date in Jan2016 with outcome of recovered, swollen glands on an unspecified date in Jan2016 with outcome of recovering, extreme muscle and joint pain on 30Jan2016 with outcome of not recovered; all she can do to get out of bed in the morning; actually got down to the floor and crawled to do things on an unspecified date with outcome of unknown. About 30Jan2016, developed extreme muscle and joint pain from her neck all the way down to her legs: neck, shoulder, arms, lower back, hips, buttocks, legs and groin, knees. Further clarified the only muscles that don't hurt were the muscles that move her eyes and stomach muscles. It was all she could do to get out of bed in the morning. Actually got down to the floor and crawled to do things. Cried when turning over in bed. Therapeutic measures were taken as a result of extreme muscle and joint pain included Ibuprofen which helped a little bit. Follow-up (08JUN2016): Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Crying, Lymphadenopathy, Mobility decreased, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non HCP. A 72-years-old female patient received PREVNAR 13, via an unspecified route of administration in the left arm on 20Jan2016 at 3:30pm at single dose. Medical history included ongoing hypertension diagnosed age 33 years old, ongoing hypothyroidism since 12 years before. Concomitant medication included ongoing quinapril (unknown manufacturer, tablet) at 40 mg 1x/day for hypertension, ongoing hydrochlorothiazide (unknown manufacturer, tablet) at 25 mg 1x/day for hypertension and diuretic therapy and ongoing levothyroxine (unknown manufacturer) at 100 ug 1x/day for hypothyroidism. The patient previously took influenza vaccine on 01Oct2015. The patient experienced left arm soreness and a little knot on 21Jan2016 with outcome of recovered, sore throat on an unspecified date in Jan2016 with outcome of recovered, swollen glands on an unspecified date in Jan2016 with outcome of recovering, extreme muscle and joint pain on 30Jan2016 with outcome of not recovered; all she can do to get out of bed in the morning; actually got down to the floor and crawled to do things on an unspecified date with outcome of unknown. About 30Jan2016, developed extreme muscle and joint pain from her neck all the way down to her legs: neck, shoulder, arms, lower back, hips, buttocks, legs and groin, knees. Further clarified the only muscles that don't hurt were the muscles that move her eyes and stomach muscles. It was all she could do to get out of bed in the morning. Actually got down to the floor and crawled to do things. Cried when turning over in bed. Therapeutic measures were taken as a result of extreme muscle and joint pain included Ibuprofen which helped a little bit. Follow-up (08JUN2016): Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Nodule, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer or other non HCP. A 72-years-old female patient received PREVNAR 13, via an unspecified route of administration in the left arm on 20Jan2016 at 3:30pm at single dose. Medical history included ongoing hypertension diagnosed age 33 years old, ongoing hypothyroidism since 12 years before. Concomitant medication included ongoing quinapril (unknown manufacturer, tablet) at 40 mg 1x/day for hypertension, ongoing hydrochlorothiazide (unknown manufacturer, tablet) at 25 mg 1x/day for hypertension and diuretic therapy and ongoing levothyroxine (unknown manufacturer) at 100 ug 1x/day for hypothyroidism. The patient previously took influenza vaccine on 01Oct2015. The patient experienced left arm soreness and a little knot on 21Jan2016 with outcome of recovered, sore throat on an unspecified date in Jan2016 with outcome of recovered, swollen glands on an unspecified date in Jan2016 with outcome of recovering, extreme muscle and joint pain on 30Jan2016 with outcome of not recovered; all she can do to get out of bed in the morning; actually got down to the floor and crawled to do things on an unspecified date with outcome of unknown. About 30Jan2016, developed extreme muscle and joint pain from her neck all the way down to her legs: neck, shoulder, arms, lower back, hips, buttocks, legs and groin, knees. Further clarified the only muscles that don't hurt were the muscles that move her eyes and stomach muscles. It was all she could do to get out of bed in the morning. Actually got down to the floor and crawled to do things. Cried when turning over in bed. Therapeutic measures were taken as a result of extreme muscle and joint pain included Ibuprofen which helped a little bit. Follow-up (08JUN2016): Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: FLUX, PNC13, PNC13, FLUX, PNC13
Symptoms: Biopsy prostate, Blood cholesterol, Blood pressure increased, Blood triglycerides
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for  himself. A 79-year-old male patient received on 05Oct2015 first dose of PREVNAR 13 at single dose in the left arm and influenza vaccine in the left arm. Medical history included ongoing thyroid disorder started about 10 years before. Concomitant medications included ongoing levothyroxine for thyroid at 0.05 mg daily in the morning since 10 years. On an unspecified date, the patient had blood pressure went up a little bit. The patient received atenolol 25 mg as treatment. Outcome was recovered on an unspecified date. Follow-up (01Apr2016): New information received from a contactable consumer includes: treatment details, outcome. Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: M
Vaccine: FLUX, PNC13, PNC13, FLUX, PNC13
Symptoms: Blood pressure increased
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for  himself. A 79-year-old male patient received on 05Oct2015 first dose of PREVNAR 13 at single dose in the left arm and influenza vaccine in the left arm. Medical history included ongoing thyroid disorder started about 10 years before. Concomitant medications included ongoing levothyroxine for thyroid at 0.05 mg daily in the morning since 10 years. On an unspecified date, the patient had blood pressure went up a little bit. The patient received atenolol 25 mg as treatment. Outcome was recovered on an unspecified date. Follow-up (01Apr2016): New information received from a contactable consumer includes: treatment details, outcome. Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received FLUARIX Quadrivalent (batch number 4A2E2, expiry date 30th June 2017). Concomitant products included levothyroxine and ZOLOFT. On 3rd December 2016, the patient received the 1st dose of FLUARIX Quadrivalent (intramuscular) .5 ml. On 4th December 2016, 1 days after receiving FLUARIX Quadrivalent, the patient experienced injection site pain and shoulder pain. On an unknown date, the outcome of the injection site pain and shoulder pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and shoulder pain to be related to FLUARIX Quadrivalent. Additional details were provided as follows: The patient received the 1st dose of FLUARIX Quadrivalent in her left arm and experienced pain on her left arm and shoulder.
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received FLUARIX Quadrivalent (batch number 4A2E2, expiry date 30th June 2017). Concomitant products included levothyroxine and ZOLOFT. On 3rd December 2016, the patient received the 1st dose of FLUARIX Quadrivalent (intramuscular) .5 ml. On 4th December 2016, 1 days after receiving FLUARIX Quadrivalent, the patient experienced injection site pain and shoulder pain. On an unknown date, the outcome of the injection site pain and shoulder pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and shoulder pain to be related to FLUARIX Quadrivalent. Additional details were provided as follows: The patient received the 1st dose of FLUARIX Quadrivalent in her left arm and experienced pain on her left arm and shoulder.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus, Local reaction
Clinical narrative: Patient reports noticing erythematous, itchy area in site of left upper arm anthrax vaccine administration day after it was administered. The area was larger in size the next day. Denies constitutional symptoms.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Dysphagia, Erythema, Lip swelling, Muscle contractions involuntary, Oropharyngeal swelling
Clinical narrative: Bilateral upper leg itching followed by fasciculations and tremors of R arm followed by facial paresthesias, followed by tightening of throat with change in swallowing sensation and swelling of lips and pharynx, followed by a facial rash/erythema.  Resolved 4 hours after and required multiple doses of diphenhydramine and other antihistamine. This was reported and consulted with an Emergency Room physician.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Paraesthesia, Pruritus, Rash, Throat tightness, Tremor
Clinical narrative: Bilateral upper leg itching followed by fasciculations and tremors of R arm followed by facial paresthesias, followed by tightening of throat with change in swallowing sensation and swelling of lips and pharynx, followed by a facial rash/erythema.  Resolved 4 hours after and required multiple doses of diphenhydramine and other antihistamine. This was reported and consulted with an Emergency Room physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with a doses of improperly stored VARIVAX in immunization series (lot # M009767 with expiry date 23-FEB-2018, lot # M019642 with expiry date 20-APR-2018, lot # M024678 with expiry date 18-MAY-2018, dose, strength, vaccination site, route of administration were unspecified) for prophylaxis. The vaccine was exposed to a cumulative temperature of -13.4 degrees Celsius (C) for 40 hours 32 minutes. The previous temperature excursions included -13.8C for 9 hours on 19-SEP-2016, -13.6 for 18 hours 28 minutes on 20-SEP-2016, -13.4 for 12 hours 34 minutes on 21-SEP-2016 and -15.9 C for 30 minutes on 25-SEP-2016. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved.  Lot number # M024678 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck). Follow up information has been received on 01-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. No additional information is available.; Sender's Comments: ,MERCK 1610USA004625:Mfr number.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.  On unspecified dates between 24-SEP-2016 and 13-OCT-2016, the patients were inadvertently vaccinated with improperly stored doses of GARDASIL 9 injection (lot # reported as M021407, expiration date: 30-APR-2018; doses and route of administration were not provided). The administered doses of vaccine were exposed to a temperature excursion of 35 degrees Fahrenheit (F) for a time frame of 40 minutes. No previous temperature excursions were reported. Data logger was not used to track the temperature. No adverse effect was reported. No product quality complaint (PQC) was involved. Lot number M021407 is an invalid lot number for GARDASIL 9. However, lot# M021407 is valid for GARDASIL. This is one of several reports received from the same reporter. Follow up information has been received from the medical assistant on 20-DEC-2016. The medical assistant stated that she would go through her system and fax the patient identifiers and dates of vaccination. Additional information has been requested. Narrative has been updated. Sender's Comments: US-009507513-1610USA012377: MERCK 1610USA005999: Mfr number.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M017334, expiration date: 05-OCT-2017), subcutaneously for prophylaxis. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Albumin status for PROQUAD (lot # M017334, expiration date: 05-OCT-2017) has been verified as recombinant human albumin (rHA). Follow-up information has been received on 13-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. The reporting nurse was unavailable. Additional information has been requested. Sender's Comments: US-009507513-1611USA002917: MERCK 1610USA010725: Mfr number.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Palpitations, Throat tightness
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 71 year old female patient, with unknown medical history, concurrent conditions and drug reactions/allergies. On 30-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous, for prophylaxis (the dose, frequency, lot number and expiration date were not reported). On 01-DEC-2016, the patient developed "a large lump" at the injection site following the administration of ZOSTAVAX. It was also reported that the patient stated she was having heart palpitations and her throat feels tight after vaccination. It was reported that none lab diagnostics studies performed, none intervention to prevent serious criteria, there was none significant disability or incapacity, no hospitalization and no life threatening. The patient sough medical attention contacting the pharmacist. No treatment was given for the adverse events. The outcome of injection site mass, throat tightness and palpitations was reported as not resolved. The relationship between injection site mass, throat tightness and palpitations and ZOSTAVAX was not reported. There was no Product Quality Complain (PQC). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient received an improperly stored dose of VARIVAX, dosage scheduled and route of administration were not provided (lot # M028552, expiration date 07-JUN-2018)for prophylaxis. The vaccine was exposed to -13° centigrade degrees for 72 hours. The temperatures were logged with a data logger and there were no previous excursions. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # M019706, expiration date 24-OCT-2017, dose not reported) orally for prophylaxis. The doses of vaccine were improperly stored at 34.4 degree Fahrenheit (F) for 63 hours. There was no previous temperature excursion. No data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Information has been received from a physician referring to a non-pregnant female patient of unknown age who was allergic to penicillin and VIOXX (reported as vioxin). Regarding to medical history, the patient was pretty healthy. The physician reported that the patient was a skinny girl and very slender. Concomitant therapy included LOESTRIN 10mg and estrogen (unspecified). On an unknown date, the patient was vaccinated with the third shot of GARDASIL 9 (lot#, expired date, dose and frequency were unknown) for prophylaxis. The physician reported vaccine route of administration was "The way it's supposed to be administered". The physician reported that "the injection site wasn't painful or red, just a bump" and the arm was "swollen and lasted for a month". The patient did not seek any medical attention. No treatment was given and no lab diagnostics studies were performed. The patient recovered from the events on an unknown date. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent medical conditions, concomitant therapies, and medical history were not provided. On 05-DEC-2016 the patient was vaccinated with a dose of ZOSTAVAX (dose unknown) (lot # L026414, expiration date 15-OCT-2016) subcutaneously for prophylaxis. No adverse effects were reported. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with VAQTA (dose, and route not reported) from lot # K005958, expiry date: 09-FEB-2017 for prophylaxis. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Seroconversion test negative
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a 25 year old female patient. Prior medical history, relevant drug history, drug or alcohol abuse, drug allergies, family history and concomitant therapies were not reported. On two unknown dates, the patient was vaccinated with two separated doses of VARIVAX for prophylaxis, dose, route, frequency, anatomic location, lot/batch number and expiration date were not reported. On an unknown date, after the second dose of VARIVAX the patient "failed to seroconvert" (seroconversion test negative).  The outcome of the patient's seroconversion was unknown. The relationship of "failed to seroconvert"(seroconversion test negative) and VARIVAX was not provided. There was no Product Quality Complain (PQC). Additional information has been requested.
Age: 23.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 29 year old patient of gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date in 2010, the patient was vaccinated with the first dose of GARDASIL (dose, frequency, lot number and expiration date were unknown) for prophylaxis. The patient had not yet received the second dose (drug used for unapproved schedule). On 12-DEC-2016, reported as at the time of the call, the patient was in the office to receive GARDASIL 9 (frequency, lot number and expiration date were unknown, for prophylaxis) as the second dose in HPV vaccination series (Interchange of vaccine products). No adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a 62 year old female patient. The patient had no concurrent conditions, medical history or concomitant medications. On 28-NOV-2016, the patient was vaccinated with ZOSTAVAX VIAL 19400 pfu (lot number reported as M032638, expiration date 04-OCT-2017, dose and route were not reported) for prophylaxis. On unspecified date in 2016 after vaccination, the patient developed a "chickenpox type rash". It was reported that the patient sought medical attention and no treatment was given for the event. It was unknown if any lab diagnostics studies were performed to the patient. The reporter stated that the "patient did not affer when the rash developed since vaccination". A product quality complaint was not involved. At the time of the report, the outcome of "chickenpox type rash" was not recovered. The causal relationship between the event and ZOSTAVAX VIAL was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Ocular hyperaemia, Ophthalmic herpes zoster
Clinical narrative: Information has been received from a currently 69 year old female consumer referring to herself. Information about concomitant drug was not provided. There was no medical history and drug allergy. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient started therapy with DULERA (200/5 mcg, oral inhalation, lot# M032647) (dose, frequency and expiration date unknown) for unknown indication. The patient also received unspecified concomitant medications. On an unspecified date after receiving ZOSTAVAX, the patient developed a "red and swollen eye" (unspecified eye) and was diagnosed with shingles (in her eye). On an unspecified date, the patient missed an unspecified amount of doses of DULERA due to unknown reason. It was not clarified that if the patient was taking DULERA prior to receiving ZOSTAVAX. Treatment was given and lab studies were performed to the patient. Action taken with DULERA and the outcome of shingles (in her eye) were unknown. The causality between the event and DULERA and receiving ZOSTAVAX was not provided. Upon internal review, ophthalmic herpes zoster was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: Information has been received a physician via field representative referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (lot#, expired date, dose, frequency and route were unknown). The patient had a rash for 2-3 days after receiving GARDASIL 9. The outcome of rash was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The medical assistant reported that unspecified patients were administered improperly stored vaccines GARDASIL on an unspecified date. No adverse effects were reported. The vaccine was stored at 35.52F for 8 hours and 2 minutes. There was no previous temperature excursion and the call was because of digital data logger. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008775:same reporter, US-009507513-1612USA008776:same reporter, US-009507513-1612USA006359:same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. From 13-NOV-2016 to 16-DEC-2016, the patients were vaccinated with improperly stored doses of PROQUAD, lot# M031941 with expiry: 27-DEC-2017 and lot# M033215 with expiry: 09-JAN-2018, for prophylaxis. The vaccine lot#s had a temperature excursion of 22.53 degree Fahrenheit for 7 hours 36 minutes. It had no previous temperature excursion. The call was because of data logger. This is one of two cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009548.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Measles post vaccine, Pharyngitis streptococcal, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a consumer referring to her son, a 12 year old male patient with mold allergies and attention deficit/hyperactivity disorder ADHD), none concomitant therapies were administered. On 19-AUG-2016, the patient was vaccinated with a dose of M-M-R II injection, for prophylaxis, dose, route, lot/batch number and expiration date were not reported. It was reported that on 21-AUG-2016, the patient had an adverse reaction to the M-M-R II. It was informed that the patient experienced rashes on both sides of face, fever, chills, throwing up, and was diagnosed at an unspecified urgent care with measles (measles post vaccine) on the body, and strep throat (pharyngitis streptococcal) when sought medical attention (allergist). The patient sought medical attention (an allergist) and no laboratory diagnostics studies were done nor were treatment given for the adverse events. The outcome of chills, throwing up, measles (measles post vaccine) on the body and strep throat (pharyngitis streptococcal) was reported as recovered on an unspecified date in 2016. Upon internal review, the event of measles post vaccine was considered to be a medically significant event. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a consumer referring to her son, a 12 year old male patient with mold allergies and attention deficit/hyperactivity disorder ADHD), none concomitant therapies were administered. On 19-AUG-2016, the patient was vaccinated with a dose of M-M-R II injection, for prophylaxis, dose, route, lot/batch number and expiration date were not reported. It was reported that on 21-AUG-2016, the patient had an adverse reaction to the M-M-R II. It was informed that the patient experienced rashes on both sides of face, fever, chills, throwing up, and was diagnosed at an unspecified urgent care with measles (measles post vaccine) on the body, and strep throat (pharyngitis streptococcal) when sought medical attention (allergist). The patient sought medical attention (an allergist) and no laboratory diagnostics studies were done nor were treatment given for the adverse events. The outcome of chills, throwing up, measles (measles post vaccine) on the body and strep throat (pharyngitis streptococcal) was reported as recovered on an unspecified date in 2016. Upon internal review, the event of measles post vaccine was considered to be a medically significant event. Additional information has been requested.