chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Impaired driving ability, Injection site pain, Malaise, Pyrexia, Renal failure
Clinical narrative: Pt received 2nd dose of Shingrix vaccine at 1600. No problems prior to administration. Fine immediately post. Went to gym but did no arm exercises. At 2000 I received a all asking me, spouse, to pick him up as he was ill and unable to drive. He displayed blurry vision, ataxia and severe Lt arm pain (site of injection). Opted to take him to ED. By now, approx. 2020 he displayed rigors. Temp spiked from afebrile to 100.8 in hour and BP dropped to 90/52 which is relative hypotension for him. Fluid resuscitated with 2L of NSS. Initial Lactate was elevated to 2.6, 2nd dropped to 1.2 post fluids. Pain was temporarily relieved with .05mg of Dilaudid. He was discharged at 0130 1/3/20. Today continues with Lt arm pain (5-6/10) will see PCP regarding pain control. Tylenol is not effective and NSAIDs are out of the picture due to renal insufficiency. He did fine with the first dose, just having just an achy arm. I appears that the side effects he experienced are listed as possible but severely exacerbated in my husband. No signs of anaphylaxis.
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Pt received 2nd dose of Shingrix vaccine at 1600. No problems prior to administration. Fine immediately post. Went to gym but did no arm exercises. At 2000 I received a all asking me, spouse, to pick him up as he was ill and unable to drive. He displayed blurry vision, ataxia and severe Lt arm pain (site of injection). Opted to take him to ED. By now, approx. 2020 he displayed rigors. Temp spiked from afebrile to 100.8 in hour and BP dropped to 90/52 which is relative hypotension for him. Fluid resuscitated with 2L of NSS. Initial Lactate was elevated to 2.6, 2nd dropped to 1.2 post fluids. Pain was temporarily relieved with .05mg of Dilaudid. He was discharged at 0130 1/3/20. Today continues with Lt arm pain (5-6/10) will see PCP regarding pain control. Tylenol is not effective and NSAIDs are out of the picture due to renal insufficiency. He did fine with the first dose, just having just an achy arm. I appears that the side effects he experienced are listed as possible but severely exacerbated in my husband. No signs of anaphylaxis.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Cellulitis, Erythema, Induration, Mobility decreased
Clinical narrative: Received Pneumovax 23 vaccine in left shoulder (only vaccine given on that day). Approximately 4 hours after vaccination, shoulder was very swollen, hard and painful (joint and muscle pain), which limited movement of arm. Swelling decreased significantly on second day (arm still painful), but new symptom appeared overnight: a cellulitis-like reaction on front of upper arm (bicep area). Swelling of shoulder and redness and swelling of front of arm decreased on third day. Swelling of shoulder and redness and swelling of front of arm mostly resolved 4 days after injection, however, 4 weeks after injection, I am still experiencing some minor joint pain when moving arm across chest (no joint pain prior to injection).
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Received Pneumovax 23 vaccine in left shoulder (only vaccine given on that day). Approximately 4 hours after vaccination, shoulder was very swollen, hard and painful (joint and muscle pain), which limited movement of arm. Swelling decreased significantly on second day (arm still painful), but new symptom appeared overnight: a cellulitis-like reaction on front of upper arm (bicep area). Swelling of shoulder and redness and swelling of front of arm decreased on third day. Swelling of shoulder and redness and swelling of front of arm mostly resolved 4 days after injection, however, 4 weeks after injection, I am still experiencing some minor joint pain when moving arm across chest (no joint pain prior to injection).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Side effects were not serious, but I elected to report them anyway. On Jan 2nd I received my 2nd dose of Shingrix (1st dose was mid-December). That evening I experienced chills and fever, then headaches. Symptoms lasted about 24 hours. Feel fine now.
Age: 55.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site mass, Rash macular
Clinical narrative: Developed pink lump 4" below injection site from flu shot 24 hours after vaccination, by 36 hours there was a line growing from the first lump. At 48 hours, I had hives and the lump spread down my arm following the vasculatory system. There were 3 distinct splotchy areas with lines connecting them. All were large and red and growing and very warm to the touch. These were on the arm that had the flu shot. There was no evidence of an issue on the arm with the shingles shot. Both did have minor redness where the bandages had been placed but that is standard for me. The red rash/splotches and hives were an unusual/unexpected reaction. Benadryl had not slowed the progression. The pharmacist showed me both vials before the injections. They were current and not expired. Not expecting a reaction, I didn't make note of the dates.
Age: 55.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: Developed pink lump 4" below injection site from flu shot 24 hours after vaccination, by 36 hours there was a line growing from the first lump. At 48 hours, I had hives and the lump spread down my arm following the vasculatory system. There were 3 distinct splotchy areas with lines connecting them. All were large and red and growing and very warm to the touch. These were on the arm that had the flu shot. There was no evidence of an issue on the arm with the shingles shot. Both did have minor redness where the bandages had been placed but that is standard for me. The red rash/splotches and hives were an unusual/unexpected reaction. Benadryl had not slowed the progression. The pharmacist showed me both vials before the injections. They were current and not expired. Not expecting a reaction, I didn't make note of the dates.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site rash, Pain, Pyrexia
Clinical narrative: Fever, chills, rash. I developed a rash, fever and chills starting the evening after receiving my second shingrix vaccine on Friday, 1/3/2020. Symptoms developed approx. 12 hours after receiving the shot. The rash was a 3" diameter red spot around the injection site (left arm). The fever measured around 99.8F, and I developed chills requiring blankets all over me. I took aspirin, the fever came down, and the next day I was better but sore all over. I was much better on Sunday. I received the shot at Pharmacy.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Fever, chills, rash. I developed a rash, fever and chills starting the evening after receiving my second shingrix vaccine on Friday, 1/3/2020. Symptoms developed approx. 12 hours after receiving the shot. The rash was a 3" diameter red spot around the injection site (left arm). The fever measured around 99.8F, and I developed chills requiring blankets all over me. I took aspirin, the fever came down, and the next day I was better but sore all over. I was much better on Sunday. I received the shot at Pharmacy.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral mucosal eruption, Rash
Clinical narrative: rash in the top of his mouth, across his face and around his ears/ shingles outbreak; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around September of 2016, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, anatomical location and route of administration were not specified), for routine health maintenance and for its intended purpose: the prevention of shingles. In or around February of 2017, pt presented to the clinic with complaints of a rash in the top of his mouth, across his face and around his ears. The shingles outbreak lasted several weeks. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms have resulted in physical limitations not present prior to using the product. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt had incurred and would continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of the event was reported as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning to a female patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.   On or about 08-APR-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, anatomical application, lot number and expiration date were not reported) for the long-term prevention of shingles and or zoster-related conditions.   On an unknown date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles, and she was treated by a healthcare provider at an urgent room. The patient had and would continue suffer ongoing injuries; significant medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies.   The causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was related.
Age: 9.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported; a patient received an expired dose of PROQUAD; This spontaneous report was received from a medical assistant, referring to a 9-year-old female patient. The patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies were not reported.  On 09-JAN-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHa) injections, administered subcutaneously as prophylaxis (dose number and anatomical location were not reported; lot number R014353 has been verified to be valid, expiration date reported and validated as 18-NOV-2019) (expired product administered). Concomitantly, an sterile diluent (MERCK STERILE DILUENT) was used with the vaccine (lot number S002623 and expiration date reported as 28-OCT-2021).   It was reported that the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was stored properly. No symptoms reported.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Lethargy, Myalgia
Clinical narrative: Pt spouse reported lethargy and muscle pain/weakness for a few days after receiving dose one of the Shingrix series. No fever presented or hospitalization was required, pt just presented with some flu-like symptoms for 3 or so days after receiving the shot.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Nasopharyngitis, Rash
Clinical narrative: cold symptoms, white bumps on the left arm, dizziness, weakness
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Hypertension, Nausea
Clinical narrative: Slight fever,fatigue,lack of appetite,nausea ,high blood pressure ,headache,tiredness
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Slight fever,fatigue,lack of appetite,nausea ,high blood pressure ,headache,tiredness
Age: 49.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Injection site reaction- redness, swelling, pain, throbbing to left arm started day after vaccine administered
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site induration, Injection site mass, Injection site pruritus, Injection site reaction
Clinical narrative: Patient described that she started feeling ill the next morning (body aches, fever, chills) and noticed that she had a large welt (1.5 inches in diameter around the injection site. The welt felt like a hard lump under the skin and she said it was very itchy. She also felt itchy sensations down both of her arms.  She did not have this reaction to the first dose of Shingrix in October.  She took Tylenol and got some triamcinolone 0.1% cream from her doctor that she put on the itchy areas. After a few days it seemed to get better and upon follow up today she said the welt/lump was down and better but she was still have some body aches and a little itch.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pruritus, Pyrexia, Urticaria
Clinical narrative: Patient described that she started feeling ill the next morning (body aches, fever, chills) and noticed that she had a large welt (1.5 inches in diameter around the injection site. The welt felt like a hard lump under the skin and she said it was very itchy. She also felt itchy sensations down both of her arms.  She did not have this reaction to the first dose of Shingrix in October.  She took Tylenol and got some triamcinolone 0.1% cream from her doctor that she put on the itchy areas. After a few days it seemed to get better and upon follow up today she said the welt/lump was down and better but she was still have some body aches and a little itch.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Hives over scalp, forehead, two on face. No periorbital or personal edema. Resolved with 1 dose of 1mg/kg benadryl oral suspension.
Age: 89.0
Sex: F
Vaccine: HEPAB
Symptoms: Chest pain, Dizziness, Dyspnoea, Hypoaesthesia, Pain in extremity
Clinical narrative: After screening patient's immunization questionnaire, vaccine was given around 4:00 p.m.. Instructed patient to stay in the pharmacy for 15 minutes to see if experience any signs/symptoms. Patient left pharmacy after 15 minutes saying she was doing okay. Patient went to the ice-cream stand tried to buy ice-cream and that was when she started to feel chest pain, difficulty breathing and dizziness. She was able to get herself sitting down on one of pharmacy's displayed chair. She administered 1 dose of her nitroglycerin lingual spray. She told us she felt better and refused the Epipen when offered. She wanted to go home but we told her to stay in the pharmacy for about 15 to 30 more minutes to make sure the symptoms were going away. She told us she was fasting and had not had any food the whole day. After about few more minutes, she started feel worse again and stated that her left arm felt sore and numbed. She administered another dose of nitroglycerin lingual spray. We called 911 and about 4:30 p.m. they took her to the ER. Patient stated she had a history of heart attack. Patient stated she did not think this was caused by the vaccine because she knew her medical condition.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Injected limb mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: pain in right arm, shoulder neck and back after injection, decreased ROM to arm, severe pain.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: patient reported arm pain starting day of vaccination that has persisted for 4 days. pain is reportedly causing weakness of arm between sholder and elbow. patient has reached out to Dr and will be seen in office at future date
Age: 27.0
Sex: M
Vaccine: FLU4, HEPAB, PPV
Symptoms: Chills, Erythema, Full blood count, Injection site cellulitis, Metabolic function test
Clinical narrative: Initially, patient presented with fever of 101, chills, redness, pain, tachycardia and rigors starting around 4:00 am at Hospital on 01/03/2020. Patient was sent home after treatment with antipydretic and told to follow up with PCP two days later. Patient then went to another Hospital on 01/05/2020 for what appeared to be a cellulitis of right upper arm to elbow. Patient was treated with IM Rocephin and prescribed Bactrim DS x 10 days. Patient went to Hospital on 01/06/2020 concerned his arm was not getting better. He was stable and was advised to follow up with PCP in 3 days. No treatment was given at this time. Patient was then seen on 01/07/2020 and started on diphenhydramine 25 mg three times daily and momentasone 0.1 % cream, BID to affected area x 10 days. US was obtained looking for possible forming infection, it was negative. Patient followed up on 01/10/2020 with great improvement. He never took the diphenhydramine because he believed medication will not work for him. He is using momentasone cream 0.1% as instructed. Arm was mildly warm to the touch with no erythema. Pain had decreased as well. He will follow up as needed.
Age: 27.0
Sex: M
Vaccine: FLU4, HEPAB, PPV
Symptoms: Pain, Pyrexia, Skin warm, Tachycardia, Ultrasound scan normal
Clinical narrative: Initially, patient presented with fever of 101, chills, redness, pain, tachycardia and rigors starting around 4:00 am at Hospital on 01/03/2020. Patient was sent home after treatment with antipydretic and told to follow up with PCP two days later. Patient then went to another Hospital on 01/05/2020 for what appeared to be a cellulitis of right upper arm to elbow. Patient was treated with IM Rocephin and prescribed Bactrim DS x 10 days. Patient went to Hospital on 01/06/2020 concerned his arm was not getting better. He was stable and was advised to follow up with PCP in 3 days. No treatment was given at this time. Patient was then seen on 01/07/2020 and started on diphenhydramine 25 mg three times daily and momentasone 0.1 % cream, BID to affected area x 10 days. US was obtained looking for possible forming infection, it was negative. Patient followed up on 01/10/2020 with great improvement. He never took the diphenhydramine because he believed medication will not work for him. He is using momentasone cream 0.1% as instructed. Arm was mildly warm to the touch with no erythema. Pain had decreased as well. He will follow up as needed.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Magnetic resonance imaging abnormal, Mobility decreased, Pain, Rotator cuff syndrome
Clinical narrative: Unable to raise elbow when resting. Severe pain with motion. Severe pain at night when still. Went to Dr. (Orthopedic) on 10/22/2019. Got Xrays, Medrol, Furibiprofen, and referral for Physical Therapy. Returned to Dr. 11/18/2019 for MRI. Got Cortizone shot 11/26/2019. Got Prednisone 01/13/2020.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Tendon disorder, X-ray
Clinical narrative: Unable to raise elbow when resting. Severe pain with motion. Severe pain at night when still. Went to Dr. (Orthopedic) on 10/22/2019. Got Xrays, Medrol, Furibiprofen, and referral for Physical Therapy. Returned to Dr. 11/18/2019 for MRI. Got Cortizone shot 11/26/2019. Got Prednisone 01/13/2020.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, PNC13
Symptoms: Blister, Pyrexia, Rash, Tongue blistering
Clinical narrative: Parent called and reported a rash that started 1/11/2020, two days after vaccination. Rash includes- two "coin sized" spots on face, a few small "blisters" on arm, and one on tongue. Parent reports child has no fever during the day and a low grade temperature at night. Parent states child is eating, drinking, urinating, and defecating normal. No treatment given so far. Rash still continues, but is not worsening.  Encouraged to monitor, seek medical attention if worsens, child has difficulty breathing/swallowing, or no improvement in next two days, as it may be an unrelated rash or need further testing/exam. Parent asked about given an allergy medication. Told parent, based on patient's age/weight, can give children's Benadryl 12.5mg chewable or 12.5mg/5mL liquid.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: This patient received an influenza vaccination in accordance with standard protocol procedures early in the season. She describes pain at the injection site days later to pharmacist on duty. Pharmacist  explained that one of the most common side effects in short term pain at the injection site. She then followed up many weeks later stating she sought medical attention and her physician said it was because of the flu shot.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Pain from the day of the shot persisted for 2 days until follow up. On day 2 at follow up in addition to the pain, swelling at injection site on L shoulder. Swelling is tender to palpation and warm.  Patient can move her shoulder normally even if she has some pain.  L shoulder: swelling localized around injection site. redness and warmth 2 inches diameter. pain at palpation of deltoid muscle around injection site. no abscess felt or pus oozing. No fever, no axillary Lympadenopathy.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Erythema, Eye swelling, Ocular hyperaemia, Pruritus
Clinical narrative: Less than 48 hours after vaccination, patient awoke to right eye swollen and red.  1 hour later, the other eye swelled up.  Over the next two hours - large, red, itchy welts appeared all over patient's face and neck.  Went to Urgent Care facility and was given prescription for Prednisone (20mg)- 2 tabs daily for 5 days; plus, advised to take 50 mg of Benadryl every 6 hours.  Welts continued to appear every day for the next five days.  As of today, 1/13/2020,  welts have decreased and patient went to PCP for follow-up.  Was taken off Prednisone and decreased the dosage of Benadryl (due to improvement and elevated blood pressure).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Less than 48 hours after vaccination, patient awoke to right eye swollen and red.  1 hour later, the other eye swelled up.  Over the next two hours - large, red, itchy welts appeared all over patient's face and neck.  Went to Urgent Care facility and was given prescription for Prednisone (20mg)- 2 tabs daily for 5 days; plus, advised to take 50 mg of Benadryl every 6 hours.  Welts continued to appear every day for the next five days.  As of today, 1/13/2020,  welts have decreased and patient went to PCP for follow-up.  Was taken off Prednisone and decreased the dosage of Benadryl (due to improvement and elevated blood pressure).
Age: 39.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Hot flush, Nausea, Neck pain, Oral administration complication
Clinical narrative: Patient took 1st pill on 1/9/2020 at 5:30 am, she states that shortly after she developed abdominal pain. She looked it up and found that was a common side effect. When it was time to take the second pill on 1/11/2020 she immediately vomited the pill back up. She states that her abdominal pain has progressed to a sharp radiating pain that shoots up her abdomen into her neck and she is having fever, nausea, vomiting and hot flashes. She has taken nyquil which has allowed her to get some sleep. As of today 1/13/2020 the pain is not getting any better so told the patient to go to urgent care/emergency department. She states that is what she will do.
Age: 39.0
Sex: F
Vaccine: TYP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient took 1st pill on 1/9/2020 at 5:30 am, she states that shortly after she developed abdominal pain. She looked it up and found that was a common side effect. When it was time to take the second pill on 1/11/2020 she immediately vomited the pill back up. She states that her abdominal pain has progressed to a sharp radiating pain that shoots up her abdomen into her neck and she is having fever, nausea, vomiting and hot flashes. She has taken nyquil which has allowed her to get some sleep. As of today 1/13/2020 the pain is not getting any better so told the patient to go to urgent care/emergency department. She states that is what she will do.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Head injury, Injection site pain, Malaise
Clinical narrative: 2nd Injection on Saturday. Slightly dizzy that evening. Still dizzy the next morning on Sunday. Very sort left shoulder. All joints sore. General malaise. Late Sunday (around 11 pm) I fainted while standing. Hit head on tile bath. Woke up a few seconds later. Otherwise, feel OK. Now on Monday, feel pretty good. No reaction of any kind after the first shot in October.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: 2nd Injection on Saturday. Slightly dizzy that evening. Still dizzy the next morning on Sunday. Very sort left shoulder. All joints sore. General malaise. Late Sunday (around 11 pm) I fainted while standing. Hit head on tile bath. Woke up a few seconds later. Otherwise, feel OK. Now on Monday, feel pretty good. No reaction of any kind after the first shot in October.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient describes continued pain at injection site days and weeks following administration.  She sought medical attention and is currently receiving NSAI therapy.
Age: 1.08
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Given extraneous 4th dose of HepB as parent provided historical immunization history, showing three previous HepB doses, after vaccine was administered.
Age: 28.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Life support
Clinical narrative: Patient reported feeling well and fully recovered from a recent undisclosed illness. Was due for third Hep B vaccine and requested the seasonal flu vaccination as well.  On Thursday, 1/9/2020, the patient's roommate reported he was hospitalized the evening before.  On Friday 1/10/2020, the patient's roommate reported he was on life support without chance of recovery.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Eye movement disorder, Fall, Injection site pain, Loss of consciousness, Seizure like phenomena
Clinical narrative: A seven-year-old girl came to the pharmacy with her mother and grandmother to get a flu shot (only the girl and mother were getting vaccinated).  The mother filled out our consent form, medical record was checked and the girl had received Fluzone Quad in the past.  They were rung up at the register for the vaccines and the VIS form was provided to them.  As per the consent form there had been no record of adverse reactions to vaccines in the past.  The mother did not have concerns regarding the vaccine and just asked how long it would take to kick in and start working.    Fluzone quad preservative free 0.5mL was given in the left thigh due to her age and thin arms, this vaccine is FDA approved ages 6 months and up at this dose.  She was sitting in her mother?s lap at the time she was given the vaccine.  She was very worked up/screaming/crying about having to get a vaccine, for which the mother was apologetic about.  After the vaccine was given the girl calmed down, she started eating starburst candy, and appeared to be doing well.  The mother was then given her vaccine.  Once that was completed I asked the girl how her leg felt and she stated ?it hurt? which was expected after giving the vaccine.  They got ready to leave the pharmacy.  As they started walking the girl passed out, eye?s were in the back of her head, and she had some tonic-clonic-like symptoms.  This was about 3-5 minutes after her vaccine had been administered.  As this was happening I had one of my technicians call 911 to get EMS.  The girl?s tonic-clonic symptoms lasted less than 10 second and she started to wake up.  She had been standing next to a wall at the time she collapsed, so it is possible that she hit her head on the wall or on the floor.  The mother was able to grab ahold of her to lessen the fall.  When she was awake she remained on the floor and was not moved until EMS had arrived.  While waiting for EMS she was asked questions such as where she was and who she was with.  Her face was very pale.   Mother asked why this might have happened, I stated that it could have been due to the fact that she was very worked up at the time the vaccine was given as that can cause someone to pass out.  Mother stated this had never happened before. EMS arrived, took vital signs which they said were normal.  They recommended that she was taken to the hospital due to seizure-like activity.  They were given the option by EMS to go in an ambulance or through their own transportation means.  I do not know which option they chose. EMS did not have any further questions from me, however they did take my name for the report.  A VAERS report was completed for this incident.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: A seven-year-old girl came to the pharmacy with her mother and grandmother to get a flu shot (only the girl and mother were getting vaccinated).  The mother filled out our consent form, medical record was checked and the girl had received Fluzone Quad in the past.  They were rung up at the register for the vaccines and the VIS form was provided to them.  As per the consent form there had been no record of adverse reactions to vaccines in the past.  The mother did not have concerns regarding the vaccine and just asked how long it would take to kick in and start working.    Fluzone quad preservative free 0.5mL was given in the left thigh due to her age and thin arms, this vaccine is FDA approved ages 6 months and up at this dose.  She was sitting in her mother?s lap at the time she was given the vaccine.  She was very worked up/screaming/crying about having to get a vaccine, for which the mother was apologetic about.  After the vaccine was given the girl calmed down, she started eating starburst candy, and appeared to be doing well.  The mother was then given her vaccine.  Once that was completed I asked the girl how her leg felt and she stated ?it hurt? which was expected after giving the vaccine.  They got ready to leave the pharmacy.  As they started walking the girl passed out, eye?s were in the back of her head, and she had some tonic-clonic-like symptoms.  This was about 3-5 minutes after her vaccine had been administered.  As this was happening I had one of my technicians call 911 to get EMS.  The girl?s tonic-clonic symptoms lasted less than 10 second and she started to wake up.  She had been standing next to a wall at the time she collapsed, so it is possible that she hit her head on the wall or on the floor.  The mother was able to grab ahold of her to lessen the fall.  When she was awake she remained on the floor and was not moved until EMS had arrived.  While waiting for EMS she was asked questions such as where she was and who she was with.  Her face was very pale.   Mother asked why this might have happened, I stated that it could have been due to the fact that she was very worked up at the time the vaccine was given as that can cause someone to pass out.  Mother stated this had never happened before. EMS arrived, took vital signs which they said were normal.  They recommended that she was taken to the hospital due to seizure-like activity.  They were given the option by EMS to go in an ambulance or through their own transportation means.  I do not know which option they chose. EMS did not have any further questions from me, however they did take my name for the report.  A VAERS report was completed for this incident.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous, Rash macular
Clinical narrative: Patient reported an red, splotchy rash "a little bit" below the injection site. She stated the rash was hot and sore to the touch.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient received 1st dose of shingrix on 10/30/2019. She experienced soon after pain at injection site. On 1/13/2020 she came in for her 2nd shingrix dose. She reported to the pharmacist that her upper left arm at injection site was still tender. Pharmacist advised patient to call provider.
Age: 14.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine for 18 yo and over. Patient was 14 yo
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Blood test normal, Injection site reaction, Muscle twitching, Muscular weakness, Nerve injury
Clinical narrative: Right arm general neuropathy, weakness in arm, twitching in right hand and especially at site where immunoglobulin was injected at bite site. Pain in fingers, hand arm up to elbow then back of arm. Pain comes and goes depending on whatever aggravates the nerve in that arm. Now well over a year since the injection in that right arm pain persists in same manner. Appears to be permanent nerve damage in that arm rather than temporary.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Neuropathy peripheral, Pain in extremity
Clinical narrative: Right arm general neuropathy, weakness in arm, twitching in right hand and especially at site where immunoglobulin was injected at bite site. Pain in fingers, hand arm up to elbow then back of arm. Pain comes and goes depending on whatever aggravates the nerve in that arm. Now well over a year since the injection in that right arm pain persists in same manner. Appears to be permanent nerve damage in that arm rather than temporary.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Joint injury, Nausea, Pain
Clinical narrative: Patient reported headache, nausea, fainting while in shower causing knee injury, fatigue, and body aches. She did not specify how long these symptoms lasted for.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Patient reported headache, nausea, fainting while in shower causing knee injury, fatigue, and body aches. She did not specify how long these symptoms lasted for.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, High-pitched crying, Immediate post-injection reaction, Intussusception, Screaming
Clinical narrative: High pitched, inconsolable  screamingly more than 24 hours immediately  following vaccination
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Sciatica, Spinal pain
Clinical narrative: shortly after patient received the vaccine she experienced a pain in her right leg and spine and the pain progressed to a sciatica like pain from her right hip down to the middle of her right thigh
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Nervousness, Syncope
Clinical narrative: 12 year old boy was administered Afluria at the request of parents.  Upon administering Afluria the patient immediately fainted while sitting and awoke within a few seconds.  Water was given to the patient upon awakening and time to rest. His blood pressure was measured after resting for about 5 minutes and measured to be approximately 60/40. After an additional 5 minutes his blood pressure was tested again and measured at 90/60.  A third measurement an additional 5 minutes later was taken and found to be 112/60.  I believed the patient had experienced a temporary episode of syncope and was slowly recovering.  The patient was very nervous upon receiving the vaccination and I encouraged the patient to relax. I stayed with patient approximately 30 to 40 minutes to ensure that his blood pressure was normalizing and healthy enough to safely leave with his parents. I recommended that the parents have the patient examined by a physician to ensure the patient's health and parents' peace of mind.   Approximately 1 1/2 hours after the patient leaving the pharmacy I followed up with parents and was told the child was being taken to health care facility for examination.  The following day I called the parents twice but no return call.  I received a call back from the mother 3 days after the initial episode and was told the patient may have experienced a seizure.  There is no seizure history on the patient from pharmacy records. The patient had received a follow up examination at an ER room according to the mother.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Gait disturbance, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: injection site pain for 2 days, followed by muscle weakness and pain in knees/thighs. Knee was so bad it was hard to walk for almost 2 days. 6 days post-vaccination and 4 days since leg/knee pain/weakness, improving but not resolved.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Fall, Head injury, Loss of consciousness, Muscle twitching, Paraesthesia
Clinical narrative: MSA called to the lobby and another donor saw donor get up and then he fell and hit his head. Donor in lobby states that this donor had LOC for 30 sec. Twitching was noted in arms and legs. Event occurred at 1718. When MSA arrived donor was alert and orientated to time and place. No laceration or bump was noted on donor's head. During waiting period for immunization donor states he started to feel tingling all over and heard ringing in his ears.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Tinnitus
Clinical narrative: MSA called to the lobby and another donor saw donor get up and then he fell and hit his head. Donor in lobby states that this donor had LOC for 30 sec. Twitching was noted in arms and legs. Event occurred at 1718. When MSA arrived donor was alert and orientated to time and place. No laceration or bump was noted on donor's head. During waiting period for immunization donor states he started to feel tingling all over and heard ringing in his ears.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Patient reported that there was redness and soreness at the arm where the shot was administered on 12/15/19.  She went to the doctor to be evaluated on 12/18/19 by dr. who discussed  a case of cellulitis of her left upper extremity rather than an allergic reaction to the shingrix shot. The  pt was given a antibiotics which cleared up the area.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Myalgia, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This was the second dose in the series. Patient reported that the first dose in the series, she had no adverse events, but had normal muscle soreness associated with receiving a vaccine. The symptoms of the second dose began the morning after receiving the vaccine. She stated that the previous night, she noted muscle soreness, but the following morning (12/31/2019), her arm became slightly swollen and a rash around the injection site that spread down to the elbow. She also noted increased heat in the left arm and significant pain. She applied ice packs, but found little relief. She saw her primary care provider on 01/03/2020 due to these symptoms and was prescribed prednisone, hydrocodone/acetaminophen, and azithromycin. Per patient, the pain lingered until 01/12/2020.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Malaise, Nausea
Clinical narrative: Had a bad reaction to second Shingrex 50 mcg shot. About 9 hours after shot had uncontrollable shivers. Went to bed and they stopped eventually but in morning nauseous and exhausted. Managed to eat something and walk my dog but ended up going back to bed. No appetite so slept through lunch. Couldn't get up anyway. Still exhausted and felt sick so not much dinner. Minimally better Wednesday but still loss of appetite and felt tired. Now Thursday and still under the weather but more functional. First shot just made me sore. I hardly ever get sick.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Had a bad reaction to second Shingrex 50 mcg shot. About 9 hours after shot had uncontrollable shivers. Went to bed and they stopped eventually but in morning nauseous and exhausted. Managed to eat something and walk my dog but ended up going back to bed. No appetite so slept through lunch. Couldn't get up anyway. Still exhausted and felt sick so not much dinner. Minimally better Wednesday but still loss of appetite and felt tired. Now Thursday and still under the weather but more functional. First shot just made me sore. I hardly ever get sick.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: I had a shingles vaccine booster yesterday. Today I have a fever of 100 degrees, a headache, and severe body aches and pains.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Injection site pain
Clinical narrative: Received Shingrix vaccine injection on January 4, 2020. Subsequently, experienced soreness at injection site, insomnia, chills, headache, fever, nausea, dizziness and difficulty breathing. Symptoms subsided 24 hours after injection.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Nausea, Pyrexia
Clinical narrative: Received Shingrix vaccine injection on January 4, 2020. Subsequently, experienced soreness at injection site, insomnia, chills, headache, fever, nausea, dizziness and difficulty breathing. Symptoms subsided 24 hours after injection.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Joint swelling, Malaise, Myalgia
Clinical narrative: SERIOUS REACTION TO FLU VACCINE, PATIENT RECEIVED FLU VACCINE ON 10/3/2019. 2 DAYS AFTER THAT SHE REPORTS FEELING SICK & MALAISE, THEN WENT ON TO DEVELOP RASH, SEVERE JOINT PAINS WITH SWELLING, MYALGIAS, LOW ENERGY, AND GENERALIZED WEAKNESS. THESE SYMPTOMS HAVE BEEN PERSISTENT UNTIL EVEN NOW (12/27/2019), + LABS REVEAL A STRIKING ELEVATION OF ESR AT 92.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Red blood cell sedimentation rate increased
Clinical narrative: SERIOUS REACTION TO FLU VACCINE, PATIENT RECEIVED FLU VACCINE ON 10/3/2019. 2 DAYS AFTER THAT SHE REPORTS FEELING SICK & MALAISE, THEN WENT ON TO DEVELOP RASH, SEVERE JOINT PAINS WITH SWELLING, MYALGIAS, LOW ENERGY, AND GENERALIZED WEAKNESS. THESE SYMPTOMS HAVE BEEN PERSISTENT UNTIL EVEN NOW (12/27/2019), + LABS REVEAL A STRIKING ELEVATION OF ESR AT 92.
Age: 61.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Dehydration, Feeling abnormal, Influenza virus test negative, Laboratory test, Pyrexia
Clinical narrative: On 12/27/19 he started running fever & feeling poorly. On 12/28/19, he had fever of 103.2 and had to go to the ER - he was severely dehydrated & had labs & other tests. He received 2L of IV NS due to fever and severe dehydration. 12/30/19 he is still feeling very poorly.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: unable to move arm where vaccination was administered. Painful at night time, Throbbing, can't lift while laying down. Hard time putting coat, shirt, etc... on - Painful when putting across stomach, etc...
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: unable to move arm where vaccination was administered. Painful at night time, Throbbing, can't lift while laying down. Hard time putting coat, shirt, etc... on - Painful when putting across stomach, etc...
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: WHOLE ARM HURT, FELT "NUMB" AND WAS NOT ABLE TO MOVE IT FOR 1 WEEK.
Age: 80.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: 4 hours after vaccination onset pain (L) upper arm constant, pain level 3-10/10
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Pain in extremity
Clinical narrative: Patient was complaining of pain to right arm
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Patient called pharmacy 1/13/20 1PM stating she had hives about 45 minutes after receiving flu vaccine. She treated w/ oral benadryl and the hives subsided. She still had some hives at time of call, but said she was planning to take another dose of Benadryl.
Age: 54.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Antinuclear antibody, Arthralgia, Blood cortisol, Blood creatine phosphokinase, Blood thyroid stimulating hormone
Clinical narrative: The Next Day had flu like symptons Muscle/Joint pain Legs/knees & hips and Buttocks - The pain has cause spasms that are severe/ painful to walk when It flares up - Hurts to sit down sometimes I feel like my life has changed My life changed the Next Day After vaccination It's hard to sit down/walk without pain. Spasms can BE so severe I'm In tears I can't Bend or Stoop at times/Always been Independent / I'm limited to what I do. No Housework / If I drop anything I can't Bend or Stoop without Being in pain. Limited to things I do now Inflammation & Numbness At times Lab tests Ran on All Muscles & More Referred to Neurologist
Age: 54.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blood uric acid, C-reactive protein, Full blood count, Hypoaesthesia, Inflammation
Clinical narrative: The Next Day had flu like symptons Muscle/Joint pain Legs/knees & hips and Buttocks - The pain has cause spasms that are severe/ painful to walk when It flares up - Hurts to sit down sometimes I feel like my life has changed My life changed the Next Day After vaccination It's hard to sit down/walk without pain. Spasms can BE so severe I'm In tears I can't Bend or Stoop at times/Always been Independent / I'm limited to what I do. No Housework / If I drop anything I can't Bend or Stoop without Being in pain. Limited to things I do now Inflammation & Numbness At times Lab tests Ran on All Muscles & More Referred to Neurologist
Age: 54.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Influenza like illness, Lipids, Loss of personal independence in daily activities, Mobility decreased, Muscle spasms
Clinical narrative: The Next Day had flu like symptons Muscle/Joint pain Legs/knees & hips and Buttocks - The pain has cause spasms that are severe/ painful to walk when It flares up - Hurts to sit down sometimes I feel like my life has changed My life changed the Next Day After vaccination It's hard to sit down/walk without pain. Spasms can BE so severe I'm In tears I can't Bend or Stoop at times/Always been Independent / I'm limited to what I do. No Housework / If I drop anything I can't Bend or Stoop without Being in pain. Limited to things I do now Inflammation & Numbness At times Lab tests Ran on All Muscles & More Referred to Neurologist
Age: 54.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Myalgia, Pain, Rheumatoid factor, Tearfulness, Vitamin B12
Clinical narrative: The Next Day had flu like symptons Muscle/Joint pain Legs/knees & hips and Buttocks - The pain has cause spasms that are severe/ painful to walk when It flares up - Hurts to sit down sometimes I feel like my life has changed My life changed the Next Day After vaccination It's hard to sit down/walk without pain. Spasms can BE so severe I'm In tears I can't Bend or Stoop at times/Always been Independent / I'm limited to what I do. No Housework / If I drop anything I can't Bend or Stoop without Being in pain. Limited to things I do now Inflammation & Numbness At times Lab tests Ran on All Muscles & More Referred to Neurologist
Age: 54.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Vitamin D
Clinical narrative: The Next Day had flu like symptons Muscle/Joint pain Legs/knees & hips and Buttocks - The pain has cause spasms that are severe/ painful to walk when It flares up - Hurts to sit down sometimes I feel like my life has changed My life changed the Next Day After vaccination It's hard to sit down/walk without pain. Spasms can BE so severe I'm In tears I can't Bend or Stoop at times/Always been Independent / I'm limited to what I do. No Housework / If I drop anything I can't Bend or Stoop without Being in pain. Limited to things I do now Inflammation & Numbness At times Lab tests Ran on All Muscles & More Referred to Neurologist