chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity, X-ray
Clinical narrative: Arm became heavy and very painful within one hour of shot.  Went to emergency ward at 9:00 pm.  Gave me one dose of hydrocod .Did nothing for pain.  Went to doctor morning of July 30 and she put me on hydrocod and prednisone for 2 1/2 weeks.  Arm still hurt so she sent me to physical therapy.  It is 4 months later and my arm still hurts.  Also, at this time put me on Ibuprofen for 14 days.  It is dec 5 and arm still hurts.  Doctor referred me to an ortho and he is saying I should get a MRI.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Lymphadenopathy, Peripheral swelling, Tenderness
Clinical narrative: right arm redness, swelling, tenderness associated with enlarged lymph nodes right neck beginning the night of injection
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Severe nausea occurring off and on during the day and at night and occasionally resulted in vomiting.  No treatment, I just stopped eating but would still have nausea every few hours regardless.  Nausea began in the afternoon on 11/28 and lasted through morning of 12/2 but  was the worst on 12/29 and 12/30.  There were absolutely no other symptoms so it was not caused by a stomach virus or other illness.   I also had a sore arm from the injection but that was expected.  This was my second Shingrix shot and I did not have this reaction to the first shot, I also received the flu shot when I received the first Shingrix shot.  The information provided by the pharmacy with the vaccine does not list nausea as a possible side effect but it is listed as a side effect on some medical websites.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received Flublok flu vaccine in our office, he then went to pharmacy and Fluzone was administered on the same day within 2 hours.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC13, VARCEL, DTAP, HEP, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Emergency care, Musculoskeletal stiffness
Clinical narrative: approximately 10 minutes after administration of vaccines patient became silent and stiff. Code blue was announced, V/S were taken, patient was seen by pediatric provider to be referred to Neurology for further work up.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC13, VARCEL, DTAP, HEP, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Crying, Musculoskeletal stiffness
Clinical narrative: approximately 10 minutes after administration of vaccines patient became silent and stiff. Code blue was announced, V/S were taken, patient was seen by pediatric provider to be referred to Neurology for further work up.
Age: 2.67
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC13, VARCEL, DTAP, HEP, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Emergency care, Musculoskeletal stiffness
Clinical narrative: 10:20 AM Toddler had just completed very first vaccines (7) ever with urgent care, toddler was walking around a few minutes when she suddenly became stiff and wide eyes (possible focal seizure) mother was crying and holding child tightly. Code Blue called + child examined | child then started crying +  was alert and active again. VS taken P.O. - 97% - P. 110. T-97.6. Taken to exam room to have flu with provider. Referred to neurology. (uncle has epilepsy)
Age: 2.67
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC13, VARCEL, DTAP, HEP, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Crying, Musculoskeletal stiffness
Clinical narrative: 10:20 AM Toddler had just completed very first vaccines (7) ever with urgent care, toddler was walking around a few minutes when she suddenly became stiff and wide eyes (possible focal seizure) mother was crying and holding child tightly. Code Blue called + child examined | child then started crying +  was alert and active again. VS taken P.O. - 97% - P. 110. T-97.6. Taken to exam room to have flu with provider. Referred to neurology. (uncle has epilepsy)
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Cerebral palsy
Clinical narrative: Patient reported reactivation of cerebral balsy with doctor 10 days after getting the shot on 11/09/2019. Talked to both doctor and patient, patient reported doing better today 12/05/2019
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient had a rash that started the day after the vaccination.  It spread up her arm to her chest and neck.  It lasted over 3 days.  I tried to follow up to verify when the rash cleared up but she never returned my phone call.  I orginally instructed her to let me know if it did not resolve.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 63-year-old 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The pharmacist also reported the patient did have some soreness in her arm after the first injection. The vaccine administration facility was the same as primary reporter. For tolerances of 2nd dose of Shingrix, refer case US2019209798.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Redness; Sore arm / soreness has worsened; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 3E279, expiry date 19th March 2022) for prophylaxis.   On 14th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 20th November 2019, the patient experienced erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovering/resolving.   It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient after vaccination within a day noted soreness, which was initially only painful if she bumped it or touched the area and also experienced redness. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Discomfort, Pain in extremity
Clinical narrative: ache on the right arm; joint pain pretty high on her right shoulder; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date).   On 23rd October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and pain in joint involving shoulder region. The patient was treated with naproxen. On an unknown date, the outcome of the pain in arm and pain in joint involving shoulder region were recovering/resolving.   It was unknown if the reporter considered the pain in arm and pain in joint involving shoulder region to be related to Shingrix.  Additional details were received as follows: The patient  had the second dose of Shingrix and she experienced a normal ache on the right arm. The ache continued and became more uncomfortable and she also  joint pain pretty high on her right shoulder depending on the position that she puts her arm in. The patient described the pain as very uncomfortable and she tried taking Neproxin but she still had the pain.  The patient consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that he was aware of a male patient that received Shingrix and experienced muscle pain. No further information was reported. This is 1 of the 4 linked cases reported by same reporter.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Back pain, Discomfort, Injection site pain, Neck pain
Clinical narrative: Patient reports pain beginning from trapezoid muscle at base of neck down into left arm, with worst pain in left deltoid area. She also reports the pain radiates into her mid back on her left side. She is unable to get her arm in a comfortable position, and it hurts when she coughs.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Malaise
Clinical narrative: Patient felt flu like symptoms for two weeks after receiving the vaccination. Patient also reported the appearance of shingles on her upper back during the two weeks that she felt ill.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia
Clinical narrative: Pain described as nerve pain in shoulder
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: shoulder pain
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NONE, tried calling parent but no answer, lmom for parent to return call 12/5/19 100pm
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash vesicular
Clinical narrative: Red dots on chest then face, some blister like. Fever 102.4.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient reported itching and rash all over her body that was not relieved with Benadryl. Patient advised to contact MD for irregular vaccine reaction
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Herpes simplex, Influenza like illness, Injection site erythema
Clinical narrative: 1. Cold/shivering/unable to remedy with hot water or blankets - continued 6 hours 2. Shot site red & swollen & painful - continued 5 days 3. When shivering stopped, felt like I had flu - mostly slept through next 2 days 4. Strange itching in skin of upper right abdomen (no signs of rash or bite to explain itch) corresponding with itching around injection site on left arm - at both sites, itching came and went (always together) 5. About 36 hrs after shot, outbreak of Herpes Simplex on outer nose - 1st outbreak in over a year - took Valacyclovir to keep it from worsening 6. On 7th day following shot, finally stopped feeling fluish/sluggish
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Pruritus, Sluggishness
Clinical narrative: 1. Cold/shivering/unable to remedy with hot water or blankets - continued 6 hours 2. Shot site red & swollen & painful - continued 5 days 3. When shivering stopped, felt like I had flu - mostly slept through next 2 days 4. Strange itching in skin of upper right abdomen (no signs of rash or bite to explain itch) corresponding with itching around injection site on left arm - at both sites, itching came and went (always together) 5. About 36 hrs after shot, outbreak of Herpes Simplex on outer nose - 1st outbreak in over a year - took Valacyclovir to keep it from worsening 6. On 7th day following shot, finally stopped feeling fluish/sluggish
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Dysphagia, Dyspnoea, Insomnia, Loss of consciousness
Clinical narrative: Pt. states he passed out 3 times, 1st time ~ @ 2:45 pm ( 1 hr. 15 min. after vaccines administered); he also experienced muscle ache & dizziness, trouble breathing & swallowing & couldn't sleep until 5 am; felt better in am next day but still dizzy
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Myalgia
Clinical narrative: Pt. states he passed out 3 times, 1st time ~ @ 2:45 pm ( 1 hr. 15 min. after vaccines administered); he also experienced muscle ache & dizziness, trouble breathing & swallowing & couldn't sleep until 5 am; felt better in am next day but still dizzy
Age: 2.75
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Injection site was red, elevated and hard to the touch. Denied fevers. Had symptoms for 8 days. Area improving
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Injection site pain, Laboratory test, Neck pain
Clinical narrative: ER visit 11/25/19 left shoulder pain radiating to neck four hours after Shingrix vaccine. Office visit 11/29/19 redness, swelling left arm treated with Keflex 500mg for cellulitis. Office visit 12/3/19 follow up on cellulitis.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, X-ray limb
Clinical narrative: ER visit 11/25/19 left shoulder pain radiating to neck four hours after Shingrix vaccine. Office visit 11/29/19 redness, swelling left arm treated with Keflex 500mg for cellulitis. Office visit 12/3/19 follow up on cellulitis.
Age: 66.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Disorientation, Syncope
Clinical narrative: Patient received shingrix/boostrix and Prevnar 13 at approximately 10:40am. She was talking and coherent after receiving the immunizations. Upon getting up out of the chair to leave, she collapsed on the ground She never closed here eyes or seemed unresponsive but she was very disoriented. 911 was called immediately and responded within minutes. Patient stated that she felt ok and was able to answer questions including where she was at and the date. EMS workers checked vitals and cleared her to leave the facility without further treatment.
Age: 38.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: red cellulitis, swelling and itching at injection site
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Hot flush, Pain
Clinical narrative: Received the Flu shot, and the Meningococcal B Vaccine at the same time and a few hours later came down with chills, hot flashes, and body aches. The same thing happened last year when she received the Flu shot.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: MUSCLE SORENESS IN DELTOID/SURROUNDING OF ARM OF ADMINISTRATION LASTING 3 WEEKS
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Insomnia, Joint stiffness
Clinical narrative: Rather severe, persistent joint pain in fingers of both hands starting evening of injection, lasting through most of second day.  Pain subsided, but joint stiffness two days after injection.   Difficulty sleeping first night after injection.
Age: 24.0
Sex: F
Vaccine: FLU4, HEPAB, PPV
Symptoms: Erythema, Pyrexia, Rash macular
Clinical narrative: local redness and blotchy skin (L) arm fever *attempted to contact pt to get more info-unable to
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported.; The patient was inadvertently administered an expired dose of GARDASIL 9; This spontaneous report was received from a nurse referring to a male patient of unknown age. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.  On 02-DEC-2019, the patient was vaccinated with the third dose in series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast )(GARDASIL 9) as prophylaxis (lot # R024264 has been verified to be a valid lot number and expiration date 29-OCT-2019 has been verified to be a valid) (expired product administered). The patient did not experienced any adverse symptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Product administered to patient of inappropriate age
Clinical narrative: lifeless; inappropriate age; This case was reported by a consumer via call center representative and described the occurrence of feeling lifeless in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling lifeless and inappropriate age at vaccine administration. On an unknown date, the outcome of the feeling lifeless and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the feeling lifeless to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in his 40s which led to inappropriate age at vaccine administration and experienced a feeling of being lifeless. No further information was reported. This is 1 of 4 linked case reported by same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 454S2, expiry date 5th November 2021) for prophylaxis.   On 1st August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient after vaccination had a spreading rash. No other details known at time of event. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site nerve damage, Pain
Clinical narrative: Feel the administration hit the nerve of her shoulder; hurts when she moves her arm
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: Rash on right arm from shoulder to elbow. Mom gave Benadryl x1 & Hydrocortisone topical x1 at home. Mom reported previous reaction on legs as an infant. Was seen in office on 12/4/19 and encouraged to use topical benadryl/hydrocortisone for the next 48hours. Monitor for swelling, redness and warmth. Call office for worsening symptoms.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: The vaccine was painful as administered and my arm was sore but it was tolerable until about 5 hrs later when I was almost unable to move my arm because the pain was excruciating and I realized I had fever. I told Tylenol and was able to sleep a couple hrs but then shivered and had to lie flat on my back because of my arm and other pain throughout my body. My temp was just under 102 in the morning and after taking more Tylenol it reduced to 100 for most of the day. I spent the day in bed in considerable pain. Later in the evening I was able to get up and warm some food for my husband and me and I drank water. I gradually improved and slept better but was still achy and shaky the following day. I wish I had been warned that this was a possibility because i would not have scheduled the shot on Monday. I missed work on Tuesday and only managed to go in on Wed afternoon for a meeting.   I'm fine now but it really took me down for 2 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: The vaccine was painful as administered and my arm was sore but it was tolerable until about 5 hrs later when I was almost unable to move my arm because the pain was excruciating and I realized I had fever. I told Tylenol and was able to sleep a couple hrs but then shivered and had to lie flat on my back because of my arm and other pain throughout my body. My temp was just under 102 in the morning and after taking more Tylenol it reduced to 100 for most of the day. I spent the day in bed in considerable pain. Later in the evening I was able to get up and warm some food for my husband and me and I drank water. I gradually improved and slept better but was still achy and shaky the following day. I wish I had been warned that this was a possibility because i would not have scheduled the shot on Monday. I missed work on Tuesday and only managed to go in on Wed afternoon for a meeting.   I'm fine now but it really took me down for 2 days.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired driving ability, Injection site nodule, Joint range of motion decreased, Loss of personal independence in daily activities, Magnetic resonance imaging
Clinical narrative: I received the shot and went home. My arm got a little sore that evening. The next day I got a large hard knot at the injection site. It was so big I showed my daughter who is a nurse. I was having more pain in the arm starting the next day. It was the weekend as I had my shot on a Friday so I didn't call anyone until the next week. I sent my primary care Dr a note stating I was having pain still a week later. They said to give it more time. I also reported the pain and knot to the Clinic number.. I continued with the pain for awhile thinking it would just take time to go away. But it hasn't.  So I went in to see my PCP and she examined me and suggested ice and exercises pushing against the wall. After several weeks it didn't feel improved at all. So she did an X-ray and that only showed the bone so she sent me for an MRI. I'm waiting for the results done 2 days ago.  I've lost my range of motion. It's difficult to drive and turn the wheel on the left.  I can't sleep on my left side. I can't dry my back after a shower or fasten my bra in the back. I can't dry my hair easily lifting my arms up and dressing myself with clothes going over my head is difficult. It has changed my life unfortunately.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Sleep disorder, X-ray
Clinical narrative: I received the shot and went home. My arm got a little sore that evening. The next day I got a large hard knot at the injection site. It was so big I showed my daughter who is a nurse. I was having more pain in the arm starting the next day. It was the weekend as I had my shot on a Friday so I didn't call anyone until the next week. I sent my primary care Dr a note stating I was having pain still a week later. They said to give it more time. I also reported the pain and knot to the Clinic number.. I continued with the pain for awhile thinking it would just take time to go away. But it hasn't.  So I went in to see my PCP and she examined me and suggested ice and exercises pushing against the wall. After several weeks it didn't feel improved at all. So she did an X-ray and that only showed the bone so she sent me for an MRI. I'm waiting for the results done 2 days ago.  I've lost my range of motion. It's difficult to drive and turn the wheel on the left.  I can't sleep on my left side. I can't dry my back after a shower or fasten my bra in the back. I can't dry my hair easily lifting my arms up and dressing myself with clothes going over my head is difficult. It has changed my life unfortunately.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling abnormal, Influenza, Nasal congestion
Clinical narrative: sick...flu symptoms started thursday following vaccine...continue with stuffed up & blah feeling as of today 12/5/19 1st & last Last time i get a flu shot!
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reactions.  Pediatric dose was given.  Should have been adult dose.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pain in extremity, Skin exfoliation
Clinical narrative: Patient came in to the store and said she got vaccines for shingrix and fluzone hd and said her arm was red peeling not painful a little sore and lasted a whole week and went away. The patient is fine now she just want to let us know. Patient said she did not need to go to the urgent care or er and she did not go see any doctors.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Nausea, Pain
Clinical narrative: Chills Body Aches Nausea Flu-like symptoms Patient described adverse events lasted approximately one day
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Fall
Clinical narrative: Patient was sitting in chair on mother's lap in waiting room, post flu vaccine administration, when patient slid off mother's lap and onto the floor. Questionable brief loss of consciousness. When RN arrived, patient was awake and alert. Patient was initially assessed for injuries in waiting room, and found to have none. Patient was brought back into an exam room where vitals were completed, along with an assessment by Dr. Patient was found to be free of injury, awake and alert. Patient was then sent home with mother.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Motor dysfunction, Musculoskeletal disorder, Pain
Clinical narrative: Around 12:30/1pm on date of administration patient experienced numbness in arm that inhibited arm function. Patient took Tylenol and Advil to relieve, and applied witch hazel to area. Improved after 24 hours. Presented to clinic today for evaluation, motor function and numbness resolved. Pain was still present but improved.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: the pt fainted for a couple of seconds after receiving the shot.   I gave the shot and was disposing of the items and caught the pt slumping over out of the corner of my eye.  the pt slumped over and out of the chair.  the pt had fainted for maybe a few second and was awake right away.  I questioned the pt as to his surrounding and he was alert.   the mother and I watched over the pt for about 15 to 20 minutes after the incident.  the mother was not surprised and told me after this happened that it tends to run in the family. mother she was not concerned and was told that if anything else happened to seek medical help
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: DTaP was given at the Department of health on 12/3/19. Patient presented to our office (PCP- 12/5/19). Mom noticed patient had a rash under the injection site this am (12/5/19), which was growing in size as the day went on. Mom states site felt firm and warm to the touch. Mom states patient was complaining of some itchiness as well.  Site was red and warm to the touch in our office. Site measured 0.5" under injection site, 35" in length, 25" in width. Patient was diagnosed with cellulitis of the left upper arm and started on Cephalexin for 10 days.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Pruritus
Clinical narrative: DTaP was given at the Department of health on 12/3/19. Patient presented to our office (PCP- 12/5/19). Mom noticed patient had a rash under the injection site this am (12/5/19), which was growing in size as the day went on. Mom states site felt firm and warm to the touch. Mom states patient was complaining of some itchiness as well.  Site was red and warm to the touch in our office. Site measured 0.5" under injection site, 35" in length, 25" in width. Patient was diagnosed with cellulitis of the left upper arm and started on Cephalexin for 10 days.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Arthus reaction
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: RED NESS AND SORENESS
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: The patients received doses of improperly stored Varivax.; This spontaneous report was received from a medical assistant and refers to a 5 patient of unknown age and gender. the patient's medical history and concurrent conditions were not provided.  The reporter stated that between 05-NOV-2019 and 27-NOV-2019, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (product storage error) lot # S014226, expiration date on 04-JUN-2021;  lot # S021926, expiration date on 15-JUL-2021 and  lot # S020159, expiration date on 15-JUL-2021, for prophylaxis (strength, dosage, frequency and route were not provided). The sterile diluent used for reconstitution of varicella virus vaccine live (oka/merck)(VARIVAX)was properly stored. It was stated that the vaccine was under 15°F to 46°F for 2 days 17 hours, 27 minutes and 32 seconds.There were not previous temperature excursion, data logger was positive.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Death
Clinical narrative: death was unconvincingly blamed on Gardasil; This spontaneous report was received from a physician via social media and refers to a 19 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, dose number, route, vaccination site, lot# and expiration date were not reported), for prophylaxis.   On an unknown date, the patient died (death). The cause of death was not reported and it was unknown if an autopsy was performed.  The reporter considered the patient's death to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) as he stated that the patient's death was unconvincingly blamed on  the vaccine.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site pain
Clinical narrative: 8/10 sharp pain in left shoulder. Persistent for >3 weeks, c/w bursitis
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Limb discomfort, Rash
Clinical narrative: patients husband reports patient unable to walk, issue with leg, possible nerve damage, rash.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Pharyngeal swelling, Swollen tongue
Clinical narrative: Patient stated anayphylaxis symptoms of delayed onset by a couple of hours.  Swollen tonuge and throat, difficulty breathing.  She sought medical attention at the emergency room and received an epi-pen injection
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Slight redness, warm, itch,   no treatment given or required, patient will advise if anything further. Stated it was a mild reactions, and was diminishing by the third day which was when it was reported.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Mucosal inflammation, Oral herpes, Pruritus, Rash
Clinical narrative: HPI:  PT  GOT SHINGRIX VACCINE #2  11/13,  FELT GENERAL MALAISE FOR A DAY OR TWO THEN DEVLOPED COLD SORE ON LIP, NOW FEEING THE SORES IN HER NOSE, NASAL PASSAGES.  AREA FEEL IRRITATED .  NO FEVER.  HAS HAD SOME INTERMITTENT GENERALIZED ICHING  W/O AND SKIN  RASH- NO NEW SOAPS, DETERGENTS, ETC.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin irritation
Clinical narrative: HPI:  PT  GOT SHINGRIX VACCINE #2  11/13,  FELT GENERAL MALAISE FOR A DAY OR TWO THEN DEVLOPED COLD SORE ON LIP, NOW FEEING THE SORES IN HER NOSE, NASAL PASSAGES.  AREA FEEL IRRITATED .  NO FEVER.  HAS HAD SOME INTERMITTENT GENERALIZED ICHING  W/O AND SKIN  RASH- NO NEW SOAPS, DETERGENTS, ETC.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: About 30 minutes after the shots were administered (4:30 pm), there was mild swelling and redness (2cm in diameter) around the injection site. The swelling worsened within 2 hours after (6:30 pm), reaching up to almost 2 inches in diameter. We did not give her any medications for this but decided to feed her a smoothie with chlorella and spirulina as well as cilantro to help with the heavy metal detoxification process,  since our assumption was that the reactions were due to the ingredients in the combo shot DTap/Hep B/IPV shot. The next day (08/18/19), a spotty red rash started developing on both injection sites, and the skin appeared to be raised and hard to the touch as if a small bean was lodged underneath her skin. This condition persisted for 5 more days until 08/22/19 and eventually subsided.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: Red, tender, with induration  of  4 to 5 cm in diameter
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: swelling measuring 5x5.5 inches in diameter
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Hypotension, Pallor
Clinical narrative: patient turned really pale , low blood pressure difficulty breatthing
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Pt experienced  a demarcated square rash around injection site a short time after received Pneumovax.  It was accompanied with pain and soreness, and notable itching.  It lasted a couple days and during that time pt took nothing that she can recall, although she may have taken some Tylenol.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pityriasis rosea, Pruritus, Rash
Clinical narrative: Patient reported a rash on her abdomen began between 11/24/19 and 11/26/19. Patient reports that on 11/28/2019 rash spread throughout her trunk and groin. Patient complained of itching and pain. Patient went to her dermatologist on 12/2/2019 and was diagnosed with pityriasis rosea.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin reaction, Skin warm
Clinical narrative: Patient stated her arm was red and hot for 1 week.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient called to let us know that she had pain in the hand & wrist of the arm she received her flu shot in.  Stated that the pain began shortly after receiving the immunization lasted that day but returned about 6 days later.  No swelling, inflammation, or pain at the actual site of injection only in hand & wrist.  She had taken ibuprofen which relieved the pain.  PCP was called to let them know to see if anything else need to be done.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Neck pain. Sore arm.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site nodule, Injection site pain
Clinical narrative: Patient has excessive bruising around injection site as well as a hard nodule at site of injection. Minor pain but no decrease in range of motion.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Pain in extremity, Rash
Clinical narrative: Patient is complaining of diarrhea, very sore arm, fatigue, and a rash all over the front of his torso from his neck to his waist.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Blood pressure decreased, Dizziness
Clinical narrative: Patient reported having a rxn to vaccine to their primary care MD the next day after receiving it. MD in turn told patient to alert pharmacy for proper reporting. Patient's adverse reactions were red face, flushing, faint feeling, weak with achy back and joints. Patient also experienced increased heart rate and slightly lowered blood pressure. Primary care MD administered steroid shot in the office and prescribed the patient Benadryl and Pepcid. Patient experienced similar outcomes after the first shot as well, but didn't know that it was the cause until after the second vaccination produced similar outcomes.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Flushing, Heart rate increased
Clinical narrative: Patient reported having a rxn to vaccine to their primary care MD the next day after receiving it. MD in turn told patient to alert pharmacy for proper reporting. Patient's adverse reactions were red face, flushing, faint feeling, weak with achy back and joints. Patient also experienced increased heart rate and slightly lowered blood pressure. Primary care MD administered steroid shot in the office and prescribed the patient Benadryl and Pepcid. Patient experienced similar outcomes after the first shot as well, but didn't know that it was the cause until after the second vaccination produced similar outcomes.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Eye swelling, Lip swelling, Pain in extremity, Swelling face
Clinical narrative: The patient woke up at 0200 n 12/5/19 with swelling of he eyes, face, lips. She took 50 mg of benadryl at 0230.  I saw her in the office at 13:15 and by then there was less swelling, but pictures the mother took looked like angioedema. She did not have any trouble breathing, swelling of her tongue, pruritis, hives, or abdominal symptoms. She has taken 400 mg of ibuprofen on 12/4/19 around 9 pm due to pain in her arm. She has take ibuprofen numerous times without any adverse reactions. She did not have any other new medications, foods, or topical exposures. Since she was improving by the time I saw her and no further treatment was recommended at this time. I did advise to not do the second dose for her vaccine in 6 months and to be proceed with caution the next time she uses ibuprofen or any nsaids.
Age: 34.0
Sex: M
Vaccine: MMR
Symptoms: Myalgia, Ocular hyperaemia, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: Developed subjective fever, sore throat, red eye, myalgias 11/17/19. Then developed rash 2-3 days following this that started on his face and evolved caudally to neck, chest, and upper abdomen.  No exposure to wild-type measles.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: The Patient Says he experienced feeling of her throat closing. possible trouble breathing. She felt better sitting up. and drinking fluids. She said her symptoms  subsided after 8 hours. She never sought medical attention. She said her symptoms subsided over time. She called her doctor the next day to report her experience. She said she had a flu shot before , but not recently.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal disorder, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: After receiving the first dose of the shingrix, pt started having pain radiating down to her fingers, along with decreased function in her hand.  pain subsided after 24 hrs.  Pt experienced swelling in her hand, as well as fever and aches.  All symptoms resolved within 72 hours
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: patient described redness, achiness on right arm. She discussed these adverse events with medical professionals (Dr.s , etc)
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received Fluarix Quad by GSK she stated had normal soreness, but when it lasted more than 24 hours she realized her arm was red, swollen, and hot. Now over 1 month later and still swollen and she has a huge bump in injection site area
Age: 38.0
Sex: M
Vaccine: DTP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: & fever, aches, chills, swelling at injection site, itching, redness, soreness METHYLPREDNISOLONE
Age: 38.0
Sex: M
Vaccine: DTP
Symptoms: Pain, Pyrexia
Clinical narrative: & fever, aches, chills, swelling at injection site, itching, redness, soreness METHYLPREDNISOLONE
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cardiac function test normal, Chest discomfort, Heart rate increased, Throat irritation
Clinical narrative: a rapid heartbeat, felt like a scratchy feeling deep down in my throat on left hand side, felt some pressure between my breasts symptons that I have never had in my life and weak
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Dysphagia, Lip swelling, Odynophagia, Oropharyngeal pain, Paraesthesia
Clinical narrative: & swelling of bottom lip, difficulty swallowing due to pain in throat, tingling in ears PREDNISONE 40mgx3 days, 30mg x3 days MG EVERY DAY ,ACETAMINOPHEN 1-2 tablets four times a day MG QID ,AZITHROMYCIN 250 MG EVERY DAY
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Arthralgia, Headache
Clinical narrative: Father called today 12/2/19 stating that when patient got home had excruciating headache + joint pain lasting through 12/2/19 am.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Injection site erythema
Clinical narrative: The patient states it was her 1st time receiving the flu shot and had Red patches occur around the area of administration and not at the site. She states feeling fatigue for several days after as well. No problems breathing nor shortness of breaths.
Age: 9.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: red, localized around vaccine admin site (Rt) arm/raised, NT & soft ~ 1 1/2 in spread (Rt) upper arm
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Hypoglycaemia, Vision blurred
Clinical narrative: Patient says she had an increased heart beat & blurred vision She said she is hypoglycemic gave her a coke and she was okay
Age: 1.1
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Diarrhoea, Eye pain, Myalgia, Seizure
Clinical narrative: she said that she lost her mind set for 1/2 hour. Muscle ache. Couldn't control the bladder. Diarrhea She said that she had Seizure. Pain in her eye
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary incontinence
Clinical narrative: she said that she lost her mind set for 1/2 hour. Muscle ache. Couldn't control the bladder. Diarrhea She said that she had Seizure. Pain in her eye
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: injection site pain n left upper arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart attack.   On 26th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th November 2019, 46 days after receiving Shingrix, the patient experienced injection site pain. The patient was treated with codeine and naproxen. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left upper arm. The patient experienced injection site pain in the upper left arm area and went to the emergency department and was given codeine and naproxen. At time of report, the pain did not subside and the injection site pain was unresolved. The report consented to Follow-up. This case was linked to case US2019210497, reported by the same reporter for patient's wife.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain n left upper arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart attack.   On 26th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th November 2019, 46 days after receiving Shingrix, the patient experienced injection site pain. The patient was treated with codeine and naproxen. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left upper arm. The patient experienced injection site pain in the upper left arm area and went to the emergency department and was given codeine and naproxen. At time of report, the pain did not subside and the injection site pain was unresolved. The report consented to Follow-up. This case was linked to case US2019210497, reported by the same reporter for patient's wife.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash
Clinical narrative: allergic reaction; rash/itchy rash on her arm opposite arm; rash appeared as bumpy round patches; rash appeared as bumpy round patches/number of patches has increased; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for an unknown indication.   On 21st October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). In October 2019, 3 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced itchy rash, papular rash and patchy rash. On an unknown date, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction, itchy rash, papular rash and patchy rash were not recovered/not resolved.   The reporter considered the allergic reaction, itchy rash, papular rash and patchy rash to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient received a dose of Fluarix Quadrivalent in an unknown arm. The patient developed an itchy rash on her arm opposite where she got the vaccine.  The rash appeared as bumpy round patches.  The patient happened to have an appointment with her dermatologist a few days later and she was told to just watch the rash.  The rash continued to get worse since the vaccination and it traveled all over her body.  The rash cleared up from one place and reappeared in another place and the number of patches was increased which was very itchy.  The patient saw her dermatologist again for the rash and was told she had an allergic reaction.  She has not had any changes in her diet, medications or supplements, so it was thought that the allergic reaction might be due to Fluarix.  The reporter consented to follow up.