chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, Product label confusion
Clinical narrative: Expired vaccine administered due to how expiration date is printed on box.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, Product label confusion
Clinical narrative: Expired vaccine administered due to how the expiration date is printed on box. Led to confusion on part of immunizer.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, Product label confusion
Clinical narrative: Expired vaccine administered to patient due to expiration date presentation on box leading to confusion for administering immunizer.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen, sore glands in left armpit., no treatment yet.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given a highdose flu and he is only 59 years old.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Immune system disorder, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: By the next morning, her arm swelled to 3 times normal size and red all the way around from elbow up to shoulder. Also had pain to touch on arm including around the shoulder to the back shoulder blade. She went to ER and doc told her he'd give her a steroid shot but she didn't want one. He said it was her immune system responding and that she should never get one again.... that she was to use ice and rest it to decrease the swelling ie. not overuse it. She had an ALLEGRA (OTC?) in her system from am of 11/16/17 and took another one on 11/17/17 in am as well. She came in to pharmacy 11/20/17 and swelling had gone down.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Two Varicella Vaccines given, one in the combination and one separate.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Vaccine was given on 11/9/2017. She had no soreness or reaction at site until 11/12/2017. The late reaction consisted of a small hard nodule under the injection site that was not visible but it was palpable. She also complained of tenderness at the site. She took Ibuprofen for the discomfort. She reports it was warm to touch on 11/12, but on 11/14/2017 when it was assessed at the health unit it was not warm to touch. She used warm compresses and it improved with decreased soreness and size. Almost gone at this date of 11/20/2017.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Blood magnesium decreased, Blood potassium decreased, Headache, Injected limb mobility decreased, Injection site swelling
Clinical narrative: During my last visit, I received the PNEUMOVAX 23 at your office. A day later I had a fever of 103 and ended up in the ER at Hospital they gave me IV fluids and sent me home thinking that I just had a viral infection. However, the next day I had to go back to the emergency room with swelling on the site of the injection, massive pain, headache, and a high fever. My white blood cells were very high so they gave me strong antibiotics and decided to admit me. I was on antibiotics for three days and my potassium and magnesium went down. The swelling on my arm got worse and I couldn't move my arms. After four days at the hospital they ruled out an infectious disease and came to the conclusion that I had a reaction to the PNEUMOVAX vaccine.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pyrexia, Vaccination complication, White blood cell count increased
Clinical narrative: During my last visit, I received the PNEUMOVAX 23 at your office. A day later I had a fever of 103 and ended up in the ER at Hospital they gave me IV fluids and sent me home thinking that I just had a viral infection. However, the next day I had to go back to the emergency room with swelling on the site of the injection, massive pain, headache, and a high fever. My white blood cells were very high so they gave me strong antibiotics and decided to admit me. I was on antibiotics for three days and my potassium and magnesium went down. The swelling on my arm got worse and I couldn't move my arms. After four days at the hospital they ruled out an infectious disease and came to the conclusion that I had a reaction to the PNEUMOVAX vaccine.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (reporting for herself/himself) of unspecified age, gender and race/ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein) (unknown trade name) on an unspecified date, at single dose, for immunization.  Medical history and concomitant medications were not reported. A month after pneumococcal vaccination, on an unspecified date, the patient was hospitalized for 14 days due to pneumonia. Event outcome was unknown at the time of report. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Musculoskeletal pain
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck & Co. Inc. (Case Number: 00644505). A non-contactable consumer reported for him/herself. A patient of unspecified age ethnicity and gender started to receive PREVNAR 13 (Lot # and Exp Date unknown by Reporter) at single dose on an unknown date in Nov2015 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe pain in the patient's shoulder after receiving the injection on an unspecified date in Nov2015 with outcome of unknown. The patient was treated for the pain with physical therapy for approximately six months. No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old Caucasian male patient received PREVNAR 13 (Lot # S89081, Expiry Date Dec 2019, NDC # Unknown) at single dose on 05Nov2017 or immunisation. The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU) on 05Nov2017 for immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect: none, this is the first time patient received PREVNAR 13.  On 05Nov2017 the patient experienced arm he received the vaccine was sore and painful so much that he is not able to sleep at night, arm was very swollen, and can't move his arm because it was very swollen. The AEs arm being swollen, sore and having difficulty sleeping at night required a visit to Physician Office. The patient's physician referred the patient back to the pharmacy per the reporter. His symptoms have worsened and were of a serious nature, clarified as medically significant, per pharmacist.; Sender's Comments: Based on the information currently available, the occurrence of events with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Neuralgia, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. This 75-year-old male patient received in Nov2017 (about a week and a half before this report) a single dose of PREVNAR 13 in the left arm as recommended by doctor. Medical history and concomitant medications were none. On 11Nov2017 the patient experienced leg pain and knee joint pain. Outcome was recovering. Course of the event was described as follows: Patient started having pain after waking on Saturday, 11Nov2017. He described it as being gradual, similar to pain from exertion like shin splints or nerve pain. Both legs were affected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: She reports approx 1.5 inch circular erythematous area to right post upper arm where varicella was given. Area is also sl warm to touch and itchy. NP looked at area and recommended ice and BENADRYL.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Injection site pruritus, Pain in extremity
Clinical narrative: Patient complained of burning when the meningococcal B vaccine was given in the right arm. The patient states the arm became very sore and red that evening. She took TYLENOL and kept cold compresses on it. The arm has become increasingly sore to the point of not being able to lift the arm. The redness and swelling are still present almost a week after the shot. Patient states that last night itching started at the injection site. Patient is seeking care with her MD today or tomorrow.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Peripheral swelling
Clinical narrative: Patient complained of burning when the meningococcal B vaccine was given in the right arm. The patient states the arm became very sore and red that evening. She took TYLENOL and kept cold compresses on it. The arm has become increasingly sore to the point of not being able to lift the arm. The redness and swelling are still present almost a week after the shot. Patient states that last night itching started at the injection site. Patient is seeking care with her MD today or tomorrow.
Age: 58.0
Sex: M
Vaccine: TD
Symptoms: Chills, Fatigue, Hyperhidrosis
Clinical narrative: Chills, fatigue, sweating.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Electroencephalogram, Eye movement disorder, Hypotonia, Immediate post-injection reaction
Clinical narrative: Patient received PENTACEL, PREVNAR and ROTATEQ. Cried immediately. Mom and grandmother took baby out to car in the carrier. Mom came back in abruptly and said that when she was putting the car seat in the child's eyes rolled back and she became limp. Did not jerk. Did not stop breathing as far as she knows but became unresponsive and would not respond immediately.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient received PENTACEL, PREVNAR and ROTATEQ. Cried immediately. Mom and grandmother took baby out to car in the carrier. Mom came back in abruptly and said that when she was putting the car seat in the child's eyes rolled back and she became limp. Did not jerk. Did not stop breathing as far as she knows but became unresponsive and would not respond immediately.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Increasing redness, swelling and tenderness that began as dime sized area of redness 24 hours following vaccination and has increased to 7 cm area erythema 4 days following vaccination.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain, Tenderness
Clinical narrative: Pt. states sore, tenderness, unable to have full ROM.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Patient called the weekend after receiving the vaccine (called Saturday 10/21) and asked if it was normal for her shoulder to be in pain. She stated that she could not lift her arm from the shoulder, and any front-to-back motion of the arm hurt as well. She said that she was expecting her arm to be sore, but not expecting her shoulder to be in so much pain/not moveable. She did mention that it felt like the injection "went in to the bone in my shoulder" and that her daughter, when helping to remove the bandaid, questioned why the bandaid was so high on the arm/touching the shoulder joint. Patient also said it felt like her shoulder was burning at the time of injection. I advised patient to rest her shoulder, take ibuprofen, and to let us & her physician know if things got worse (or didn't improve). I am not sure if she ever contacted her physician, but she called again on Friday 11/17 (a month after receiving the vaccine) to inform me that she still could not raise her arm and that any shoulder movement still caused a large amount of pain. I informed patient that I would report her injury/reaction to VAERS and to let me know if she had any other questions/issues.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Aphasia, Autism spectrum disorder, Decreased eye contact, Stereotypy
Clinical narrative: WITHIN A WEEK AFTER GETTING VACCINE PATIENT STOPPED GIVING US EYE CONTACT, THE MILD TALKING "DADA" HE USED TO DO PRIOR TO VACCINE STOPPED. I BEGAN THEN TO WONDER THAT THE VACCINE CAUSED THIS. HE STARTED DOING REPETITIVE MOVEMENTS SHORTLY THEREAFTER. I DISCUSSED CONCERNS WITH PROVIDER AT HIS 15 MONTH WELL VISIT AND HE BEGAN EARLY INTERVENTION SHORTLY THEREAFTER.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Cellulitis like symptoms. Redness and swelling down to the elbow. Lasted several days and I told her to see her doctor. Unaware of the final result.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives starting on 11/19/17 @ 10-11am. Mom initially noted few hives on face/chin, then changed diaper & realized legs were covered as well. Eventually spread to arms, trunk, scalp. Parents took patient to ER (11/19/17 @ 1pm), where he was given BENADRYL PO & told to follow up with his PCP. Hives improved with BENADRYL, but returned after approx. 12 hours. Seen today at clinic (11/20/17 @ 10am); hives still present & confirmed by this writer as true hives, not other type of rash that parents identified as "hives." Instructed mom to continue BENADRYL prn for hives until resolved.  Afebrile at both ER & clinic visits No respiratory symptoms, SpO2 100% at both ER & clinic visits
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash generalised, Rash macular, Tinea infection
Clinical narrative: Patient told us that she got round pink splotches all over her body and on injection site. Her Dr. originally thought it was ringworm, but then spread to entire body. She was given medication for ringworm. The adverse event resolved on its own.
Age: 52.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Chest pain, Electrocardiogram normal, Hypoaesthesia, Laboratory test normal, Palpitations
Clinical narrative: Patient called today stating that after her vaccines on Wednesday she had some numbness in her arm. Thursday she had racing heart and chest soreness all day. Friday morning heart racing and chest soreness continued. She went to work. After work went to the ER at 3:30pm. After normal EKG and lab work she signed out of ER at 7:30 pain free. Saturday ran 2.5 miles without any difficulty or symptoms. She canceled her trip and refuses to get vaccine boosters. She was thankful for the call and discussion.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Headache, Nausea
Clinical narrative: Knee/joint pain, headache, nausea, chills. Resolved after 24 hours.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at inj. site on day of vaccine.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 02-JUN-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. The administered dose of PEDVAXHIB underwent multiple temperature excursion between 49 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Severe back pain radiating down left leg. Extreme stiffness of both hands, particularly upon waking. Symptoms gradually diminished over time for me--not for my spouse.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Contraindication to vaccination
Clinical narrative: Zoster vaccine was administered to immunocompromised patient. Didn't had any reaction to the vaccine. However, we send patient to Hospital to received Verazig and treated with valacylovir.
Age: 16.0
Sex: M
Vaccine: FLU4, IPV, MMR, TDAP, VARCEL
Symptoms: Asthenia, Headache, Myalgia, Pain in extremity, Pruritus
Clinical narrative: One week after receiving  immunizations, pt developed a rash starting on face and neck and going down body, fever, sore arms, extreme muscle aches, a headache behind the eyes and felt sluggish with no energy. The pt was usually very active but felt he could only lie in bed. Over the next few days the rash progressed and was described as hundreds of spots all over his body with severe itching. Pt went to an Urgent Care and saw a PA who said the reaction was due to receiving too many vaccines at one time. The rash lasted approximately 12 days.
Age: 16.0
Sex: M
Vaccine: FLU4, IPV, MMR, TDAP, VARCEL
Symptoms: Rash, Rash generalised, Sluggishness
Clinical narrative: One week after receiving  immunizations, pt developed a rash starting on face and neck and going down body, fever, sore arms, extreme muscle aches, a headache behind the eyes and felt sluggish with no energy. The pt was usually very active but felt he could only lie in bed. Over the next few days the rash progressed and was described as hundreds of spots all over his body with severe itching. Pt went to an Urgent Care and saw a PA who said the reaction was due to receiving too many vaccines at one time. The rash lasted approximately 12 days.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site rash
Clinical narrative: Minor reaction. Redness, rash and soreness occurred at injection site. This was for the DTaP vaccine but I do not know the brand. Area is still irritated today but slightly better.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt reported swelling and pain around the injection site requiring drug therapy to treat.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: The night after vaccination the patient ran a low grade fever of 100 degrees. There was redness and swelling at the injection site. The patient started taking an NSAID to help with the fever and body aches. The following day (11/20/2017) the fever was gone and the injection site was clear, no swelling or redness. However, the redness and swelling had moved down the arm to the bicep. The patient reports it encompasses an area of 3 inches by 4 inches. It is sore but not warm to the touch. Patient is continuing the NSAID as directed.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever up to 102 degree F for aprox 12-13 hours. Alternating Acetaminophen/Ibuprofen-fluids rest.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Patient came in 9 days after receiving PREVENAR 13 with redness and heat spreading down right arm.
Age: 4.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Mother brought child in with C/O fever during the night, with red, hot swollen area to right thigh. Child had 2 shots in each thigh on 1/7/17 at clinic. Mother is unsure what immunizations were given in which thigh.
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Patient received flu vaccine (FLUAD) in her right arm and PNEUMOVAX 23 in her left arm on 10/30/2017. She returned to pharmacy on 11/1/2017 with complaints of rash and pain in her left arm (from injection site to left elbow). Pt was advised to take BENADRYL and put ice on it. The Pharmacist called the pt back at 1740 on 11/1/2017 and rash was the same but pain was less. Pt followed up with PCM and got Rx for MEDROL and.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Blood test normal, Chills, Fatigue, Headache
Clinical narrative: Oct. 2, 2017 - given flu vaccine - within few hours, severe pains started in left hip joint; pain continued to move to knees and ankles and within 24 hrs. severe pain was in every joint on Lt. and Rt. sides below my waist with burning pain in all muscles. Oct. 2nd to 12th - joint pain w/burning muscles too severe to sleep. Doctor office where vaccine was given told me to see my "PCP"! Oct 12th - went to PCP who gave me anti-inflammatory shot, "ketorolac" which gave me relief for 4-5 days! Oct. 19th - pains returned; Oct. 20th "PCP" gave me a second "ketorolac" shot which lasted another 4-5 days. Started on Oct. 25th and has continued as joint pain has started to become less, each day I have been hit w/debilitating flu symptoms" of chills, feeling "feverish" (but no elevation in temp.), headaches, aching, extreme tiredness and nausea! It will stay w/me from a few hours to all day, so I am unable to plan any activities! Nov. 12th - I am starting my 7th week since flu vaccinations and each day I still face some joint pain, flu symptoms, or both in varying degrees!!!
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Loss of personal independence in daily activities, Myalgia, Nausea, Pain
Clinical narrative: Oct. 2, 2017 - given flu vaccine - within few hours, severe pains started in left hip joint; pain continued to move to knees and ankles and within 24 hrs. severe pain was in every joint on Lt. and Rt. sides below my waist with burning pain in all muscles. Oct. 2nd to 12th - joint pain w/burning muscles too severe to sleep. Doctor office where vaccine was given told me to see my "PCP"! Oct 12th - went to PCP who gave me anti-inflammatory shot, "ketorolac" which gave me relief for 4-5 days! Oct. 19th - pains returned; Oct. 20th "PCP" gave me a second "ketorolac" shot which lasted another 4-5 days. Started on Oct. 25th and has continued as joint pain has started to become less, each day I have been hit w/debilitating flu symptoms" of chills, feeling "feverish" (but no elevation in temp.), headaches, aching, extreme tiredness and nausea! It will stay w/me from a few hours to all day, so I am unable to plan any activities! Nov. 12th - I am starting my 7th week since flu vaccinations and each day I still face some joint pain, flu symptoms, or both in varying degrees!!!
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Oct. 2, 2017 - given flu vaccine - within few hours, severe pains started in left hip joint; pain continued to move to knees and ankles and within 24 hrs. severe pain was in every joint on Lt. and Rt. sides below my waist with burning pain in all muscles. Oct. 2nd to 12th - joint pain w/burning muscles too severe to sleep. Doctor office where vaccine was given told me to see my "PCP"! Oct 12th - went to PCP who gave me anti-inflammatory shot, "ketorolac" which gave me relief for 4-5 days! Oct. 19th - pains returned; Oct. 20th "PCP" gave me a second "ketorolac" shot which lasted another 4-5 days. Started on Oct. 25th and has continued as joint pain has started to become less, each day I have been hit w/debilitating flu symptoms" of chills, feeling "feverish" (but no elevation in temp.), headaches, aching, extreme tiredness and nausea! It will stay w/me from a few hours to all day, so I am unable to plan any activities! Nov. 12th - I am starting my 7th week since flu vaccinations and each day I still face some joint pain, flu symptoms, or both in varying degrees!!!
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: From 11-03-2017 until 11-05-2017 dizziness, nausea, headache, swollen warm, hard, red patch on arm just below injection site.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Nausea
Clinical narrative: From 11-03-2017 until 11-05-2017 dizziness, nausea, headache, swollen warm, hard, red patch on arm just below injection site.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Erythema, Fatigue, Myalgia, Pain
Clinical narrative: Pneumococcal vaccine in right arm: red, very sore, rash, weak, muscle aches, very tired. Took TYLENOL.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rash
Clinical narrative: Pneumococcal vaccine in right arm: red, very sore, rash, weak, muscle aches, very tired. Took TYLENOL.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal disorder
Clinical narrative: Extreme pain on both side of right arm (site of injection) from shoulder to elbow, 24 hrs. Pain bad for 4 days. Could not lift arm at all 3 days. Manageable pain for 3 days of a week after shot. Almost back to normal 1 week and 2 days after shot. Complete loss of arm function for 4 days.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Skin reaction
Clinical narrative: Local skin reaction.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Injection site erythema, Injection site pruritus, Injection site swelling, Peripheral swelling
Clinical narrative: ON 11-17-2017, AREA AROUND INJECTION SITE WAS SWOLLEN AND RED, WITH NONE HIVES AND TEMP OF 100F. ON 11-20-2017, MOM STATES HIS ARM HAD SWELLING FROM THE INJECTION SITE TO HIS WRIST, DESPITE ELEVATION AND COLD COMPRESS OVER THE WEEKEND. TODAY IS IMPROVED WITH ONLY SLIGHT ITCHING BUT REDNESS AND SWELLING HAS GONE AWAY.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Paraesthesia oral, Pruritus generalised, Rash erythematous
Clinical narrative: She started breaking out in a red rash and was itching all over within an hour of receiving the vaccine.  Went to see pt next door and she states she could not take Benadryl because she was at work and it would knock her out. Had epipen available and she stated she did not need. However, a couple hours later she felt worse and went home. She had taken Benadryl and took a nap then woke up and her lips were tingling, she decided to seek medical attention, while driving to clinic she had to stop because her tongue was tingling and she had to pull over to take Benadryl she was unable to swallow at this time and administered her epipen. She states she doesn't remember much after this.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: EDD 4/23/18 at 14 weeks gestation at time of vaccination. Miscarried 11/17/17.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Patient called 11/19/2017. She said she woken up Friday (11/17/2017) to a very sore arm. She reported redness on that arm. She said the redness was not where she was injected but was on the left arm under the injection side. Patient alternated between warm and cold compresses and the swelling and redness did go down. By sunday she said it didn't hurt and it was almost back to normal. I recommended adding Benadryl and continuing the compress because they had helped.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Hard red golf ball sized lump in pt. left arm at injection site producing some heat. Pt. reports it had "gone down" compared to what it was over the weekend. Pt. will give it time and return to clinic if condition worsens.
Age: 83.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Thinking abnormal, Vertigo
Clinical narrative: PATIENT REPORTED VERTIGO AND DECISION MAKING PROBLEMS OVER THE WEEKEND.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein, Dizziness, Electromyogram, Hypoaesthesia, Muscle spasms
Clinical narrative: Fever, Tremors/shaking, muscle twitching, muscle spasms. dizziness, numbness/tingling in legs, electrical like feeling throughout body date of reaction. Continue to have muscle twitching, spasms, dizziness at the current time.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle twitching, Nerve conduction studies, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Nuclear magnetic resonance imaging thoracic
Clinical narrative: Fever, Tremors/shaking, muscle twitching, muscle spasms. dizziness, numbness/tingling in legs, electrical like feeling throughout body date of reaction. Continue to have muscle twitching, spasms, dizziness at the current time.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pyrexia, Red blood cell sedimentation rate, Thyroid function test normal, Tremor
Clinical narrative: Fever, Tremors/shaking, muscle twitching, muscle spasms. dizziness, numbness/tingling in legs, electrical like feeling throughout body date of reaction. Continue to have muscle twitching, spasms, dizziness at the current time.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Fall, Malaise, Pain
Clinical narrative: Client when rising from bed in AM was very "dizzy" falling back onto the bed. States she felt this way all day. Saw chiropractor for neck adjustment later in the day. Was still feeling "unwell" several days after receiving vaccine. No local reaction. Also complained of body aches, fever, and diarrhea. Came into health department 11/14/17 to verbalize complaint.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Client when rising from bed in AM was very "dizzy" falling back onto the bed. States she felt this way all day. Saw chiropractor for neck adjustment later in the day. Was still feeling "unwell" several days after receiving vaccine. No local reaction. Also complained of body aches, fever, and diarrhea. Came into health department 11/14/17 to verbalize complaint.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Erythema, Injection site erythema, Pyrexia
Clinical narrative: Red quarter-size mark on left leg where VARIVAX given. Rosy cheeks, little diarrhea, Fever 101 degrees (higher at nite). Referred to allergist for testing.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 3-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 7SJ25, expiry date 31st May 2018). On 25th October 2017, the patient received FLULAVAL QUADRIVALENT .5 ml. In October 2017, less than a week after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site induration. On 25th October 2017, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site tenderness. On 27th October 2017, the patient experienced injection site discoloration. The patient was treated with Cephalexin, diphenhydramine and Hydrocortisone Cream. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site tenderness and injection site induration were recovering/resolving and the outcome of the injection site discoloration was unknown. The reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site tenderness to be almost certainly related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the injection site induration and injection site discoloration to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: No concomitant medications or vaccines reported. At 12 pm, the patient received FLULAVEL QUADRIVALENT on the right thigh. In the evening after vaccination, the symptoms were developed and the patient was seen in the office on the following day. A 10 centimeters area on the right thigh was noted to be erythematous, swollen and questionably tender. The patient was prescribed oral cephalexin and diphenhydramine and topical hydrocortisone cream. On 27th October 2017, the patient went for follow up visit and revealed a persistent 10 centimetre erythematous area with induration improved and a purple horseshoe area in the middle of the involved area. Continuation of all prescribed medications was recommended. No further visits were reported.
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: Erythema, swelling, warmth and pain (L) AE allergic vs cellulitis.
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Erythema, swelling, warmth and pain (L) AE allergic vs cellulitis.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site oedema
Clinical narrative: Information has been received from the authors of the spontaneous literature article concerning to a 71-year-old woman who underwent a posttherapy radioiodine scan after 131I administration for papillary thyroid carcinoma. On day 1 of the posttreatment hospital isolation, the patient received a PNEUMOVAX 23 injection in the left deltoid muscle. A localized hypersensitivity reaction ensued with development of soft tissue edema and erythema at the PNEUMOVAX 23 injection site. This localized reaction persisted up to the subsequent posttherapy radioiodine scan 5 days after injection. Increased activity at the left deltoid region suggests a false-positive finding related to radiotracer sequestration due to inflammation from a localized postvaccination hypersensitivity reaction. The authors considered that hypersensitivity reaction was related to vaccination with PNEUMOVAX 23.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling jittery, Hypoaesthesia
Clinical narrative: Ten minutes after receiving the vaccination I started having numbness down my left arm, left leg and side of face on left side. This numbness lasted for over 10 hours. Also, right after receiving vaccination I had a jittery feeling, almost like a panic attack or rush of adrenaline.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient was in for vaccines on 10/30/2017. Patient was given PROQUAD (MMR and varicella) and KINRIX (DTaP and Polio). Patient came in on 10/31/17 with indurations, redness, pain, swelling, and area is warm to the touch. Patient's mother denied giving any medication or using any cool compresses. MMRV was given on the right arm and redness/swelling measures 4.5 cm vertical, 5 cm horizontal. DTaP was given on the left deltoid and redness/swelling measures 9.5 cm vertical, 9 cm horizontal. When patient's mother came in to speak with nurse on 10/31/17, RN, advised patient's mother to use cool compresses over areas, areas were measured and marked, and patient's mother was advised to call and let us know if redness and/or swelling extended past the markings. Patient's mother was advised to give TYLENOL as needed for pain and to give a dose of BENADRYL for possible allergic reaction. Patient's mother was informed reaction would be reported to the state. Patient's mother contacted clinic on 11/1/17 and stated symptoms persisted. Patient was seen on 11/1/17 by provider. Area where KINRIX was given and marked was less red although the redness had spread about 1 inch outside markings. Area where PROQUAD was given was also smaller although there was still an induration about half the previous size. Provider recommended keeping an eye on it and continue recommendations given by nursing staff and patient will follow up Friday 11/3/17 to re-assess and see if reactions continue to get better or if there is a need for antibiotics for possible cellulitis. VAERS form was filled out and faxed after patient was seen by provider. 11/01/2017 05:20 PM. This 4 year female presents for Immunization reaction. Monday patient got immunization shot to both arms. There is redness to the arm. This morning the patient complained of pain to right arm. Denies any fevers, but the areas have been itchy. Denies noticing any difficulty breathing. Pt was in the other day and a skin marker was used to mark where the redness was and the redness went over the line. Patient is presenting to clinic for follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Skin warm
Clinical narrative: Patient was in for vaccines on 10/30/2017. Patient was given PROQUAD (MMR and varicella) and KINRIX (DTaP and Polio). Patient came in on 10/31/17 with indurations, redness, pain, swelling, and area is warm to the touch. Patient's mother denied giving any medication or using any cool compresses. MMRV was given on the right arm and redness/swelling measures 4.5 cm vertical, 5 cm horizontal. DTaP was given on the left deltoid and redness/swelling measures 9.5 cm vertical, 9 cm horizontal. When patient's mother came in to speak with nurse on 10/31/17, RN, advised patient's mother to use cool compresses over areas, areas were measured and marked, and patient's mother was advised to call and let us know if redness and/or swelling extended past the markings. Patient's mother was advised to give TYLENOL as needed for pain and to give a dose of BENADRYL for possible allergic reaction. Patient's mother was informed reaction would be reported to the state. Patient's mother contacted clinic on 11/1/17 and stated symptoms persisted. Patient was seen on 11/1/17 by provider. Area where KINRIX was given and marked was less red although the redness had spread about 1 inch outside markings. Area where PROQUAD was given was also smaller although there was still an induration about half the previous size. Provider recommended keeping an eye on it and continue recommendations given by nursing staff and patient will follow up Friday 11/3/17 to re-assess and see if reactions continue to get better or if there is a need for antibiotics for possible cellulitis. VAERS form was filled out and faxed after patient was seen by provider. 11/01/2017 05:20 PM. This 4 year female presents for Immunization reaction. Monday patient got immunization shot to both arms. There is redness to the arm. This morning the patient complained of pain to right arm. Denies any fevers, but the areas have been itchy. Denies noticing any difficulty breathing. Pt was in the other day and a skin marker was used to mark where the redness was and the redness went over the line. Patient is presenting to clinic for follow up.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, Product label confusion
Clinical narrative: Presentation of expiration date on box was confusing for immunizer. They did not believe product was expired when administered.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Red raised areas on upper chest, bilateral arms, face. Itchy scalp. Will continue BENADRYL. Pt was seen in clinic for this concern. Follow-up with-in 2 weeks if symptoms continue.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MENB
Symptoms: Dizziness, Fall, Head injury, Hyperhidrosis, Unresponsive to stimuli
Clinical narrative: Patient entered the room and received vaccines @ 9:10 am. At 9:14am the patient stated he felt dizzy and sweaty. The patient then fell towards the wall, hitting his head, and fell to the floor. The patient was unresponsive for 1-2 minutes and was incontinent of urine. Around 9:23 the patient was able to move from the floor to a seated position and was able to answer questions appropriately. He was alert and oriented x3. Vitals were 144/83, HR 80, temp 99.3. Initial vitals were 139/53 HR of 75 and temp of 98.3. The patient was transported to the emergency department via ambulance for further evaluation.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MENB
Symptoms: Urinary incontinence
Clinical narrative: Patient entered the room and received vaccines @ 9:10 am. At 9:14am the patient stated he felt dizzy and sweaty. The patient then fell towards the wall, hitting his head, and fell to the floor. The patient was unresponsive for 1-2 minutes and was incontinent of urine. Around 9:23 the patient was able to move from the floor to a seated position and was able to answer questions appropriately. He was alert and oriented x3. Vitals were 144/83, HR 80, temp 99.3. Initial vitals were 139/53 HR of 75 and temp of 98.3. The patient was transported to the emergency department via ambulance for further evaluation.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Pain in extremity
Clinical narrative: Right arm pain and bruising following the vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient complained about red spot and itchiness at the site of the injection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema
Clinical narrative: Well localized area of erythema to injection site. Child otherwise well. Recommend icing the area with cool compresses and massage. Marked area of erythema with surgical pen and discussed with mother to return to care with any increase of redness outside marked area.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm sore and patient states she is not able to lift her arm high or lift anything with her arm. Symptoms are still occurring a month later. Patient states she is going to see MD tomorrow.
Age: 0.75
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient is 9 months old, should have been given vaccine for age 6-35 months. Patient was given FLUARIX vaccine that is for age 3 and up. Mix up was made due to how it was stored. Patient was contacted and monitored for adverse effects. none reported.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site induration, Injection site warmth, Joint range of motion decreased
Clinical narrative: Patient is 29 weeks, received routine Tdap vaccine. Patient called PCP with red, warm area on R deltoid measuring 6cmX4.5cm. Small hard area noted at injection site. Reports pain and decreased range of motion as a result of pain. Also reported symptoms of feeling feverish.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Patient is 29 weeks, received routine Tdap vaccine. Patient called PCP with red, warm area on R deltoid measuring 6cmX4.5cm. Small hard area noted at injection site. Reports pain and decreased range of motion as a result of pain. Also reported symptoms of feeling feverish.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood thyroid stimulating hormone normal, Differential white blood cell count normal, Dizziness, Full blood count normal, Loss of consciousness
Clinical narrative: Dizziness and syncope. LOC about 5 seconds.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Metabolic function test normal, Red blood cell sedimentation rate normal, Syncope
Clinical narrative: Dizziness and syncope. LOC about 5 seconds.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Pt called the pharmacy on 11/20/17 to report that her right arm (where she got her flu shot) has a red rash and is sore. This started on Saturday, 11/18/17 (one day after her flu shot). She also states that the rash is also above each breast. The pt does not have a fever and states she is otherwise fine. She states if it is not gone by Friday she will go to her doctor.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient reports rash/ redness developed at injection site on the same day of IM administration.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Presyncope
Clinical narrative: Dizziness and presyncope.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Administration site rash, Injection site erythema
Clinical narrative: Patient reports redness/rash at the site of administration. Rash appeared same day of administration.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Rash, Rash erythematous, Vaccination site reaction
Clinical narrative: Red rash surrounding sites of vaccination. Rash also radiated towards torso of the body.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Influenza
Clinical narrative: Heavy Flu symptoms.
Sex: U
Vaccine: HIBV, HPV9, MMR, PPV, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse, and refers to an unknown number of patients of unknown age and gender. No information was provided regarding medical history, concurrent conditions or concomitant medications of the patients. On an unspecified date, the patients were vaccinated with a dose of vaccines following a temperature excursion. The involved vaccines were GARDASIL 9 (lot # M041990, expiration date 28-JUN-2017 and lot # N019923, Exp date 28-APR-2019), M-M-R II (HSA) (Lot #M045402, Exp date 14-NOV-2018, Lot # N009800 Exp date 24-MAR-2019 and lot # M045101 exp date 10-NOV-2018), PNEUMOVAX 23 (lot #N010488, Exp date 22-JAN-2019), ROTATEQ orally (lot # M042169, Exp date 22-JUN-2018) and VARIVAX (lot # N001530 Exp date 13-JAN-2019). The temperature excursion time frame was 14.9 °C for 4 hours for all the vaccines, except to VARIVAX with - 4.1 °C for 3 hours. There was not a previous excursion and the event was call because the digital data logger. There was not adverse event or product quality complaint involved. Lot number N010488 is an invalid lot number for Pneumococcal Vaccine, Polyvalent (23-valent).
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient started with arm pain at 9 PM on 11/13/17. She had severe pain until 11/15/17. The pain has decreased each day since then, but she still has pain when she raises her arm on 11/20/17. She said this has never happened to her in the past with flu shots.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site induration, Injection site swelling
Clinical narrative: Immediately after injection patient experienced a swollen hardened bump and bruising at the injection site. She said she felt fine and that it was not painful. She also said she bruises easily. She was not concerned at the time of the injection. I called her at home later in the day to follow up with her and she said she was doing fine. She said it was still not painful and she felt well. She said the swelling had gone down some and she did not experience any other issues.
Age: 0.75
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: She started out with a rash on her side hips that started a few days after the vaccine. She has never had a rash like this before and we have not changed anything about her diet or daily habits. The rash has progressively gotten worse over the last 9 days and today being the worst. It has spread to her chest and her thigh where it originally started is a deep red rash. We have an appointment scheduled with the Dr to have her checked 11/21.
Age: 24.0
Sex: F
Vaccine: DTAP, MNQ, TDAP
Symptoms: Altered state of consciousness, Blood pressure decreased, Discomfort, Dizziness, Immediate post-injection reaction
Clinical narrative: Immediately felt sick and like I was going to black out. I got lightheaded and felt heavy everywhere, then I started throwing up and my blood pressure dropped to 96/67.
Age: 24.0
Sex: F
Vaccine: DTAP, MNQ, TDAP
Symptoms: Malaise, Vomiting
Clinical narrative: Immediately felt sick and like I was going to black out. I got lightheaded and felt heavy everywhere, then I started throwing up and my blood pressure dropped to 96/67.