chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Flushing, Hyperhidrosis, Injection site pain, Malaise, Oropharyngeal pain
Clinical narrative: On 12/28/2018 at 1405 Patient received the 2nd in the series of 3 Hepatitis B Vaccinations. She had been coughing few weeks before 12/12/2018 (scheduled date for 2nd shot). Vaccine not given this day. The coughing spells were diagnosed as a "virus" by her MD and it must run its' course. Coughing spells ended about 8 days ago, sore throat had passed with this "virus". Temperature was 97.5 degree Fahrenheit oral-stated she was feeling the best today than in past few weeks. Vaccine given MSA checked on employee at 1421 hours she had a sore right deltoid muscle. Again checked at 1430-she asked MSA if she felt "warm" she did, face was flushed and diaphartic. At 1744 hours states not feeling well is drinking fluids to she is drinking water, still not feeling as well as prior to the vaccination. At 1547 hours she feels like "I have to throw up, I should have eaten before the vaccination". Temp is 97.3 degree Fahrenheit, BP 130/85 left arm, pulse 121. She stated her pulse has never been this high before. At 1814 hours still looks flushed, feels diaphoretic, and not as good as prior to vaccination. At 1843 hours she has vomited, face less flushed, still feels unwell. To clarify: MSA (Medical Staff Associate) are medical staff who are RN's, LPN's, EMT's and Paramedics with a medical background who deal with medical issues of the employees and the donors.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: On 12/28/2018 at 1405 Patient received the 2nd in the series of 3 Hepatitis B Vaccinations. She had been coughing few weeks before 12/12/2018 (scheduled date for 2nd shot). Vaccine not given this day. The coughing spells were diagnosed as a "virus" by her MD and it must run its' course. Coughing spells ended about 8 days ago, sore throat had passed with this "virus". Temperature was 97.5 degree Fahrenheit oral-stated she was feeling the best today than in past few weeks. Vaccine given MSA checked on employee at 1421 hours she had a sore right deltoid muscle. Again checked at 1430-she asked MSA if she felt "warm" she did, face was flushed and diaphartic. At 1744 hours states not feeling well is drinking fluids to she is drinking water, still not feeling as well as prior to the vaccination. At 1547 hours she feels like "I have to throw up, I should have eaten before the vaccination". Temp is 97.3 degree Fahrenheit, BP 130/85 left arm, pulse 121. She stated her pulse has never been this high before. At 1814 hours still looks flushed, feels diaphoretic, and not as good as prior to vaccination. At 1843 hours she has vomited, face less flushed, still feels unwell. To clarify: MSA (Medical Staff Associate) are medical staff who are RN's, LPN's, EMT's and Paramedics with a medical background who deal with medical issues of the employees and the donors.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Extreme shivers, fever, bad Headache. Shivers lasted around 2 hours. Headache was longer but was relieved with TYLENOL. Still feel poorly today.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever 100 degrees. Shivering. Body aches all over. Lasted 1-1/2 days (from Saturday evening until Monday morning).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site rash, Rash erythematous
Clinical narrative: Patient came into the pharmacy on 12-28-2018 with a rash surrounding injection site on upper left arm. Rash was red. Patient also stated they had pain and tenderness at the injection site. They also stated they had a headache as well. I recommended that they take BENADRYL to help with the rash and could also use either BENADRYL cream or hydrocortisone cream. I consulted the patient that if the symptoms continued to get worse to follow up with their doctor and seek medical attention.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Firm, tender 4cm in diameter circular area on right upper thigh.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pain in extremity, Pruritus
Clinical narrative: Patient developed pain/stiffness and itching in L arm the night of vaccine admin. The next morning it was more severe and she went to ER. They administered a steroid shot.
Age: 83.0
Sex: F
Vaccine: FLUA3
Symptoms: Ocular hyperaemia
Clinical narrative: Patient called the pharmacy on 12/27/18 to question a possible side effect of the FLUAD she got on 12/26/18. A day after her shot, patient experienced a blood shot in the eye, red eye. No other symptoms, no pain beside the redness. Patient will check with MD if not going away.
Age: 74.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Extreme arm pain (unable to lift arm or move shoulder lasting more than 3 weeks).
Age: 29.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Blister, Pallor, Procedural site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Blisters and rash to lap sites, left proximal thigh. Ruptured and unroofed vesicles in LLQ abd, and suprapubic abdominal regions, away from lap sites that had dermabond s/p surgery.
Age: 29.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Appendicectomy, Blister, Incision site rash, Incision site vesicles, Laparoscopic surgery
Clinical narrative: Blisters and rash to lap sites, left proximal thigh. Ruptured and unroofed vesicles in LLQ abd, and suprapubic abdominal regions, away from lap sites that had dermabond s/p surgery.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, Full blood count normal
Clinical narrative: Patient reported having only the PCV13 previously, so it was recommended that she vaccinate with PNEUMOVAX 23. Later, we received notice that she'd already had the vaccine in June 2018. So this was the patient's 2nd PNEUMOVAX within 6 months.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: As a parent, I am not sure which of the meningitis shots it was. The doctor would know. The reaction is severe pain in the area of the injection. It woke her up during the night. She is unable to move the arm. There is mild swelling but no discoloration. The pain did not begin until approx 24 hours after the shot. No fever.
Age: 68.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain
Clinical narrative: Severe full body aches for about six hours that night.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Musculoskeletal stiffness
Clinical narrative: Upper left arm and shoulder pain sufficient to limit mobility of the arm and prevent sleep. Treated with 650 mg acetaminophen once, and later with 75/325 mg hydrocodone/acetaminophen once. Pain and stiffness ongoing at this report (10:30 am 12/29/2018), but enough less to get by without medication. I consider this clinically significant because I am the sole caregiver for a bed-bound person, and the event is hampering my duties.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reports redness the size of a fist, warmth, and tender to the touch on "front" of left upper arm, not specifically at the injection site, but near the injection site.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site urticaria, Urticaria
Clinical narrative: No reactions on the 1st dose. On the 2nd dose experienced a strong headache the next morning, followed by hives below the injection point which lasted three days. From 10/17/18 through 10/19/18 experienced hives on upper chest area. From 10/19 through 10/21 experienced hives in genital area. On the 29th the hives returned to arm area.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Pain in extremity, Pyrexia
Clinical narrative: Very red and sore arm, fever, chills, very soon after and all day yesterday. Some better today
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Area around and below injection site is red raised, hot to the touch and firm. Left arm is swollen to the point patient could not put rings on. Symptoms began 24 hours prior and was still present. Patient was going to walk in clinic to follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Urinary tract infection, Urine analysis abnormal, Urticaria
Clinical narrative: Rash and hives starting on torso and spreading to entire body. Patient first sought treatment at the pharmacy and was given diphenhydramine to be taken orally on 12/28/18. Patient then sought further treatment at the ER and was given a MEDROL Dose PAK prescription on 12/29/18 after given prednisone in the ER. No resolution of rash yet as of 12/29/18.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: Within 8 hours of getting the shot, I developed intense arm pain, redness, swelling, hot to touch. Fever, body aches, and muscle pains (especially back) persisted through the night. Tired, weak, lightheaded the next morning. Headache and body aches persisted through the next day. After two days, the arm and injection site was itchy, sore, and red and this lasted three days before gradually resolving.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Myalgia, Pain
Clinical narrative: Within 8 hours of getting the shot, I developed intense arm pain, redness, swelling, hot to touch. Fever, body aches, and muscle pains (especially back) persisted through the night. Tired, weak, lightheaded the next morning. Headache and body aches persisted through the next day. After two days, the arm and injection site was itchy, sore, and red and this lasted three days before gradually resolving.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Skin warm, Swelling
Clinical narrative: Within 8 hours of getting the shot, I developed intense arm pain, redness, swelling, hot to touch. Fever, body aches, and muscle pains (especially back) persisted through the night. Tired, weak, lightheaded the next morning. Headache and body aches persisted through the next day. After two days, the arm and injection site was itchy, sore, and red and this lasted three days before gradually resolving.
Age: 35.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Skin warm, Swelling, Tenderness
Clinical narrative: Redness, swelling, induration (7 cm x 6 cm), warmth, tenderness.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Experienced shoulder pain day of vaccination without improvement and limited mobility from date of vaccination. Has seen nurse practioner who prescibed 600 mg of IBU twice daily and is currently doing physical therapy. Pt noticed shot had been given higher than usual.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Patient is experiencing moderate muscle pain resulting in "pain when raising her arm" after over a month from vaccination. She states she has tried icing it and applying lidocaine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Dysstasia, Malaise, Pain
Clinical narrative: Felt very faint, sick and had body aches. Blood pressure dropped to 75\40. Could not stand up for several hours due to light headedness. Lasted for 12 hours. Slowly got better over that time period.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Ocular hyperaemia, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Pt stated she had a lot of pain & swelling the next day and the swelling got increasingly bigger over the week. 2nd day, she woke up to her eye being blood shot (sclera will all bloody contained inside). There was pain on touch; when examined on 12/28/18 the affected area was still hot on touch.
Age: 27.0
Sex: F
Vaccine: HEPA, JEV1, TYP
Symptoms: Dizziness, Unresponsive to stimuli
Clinical narrative: Patient completed the vaccines and became lightheaded with 2 minutes of unresponsiveness. Vital signs monitored. Patient alert and talking within 2 minutes and vital signs stable within 10 minutes. Monitored and checked by physician. Released in 40 minutes wth no other reactions.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: PATIENT CALLED AND SAID SHE IS HAVING SEVERE ARM PAIN AND REDNESS.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Chills, Decreased appetite, Erythema, Headache
Clinical narrative: Had a severe allergic reactions: 12/21/2018. Arm swollen around 5 PM and complaining about pain in the arm and stiffness. 12/21/2018. At 11:30 PM noticed discoloration in skin, really red with white spots on Stomach, Chest, Arms, Back and Legs. Took an over counter allergy med and went to bed. 12/22/2018, Itching, burning, pain in arm, loss of appetite, chills, fever, hives, rashes and headache. 12/23/2018, Took over counter BENADRYL all day with no results. 12/24/2018  Went to emergency room.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Had a severe allergic reactions: 12/21/2018. Arm swollen around 5 PM and complaining about pain in the arm and stiffness. 12/21/2018. At 11:30 PM noticed discoloration in skin, really red with white spots on Stomach, Chest, Arms, Back and Legs. Took an over counter allergy med and went to bed. 12/22/2018, Itching, burning, pain in arm, loss of appetite, chills, fever, hives, rashes and headache. 12/23/2018, Took over counter BENADRYL all day with no results. 12/24/2018  Went to emergency room.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash, Skin discolouration, Urticaria
Clinical narrative: Had a severe allergic reactions: 12/21/2018. Arm swollen around 5 PM and complaining about pain in the arm and stiffness. 12/21/2018. At 11:30 PM noticed discoloration in skin, really red with white spots on Stomach, Chest, Arms, Back and Legs. Took an over counter allergy med and went to bed. 12/22/2018, Itching, burning, pain in arm, loss of appetite, chills, fever, hives, rashes and headache. 12/23/2018, Took over counter BENADRYL all day with no results. 12/24/2018  Went to emergency room.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Pyrexia
Clinical narrative: PATIENT DEVELOPED A FEVER 1 DAY POST VACCINATION AND THEN DEVELOPED BELL'S PALSY.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT DESCRIBED EXPERIENCING A "VERY SWOLLEN" ARM EXTENDING FROM SHOULDER TO WRIST WITH REDNESS AND PAIN. SHE EXPERIENCED NAUSEA, FEVER AND CHILLS FOR APPROXIMATELY 24 HOURS FOLLOWING ONSET OF SYMPTOMS (ONSET APPROXIMATELY 24 HOURS AFTER VACCINE ADMINISTRATION). THE ARM PAIN AND SWELLING LASTED FOR APPROXIMATELY 7 DAYS, PATIENT TREATED SYMPTOMS WITH OTC IBUPROFEN FOR DURATION OF SYMPTOMS AND DID NOT SEEK MEDICAL ATTENTION.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: PATIENT DESCRIBED EXPERIENCING A "VERY SWOLLEN" ARM EXTENDING FROM SHOULDER TO WRIST WITH REDNESS AND PAIN. SHE EXPERIENCED NAUSEA, FEVER AND CHILLS FOR APPROXIMATELY 24 HOURS FOLLOWING ONSET OF SYMPTOMS (ONSET APPROXIMATELY 24 HOURS AFTER VACCINE ADMINISTRATION). THE ARM PAIN AND SWELLING LASTED FOR APPROXIMATELY 7 DAYS, PATIENT TREATED SYMPTOMS WITH OTC IBUPROFEN FOR DURATION OF SYMPTOMS AND DID NOT SEEK MEDICAL ATTENTION.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Administration site rash, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Patient stated that she had a sore arm from the flu shot lasting 2 months after administration. She stated that about 2 days after receiving the shot, that she noticed her arm hurt when trying to lift plates over her head. About 2 days after that, a rash started to develop that extended from the administration site, and eventually grew down the length of her arm to her elbow. She stated that the rash was raised, red, and hot, and that it took about 3 weeks for the rash to go away.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain
Clinical narrative: Pain under the armpit on arm that she recieved the shot.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Patient had adverse reaction in back of the arm containing redness, swelling and tenderness. Appears vaccination may have been administered subcutaneously instead of intramuscularly.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue, aches, chills, fever, diarrhea for at least 24 hours as of this writing.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Same day of shot experienced sore arm and shoulder pain. To date dull numbness and decreased range of motion to left upper arm. Have been working on range of motion  exercises, but progress is slow..never had  ARM PROBLEMS BEFORE SHOT.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspepsia, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: First vaccine was given on 09/08/2018. Very painful arm pain (immediately after shot and last three days). 10 hours after the shot, I began to have shakes, shivering, aches and pains, fever that went as high as 101 degrees, headache, fatigue and indigestion. These side effects lasted approximately 24 hours. Fatigue was for 3 days. The second vaccine was given on 12/28/2018.  Arm pain was not as severe. Last night (again approximately 10 hours after shot), I had the same side effects as above - shakes, shivering, aches and pains, fever (only up to 100 degrees), headache and fatigue. In addition, I did have nausea and began vomiting/dry heaves which lasted approximately 7 hours. A general feeling of having the flu. Today things are improving, however the aches and pains and fatigue are still rather severe. Fever is down to 99 degrees.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: First vaccine was given on 09/08/2018. Very painful arm pain (immediately after shot and last three days). 10 hours after the shot, I began to have shakes, shivering, aches and pains, fever that went as high as 101 degrees, headache, fatigue and indigestion. These side effects lasted approximately 24 hours. Fatigue was for 3 days. The second vaccine was given on 12/28/2018.  Arm pain was not as severe. Last night (again approximately 10 hours after shot), I had the same side effects as above - shakes, shivering, aches and pains, fever (only up to 100 degrees), headache and fatigue. In addition, I did have nausea and began vomiting/dry heaves which lasted approximately 7 hours. A general feeling of having the flu. Today things are improving, however the aches and pains and fatigue are still rather severe. Fever is down to 99 degrees.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Retching, Tremor, Vomiting
Clinical narrative: First vaccine was given on 09/08/2018. Very painful arm pain (immediately after shot and last three days). 10 hours after the shot, I began to have shakes, shivering, aches and pains, fever that went as high as 101 degrees, headache, fatigue and indigestion. These side effects lasted approximately 24 hours. Fatigue was for 3 days. The second vaccine was given on 12/28/2018.  Arm pain was not as severe. Last night (again approximately 10 hours after shot), I had the same side effects as above - shakes, shivering, aches and pains, fever (only up to 100 degrees), headache and fatigue. In addition, I did have nausea and began vomiting/dry heaves which lasted approximately 7 hours. A general feeling of having the flu. Today things are improving, however the aches and pains and fatigue are still rather severe. Fever is down to 99 degrees.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Neuropathy peripheral, Pain in extremity
Clinical narrative: PATIENT EXPERIENCED NEUROPATHY PAIN RADIATING UP RIGHT ARM AND INTO NECK.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Patient complained of developing rashes on her skin the next morning after taking the shot.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PRONOUNCED REDNESS/SWELLING/PAIN AT INJECTION SITE- INFORMED PHARMACY A COUPLE OF DAYS AFTER INJECTIONS. ADVISED PATIENT TO PUT ICE ON THE AREA FOR 10-15MINS AT A TIME, TRY BENADRYL PO, OR GO TO A DR TO BE SEEN. PT STATED THAT THE SYMPTOMS STARTED THE DAY AFTER THE INJECTION
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain
Clinical narrative: I had intense underarm lymph node pain reaction in my left arm (same arm of the injection), which has been gradually diminishing over the past few days.
Age: 60.0
Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Computerised tomogram normal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Impaired work ability
Clinical narrative: A patient came in today and reported developing Guillain-Barre Syndrome from vaccinations (FLUCELVAX QUAD and BOOSTRIX) given back on 10/9/18. The patient reports starting to have symptoms on 10/14/18 "heaviness in foot and dragging the leg" but did not know why. On 11/9/18, the numbness and heaviness in the legs continued to be bothersome. On 12/7/18, the patient reports having a hard time walking up the stairs and had to leave work early. He called off from work on 12/9/18 because of the heaviness in his legs. On 12/10/18, he was found paralyzed in his bed and 911 was called. He was taken to Medical Center and was put into the ICU until 12/15/18. From there he was moved to the neurology unit until 12/18/18 and then to Rehab Center until 12/28/18. He was discharged from the rehab center on 12/29/18. According to the caregiver, the patient was under the care of Dr. His CT and MRI scans were negative so a spinal tap was done and that is what confirmed the diagnosis of Guillain-Barre Syndrome, again according to caregiver.
Age: 60.0
Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Intensive care, Limb discomfort, Lumbar puncture abnormal, Nuclear magnetic resonance imaging normal, Paralysis
Clinical narrative: A patient came in today and reported developing Guillain-Barre Syndrome from vaccinations (FLUCELVAX QUAD and BOOSTRIX) given back on 10/9/18. The patient reports starting to have symptoms on 10/14/18 "heaviness in foot and dragging the leg" but did not know why. On 11/9/18, the numbness and heaviness in the legs continued to be bothersome. On 12/7/18, the patient reports having a hard time walking up the stairs and had to leave work early. He called off from work on 12/9/18 because of the heaviness in his legs. On 12/10/18, he was found paralyzed in his bed and 911 was called. He was taken to Medical Center and was put into the ICU until 12/15/18. From there he was moved to the neurology unit until 12/18/18 and then to Rehab Center until 12/28/18. He was discharged from the rehab center on 12/29/18. According to the caregiver, the patient was under the care of Dr. His CT and MRI scans were negative so a spinal tap was done and that is what confirmed the diagnosis of Guillain-Barre Syndrome, again according to caregiver.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersomnia, Malaise, Pyrexia, Somnolence
Clinical narrative: Patient had Fever for 24 hours after vaccine. Sleepiness/malaise for 36 hours after vaccination. Slept for 24 hours over 48 hour period.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hyperaesthesia, Pain
Clinical narrative: Red streaks over the shoulder and under the arm. Very painful and sensitive. Injection site itself was okay.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Fever of 100.8 approximately 13 hours after vaccination. Resolved with 800 mg ibuprofen. Headache, muscles aches and general feeling of malaise the following day.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Eye movement disorder, Fall, Flushing, Hyperhidrosis, Loss of consciousness
Clinical narrative: Pt had the flu shot and was fine, in less than 10 minutes Mom came back to Rx saying she is fainted. I went out and saw her laying on the floor. When I got to the site, she was conscious and told me she felt fine. The pulse was OK and she was a little sweaty. I offered to check her BP. When I came back with BP machine, she already sat up. I tried to measure her BP while she was sitting on the floor. All of a sudden, she fell down to the floor with short time unconsciousness and eyes turning/rolling up like seizure episode. After getting OK from the mom, we called 911. The team and I checked BP in different positions and were in normal range. After she got up, she felt the feeling of flash like the first time. Just called mom, she said they stayed in ER for 3 hrs and checked her BP, heart and couldn't find any abnormality.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Pt had the flu shot and was fine, in less than 10 minutes Mom came back to Rx saying she is fainted. I went out and saw her laying on the floor. When I got to the site, she was conscious and told me she felt fine. The pulse was OK and she was a little sweaty. I offered to check her BP. When I came back with BP machine, she already sat up. I tried to measure her BP while she was sitting on the floor. All of a sudden, she fell down to the floor with short time unconsciousness and eyes turning/rolling up like seizure episode. After getting OK from the mom, we called 911. The team and I checked BP in different positions and were in normal range. After she got up, she felt the feeling of flash like the first time. Just called mom, she said they stayed in ER for 3 hrs and checked her BP, heart and couldn't find any abnormality.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on trunk, arms, groin.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Left side of face extremely swollen did not go to throat subsided some 12 hours later.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Musculoskeletal pain
Clinical narrative: Severe shoulder pain, headache, tiredness.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Pruritus, Urticaria
Clinical narrative: Extreme break out of hives covering legs, arms, head, lips. Itching and very uncomfortable. Occurred 2.5 days after the injeciton. Lasted for 7 days even with treatment with steroids and antihistamines.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Same day of injection (within 4-6 hours) injection site pain, redness & swelling to a size over 3.5 inches, myalgia over entire body, fatigue, headache. 34 hours after injection: shivering, fever. Still experiencing adverse reaction, not resolved at this time.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Same day of injection (within 4-6 hours) injection site pain, redness & swelling to a size over 3.5 inches, myalgia over entire body, fatigue, headache. 34 hours after injection: shivering, fever. Still experiencing adverse reaction, not resolved at this time.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Insomnia, Malaise
Clinical narrative: Onset 12 hours after IM vaccination SHINGRIX. Flu-like symptoms of myalgia, shivers, low grade fever, malaise and insomnia. Stayed in bed next day and night. Symptoms resolved gradually. Able to resume normal activity about 36 hours later, though quite fatigued.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Onset 12 hours after IM vaccination SHINGRIX. Flu-like symptoms of myalgia, shivers, low grade fever, malaise and insomnia. Stayed in bed next day and night. Symptoms resolved gradually. Able to resume normal activity about 36 hours later, though quite fatigued.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Injection site soreness, diffuse muscle aches, fatigue, fever (102 degrees) - occurred on first day post vaccination, extending into second day post vaccination - largely resolved with Advil. Did not have symptoms except injection site soreness with the first in the series of this vaccine.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Lethargy, Pain of skin, Sensitive skin
Clinical narrative: CHILLS AND SHAKING THE WHOLE FIRST DAY AND EVENING; WEAKNESS AND OVERALL LETHARGY; VERY SENSITIVE AND PAINFUL SKIN SURFACES--ALL OVER BODY, EVEN SKIN ON SCALP.  ALMOST NO PAIN AT INJECTION SITE. FIRST SHINGRIX SHOT IN OCTOBER GAVE ME ALL OF THE ABOVE, PLUS A RASH/ITCHING ON THE TRUNK OF MY BODY.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: CHILLS AND SHAKING THE WHOLE FIRST DAY AND EVENING; WEAKNESS AND OVERALL LETHARGY; VERY SENSITIVE AND PAINFUL SKIN SURFACES--ALL OVER BODY, EVEN SKIN ON SCALP.  ALMOST NO PAIN AT INJECTION SITE. FIRST SHINGRIX SHOT IN OCTOBER GAVE ME ALL OF THE ABOVE, PLUS A RASH/ITCHING ON THE TRUNK OF MY BODY.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Headache, Hypersensitivity, Pain
Clinical narrative: After having an allergy attack that involved about an hour of coughing, patient developed headache, chills, body aches and fever of 102 degrees F. The reaction started about 3 hours after receiving vaccine and resolved about 24 hours after injection.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: After having an allergy attack that involved about an hour of coughing, patient developed headache, chills, body aches and fever of 102 degrees F. The reaction started about 3 hours after receiving vaccine and resolved about 24 hours after injection.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site rash
Clinical narrative: PATIENT FELT VERY TIRED ON SAME DAY HE GOT THE VACCINE. ALSO ON THE SECOND DAY HE DEVELOPED SPOTTED RED AREA AROUND INJECTION SITE WITH RASH HOWEVER AS PER PATIENT IT IS GETTING BETTER.
Age: 72.0
Sex: M
Vaccine: TYP
Symptoms: Arthralgia, Chills, Malaise, Muscle spasms, Nausea
Clinical narrative: Starting day after first dose: severe nausea, vomiting (three times), joint pain, malaise starting day of third dose: chills with muscle spasm.
Age: 72.0
Sex: M
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: Starting day after first dose: severe nausea, vomiting (three times), joint pain, malaise starting day of third dose: chills with muscle spasm.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site reaction, Rash erythematous
Clinical narrative: PATIENT FELT VERY TIRED ON THE SAME DAY SHE GOT THE VACCINE AND ON THE SECOND DAY SHE DEVELOPED A SPOTTED RED RASH AROUND THE INJECTION SITE, GETTING BETTER.
Age: 3.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Generalised erythema, Hypersensitivity, Urticaria
Clinical narrative: My daughter got the shots on 12/27/2018 around 11:40 am, the next morning when she woke up at 8:00 am she had hives/welps/red spots all over her body. From her eyelids, face, ears, arms, torso, legs, private areas, and feet. Today is now 12/30/2018 11:17 am and she still has severe hives/welps covered in hives/welps. It has not gotten better.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Nurse missed deltoid, burning and pain at time of injection. Continuing pain and shoulder stiffness 2 months past injection.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: DONOR AWOKE 12/29/18 WITH PAIN IN RIGHT SHOULDER AT 7/10 SCALE, RADIATING TO LATERAL RIGHT CHEST AREA. NOTICED IT WAS SWOLLEN, PAIN WITH MOVEMENT, ESPECIALLY LIFTING ARM. STATES FELT FEVERISH AT HOME, BUT DID NOT TAKE HIS TEMPERATURE. NOTED AREA WAS HOT TO TOUCH. DENIES ANY SHORTNESS OF BREATH/DIFFUCULTY BREATHING OR HIVES/RASH. SLIGHTLY BETTER MOVEMENT TODAY, BUT STILL SWOLLEN AND WARM, SO HE PRESENTED TO CENTER. VS: 96 PULSE, BP 134/90, TEMP 101.7, AGAIN DENIES OTHER COMPLAINTS AT PRESENT. ABLE TO RAISE ARM WITH SOME EFFORT, BUT STATES IS BETTER THAN BEFORE. RIGHT DELTOID AREA SWOLLEN > 3INCH AREA AND WARM TO TOUCH WITH SOME GENERAL SWELLING NOTED IN AXILLARY REGION. SEEN BY CMD, DR. INSTRUCTED BY MD TO UTILIZE IBUPROFEN OR ACETAMINOPHEN FOR FEVER AND COMFORT AND ICE TO AREA TO DECREASE SWELLING. INSTRUCTED SEEK MEDICAL ATTENTION OF PRIMARY CARE MD OR EMERGENCY DEPARTMENT IF NECESSARY.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: DONOR AWOKE 12/29/18 WITH PAIN IN RIGHT SHOULDER AT 7/10 SCALE, RADIATING TO LATERAL RIGHT CHEST AREA. NOTICED IT WAS SWOLLEN, PAIN WITH MOVEMENT, ESPECIALLY LIFTING ARM. STATES FELT FEVERISH AT HOME, BUT DID NOT TAKE HIS TEMPERATURE. NOTED AREA WAS HOT TO TOUCH. DENIES ANY SHORTNESS OF BREATH/DIFFUCULTY BREATHING OR HIVES/RASH. SLIGHTLY BETTER MOVEMENT TODAY, BUT STILL SWOLLEN AND WARM, SO HE PRESENTED TO CENTER. VS: 96 PULSE, BP 134/90, TEMP 101.7, AGAIN DENIES OTHER COMPLAINTS AT PRESENT. ABLE TO RAISE ARM WITH SOME EFFORT, BUT STATES IS BETTER THAN BEFORE. RIGHT DELTOID AREA SWOLLEN > 3INCH AREA AND WARM TO TOUCH WITH SOME GENERAL SWELLING NOTED IN AXILLARY REGION. SEEN BY CMD, DR. INSTRUCTED BY MD TO UTILIZE IBUPROFEN OR ACETAMINOPHEN FOR FEVER AND COMFORT AND ICE TO AREA TO DECREASE SWELLING. INSTRUCTED SEEK MEDICAL ATTENTION OF PRIMARY CARE MD OR EMERGENCY DEPARTMENT IF NECESSARY.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, pain, swelling  and weeping liquid at injection site. Pt sort treatment and was given antibiotic.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: No adverse event - vaccine error. Patient was told he needed PNEUMOVAX 23 by a pharmacist after checking MCIR. MCIR confirmed patient had previously had two PREVNAR 13 vaccines (2nd was unnecessary and should have been PNEUMOVAX 23). Patient came in for vaccination, and the RPh on duty states that the patient told her he had never had a pneumonia shot. Patient was given a 3rd PREVNAR 13 vaccine, instead of PNEUMOVAX 23.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Chills and general pain pain and weakness during first 4 hours, general muscle pain and weakness, fever, and headache for another 4 or five hours. Pain at injunction site continues as of today.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Chills and general pain pain and weakness during first 4 hours, general muscle pain and weakness, fever, and headache for another 4 or five hours. Pain at injunction site continues as of today.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient had started the BEXSERO meningococcal B series on 11/16/18 and needed her 2nd vaccine in the series. She received TRUMENBA which was the wrong vaccine. She did not have an adverse reaction.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: SWOLLEN INJECTION SITE.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: PATIENT EXPERIENCING SORENESS MORE THAN USUAL FEW HOURS AFTER INJECTION AND SORENESS REMAINED THE SAME UP TO TODAY.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: PATIENT EXPERIENCING SORENESS MORE THAN USUAL FEW HOURS AFTER INJECTION AND SORENESS PERSIST EVEN UNTIL NOW.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Redness and rash in oval around injection site. 1.5 inches top to bottom, 4 inches left to right.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Antinuclear antibody, Blood culture, Blood magnesium, Full blood count, Metabolic function test
Clinical narrative: Cellulitis at the vaccine site.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis at the vaccine site.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Headache, Hypopnoea
Clinical narrative: Cold feet, chills, fever 101, body ache, joints pain, cramps in both feet, mild headache, shallow breathing and general weakness. These started around 9pm on date of vaccine 12/28/2018, and lasted most of the next day. Did not take any medication, but drunk a lot of water.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms, Pain, Peripheral coldness, Pyrexia
Clinical narrative: Cold feet, chills, fever 101, body ache, joints pain, cramps in both feet, mild headache, shallow breathing and general weakness. These started around 9pm on date of vaccine 12/28/2018, and lasted most of the next day. Did not take any medication, but drunk a lot of water.
Age: 68.0
Sex: M
Vaccine: FLUA3
Symptoms: Blister, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient reported blistering that subsequently fell off a few days later, but the arm/hand/shoulder remained numb and tingling at least for 9 days after receiving vaccine.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives breakout on lower/mid back.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Injection site erythema, Injection site induration, Injection site warmth, Irritability
Clinical narrative: The area was first noticed to be warm and red. Throughout the day it become more inflamed, painful and firm. Upon presentation to the urgent care the patient thigh was warm, red and firm from knee to hip with about 50% circumference. Parents also report patient is not acting himself, extremely fussy/irritable and decreased interactions.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Flushing, Musculoskeletal stiffness
Clinical narrative: Flushing of skin, dizziness, feeling weak. After 30 minutes of observation stiffness of the neck.
Age: 18.0
Sex: F
Vaccine: HEPA, MEN
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Pt had hepatitis A and Meningococcal group B vaccine on 12/28/18, in both right and left deltoid. It is unknown which vaccine was injected in which arm. Pt has red, swollen rash on right deltoid.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: Patient complained of pain at the injection site during vaccination but did not require treatment at this time.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia
Clinical narrative: Patient had pain in the shoulder muscles the same evening as getting the flu shot. It was getting better, but then it was aggravated again. The patient went in to see the doctor who believed the flu shot was given into the joint. The doctor recommended resting the arm and it should get better. The patient is still having some pain at the time of the report.
Age: 43.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site mass, Injection site nodule, Injection site pain, Injection site reaction, Pain
Clinical narrative: Lump (nodule, knot, lump) developed Day 15 post-vaccination at MMR injection site. Right arm, subcutaneous. Lump became tender on Day 15 and has continued to grow daily. Day 18 lump throbbing. Roughly 1" in diameter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ear pain, Fatigue, Feeling cold, Headache
Clinical narrative: About 7 hours after the vaccination I began to feel cold. About 12 hours after the vaccination I began to experience body aches and pains, continued chills, headache, ear ache in right ear, and a fever of at least 101 degrees. (The fever was probably higher, but I didn't take my temperature until I began feeling better.) I continued to feel tired throughout the next day. A low grade fever of around 99 degrees continued in spite of taking Tylenol. My arm was sore for about a day after the vaccination,  and a red area about 6 square inches was apparent at the injection site for nearly three days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: About 7 hours after the vaccination I began to feel cold. About 12 hours after the vaccination I began to experience body aches and pains, continued chills, headache, ear ache in right ear, and a fever of at least 101 degrees. (The fever was probably higher, but I didn't take my temperature until I began feeling better.) I continued to feel tired throughout the next day. A low grade fever of around 99 degrees continued in spite of taking Tylenol. My arm was sore for about a day after the vaccination,  and a red area about 6 square inches was apparent at the injection site for nearly three days.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Contusion, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen, bruised left arm that is painful and hot touch. Adverse event was first noticed by patient on 12/29/2018 (the day after the immunization). She went in and saw her PCP and was prescribed keflex antibiotic (SIG: 1qid x5d) which she filled and picked up on 12/30/2018.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site urticaria, Pyrexia, Urticaria
Clinical narrative: Fevers, hives at injection site, hives on trunk. Rigors.
Age: 0.08
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Patient developed an outbreak of shingles 2 days after receiving the vaccine, on her lower left quadrant. Patient states that this outbreak is worse pain/Sx-worse compared to her 2 previous episodes, just in blister stage at this point.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Axillary pain, Oedema peripheral
Clinical narrative: Patient states she has a large lump underneath her right arm and it's sore, swollen and hurts.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: RED SCAR THAT IS WARM TO THE TOUCH, AND SORE AT INJECTION SITE. PATIENT ALSO REPORTED ACHES AND FEVER ON DAY 1 THAT WENT AWAY. HER MAIN CONCERN IS THE INJECTION SITE, BECAUSE IT IS REALLY RED, AND SORE, AND WARM, AND BUMP, SHE HAD REPORTED HAVING REACTION BEFORE.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site scar, Injection site swelling, Injection site warmth
Clinical narrative: RED SCAR THAT IS WARM TO THE TOUCH, AND SORE AT INJECTION SITE. PATIENT ALSO REPORTED ACHES AND FEVER ON DAY 1 THAT WENT AWAY. HER MAIN CONCERN IS THE INJECTION SITE, BECAUSE IT IS REALLY RED, AND SORE, AND WARM, AND BUMP, SHE HAD REPORTED HAVING REACTION BEFORE.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: RED SCAR THAT IS WARM TO THE TOUCH, AND SORE AT INJECTION SITE. PATIENT ALSO REPORTED ACHES AND FEVER ON DAY 1 THAT WENT AWAY. HER MAIN CONCERN IS THE INJECTION SITE, BECAUSE IT IS REALLY RED, AND SORE, AND WARM, AND BUMP, SHE HAD REPORTED HAVING REACTION BEFORE.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: CSF protein increased, CSF white blood cell count negative, Electromyogram abnormal, Guillain-Barre syndrome, Nerve conduction studies abnormal
Clinical narrative: Pt experienced Guillain-Barre syndrome, pt then received IVIG, was in ICU for 2 weeks, then in patient rehab for 2 weeks, then physical therapy for 6-7 weeks, now still doing occupational therapy, pt still has neuropathic pain in hands and feet pt couldn't stand or walk for about 3 weeks , lost all stamina and endurance.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dysstasia, Exercise tolerance decreased, Gait inability, Guillain-Barre syndrome
Clinical narrative: Pt experienced Guillain-Barre syndrome, pt then received IVIG, was in ICU for 2 weeks, then in patient rehab for 2 weeks, then physical therapy for 6-7 weeks, now still doing occupational therapy, pt still has neuropathic pain in hands and feet pt couldn't stand or walk for about 3 weeks , lost all stamina and endurance.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immunoglobulin therapy, Intensive care, Lumbar puncture, Neuralgia
Clinical narrative: Pt experienced Guillain-Barre syndrome, pt then received IVIG, was in ICU for 2 weeks, then in patient rehab for 2 weeks, then physical therapy for 6-7 weeks, now still doing occupational therapy, pt still has neuropathic pain in hands and feet pt couldn't stand or walk for about 3 weeks , lost all stamina and endurance.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Pyrexia, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 29th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th October 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site itching and injection site hives. On 30th October 2018, the patient experienced fever, chills, erythema, headache, pain and nausea. On 31st October 2018, the patient experienced low blood pressure, heart rate increased and tremor. The patient was treated with naproxen (Aleve) and benadryl (nos) (Benadryl). On 1st November 2018, the outcome of the injection site itching, injection site hives, fever, chills, erythema, headache, low blood pressure and tremor were recovered/resolved. In November 2018, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the heart rate increased was recovered/resolved and the outcome of the nausea was unknown. It was unknown if the reporter considered the injection site itching, injection site hives, fever, chills, erythema, headache, pain, low blood pressure, heart rate increased, tremor and nausea to be related to SHINGRIX. Additional details were provided as follows: About 4 hours later the patient noticed hives around the site of injection with 3 inches in diameter circle. Next day she experienced low grade fever of 99.8, chills, nausea, redness, headache, and pain. She took alleve and Benadryl as a treatment at night. She visited her physician on 31st October 2018. During her visit her heart rate was 86 and blood pressure was 90/60. She was also shaky, and nauseated during the visit. She recovered from all the side effects on 1st November 2018 except the pain which lasted for about a week. The reporter did not gave consent for follow up. No further details were provided. The reporter stated that the nurse from her doctor office might have already reported this but she was not 100% sure.