chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, TD
Symptoms: Syncope
Clinical narrative: Patient here for vaccine only appointment . Vaccines given at 3:45P Due to receive today per  Shots & checked by employee: Flulaval, TD, Hep A, Hep B, HPV, IPV. PTID x 2 Allergies reviewed. VIS given to parent & after care of vaccine discussed. Vaccine checked by provider. T emp 98 RN Child fell off bed suddenly after vaccines were given at & fell onto scale floor face down. Child had just spoken to Uncle & myself & gave no signs of fainting. Child placed on bed ,lying on back in trendelenburg by uncle & myself. Bleeding noted from under left nostril & right bottom lip. Child responding & denied any pain with red area on top of right hand & right temporal area. . Seen by employee & Dr. BP 110/80, P 59,RR 20 & O2 sat 99. Given juice & tolerated well. Kept for observation. V/S at 4:10P BP 110/54,P 87, RR 24 & O2 sat 99. Child denies nausea,dizziness,blurry vision,headache or any other pain. Staes a bit sleepy. Seen by DR at 4:25 P . Child still denies pain sleepiness at this time or any other sx. Child is living with Uncle,as parents are in another country. Instructed to watch for child unable to stay awake (except during night time, when he will wake child every 2 hrs) , nausea vomiting, headache,blurry vision,dizziness. Please take to ER if he has any of these sx. Given antibiotic oint to use on cut under nostril. If any pus is seen for either cut please have checked. Given appointment for 11/12/19 3:30P with Dr for follow up. Aware he can call our office 24 hrs per day & there will be a covering doctor he can speak with. Uncle voiced understanding. RN
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Loss of consciousness
Clinical narrative: severe dizziness, passed out twice, nausea, severe headache, body ache, chills alternating with sweats lasting for 24 hours.  She had a similar reaction after the 1st dose, but less severe.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: severe dizziness, passed out twice, nausea, severe headache, body ache, chills alternating with sweats lasting for 24 hours.  She had a similar reaction after the 1st dose, but less severe.
Age: 39.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Influenza like illness, Malaise, Pain
Clinical narrative: My arm is red and sore. Large area has developed under injection site in right arm that is swollen, red, hot to touch, and very painful. I developed flu like symptoms within 2 hours or receiving the vaccine which lasted for 48 hours, which included fever, body aches all over, tiredness and general malaise.
Age: 39.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: My arm is red and sore. Large area has developed under injection site in right arm that is swollen, red, hot to touch, and very painful. I developed flu like symptoms within 2 hours or receiving the vaccine which lasted for 48 hours, which included fever, body aches all over, tiredness and general malaise.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Lethargy, Myalgia
Clinical narrative: MUSCLE PAIN FATIGUE WEAKNESS FEVER CHILLS LETHARGIC
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: MUSCLE PAIN FATIGUE WEAKNESS FEVER CHILLS LETHARGIC
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: During  the evening the inner aspect of the patient's upper arm became painful, red, swollen, and hot to the touch.  This was not in the area of the injections, which had been given in the deltoid.   A few days later (unable to determine when), she developed a "bruised looking  area in the same spot, brownish in color."   She took Tylenol and Benadryl the first two days.  Patient states that it was five days until her arm looked "normal" again.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscular weakness, Pain
Clinical narrative: On 11/16/2019, patient briefly stopped by the clinic and stated that he has had pain and weakness of his left shoulder since he received flu vaccine on 9/6/19. Per patient, he is unable to raise his left shoulder and arm up to 90 degree. He feels pain with movement of the affected site. Patient denies numbness or tingling of left shoulder and arm.  We suggested diagnostic test and treatment for pain but patient declined.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased, Dizziness, Dry mouth, Laboratory test
Clinical narrative: Went to the ER with severe dizziness, light-headedness, and dry mouth.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Vaccine was reconstituted with sterile water, no diluent that comes with menveo.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Seizure, Syncope
Clinical narrative: Post Gardasil Vaccine Syncopal Event Syncope x ~3 seconds, seized, and regained consciousness after Gardasil shot was given. Patient states she passed out from shots when she was in 6th grade. Patient states she has a hx of fainting from blood draws. Last time she fainted from blood draw was this year.  Insists to take her exam, "I cant get out of it."  Last meal more than six hours prior. Given croissant to eat and stayed in office until felt better.   5:15 PM BP: 101/52, Pulse: 52 - laying 5:24 PM: BP:107/64, Pulse: 58 - laying  5:30 PM: BP: 108/72, Pulse 66 - sitting  5:38 PM: BP: 111/71 , Pulse 60 - sitting 5:47 PM: BP 114/81, Pulse 66 - sitting  5:52 PM: BP 111/66, Pulse 66  - standing 6:01 PM: BP 118/75 Pulse 78 - standing  Patient is going to get her 2nd HPV at home
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site bruising, Insomnia, Malaise, Myalgia
Clinical narrative: 1. Night of the vaccine, 11/12/19, chills, extreme shivers, slight fever of one degree, malaise, inability to sleep, muscle soreness all over body. 2. Next day 11/13/19, shivers and fever subsided, continued malaise and muscle soreness. Appearance of very dark bruise at injection site. 3. Next day, 11/14/19, felt better in terms of malaise but  a  raised, pink, hot rash appeared 2 inches BELOW the injection site. The rash was approx 4 inches horizontally across upper outer left arm and approx 3 inched lengthwise. So a rectangle of 4"x3," appearing as if someone had slapped me hard laterally across the arm. It felt warm to the touch. It did NOT itch. It was very marked and surprising to anyone who saw it. I called the pharmacist who said that as long as it faded and I felt ok that it was possibly a reaction from the vaccination but that would go away on its own. Since I did FEEL better and was not in pain, I decided to wait and see rather than go to my doctor.  Over the next several days, it gradually faded away without issue. Today 11/20/19 it is only barely visible as a slight pink blush. The blue bruise is fading but is still quite visible at the injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash erythematous, Skin discolouration, Skin warm
Clinical narrative: 1. Night of the vaccine, 11/12/19, chills, extreme shivers, slight fever of one degree, malaise, inability to sleep, muscle soreness all over body. 2. Next day 11/13/19, shivers and fever subsided, continued malaise and muscle soreness. Appearance of very dark bruise at injection site. 3. Next day, 11/14/19, felt better in terms of malaise but  a  raised, pink, hot rash appeared 2 inches BELOW the injection site. The rash was approx 4 inches horizontally across upper outer left arm and approx 3 inched lengthwise. So a rectangle of 4"x3," appearing as if someone had slapped me hard laterally across the arm. It felt warm to the touch. It did NOT itch. It was very marked and surprising to anyone who saw it. I called the pharmacist who said that as long as it faded and I felt ok that it was possibly a reaction from the vaccination but that would go away on its own. Since I did FEEL better and was not in pain, I decided to wait and see rather than go to my doctor.  Over the next several days, it gradually faded away without issue. Today 11/20/19 it is only barely visible as a slight pink blush. The blue bruise is fading but is still quite visible at the injection site.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site indentation, Injection site pain
Clinical narrative: Patient called around 7:30 p.m. on the day of the vaccination to report that he has been experiencing  significant pain in his left upper arm since he received the vaccination.  He said the pain is located at the upper deltoid area.  He said that if you lift your arm up, you can feel an indentation in the upper arm and that's where the pain is located and that's where he received the vaccination.  He said the pain is significant enough that he will not be able to go to the gym tomorrow and he had trouble using a blower doing his yard work.  He did not say that he is going to go to a doctor for treatment.  He said he's going to use Acetaminophen and heat/ice to treat the pain.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Blood test, Erythema, Peripheral swelling, Ultrasound scan
Clinical narrative: Patient states when she got home from receiving the vaccine, her arm turned red. The following morning she went to the hospital because it became more red and swollen. Patient states the hospital did blood work and ultrasound. After the tests were done, patient went home and it got worse. Patient then went to the ER and they diagnosed her with a bacterial infection and provided antibiotics.
Age: 87.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema
Clinical narrative: Patient received flu shot on 10/24, and returned to pharmacy on 11/20 to report injection site reaction. Patient reports small red spot still present at site of administration. (she declined to show me, but said it is smaller than the head of an eraser). She said it is not itchy, raised, hard, warm, painful, or otherwise bothersome - just that it is red and still present and she wanted to make note of it. She just noticed it now, she did not know when it had started, and has no other complaints related to the vaccine or administration
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Hypertension
Clinical narrative: isolated hypertensive event occurred approximately 1 hour after vaccination, pt proceeded to go to urgent care, at which point they identified this as an isolated hypertensive event, no treatment changes. Pt was advised to return home that evening.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt states the day after the IMZ, her arm was red and swollen for about 4 days and then went away.  She states it was clear for about 2-3 days and then she started painting yesterday and her arm got red and hot today.  I told her to ice it and take APAP (she can't take NSAIDs).  If it doesn't get better she should see the dr.
Age: 94.0
Sex: M
Vaccine: FLUX
Symptoms: Aggression, Agitation, Depressed level of consciousness, Encephalitis, Lethargy
Clinical narrative: Flu vaccine - not sure what kind.  Paper simply says Influenza Vaccine Inactivated or Recombinant.  Patient was given shot and became increasingly combative and ripped out his IV twice.  He was on a Milrinone drip at the time.  He was first given benadryl in an attempt to allow him to sleep.  His agitation got worse over several more hours.  He was then given 0.5mg of ativan IV push.  He immediately fell asleep.  The next morning it was discovered that he failed to regain full consciousness and was extremely lethargic and difficult to arouse.  It was assumed at the time that this was the result of the ativan not clearing his system.  However, over the course of the day, he remained unconscious for the most part without any signs of improvement.  Suspecting the vaccine was causing encephalitis, he was given 200mg of Ibuprofen at 4:30pm that day.  His condition slowly started improving and he became increasingly easier to arouse.  By the next morning, he was able to open his eyes spontaneously and walk with assistance.
Age: 94.0
Sex: M
Vaccine: FLUX
Symptoms: Loss of consciousness
Clinical narrative: Flu vaccine - not sure what kind.  Paper simply says Influenza Vaccine Inactivated or Recombinant.  Patient was given shot and became increasingly combative and ripped out his IV twice.  He was on a Milrinone drip at the time.  He was first given benadryl in an attempt to allow him to sleep.  His agitation got worse over several more hours.  He was then given 0.5mg of ativan IV push.  He immediately fell asleep.  The next morning it was discovered that he failed to regain full consciousness and was extremely lethargic and difficult to arouse.  It was assumed at the time that this was the result of the ativan not clearing his system.  However, over the course of the day, he remained unconscious for the most part without any signs of improvement.  Suspecting the vaccine was causing encephalitis, he was given 200mg of Ibuprofen at 4:30pm that day.  His condition slowly started improving and he became increasingly easier to arouse.  By the next morning, he was able to open his eyes spontaneously and walk with assistance.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: The patient received a flu shot at an offsite flu clinic on  10/29/2019 and informed me on 11/13/19 she feels the flu shot received was given in her shoulder/may have struck a nerve. She mentioned this has affected her daily activities and received a prescription earlier for Ibuprofen 800 mg from her doctor because she has ongoing pain.   On 11/15/19, she stated she's not feeling much better and felt the Ibuprofen was not working. The doctor gave her a short course of steroids on 11/15/19 to try instead.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: PATIENT FAINTED
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Shingrix
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: PATIENT HAD RASH WITH ITCH ON LEFT ARM AND PATIENT WENT TO PCP ON 11/20/19. PCP DETERMINED PATIENT HAS SHINGLES.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Back pain, Contusion, Dizziness, Epistaxis
Clinical narrative: Swelling, bruising, painful, warm to the touch (about size of a baseball).  For 2 or 3 weeks then got a little better.   Then on Nov 17th the arm swelled up again.  Painful, warm to the touch, bruising, about the size of a baseball again.  Also had joint pain in the left arm.  Neck was also sore as was her back.   She is also having dizziness.  She also had pain above her left eye. She also had a bloody nose every morning for 6 days in a row between episodes of her sore arm.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Headache, Neck pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swelling, bruising, painful, warm to the touch (about size of a baseball).  For 2 or 3 weeks then got a little better.   Then on Nov 17th the arm swelled up again.  Painful, warm to the touch, bruising, about the size of a baseball again.  Also had joint pain in the left arm.  Neck was also sore as was her back.   She is also having dizziness.  She also had pain above her left eye. She also had a bloody nose every morning for 6 days in a row between episodes of her sore arm.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: Patient states that the next day (11/12/19), typical local site reactions occurred (pain at injection site, tenderness, warmth in the upper arm, and redness). Starting two days after injection, the pain had subsided, but redness began to spread further down the arm. This continued until it reached the elbow. On today's date (10/20/19), the redness in the skin has begun to subside. Patient denies any pain or swelling with the redness, but mentioned a slight itchiness initially. When asked what measures she has taken, she stated she has taken ibuprofen, but no diphenhydramine because she was unsure that it was an allergic type reaction.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Pt states 1 week after vaccination she developed swelling, redness, a hot feeling, and itchiness over her entire arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Fever, chills, body aches, site tenderness, swelling, warmth x 3 weeks
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, body aches, site tenderness, swelling, warmth x 3 weeks
Age: 66.0
Sex: F
Vaccine: FLUA3, PNC13, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Patient said she developed blister rash on her face under her eye - she visited a physician & was prescribed Valacyclovir.
Age: 79.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Nodule, Pain in extremity
Clinical narrative: extreme painful knot in arm immediately after given
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: pt developed sore arm immediately after shingles #2, still very painful 3 mos after shot. Tolerated #1 ok.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood glucose normal, Blood pressure increased, Chills, Dizziness
Clinical narrative: -Local reaction "lump", soreness, redness/rash -Blood pressure 170/90, unusually elevated -Weak, light headed -Blood sugar less than 100 -Chills, couldn't get warm
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling cold, Local reaction, Mass, Pain
Clinical narrative: -Local reaction "lump", soreness, redness/rash -Blood pressure 170/90, unusually elevated -Weak, light headed -Blood sugar less than 100 -Chills, couldn't get warm
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: -Local reaction "lump", soreness, redness/rash -Blood pressure 170/90, unusually elevated -Weak, light headed -Blood sugar less than 100 -Chills, couldn't get warm
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Skin warm
Clinical narrative: Patient presented with a red, raised, itchy rash, that started a day after getting vaccines at the pharmacy 11/18/19. Area is warm to touch. Patient placed on diphenhydramine 25mg., cimetidine 200mg and Doxycycline Hyclate 100mg.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Mild rash began 11/13/19, seen in office 11/20/19. Fine, pink (faint) blotchy rash on trunk, shoulders, thighs). Asymptomatic
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hypoaesthesia, Nausea, Stomatitis
Clinical narrative: Numbness in right hand and lower right leg Sores in mouth requiring treatment Nausea and chills for 3 weeks
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: -Very sore arm. Constant issues -Keeps me from sleeping (no sleep on left side) -Wakes me up -Cannot extend arm overhead as usual
Age: 10.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia, Wrong product administered
Clinical narrative: RPh administered Shingrix instead of Fluzone by mistake. Patients mother reported patient woke up following morning with headache and fever. Symptoms were relieved with Advil.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Cold sweat, Feeling abnormal, Headache
Clinical narrative: Within 2 hours this patient reported feeling feverish, clammy, backache headache, chills, shakes. Patient felt like she was in a fog or daze.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: Within 2 hours this patient reported feeling feverish, clammy, backache headache, chills, shakes. Patient felt like she was in a fog or daze.
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Muscular weakness, Nerve conduction studies abnormal, Neuralgic amyotrophy
Clinical narrative: Parsonage Turner syndrome/still has weakness in his left arm; limitation of arm movement; This is a spontaneous report from a contactable physician who reported for himself, a 78-year-old male patient who received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot/batch number and expiry date not provided), intramuscular in his left arm on 2015 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in his left arm in 2015 and six weeks later, he developed Parsonage Turner syndrome and still has weakness in his left arm. He has had nerve studies done and it looks as though it may be permanent. He was trying to get more details on the reports of "limitation of arm movement" reported with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The patient wanted to know what caused the limitation, if it was muscle soreness, weakness due to a neurological issue or was it a frozen shoulder and how long it would last. He has seen online on a vaccine board that reports injuries that brachial neuritis was reported under shoulder injuries specifically related to measles, mumps and possible influenza vaccine. The patient also wanted to know if brachial neuritis been reported with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and if that was what was causing limitation of arm movement. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: The reported event of Parsonage Turner syndrome is considered as unrelated to PREVENAR 13 due to the absence of a biological plausibility.  The event more likely represents an intercurrent medical condition.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: severe pain in left arm at injection site
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: severe pain in left arm at injection site
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Peripheral swelling
Clinical narrative: Pt stated, "one week later arm became swollen  and tingly at injection site.  She obtained some white cream from her friend that is used in another country for allergy. She used it for 2 to 3 days and the swelling went away.  After the swelling went away; she stopped feeling anything in her left arm."
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site paraesthesia, Injection site swelling
Clinical narrative: Pt stated, "one week later arm became swollen  and tingly at injection site.  She obtained some white cream from her friend that is used in another country for allergy. She used it for 2 to 3 days and the swelling went away.  After the swelling went away; she stopped feeling anything in her left arm."
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Myalgia, Pain
Clinical narrative: Severe flu-like symptoms: muscle or body aches as well as extreme fatigue (tiredness) that started approximately 5 hours after receiving the vaccination and lasted for 2.5 days afterwards.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: chills and fever started around 2:30am, shivering occurred for an hour and a half
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Diarrhoea, Injection site reaction, Injection site urticaria, Rash macular, Urticaria
Clinical narrative: 5 mins after shot (red, blotchy 1.5 cm urticarial on leg), 10 mins after shot (hives on stomach, thigh wasn't worse), diarrhea.  Benedryl given in office.
Age: 37.0
Sex: U
Vaccine: FLU4, FLU4, VARCEL
Symptoms: Asthenia, Diarrhoea, Herpes zoster, Hyperhidrosis, Hypotension
Clinical narrative: AFTER RECEIVING THE VARICELLA IN THE UPPER LEFT ARM, THE NEXT DAY I BEGAN HAVING A RASH ON THE LEFT SIDE OF MY SHOULDER AND BACK. A COUPLE OF WEEKS LATER THE PAIN AND ITCHING WAS SO BAD I SAW MY PCP. I WAS THEN DIAGNOSED WITH SHINGLES. I MISSED A MONTH OF WORK, APPROX. CAN'T REMEMBER THE YEAR, 2008-2010. TWICE AFTER HAVING THE FLU VAC WITHIN 20 MINUTES I BECAME PALE, DIAPHORETIC, TACHYCARDIC, HYPOTENSIVE, WEAK, BODY ACHES AND PAIN, VERTIGO AND SEVERE NAUSEA/DIARRHEA. LATER FEVER. I NOTIFIED MY SIPERVISOR WHO SENT ME HOME. I MISSED APPROX 2-4 WEEKS OF WORK. (CONT.)
Age: 37.0
Sex: U
Vaccine: FLU4, FLU4, VARCEL
Symptoms: Injection site rash, Loss of personal independence in daily activities, Nausea, Pain, Pallor
Clinical narrative: AFTER RECEIVING THE VARICELLA IN THE UPPER LEFT ARM, THE NEXT DAY I BEGAN HAVING A RASH ON THE LEFT SIDE OF MY SHOULDER AND BACK. A COUPLE OF WEEKS LATER THE PAIN AND ITCHING WAS SO BAD I SAW MY PCP. I WAS THEN DIAGNOSED WITH SHINGLES. I MISSED A MONTH OF WORK, APPROX. CAN'T REMEMBER THE YEAR, 2008-2010. TWICE AFTER HAVING THE FLU VAC WITHIN 20 MINUTES I BECAME PALE, DIAPHORETIC, TACHYCARDIC, HYPOTENSIVE, WEAK, BODY ACHES AND PAIN, VERTIGO AND SEVERE NAUSEA/DIARRHEA. LATER FEVER. I NOTIFIED MY SIPERVISOR WHO SENT ME HOME. I MISSED APPROX 2-4 WEEKS OF WORK. (CONT.)
Age: 37.0
Sex: U
Vaccine: FLU4, FLU4, VARCEL
Symptoms: Pruritus, Pyrexia, Rash, Tachycardia, Vertigo
Clinical narrative: AFTER RECEIVING THE VARICELLA IN THE UPPER LEFT ARM, THE NEXT DAY I BEGAN HAVING A RASH ON THE LEFT SIDE OF MY SHOULDER AND BACK. A COUPLE OF WEEKS LATER THE PAIN AND ITCHING WAS SO BAD I SAW MY PCP. I WAS THEN DIAGNOSED WITH SHINGLES. I MISSED A MONTH OF WORK, APPROX. CAN'T REMEMBER THE YEAR, 2008-2010. TWICE AFTER HAVING THE FLU VAC WITHIN 20 MINUTES I BECAME PALE, DIAPHORETIC, TACHYCARDIC, HYPOTENSIVE, WEAK, BODY ACHES AND PAIN, VERTIGO AND SEVERE NAUSEA/DIARRHEA. LATER FEVER. I NOTIFIED MY SIPERVISOR WHO SENT ME HOME. I MISSED APPROX 2-4 WEEKS OF WORK. (CONT.)
Age: 0.25
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Afluria Vaccine at 3 months old at Flu Line. (no adverse symptoms)
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site irritation, Injection site scab
Clinical narrative: Pt relates that the area that the shot was given got red, irritated and scabbed starting the day after(10/1/2019). He says he used Neosporin on it. He came in late afternoon yesterday(11/20/2019) to report it and there was a small red mark on his arm. I related due to his concerns that he could see his provider and that I would report it.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: The evening of the vaccination I began to experience some achiness in my neck and shoulders.  Overnight I developed a crushing headache, fever, the achiness spread to my entire body and I felt nauseous.  I also had the sore arm which was totally expected given the intramuscular injection.  I went to work the following morning but had to leave early as the symptoms continued to increase to an unmanageable level.  The headache intensified and the fever rose.  I couldn't lift my head to do anything.  I am now on the second day post-vaccination and most of the symptoms still remain but at a much more manageable level.  I did not seek any medical treatment for the symptoms, living alone and being as sick as I was I couldn't have even if I needed to.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: The evening of the vaccination I began to experience some achiness in my neck and shoulders.  Overnight I developed a crushing headache, fever, the achiness spread to my entire body and I felt nauseous.  I also had the sore arm which was totally expected given the intramuscular injection.  I went to work the following morning but had to leave early as the symptoms continued to increase to an unmanageable level.  The headache intensified and the fever rose.  I couldn't lift my head to do anything.  I am now on the second day post-vaccination and most of the symptoms still remain but at a much more manageable level.  I did not seek any medical treatment for the symptoms, living alone and being as sick as I was I couldn't have even if I needed to.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Arthritis, Joint injection, Joint swelling, X-ray limb abnormal
Clinical narrative: Swelling  in knees, pain - ibuprofen, ice, super CBD Dragon Balm Cortisone shot in knee, naproxen, biofreeze - pain relieved for 2 weeks Physical therapy - 8 sessions - relief of pain
Sex: U
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site inflammation
Clinical narrative: Redness (cellulitis like) on the injection site (upper deltoid muscle); Inflammation; Redness (cellulitis like) on the injection site (upper deltoid muscle); This is a spontaneous report from contactable Pharmacist via Pfizer Sales Representative.  A patient of unspecified age and gender received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced inflammation, redness (cellulitis like) on the injection site (upper deltoid muscle), non-serious,  on an unspecified date after vaccination. The outcome of the events was unknown.  The information on the batch/lot number has been requested.; Sender's Comments: Based on the information currently available, it cannot be fully excluded that vaccination with PREVNAR 13 may play a contributory role in triggering the onset of cellulitis like reaction on the injection site.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect reported.; schedule: "8/18/2011, 1/11/2012, and 2/13,2012".; This spontaneous report was received from a consumer referring to her 15 years old female patient daughter. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.  The patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, route, lot # and expiration date were not provided) for prophylaxis on the following schedule: "18-AUG-2011, 11-JAN-2012 and 13-FEB-2012" (inappropriate schedule of product administration). No adverse effect was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA008183:
Age: 33.0
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported.; a patient received an expired dose of VARlVAX; Information was received from a medical assistant referring to a 33 years old male patient. The patient's medical history, concurrent condition and concomitant medications were unknown.  On 24-OCT-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N023961, expiration date 01-SEP-2019; dose and strength were unknown) subcutaneously for prophylaxis along with sterile diluent (STERILE DILUENT) (lot # N026288, expiration date 8-FEB-2020, dose and strength were unknown). The varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. No adverse effects were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015506:
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: vaccine exposure during pregnancy; No effects reported; She received GARDASIL 9 because the nurse grabbed the wrong vaccine. The consumer could not confirm if confusion or human error by the nurse.; This spontaneous report was received from a 32-year-old female pregnant patient referring to herself.           The patient's medical history and concurrent conditions were not provided. Her concomitant therapies included pre-natal vitamins (unspecified).     At the time of reporting the patient was pregnant with 28 weeks and 2 days. The fetus was believed to be male by the physician.   On 21-OCT-2019 (26 weeks of gestational age), the patient was supposed to be vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (TDAP). However, on that day, according to her chart, she was instead vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscularly in the right gluteus (dose, frequency, lot#, and expiration date were not provided) for prophylaxis (Wrong product administered and vaccine exposure during pregnancy). The reason given was ''because the nurse grabbed the wrong vaccine". The consumer could not confirm if it was a confusion or human error by the nurse. No adverse event was reported. At the time of the report, the pregnancy outcome was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received improperly stored ROTATEQ on an unspecified date; No adverse effect; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On an unknown date, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) one vial/ once,(lot # R033251 with an expiration date in 29-JUN-2020), orally, for prophylaxis (strength was not provided), that underwent an unspecified temperature excursion, during a time frame of 60 hours. There was no previous temperature excursion, but digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Redness below the injection site; Swelling below the injection site; tired and fatigued; This spontaneous report was received from a consumer of unknown age and gender reporting on her/himself through customer survey. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis.  On an unknown date, the patient experienced Redness and swelling below the injection site for three days (injection site erythema and injection site swelling). Additionally, the patient experienced fatigue and was tired. She/he enquired if it was normal for pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).  At the time of the report, the outcome of injection site erythema, fatigue and injection site swelling was not provided.  The reporter did not assess the relatedness between injection site erythema, fatigue and injection site swelling with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: A patient was administered a dose of improperly stored ROTATEQ; No adverse effects; This spontaneous report was received from a medical assistant referring to a patient, age and gender were not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date, the patients were vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally,  for prophylaxis (lot # S000961 has been verified to be a valid lot number stored rotavirus vaccine, live, oral, pentavalent, expiration date reported and establish as 19-OCT-2020) (strength, dose and frequency were not provided).   The temperature of storage and time frame of the excursion were above 47° Fahrenheit and 37 minutes. A digital data logger was involved but there was no previous temperature excursion. No adverse effect was reported.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Polymerase chain reaction positive, Rotavirus infection
Clinical narrative: the patient was diagnosed with "an active rotavirus infection 2 weeks ago"; This spontaneous report was received from a nurse prescriber referring to a 6 month old female patient. The patient did not had any pertinent medical history, concomitant therapy or allergies. On 15-JUL-2019, the patient received first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (of lot # R034103, expiration date not reported, but upon internal validation established as 26-JUN-2020) and on 16-SEP-2019, the patient received second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # R030924, expiration date not reported, but upon internal validation established as 10-JUL-2020) via oral route (strength, dose, frequency unknown) for prophylaxis. On an unknown date in 2019, the patient experienced active rotavirus infection. On approximately 04-NOV-2019 (reported as "2 weeks ago"), the above infection was diagnosed by polymerase chain reaction (PCR) test. The patient sought medical attention and seen at physician's office. The patient did not received any treatment for the event. No significant disability, incapacity, seriousness or overdose was reported. On 15-NOV-2019, the event was resolved. Causality assessment was not reported by the reporter. Furthermore, no product quality complaint involved.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Inappropriate schedule of vaccine administered/another child who received GARDASIL on similar, if not the same, dosage dates.; No adverse effect reported.; This spontaneous report was received from a consumer referring to her child of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.  The patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, route, lot # and expiration date were not provided) for prophylaxis. Another patient on the following schedule: "18-AUG-2011, 11-JAN-2012 and 13-FEB-2012". And the patient who received quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) on similar, if not the same, dosage dates (inappropriate schedule of product administration). No adverse effect was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA013789:
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: reddness and swelling from their deltoid to elbow; reddness and swelling from their deltoid to elbow; This spontaneous report was received from a physician via company representative referring to a 66-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medications, drug reactions and allergies were unknown. Approximately on an unknown date in October 2019 (reported as with in the past month), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with lot # S012246, expiration date was not reported, but upon internal validation established as 10-FEB-2021 (dosing details, anatomical location were unknown) via intramuscular route for prophylaxis. Approximately on an unknown date in 2019 (reported as after an unknown amount of time), the patient had redness (erythema) and swelling from deltoid to elbow (peripheral swelling). The patient did not seek medical attention. There was no significant disability or incapacity, hospitalization, life-threatening, cancer and overdose. The outcome of the events erythema and peripheral swelling was recovered on an unknown date in 2019. The causal relationship between the suspect therapy and the events was not provided. No product quality complaint (PQC) involved.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; patient received her second GARDASIL 9 dose one month after the initial injection of the two dose series.; This spontaneous report as received from a medical assistant refers to a female patient of unknown age.   The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 18-NOV-2019, the patient was vaccinated with her second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# expiry date, strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis. It was reported that the second dose was one month after the initial injection of the two dose series (inappropriate schedule of product administration).  No adverse effects were reported in the patient. No other information is available.  The outcome of inappropriate schedule of product administration and no adverse event was unknown.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored dose of PEDVAX and ROTATEQ; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications, drug reactions and allergies were unknown. On 18-NOV-2019, the patient was vaccinated with improperly stored (product storage error) haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) with lot # S006470, expiration date reported as 15-JAN-2021 but upon internal validation established as 15-JAN-2022 and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) with lot # R029818, expiration date 09-JUL-2020 (both suspect therapies dosing details, route, anatomical location were unknown). Both vaccines were at a temperature of 10.1 degree Celsius for a time frame of 1 hour. The previous temperature excursion was 10.6 degree Celsius for 15 minutes. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: vaccination failure; Shingles; Drug dose administration interval too long; This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immune system disorder (at time of vaccination) and sarcoidosis.   On 3rd March 2018, the patient received the 1st dose of Shingrix. On 4th October 2018, the patient received the 2nd dose of Shingrix. On 4th October 2018, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 6th September 2019, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix later than recommended schedule, which led to lengthening of the vaccination schedule. The patient came down with Shingles. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain
Clinical narrative: pain in the whole body; Can't move her back; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose. On an unknown date, unknown after receiving Boostrix, the patient experienced general body pain and mobility decreased. On an unknown date, the outcome of the general body pain and mobility decreased were unknown.   It was unknown if the reporter considered the general body pain and mobility decreased to be related to Boostrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got pain in her whole body since she got the tdap. The patient could not move her back. The patient asked could anyone else let her know if they received any side effects. The follow up was not required.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter had shingles vaccine 10 years ago when it was only 1 dose and asked do he or she need to have a do over with the 2 injections. The reporter knew someone who had one dose of vaccine and just learned on day of reporting that she now had shingles. The permission to follow up denied.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Headache; Chills; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and chills. On an unknown date, the outcome of the headache and chills were unknown.   It was unknown if the reporter considered the headache and chills to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The patient received Shingrix shot and had a reaction of headache and chills. The patient enquired whether he or she expect this reaction again after receiving the second shot . The permission to follow up was denied.