chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Somnolence
Clinical narrative: Fever (103F), chills, encephalopathy (somnolence, large change in mental status compared to baseline). Onset 3 days after immunization. Persisted for 2 more days until spontaneous recovery
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: Chills, fever 99.5,  nausea, diarrhea,  stomach  pain, headache
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, fever 99.5,  nausea, diarrhea,  stomach  pain, headache
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Dizziness
Clinical narrative: At 3:24pm I gave the patient both Shingrix and Adacel vaccines, and advised patient to wait for 20 minutes in order to monitor. After 20 minutes, patient complained of being "a little dizzy". I told patient to wait a little more. Patient waited for another 10 minutes. Patient said she can be able to drive home now and asked me what she should do in case the dizziness got worse. I counseled her that if it got worse on the road while driving, she should pull over and call 911, and that while at home she should lay flat and raise her legs above heart level, but call 911 if it got worse. I called patient two hours later to make sure she arrived home safely. Patient arrived home safely and no more dizzy
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Severe redness and swelling developed at site of injection-photos available upon request
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported warmth, tenderness, redness, and slight swelling about 1 inch below injection site that went down a few inches above elbow on left arm.  No other issues reported. Pt was advised to monitor for progression of side effects.
Age: 10.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Dermatitis acneiform, Rash erythematous
Clinical narrative: Child has broken out in a very large red, pimple-looking rash that covers his entire torso in the front and the front of his thighs. No other changes noted in his life to have caused this except for the vaccines he received days ago.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received vaccine around 11 am by evening the arm was red and swollen and warm, and aching around 10 pm the patient started becoming dizzy and vomited 3 times. patient went to sleep and her fingers and toes curled up and became rigid overnight. everything was resolved by morning time when she reported to me. except the arm was still swollen and achy, but much better since the evening before. advised pt to report to doctor if anything else occurs, or if arm swelling increase or becomes painful
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Vomiting
Clinical narrative: Patient received vaccine around 11 am by evening the arm was red and swollen and warm, and aching around 10 pm the patient started becoming dizzy and vomited 3 times. patient went to sleep and her fingers and toes curled up and became rigid overnight. everything was resolved by morning time when she reported to me. except the arm was still swollen and achy, but much better since the evening before. advised pt to report to doctor if anything else occurs, or if arm swelling increase or becomes painful
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Patient reports warmth, redness, & swelling around site of injection and general feeling of being unwell
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Musculoskeletal pain, Pyrexia
Clinical narrative: Pain on shoulder and fever
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Rash down distal aspect of left arm
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Experienced 1 hive close to the injection site in right arm. Hive is on the back of the right shoulder. Yhis is my first dose of Shingrix
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Chills, Gastrointestinal disorder, Hyperhidrosis, Injection site erythema
Clinical narrative: Received Vacccine on 8/8/20. Rt arm soreness 9th thru 14th.  Aug 14th 2:30am awoke with severe vertigo, sweating, nausea, GI symptoms,  I took Dramamine 24 hr less drowsy med (1tab) at 4am. Got up around 10am. Noticed redness on Rt upper arm from deltoid down to about 3 inches above elbow, same area that has been sore all this time. temp 99.8 and slightly chills. Severe lethargy all day from dramamine, vertigo continues. Aug 15 vertigo less severe initially, took 1/4 of dramamine tablet.. Vertigo continues if I move head suddenly or lean forward. Sunday August 16th vertigo contines but less severe, Took another 1/4 tab of Dramamine.  Temp normal.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Lethargy, Nausea, Pain in extremity, Vertigo
Clinical narrative: Received Vacccine on 8/8/20. Rt arm soreness 9th thru 14th.  Aug 14th 2:30am awoke with severe vertigo, sweating, nausea, GI symptoms,  I took Dramamine 24 hr less drowsy med (1tab) at 4am. Got up around 10am. Noticed redness on Rt upper arm from deltoid down to about 3 inches above elbow, same area that has been sore all this time. temp 99.8 and slightly chills. Severe lethargy all day from dramamine, vertigo continues. Aug 15 vertigo less severe initially, took 1/4 of dramamine tablet.. Vertigo continues if I move head suddenly or lean forward. Sunday August 16th vertigo contines but less severe, Took another 1/4 tab of Dramamine.  Temp normal.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Condition aggravated, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Friday migraine within 30 minutes took migraine otc pills. Saturday morning noticed swelling and redness at injection site. Muscle pain, felt tired and weak and felt nauseous all day. Sunday the  same as Saturday.  Monday will call my doctor.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Myalgia, Nausea
Clinical narrative: Friday migraine within 30 minutes took migraine otc pills. Saturday morning noticed swelling and redness at injection site. Muscle pain, felt tired and weak and felt nauseous all day. Sunday the  same as Saturday.  Monday will call my doctor.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: PATIENT REPORTED TODAY THAT ABOUT 24 HOURS AFTER RECEIVING 2ND SHINGRIX VACCINATION, SHE BEGAN HAVING THE FOLLOWING SYMPTOMS: BLOOD SUGARS BETWEEN 200-300; PROLONGED HEADACHE; PAINFUL, RED, SWOLLEN AREA AT INJECTION SITE THE SIZE OF FOOTBALL; RECURRING FEVER UPWARDS 102.8; FATIGUE.  PATIENT WAS GOING TO SEEK MEDICAL TREATMENT.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: PATIENT REPORTED TODAY THAT ABOUT 24 HOURS AFTER RECEIVING 2ND SHINGRIX VACCINATION, SHE BEGAN HAVING THE FOLLOWING SYMPTOMS: BLOOD SUGARS BETWEEN 200-300; PROLONGED HEADACHE; PAINFUL, RED, SWOLLEN AREA AT INJECTION SITE THE SIZE OF FOOTBALL; RECURRING FEVER UPWARDS 102.8; FATIGUE.  PATIENT WAS GOING TO SEEK MEDICAL TREATMENT.
Age: 83.0
Sex: M
Vaccine: FLUA4
Symptoms: Defaecation urgency, Diarrhoea
Clinical narrative: Patient received vaccination in the store and said that about 5 minutes later he had a sudden urgency to defecate and experienced severe diarrhea.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Patient states that area where the vaccine was given started off being very sore. She states that on 8/15/20 hives began on the area that she had received the vaccine. She states today (8/16/20) that the hives have subsided and the area is slightly swollen, has larger red patches around the vaccine site, and is warm to the touch. She states the adverse effects are not bothersome.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Normal sore arm @3hrs, mod to severe all over body aching, chills started @8hrs lasted through the night about 12 hrs. accompanied by headache.  Fatigue after that but feeling better, then @32hrs lymph nodes under vaccinated arm became very swollen, about 1/2 tennis ball size, painful pressure with arm down at side.  Still swollen @48 hours (time of reporting) but otherwise feeling well.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Normal sore arm @3hrs, mod to severe all over body aching, chills started @8hrs lasted through the night about 12 hrs. accompanied by headache.  Fatigue after that but feeling better, then @32hrs lymph nodes under vaccinated arm became very swollen, about 1/2 tennis ball size, painful pressure with arm down at side.  Still swollen @48 hours (time of reporting) but otherwise feeling well.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction, Biopsy skin abnormal, Chest discomfort, Erythema, Pruritus
Clinical narrative: Two weeks following injection 1 I began to break out with large sores all over my left leg and foot.  They were large sores, very red and intensely itched to the point of bleeding.  The then broke out on my left foot with intense itching.  My right leg began to break out with the large sores that somewhat resembled chicken pox with intense itching.  Following the 2 Shingrix injection I began to break out both hands, both arms and both bottoms, mouth, lips and vagina, face.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Skin haemorrhage, Skin ulcer, Weight increased
Clinical narrative: Two weeks following injection 1 I began to break out with large sores all over my left leg and foot.  They were large sores, very red and intensely itched to the point of bleeding.  The then broke out on my left foot with intense itching.  My right leg began to break out with the large sores that somewhat resembled chicken pox with intense itching.  Following the 2 Shingrix injection I began to break out both hands, both arms and both bottoms, mouth, lips and vagina, face.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: patient received pnuemovax and fluzone quad in same arm on 08/14 and returned 08/16 with red band of swelling below the injection sites. patient reported pain/soreness with it. Visually inspected for rash or blisters and found none. Red area was warmer than non. Patient reported it looked better than day 1 of noticing the redness. Instructed patient to take TYLENOL/Ibuprofen for heat/swelling/pain and she stated she was already had been. Also advised to take BENADRYL if it began to itch and contact the doctor in 48 hours if there was no improvement.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Severe flu-like symptoms, fever, chills, muscle pains, headache, exhaustion.  Symptom onset about 6 hours after injection and lasted for about 2-3 days.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe flu-like symptoms, fever, chills, muscle pains, headache, exhaustion.  Symptom onset about 6 hours after injection and lasted for about 2-3 days.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Day of the vaccines (08/13) he had a low grade temperature - highest it got was 99.6°. No redness, no swelling, wasn?t hot to the touch.   08/14 - had a little visible redness that was ?localized? to the shot location, and a bit of swelling. He had a low grade temperature all day long, and complained of a headache. He laid around most of the day, didn?t play much, and said he was tired.   08/15 - swelling is down to just below his elbow, very visible redness, and is VERY warm to the touch. We?ve been applying ice to the area to combat the swelling, but not much happened. I drew around the red areas and nothing seemed to get ?bigger? in terms of redness but the swelling is very visible. He says his arm is sore and doesn?t want anyone to touch it.   We have been applying bentonite clay to the shot area and taking warm Epsom salt baths.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Day of the vaccines (08/13) he had a low grade temperature - highest it got was 99.6°. No redness, no swelling, wasn?t hot to the touch.   08/14 - had a little visible redness that was ?localized? to the shot location, and a bit of swelling. He had a low grade temperature all day long, and complained of a headache. He laid around most of the day, didn?t play much, and said he was tired.   08/15 - swelling is down to just below his elbow, very visible redness, and is VERY warm to the touch. We?ve been applying ice to the area to combat the swelling, but not much happened. I drew around the red areas and nothing seemed to get ?bigger? in terms of redness but the swelling is very visible. He says his arm is sore and doesn?t want anyone to touch it.   We have been applying bentonite clay to the shot area and taking warm Epsom salt baths.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Arm has been sore since receiving vaccine.  Not in the shoulder area though.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Shivers, COLD,  headache, low grade fever, muscle aches, stomach pain. Only a little red and swollen at injection site
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nasopharyngitis, Pyrexia
Clinical narrative: Shivers, COLD,  headache, low grade fever, muscle aches, stomach pain. Only a little red and swollen at injection site
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: swelling, rash developed around injection area
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: arm painfull and difficult to lift
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased activity, Fatigue, Feeling hot, Insomnia, Myalgia
Clinical narrative: Fatigue and moderate pain in the left arm later that day and night.  At 10:00 pm (approximately 10 hours after the injection) experienced extreme body heat, but temperature from oral thermometer was normal at 98.6 degrees.  Took 400mg Ibuprofen at bedtime (11:45 pm).  Got up at 1:45 am, could not sleep because of extreme body heat, oral thermometer temperature was 98.8 degrees.  Took 200 mg ibuprofen at 5:30 am and 400 mg at 11:45 am.  Approximately 26 hours after the injection, body heat was no longer a problem and only minor muscle pain in the left arm. Resumed normal activity 32 hours after the injection.  Note: First Shingrix dose was on 11/21/2019 with no side effects.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Fatigue and moderate pain in the left arm later that day and night.  At 10:00 pm (approximately 10 hours after the injection) experienced extreme body heat, but temperature from oral thermometer was normal at 98.6 degrees.  Took 400mg Ibuprofen at bedtime (11:45 pm).  Got up at 1:45 am, could not sleep because of extreme body heat, oral thermometer temperature was 98.8 degrees.  Took 200 mg ibuprofen at 5:30 am and 400 mg at 11:45 am.  Approximately 26 hours after the injection, body heat was no longer a problem and only minor muscle pain in the left arm. Resumed normal activity 32 hours after the injection.  Note: First Shingrix dose was on 11/21/2019 with no side effects.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site swelling, Insomnia, Pain in extremity
Clinical narrative: AT 7PM HER ARM WAS HURTING. SHE WOKE UP AT NIGHT WHEN SHE SLEPT ON THAT SIDE. HER ARM WAS SWOLLEN TODAY AROUND THE INJECTION SITE, BUT THE ARM OVERALL WAS MOBLE AND HAD NO OTHER PAIN ON THE ARM OTHERWISE. HER TEMP TODAY WAS 98.9 DEGREES, AND FELT TIRED. SHE WAS COUNSELED TO FOLLOWUP WITH PCP  AND PUT AN ICE PACK ON IT FOR COMFORT. IF SHE HAS ANY ITCHING TO TAKE BENADRYL AT NIGHT AND CONSULT WITH HER PHYSICIAN.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: pt had hives all over body 1-2 days after the vaccine. pt reports she often has a red area around injection site, but this time it is hives on arms, middle and many places
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: CONTINUED REDNESS, SLIGHT PAIN, AND HEAT EVEN 1+ WEEK AFTER VACCINATION
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hypoaesthesia, Limb discomfort, Pain in extremity, Vision blurred
Clinical narrative: PATIENT CALLS THE PHARMACY ABOUT 2 HRS AFTER RECEIVING THE SHOT AND COMPLAINED OF BLURRY VISION, DIZZINESS, NUMBNESS AND SORENESS IN THE ARM WITH THE INJECTION.  I INFORMED PT TO CALL MD REGARDING THE BLURRY VISION IN CASE FOLLOW-UP  IS NEEDED.  I INFORMED PT SHE CAN TAKE SOME TYLENOL TO HELP WITH THE SORENESS AND DISCOMFORT IN THE INJECTION ARM.  I TOLD PT I WOULD CALL HER BACK IN ABOUT 2-3 HRS TO CHECK ON HER. CALLED TODAY 8/16/20 AT 5PM, PT DIDN'T ANSWER AND I WAS ONLY ABLE TO LEAVE A MESSAGE
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Neck pain
Clinical narrative: Pain traveled up left side of neck into left side of skull base. Applied ice pack.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Got Hives Day After Shot and they lasted 5 days She took Benadryl She tells me and got better each day
Age: 57.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Inflammation, Injection site inflammation, Injection site streaking, Pain in extremity
Clinical narrative: inflammation, "streaking" @ injection site to underarm 48hr. onset after admin. Sore arm, but able to lift above head still. admin 8/12/2020 @ around 1:00pm pt. called 8/14/2020 @ around 1:00pm discussing inflammation and "streaking" that started @ injection site and spread to under arm. on Left arm w/ Tdap vaccine was given. Sore arm reported, but able to freely move. No doctor visit so far. Additional follow up is needed w/patient.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Fever 101.5 for 24 hours  (First dose, in 2019, experienced red, hot, swelling of arm, 3 days after vaccination.)
Age: 1.0
Sex: M
Vaccine: MMR, MMRV, UNK
Symptoms: Hypersomnia, Nausea, Pyrexia, Rash, Vaccination complication
Clinical narrative: Next day 100.5 fever sleeped almost all day, 2 days 103.5 fever, threw up and a  trip to emergency room sleep all day and was prescribed Zofran ODT 4mg oral tablet for nausea. 3rd day fever reduced but broke out in a rash back of neck and his back and face.
Age: 1.0
Sex: M
Vaccine: MMR, MMRV, UNK
Symptoms: Vomiting
Clinical narrative: Next day 100.5 fever sleeped almost all day, 2 days 103.5 fever, threw up and a  trip to emergency room sleep all day and was prescribed Zofran ODT 4mg oral tablet for nausea. 3rd day fever reduced but broke out in a rash back of neck and his back and face.
Age: 1.08
Sex: F
Vaccine: IPV, PNC13
Symptoms: Appetite disorder, Crying, Decreased interest, Diarrhoea, Fatigue
Clinical narrative: On 01/23/2018, we went in to a wellness check for and were prepared that it was time to start her on a vaccine schedule, she received her first round of PCV and IPV,and the only symptom she experienced that day was tiredness/sleepiness. About 3 days after the shots, patient woke up one evening throwing up.  It hadnt even occurred to me that she could still be having a reaction, so after watching her carefully, she was feeling better soon after so i wrote it off as it possibly being something she ate. Exactly 3 months later, the same story happened, except this time she didnt bounce back as quickly. She would wake up exhausted, lethargic, having diarrhea, vomitting, didnt want to eat for about 2-3 days, no interest in anything, crying, it just wasnt the same baby anymore. I took her in for an emergency appt, when her fever reached 102 fast, The dr on call did a few tests and sent us home, saying that the results were all negative and that it was possibly a reaction to the vaccine. She was sick like that for 3-4 weeks until completely better a month after.
Age: 1.08
Sex: F
Vaccine: IPV, PNC13
Symptoms: Lethargy, Pyrexia, Somnolence, Streptococcus test negative, Vomiting
Clinical narrative: On 01/23/2018, we went in to a wellness check for and were prepared that it was time to start her on a vaccine schedule, she received her first round of PCV and IPV,and the only symptom she experienced that day was tiredness/sleepiness. About 3 days after the shots, patient woke up one evening throwing up.  It hadnt even occurred to me that she could still be having a reaction, so after watching her carefully, she was feeling better soon after so i wrote it off as it possibly being something she ate. Exactly 3 months later, the same story happened, except this time she didnt bounce back as quickly. She would wake up exhausted, lethargic, having diarrhea, vomitting, didnt want to eat for about 2-3 days, no interest in anything, crying, it just wasnt the same baby anymore. I took her in for an emergency appt, when her fever reached 102 fast, The dr on call did a few tests and sent us home, saying that the results were all negative and that it was possibly a reaction to the vaccine. She was sick like that for 3-4 weeks until completely better a month after.
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: The patient was administered GARDASIL 9, and was 5 weeks pregnant at the time of administration; This spontaneous prospective pregnancy report was received from a 29 year old female patient. The patient had no medical history, concurrent conditions, and historical drugs were not reported. The last menstrual period of  the patient was reported as 06-JAN-202 , and the patient became pregnant on 20-JAN-2020,   On 12-FEB-2020, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in the arm muscle(strength, route, dose, frequency, lot # and expiration date were unknown) for prophylaxis, and was 5 weeks pregnant at the time of administration. The patient stated that was her first dose and only dose she received of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exposure during pregnancy).   Additionally, the patient stated that she was on the medroxyprogesterone acetate(DEPO-PROVERA) shot at the time, and did not know she was pregnant, and stated that she now takes unspecified "prenatal vitamins", but was not taking them when she received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). She stated that her due date was 12 -OCT-2020, the pregnancy outcome was pending. The patient did not seek for medical attention and no treatment was given for the adverse event.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Urticaria
Clinical narrative: an outbreak of HIVES; lhe hives were "super uncomfortable"; This spontaneous report was received from a 65-year-old female patient referring to herself. The patient's drug reactions/ allergies included sulfa. The patient had no concomitant medications or pertinent medical history.  On 29-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, lot # and expiration date were not reported) via intramuscular route for prophylaxis.    On 30-JUL-2020, the patient experienced an outbreak of HIVES, which were "super uncomfortable" but not life threatening. Treatment diphenhydramine hydrochloride (BENADRYL) was given. The outcome of the events was recovering. The patient confirmed it was not anaphylactic shock, but a possible reaction from the syringe/vaccine's administration itself. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 62.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: significant pain, swelling, redness, and itching around the injection site.; significant pain, swelling, redness, and itching around the injection site.; significant pain, swelling, redness, and itching around the injection site.; significant pain, swelling, redness, and itching around the injection site.; Swelling was from the top of the patient's shoulder down to her elbow.; This spontaneous report was received from a pharmacist referring to a 62 years old female patient. The patient's pertinent medical history, concomitant medication and concurrent condition were not provided.    On 29-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml syringes; route, strength, lot# and expiration date were not provided) for prophylaxis.  On 30-JUL-2020 (the next day), the patient experienced significant pain, swelling, redness, and itching around the injection site. It was reported that the swelling was significant enough that you could see it. Swelling was from the top of the patient's shoulder down to her elbow. The swelling got worse every day until this morning. The patient took diphenhydramine hydrochloride (BENADRYL) for treatment. At the reporting time, it did look better but still itches. The outcome of the events was reported as recovering.  The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were not provided.  This is one of the linked reports from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2008USA001082: US-009507513-2008USA001498:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; Nurse reported that GARDASIL 9 was administered to one patients since the reported excursion on August 4, 2020; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies were not provided.      On 04-AUG-2020, the temperature excursion of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was 33.8 degrees Fahrenheit  for 4 hours and 33 minutes and 35.2 degrees Fahrenheit (below 36 degrees Fahrenheit) for 2 hours and 47 minutes. On 05-AUG-2020, at 14:00, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 milliliter, lot # S020255, expiration date 09-DEC-2021; strength and frequency were unknown) intramuscularly for prophylaxis (product storage error). There was no previous temperature excursion. Data logger was involved. There was no additional adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020255; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a patient that received her first dose of GARDASIL 9 at the age of 12 and received the second dose one month later instead of 6 months later; No other AE; Information has been received from a medical assistant referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not provided.      On an unknown date, the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot # and expiration date were unknown) at the age of 12 and received the second dose one month later instead of 6 months later (inappropriate schedule of product administration). The reporter was inquiring if the patient now needed a third dose. No other adverse event were reported.
Age: 36.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No other AE reported at this time.; gave an MMR II injection IM instead of SubQ; This spontaneous report has been received from a medical assistant referring to a 36 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.      On 06-AUG-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S023654 with expiration date 30-JUL-2021) for prophylaxis via intramuscular instead of subcutaneous (incorrect route of product administration). No other adverse event was reported.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: she was pregnant sometime after; No further adverse event reported; This spontaneous prospective pregnancy report was received from the patient's family member referring to a 32 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 13-JUN-2020 the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route, lot# and expiration date were not reported) for prophylaxis.   The patient was found out she was pregnant sometime after (exposure during pregnancy). The patient's  last period (LMP) was 15-JUN-2020. Date of conception was assumed as 29-JUN-2020 and the estimated due date (EDD) was 22-MAR-2021. Pregnancy outcome was pending. No further adverse event reported and no product complaint.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect; a patient received improperly stored PROQUAD; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.   On 21-JUL-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength, vaccination scheme frequency, route of administration and anatomical site of vaccination were not provided; lot number S027466 has verified to be valid, expiration date was reported and validated as 02-MAR-2021) as prophylaxis (product storage error). It was reported that the sterile diluent used to reconstitute the vaccine was properly stored (lot number and expiration date was not provided).   The administered vaccines were stored in a temperature of 47 degrees Fahrenheit (F) to 77 degrees F (66 degrees F) for 3 days, as recorded by a data logger. There was no previous temperature excursion reported. No adverse effect was reported.
Age: 8.0
Sex: M
Vaccine: HEPA, UNK
Symptoms: Expired product administered
Clinical narrative: an 8 year old male was administered an expired VAQTA on August 8, 2020. The vaccine was expired on July 24, 2020.; This spontaneous report was received from a registered nurse referring to an 8 years old male patient. The patient's pertinent medical history, concomitant medication and concurrent condition were not provided.     On 08-AUG-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (1 dose, lot# S007768, expiration date 24-JUL-2020; strength and route were not provided) for prophylaxis (expired product administered).  The outcome of expired product administered was unknown. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. Devicelotnumber: S007768; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: She received her pneumacocal 13 vaccine. She has not received the next shot yet/the vaccine shots are a year apart; This spontaneous report was received from a female patient of unknown age referring to herself. In August 2019 (one year apart), the patient received pneumococcal 13v conj vaccine. The patient's pertinent medical history, concomitant medication and concurrent condition were not provided.       The patient's next shot was the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (scheduled on 03-AUG-2020) (route was reported as injection; dose detail, strength, lot# and expiration date were not provided), but she had not received it yet. The patient stated that she got the vaccines a year apart from each other. When the year was up, she had not received the next shot yet (inappropriate schedule of product administration). The outcome of inappropriate schedule of product administration was unknown.  This is one of the linked reports from the same reporter.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site macule, Injection site swelling, Product administered at inappropriate site, Pruritus, Varicella
Clinical narrative: she broke out into live chicken pox; the injection site began to lump up and swell; the injection site began to lump up and swell; she was administered the shot in the left side of her stomach and not the upper backside of her arm; This spontaneous report was received from a consumer referring to herself, a 21 year old female patient. Information regarding her pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On 18-JAN-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 injection, received the shot in the left side of her stomach and not the upper backside of her arm (product administered at inappropriate site), lot # R009409 with expiration date 29-MAR-2020, as part of an immunization update, as she was applying for an internship and was required to receive the vaccine.  On 25-JAN-2019, reported as exactly one week after receiving the shot, the injection site began to lump up and swell (injection site mass and injection site swelling), and she broke out into live chickenpox (varicella). She sought for medical attention and her primary doctor misdiagnosed her symptoms for eczema, and prescribed triamcinolone acetonide ointment, which helped her improve the itching. At the reporting time, the patient stated that she had not yet recovered from the adverse experience and that she still had bumps on her skin from the chickenpox outbreak.  The causality assessment between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided by the reporter.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Rash
Clinical narrative: she broke out into live chicken pox; the injection site began to lump up and swell; the injection site began to lump up and swell; she was administered the shot in the left side of her stomach and not the upper backside of her arm; This spontaneous report was received from a consumer referring to herself, a 21 year old female patient. Information regarding her pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On 18-JAN-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 injection, received the shot in the left side of her stomach and not the upper backside of her arm (product administered at inappropriate site), lot # R009409 with expiration date 29-MAR-2020, as part of an immunization update, as she was applying for an internship and was required to receive the vaccine.  On 25-JAN-2019, reported as exactly one week after receiving the shot, the injection site began to lump up and swell (injection site mass and injection site swelling), and she broke out into live chickenpox (varicella). She sought for medical attention and her primary doctor misdiagnosed her symptoms for eczema, and prescribed triamcinolone acetonide ointment, which helped her improve the itching. At the reporting time, the patient stated that she had not yet recovered from the adverse experience and that she still had bumps on her skin from the chickenpox outbreak.  The causality assessment between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided by the reporter.
Sex: M
Vaccine: MEN
Symptoms: Gait disturbance, Malaise, Pyrexia, Vaccination complication
Clinical narrative: high fever; was so sick; couldn't walk; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced fever, sickness and walking difficulty. On an unknown date, the outcome of the fever, sickness and walking difficulty were recovering/resolving.   It was unknown if the reporter considered the fever, sickness and walking difficulty to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient had a severe reaction to this vaccine. The patient was so sick, he had a high fever and couldn't walk for a week. It was a slow recovery.  The parent stated that they would never put any children through this again.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: lower arm pain; shoulder pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In July 2020, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm and shoulder pain. On an unknown date, the outcome of the pain in arm and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had lower arm and shoulder pain very similar to when the patient had shingles in other arm.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: Sore throat; Headache; This case was reported by a consumer via interactive digital media and described the occurrence of sore throat in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced sore throat and headache. On an unknown date, the outcome of the sore throat and headache were unknown.   It was unknown if the reporter considered the sore throat and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient vaccinated with Shingrix vaccine 2 days ago and now had sore throat and headache
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Body rash; This case was reported by a consumer via interactive digital media and described the occurrence of generalized rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovered/resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had a body rash from Shingrix for four days.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Incomplete course of vaccination, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 1 of Shingrix a year ago and has not yet gotten dose 2; felt "crummy"; red, swollen, sore arm at the injection site; Swollen, sore arm at the injection site; Sore arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In August 2019, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On 24th August 2019, the patient experienced feeling bad and injection site erythema. On an unknown date, the patient experienced incomplete course of vaccination. On 31st August 2019, the outcome of the feeling bad and injection site erythema were recovered/resolved. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the feeling bad, injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional information was provided as follows: The patient received dose 1st dose of Shingrix a year ago and has not yet gotten dose 2 within the recommended time frame which led to incomplete course of vaccination. The patient received dose 1, and she felt crummy and had a red, swollen, sore arm at the injection site that lasted for one week and then resolved. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: developed a rash on her face/Arm/chest; This case was reported by a consumer via call center representative and described the occurrence of rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix and an unknown time after starting prednisone, the patient experienced rash. The patient was treated with prednisone and famotidine (Pepcid). On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The reporter reports that the patient received the shingrix and developed a rash on her face,arms and chest.  The reporter put patient on Pepcid and prednisone but was not able to diagnose what kind of rash patient had developed. The follow up consent was not granted.
Age: 0.58
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: received dose 1 on 6/17/2001 (birth) and dose 2 on 01/25/2002; received dose 1 on 6/17/2001 (birth) and dose 2 on 01/25/2002.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 19-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 17th June 2001).   On 25th January 2002, the patient received the 2nd dose of Engerix B. On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long and incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.  Additional information was provided as follows: The patient who was going to College and was required Engerix B vaccination but looking on his records patient received dose 1 on 17th June 2001 and dose 2 on 25th January 2002 which led to lengthening of vaccination schedule. The patient did not received 3rd dose of Engerix B which led to incomplete course of vaccination. The pharmacist wanted to enquire that if the patient need to restart vaccination course. The reporter consented for follow up.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old male patient who experienced expired vaccine used, while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via intramuscular route in the left arm.  The patient developed a non-serious expired vaccine used (expired product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  (Other relevant tests included No lab data.) Final diagnosis was expired vaccine used.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Applicable for expired vaccine used.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.