chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: patient's girlfriend called pharmacy at 5:25 pm, she stated that patient and herself (she also received vaccination same day) was experiencing numbness in face and face felt like pins and needles. I told girlfriend for her and patient to both take a Benadryl and that I would contact our clinical department to seek further advice.  at 5:27 pm I called clinical department; they told me symptoms could possibly be anaphylaxis or affecting nerves. at 5:35 pm I called girlfriend back, instructed for her and patient to go to emergency room due to the possible side effects explained to me by our clinical  department. Girlfriend said the she and patient are going to "wait it out". I told girlfriend I would follow up with her and patient in an hour.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Altered state of consciousness, Blood test normal, Cardiac stress test normal, Contusion, Dizziness
Clinical narrative: Just a pinch at time of receiving vaccine and no pain up until the next  morning on 7/15/20. At 4pm patient felt light headed and dizzy. Felt like passing out. Thought it was heart issue because she has a-fib, 911 called. At this time left arm only was in a lot of pain, fingers felt tingly and it was difficult to move arm due to pain - doctors thought it was a heart attack at hospital. At this time patient said left arm only had swelling/bruising and scratch-like marks. After 2 weeks, still some soreness in left arm only.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Electrocardiogram normal, Mobility decreased, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Just a pinch at time of receiving vaccine and no pain up until the next  morning on 7/15/20. At 4pm patient felt light headed and dizzy. Felt like passing out. Thought it was heart issue because she has a-fib, 911 called. At this time left arm only was in a lot of pain, fingers felt tingly and it was difficult to move arm due to pain - doctors thought it was a heart attack at hospital. At this time patient said left arm only had swelling/bruising and scratch-like marks. After 2 weeks, still some soreness in left arm only.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: SARS-CoV-2 test negative, Scratch
Clinical narrative: Just a pinch at time of receiving vaccine and no pain up until the next  morning on 7/15/20. At 4pm patient felt light headed and dizzy. Felt like passing out. Thought it was heart issue because she has a-fib, 911 called. At this time left arm only was in a lot of pain, fingers felt tingly and it was difficult to move arm due to pain - doctors thought it was a heart attack at hospital. At this time patient said left arm only had swelling/bruising and scratch-like marks. After 2 weeks, still some soreness in left arm only.
Age: 51.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Immediate post-injection reaction, Sensory disturbance
Clinical narrative: patient received the tdap shot first, then requested the shingrix shot in same arm. He claims immediately following getting both vaccinations he felt the sensation of the liquid in his arm shooting downwards. No pain, just sensational.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Joint swelling, Peripheral swelling, Sensory disturbance
Clinical narrative: Patient had a swollen arm, specifically the elbow and she can feel the medication slowly crawling down her arm.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt called next day on 7/28, reporting red swollen arm as well as the skin being hot. specifically, the swelling was occuring closer to the elbow and towards the bicep. pt was advised to apply ice to area, and to go to md or urgent care if pt is concerned. unable to determine what kind of reaction the pt was having upon inspection. immunization was given by rph on 7/27
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour
Clinical narrative: Patient had vaccines on 7/15/20. Around 7/17/20 to 7/18/20, mother noted patient not making as much typical vocalizations. Saw in clinic myself on 7/27/20, by then, mother said almost back to baseline.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Patient received the above vaccines on 7-20-20 along with a PPD skin test. Was fine until 7-26 when Lt upper arm became red, inflamed, waRm, sore. 4 x 4 1/2" inch area induration. Had been outside in the heat most of the previous day. Some confusion about which arm had Bexsero - pt says Left, Nurse charted Right
Age: 18.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Tuberculin test
Clinical narrative: Patient received the above vaccines on 7-20-20 along with a PPD skin test. Was fine until 7-26 when Lt upper arm became red, inflamed, waRm, sore. 4 x 4 1/2" inch area induration. Had been outside in the heat most of the previous day. Some confusion about which arm had Bexsero - pt says Left, Nurse charted Right
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Urticaria
Clinical narrative: At the time of the reported ADR on March 15, 2016, a 62yo male who complained of dyspnea and hives, while in the Pre-op clinic, which post evaluation was suspected to be from the Pneumovax the patient received. Documentation included he was hemodynamically stable while in Pre- op and was transported to the ED. In the Emergency Department, the reaction was treated with methylprednisolone 125mg iv, Benadryl 50mg iv, epinephrine 0.3mg IM and ranitidine 50mg iv Medical Hx at the time and prior 2016 included: Major Depression, PTSD, HTN, Splenomegaly, Basal cell Carcinoma of skin, Lentigo, Actinic Keratosis, Anxiety, Idiopathic Peripheral Neuropath, Rosacea After 2016 - Seborrheic Keratosis, Leiomyosarcoma, Benign enlargement of the Prostate, Fatty iver patient's allergic profile included -hydrochlorothiazide, Idoine contrast media even w/prep, shellfish & Throat swelling (soft palat and uvula)
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Headache, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Had Kinrix on right thigh and within 24hrs had  fever, HA, + swollen right thigh - 6/30/20. Had quarter size red area 7/1/2020 - called again leg more swollen, size of red area has double w/ purplish bruise around perimeter. Improved w/ compress & Ibuprofen 7/25/2020 - seen in office still limping w/ pain in right thigh. Has knot in muscle 1-2 cm on right  site of shot.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Injection site swelling, Muscle mass, Pyrexia
Clinical narrative: Had Kinrix on right thigh and within 24hrs had  fever, HA, + swollen right thigh - 6/30/20. Had quarter size red area 7/1/2020 - called again leg more swollen, size of red area has double w/ purplish bruise around perimeter. Improved w/ compress & Ibuprofen 7/25/2020 - seen in office still limping w/ pain in right thigh. Has knot in muscle 1-2 cm on right  site of shot.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: severe HA
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient developed redness & warmness on her arm about 1 inch below the injection site. It's about 3 inches wide and very painful. She's been used ice at night but still hurting.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Fatigue, Feeling abnormal, Mobility decreased
Clinical narrative: Within 5 minottes (min) she Felt tired looked dazed. dev. hA. felt she cooldn't move her legs. She was lied down. Approx 10 minutes later she started to Feel Better. She remained lying For 10 More Minutes She was then Sat Up and felt well. She was able to stand + All symptoms had resolved
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Scan brain, Seizure
Clinical narrative: After my last dose of Gardasil in March i started with seizures in July 2013 i do not have a family history of seizure disorder. I had 3 full blown seizures had to go to Hospital get an IV in me and rest. Now on Keppra 1000mg's still.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender, regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Injection site mass, Oedema, Product administered at inappropriate site, Swelling face
Clinical narrative: The patient received the 2nd dose of GARDASIL 9 and experienced redness tenderness and swelling of the face, a 4.5cm lump on buttocks where injection was given, and also edema in unspecified locations.; The patient received the 2nd dose of GARDASIL 9 and experienced redness tenderness and swelling of the face, a 4.5cm lump on buttocks where injection was given, and also edema in unspecified locations.; The patient received the 2nd dose of GARDASIL 9 and experienced redness tenderness and swelling of the face, a 4.5cm lump on buttocks where injection was given, and also edema in unspecified locations.; The patient received the 2nd dose of GARDASIL 9 and experienced redness tenderness and swelling of the face, a 4.5cm lump on buttocks where injection was given, and also edema in unspecified locations.; The patient received the 2nd dose of GARDASIL 9 and experienced redness tenderness and swelling of the face, a 4.5cm lump on buttocks where injection was given, and also edema in unspecified locations.; This spontaneous report was received from a 31 year old female patient reporting on herself via company representative. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.   On 19-JUL-2020 the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, lot # and expiration date were unknown) for prophylaxis.   After vaccination on 20-JUL-2020, the patient experienced redness (erythema) tenderness and swelling of the face, a 4.5 cm lump (injection site mass) on buttocks where injection was given, and also edema in unspecified location. The patient seek for medical attention and was treated with diphenhydramine (BENADRYL). No laboratory diagnostics or studies were performed.   At the time of the report, the outcome of erythema, oedema, injection site mass, tenderness and swelling face was reported as resolving. The reporter did not mention the causality assessement between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Tenderness
Clinical narrative: The patient received the 2nd dose of GARDASIL 9 and experienced redness tenderness and swelling of the face, a 4.5cm lump on buttocks where injection was given, and also edema in unspecified locations.; The patient received the 2nd dose of GARDASIL 9 and experienced redness tenderness and swelling of the face, a 4.5cm lump on buttocks where injection was given, and also edema in unspecified locations.; The patient received the 2nd dose of GARDASIL 9 and experienced redness tenderness and swelling of the face, a 4.5cm lump on buttocks where injection was given, and also edema in unspecified locations.; The patient received the 2nd dose of GARDASIL 9 and experienced redness tenderness and swelling of the face, a 4.5cm lump on buttocks where injection was given, and also edema in unspecified locations.; The patient received the 2nd dose of GARDASIL 9 and experienced redness tenderness and swelling of the face, a 4.5cm lump on buttocks where injection was given, and also edema in unspecified locations.; This spontaneous report was received from a 31 year old female patient reporting on herself via company representative. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.   On 19-JUL-2020 the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, lot # and expiration date were unknown) for prophylaxis.   After vaccination on 20-JUL-2020, the patient experienced redness (erythema) tenderness and swelling of the face, a 4.5 cm lump (injection site mass) on buttocks where injection was given, and also edema in unspecified location. The patient seek for medical attention and was treated with diphenhydramine (BENADRYL). No laboratory diagnostics or studies were performed.   At the time of the report, the outcome of erythema, oedema, injection site mass, tenderness and swelling face was reported as resolving. The reporter did not mention the causality assessement between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2020, the patient received the 1st dose of Shingrix. On 14th May 2020, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by the nurse who reported for her mother in law. The age at vaccination was not reported. The patient just received shingrix yesterday and had fever today (on the day of reporting). The reporter asked how high might her fever be after receiving the vaccine. The reporter was trying to determine whether she had a reaction to vaccine or had CoVid 19. The reporter nurse had a COVID positive patient on last shift and then went to her mother in law house to pick up little girls.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: she almost called 911, problems:fever, diarrhea, nausea, pain arm, flu like symptoms , dry heaves
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Retching
Clinical narrative: she almost called 911, problems:fever, diarrhea, nausea, pain arm, flu like symptoms , dry heaves
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Asthenia, Dizziness, Fall, Pallor, Syncope
Clinical narrative: Syncopal episode:  Patient experienced pallor, weekness, lightheaded,  fainted and fell to floor. Did not respond to verbal stimuli x 1 minute.  Awakened  and responded appropriately within 2 minutes.   Sustained no injury.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: Syncopal episode:  Patient experienced pallor, weekness, lightheaded,  fainted and fell to floor. Did not respond to verbal stimuli x 1 minute.  Awakened  and responded appropriately within 2 minutes.   Sustained no injury.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Redness, swelling and itching to the left upper extremity. Localized hard area in upper arm at injection site one day after injection.  Day 7 reported to office.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Muscle swelling, Tenderness
Clinical narrative: tenderness, heat, redness, extreme swelling of bicep
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Lethargy, Oxygen saturation decreased, Pyrexia, Tremor
Clinical narrative: Patient was lethargic, but no noteworthy symptoms throughout the day. I put him to sleep in his crib, on his back, without any surrounding blankets, toys, or pillows. At approx. 8:30 pm, his owlet monitor alarm went off alerting us his oxygen levels were rapidly decreasing. When I went to his room to wake him, his body was shaking. No foaming at mouth to note. After checking breathing vitals, and for fever, I put him back to sleep and monitored him all night. The next morning, the alarm did go off again, alerting us of low oxygen levels. I placed a call to the pediatrician, and I made sure the call was recorded. I was told they "do not recommend Owlet monitors" and he was "probably shaking from a fever" and this was "normal". They had no further concerns and did not think he should be seen for any symptoms.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: The pt was due for her immunizations of :  Dtap, MMR, Varicella, and Polio Unknown that we had ordered PROQUAD in the office, as we never had this before. The patient was given Varicella, Kinrix, and Proquad.  Double dose of varicella
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Headache, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Immediately after receiving the HPV vaccine patient became unresponsive. Nurse and patient's mother assisted patient to the floor. Patient convulsed a couple times while lying on the floor. Nurse administered ammonia inhalant under patient' nose. Skin color extremely pale and diaphoretic. No cardio/respiratory distress noted. Patient alert after two minutes of unconsciousness. Patient did not remember where he was or what happened. Safety maintained. Nurse advised parent to get patient checked out by a doctor at ER, Urgent Care, First Care, or family doctor. Patient c/o dizziness, ringing in ears, weakness, and headache after vaccine. Nurse assisted patient to the car in a wheelchair.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Memory impairment, Pallor, Seizure, Tinnitus
Clinical narrative: Immediately after receiving the HPV vaccine patient became unresponsive. Nurse and patient's mother assisted patient to the floor. Patient convulsed a couple times while lying on the floor. Nurse administered ammonia inhalant under patient' nose. Skin color extremely pale and diaphoretic. No cardio/respiratory distress noted. Patient alert after two minutes of unconsciousness. Patient did not remember where he was or what happened. Safety maintained. Nurse advised parent to get patient checked out by a doctor at ER, Urgent Care, First Care, or family doctor. Patient c/o dizziness, ringing in ears, weakness, and headache after vaccine. Nurse assisted patient to the car in a wheelchair.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Unresponsive to stimuli
Clinical narrative: Immediately after receiving the HPV vaccine patient became unresponsive. Nurse and patient's mother assisted patient to the floor. Patient convulsed a couple times while lying on the floor. Nurse administered ammonia inhalant under patient' nose. Skin color extremely pale and diaphoretic. No cardio/respiratory distress noted. Patient alert after two minutes of unconsciousness. Patient did not remember where he was or what happened. Safety maintained. Nurse advised parent to get patient checked out by a doctor at ER, Urgent Care, First Care, or family doctor. Patient c/o dizziness, ringing in ears, weakness, and headache after vaccine. Nurse assisted patient to the car in a wheelchair.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Autism spectrum disorder, Cough, Developmental delay, Pyrexia
Clinical narrative: Fever developed about 8.5 hours later, per parent report. Fever lasted for ~ 5 days after vaccine was given. Cough developed on day 4 of fever. No other symptoms.
Age: 0.92
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Dtap was given to a 11 month 7 day old when due at 15 months. Was due for Polio at the time, so combo was given in error
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Feeling abnormal, Tremor
Clinical narrative: Patient was very excited to receive injections. Patient first received Hep A with no reaction. Then she received HPV and she did not feel good. Had her lay down on bed and applied wet paper towel to her head. Patient right side leg and arm was shaking. Patient calmed down later. Patient able to leave at 9:21am after receiving injection at 9am.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Electrocardiogram, Facial paralysis, Facial paresis, Headache
Clinical narrative: arm tenderness, bad aches in all muscles, high fever and chills, nausea and vomiting, severe headache for the following 18 hours  Days later developed facial drooping/weakness.   Tylenol-Motrin Tested for Covid.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Hypoacusis, Hypoaesthesia oral, Laboratory test, Myalgia
Clinical narrative: arm tenderness, bad aches in all muscles, high fever and chills, nausea and vomiting, severe headache for the following 18 hours  Days later developed facial drooping/weakness.   Tylenol-Motrin Tested for Covid.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test, Tenderness, Vomiting
Clinical narrative: arm tenderness, bad aches in all muscles, high fever and chills, nausea and vomiting, severe headache for the following 18 hours  Days later developed facial drooping/weakness.   Tylenol-Motrin Tested for Covid.
Age: 55.0
Sex: F
Vaccine: JEV1, TYP
Symptoms: Dysgeusia, Headache, Immediate post-injection reaction, Joint stiffness, Nausea
Clinical narrative: Immediate metallic taste in her mouth at the time of injection.  Began having headache, joint stiffness, and nausea the next day.  Symptoms continued for 10 days.  Was on Macrobid for UTI.  Has history of not feeling well after annual flu vaccine and so pt plans to get flu vaccine on Friday afternoon every year so to have symptoms over the weekend and recover before returning to work the following Monday.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated arm was swollen and in pain the evening after the vaccination. Patient self-treated with naproxen and 2 days later, when they called to inform us of the reaction, the pain has since subsided, however their arm is still swollen.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discharge, Injection site discomfort, Injection site erythema, Injection site rash
Clinical narrative: patient received vaccine on 7/23/20.  On 7/29/20, patient called the pharmacy and said she has a red rash around the injection site and slight discomfort at injection site, she has full range of motion with arm. Patient believes rash began on or around 7/29 but not on days immediately following vaccination.   Advised patient to take ibuprofen and watch rash for any spreading.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Arthropod sting, Erythema, Rash erythematous, Skin ulcer
Clinical narrative: 16 hours after injection, I was stung by a bumble bee.  24 - 48 hours after receiving injection I developed a red "sunburn" like reaction around waist and on stomach.  8 days after injection I developed red sores on chest and back.  Sent picture to Dr.   She confirmed it is a reaction, but not shingles and prescribed prednisone.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection very swollen. Started as small area and now is 7? long and 3.5 inches wide. Very hot and itchy.  Also had chills first night and have had 102.2 temp each day when I wake up.  Temp goes back to normal as I move around.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient stated that he had arm pain occurring after the immunization and continuing.  He says it gets better some days then worse again.  He says it's sometimes hard to lift his arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Hypotonia
Clinical narrative: Patient turned red and became limp 5 minutes after receiving vaccines. Stats at 96%, no wheezing, no stridor. Patient was given 5ml of Claritin and oral steroid 10mL. Patient monitored for 30 minutes.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Patient given pediatric dose Hep B of 0.5 ml. Needed full adult dose of 1.0 ml. Patient notified and will receive second pediatric Hep B dose of 0.5ml on 7/29/2020
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Skin warm
Clinical narrative: today pt has swelling of left upper arm where injection was given. last night pt states there arm was red and hot.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Death, Myocardial infarction, Nausea, Vomiting
Clinical narrative: Morning after administration, husband called pharmacy and reported patient had been up all night vomiting and had severe stomach pain. Vomiting had subsided (stomach was empty) but still nausea and not able to keep anything down. Patient was recommended to treat hydration with pedialyte and try to eat non-irritating foods such as saltines. She was considering self treating pain with medical marijuana. Next encounter with patient ws 2 days later, husband called pharmacy staff to inform patient had a heart attack and passed away. It is unknown if related to vaccine administration.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site rash, Rash vesicular
Clinical narrative: Started with site injection a day of vaccine, and small rash. 8 days later, developed varicella like rash, continues to spread today on day 9. No fever or other systemic symptoms. Site injection/bruise still present 9 days after vaccine.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Body temperature increased, Chills, Headache, Influenza virus test negative, Mononucleosis heterophile test negative
Clinical narrative: Patient developed 103.9, headache, and chills within 2 hours of vaccines.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Patient developed 103.9, headache, and chills within 2 hours of vaccines.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Eye swelling, Lip swelling, Rash
Clinical narrative: Patient reported small rash on arms and lips swelling last night. She took an antihistamine and it seemed to help. Today she has less rash and swollen eyes.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 15 X 8-1/2 cm erythematous slightly raised injection site on anterior left thigh.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PAtient developed significant swellinf of the arm and redness
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever to 102.7 (with ibuprofen) during night with vomiting.  Fever spiked again in morning with 2 bouts of vomiting
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Insomnia, Pain, Pain in extremity
Clinical narrative: PATIENT HAD CHILLS AND BODY ACHES AT NIGHT AND WOKE UP NEXT DAY 7/27/20 WITH REDNESS, PAIN IN ARM ALONG WITH IT BEING SWOLLEN AND HOT. PAINFUL TO SLEEP AND IT ALSO BECOME ITCHY THROUGHOUT THE DAY THEN
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: PATIENT HAD CHILLS AND BODY ACHES AT NIGHT AND WOKE UP NEXT DAY 7/27/20 WITH REDNESS, PAIN IN ARM ALONG WITH IT BEING SWOLLEN AND HOT. PAINFUL TO SLEEP AND IT ALSO BECOME ITCHY THROUGHOUT THE DAY THEN
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: REDNESS AND WARMTH AT INJECTION SITE LASTING ONE WEEK AND STILL PRESENT
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Pyrexia
Clinical narrative: Fever , chills, upset stomach, shivering
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Dysgeusia, Malaise, Neck pain, Swelling
Clinical narrative: Patient received vaccine and said she had a metallic taste. Patient waited a couple of minutes to ensure she would not have sycope. Patient called after leaving pharmacy saying she has some pain in her neck and swelling. I reviewed common side effects with her and stating she might have muscle pain, she was not feeling well so she went to urgent care.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: immunization was given intramuscularly instead of subcutaneously
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: Patient developed Redness & Swelling of Left arm Chills, Headache, myalgia and fatigue after Shingrix vaccine then developed fever of 103 F. Last 3 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Patient developed Redness & Swelling of Left arm Chills, Headache, myalgia and fatigue after Shingrix vaccine then developed fever of 103 F. Last 3 days.
Age: 25.0
Sex: F
Vaccine: HEP, MMRV, TDAP
Symptoms: Anxiety, Balance disorder, Nausea
Clinical narrative: Patient stood up a few minutes after completion of vaccination to ask questions, and then said she felt nauseated and when she went to sit down lost balance, but did not completely lose consciousness. At this time she informed the vaccinating  pharmacist that she had not eaten anything all day and was quite anxious about the vaccinations. She requested the pharmacy call 911 and the paramedics arrived and left with the patient. Upon follow up call today by pharmacy manager (07/29/2020, the day after) patient stated she felt "perfectly fine" after she went home that day, and had no signs or symptoms.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Fatigue, Injection site pain, Migraine
Clinical narrative: Migraine Headache At 12:30pm.  Fatigue at 2:30pm Temperature at 12:00am  Pain at injection site.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain, Swelling
Clinical narrative: bruise, swelling, redness, and pain
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Injection site pain, Musculoskeletal stiffness
Clinical narrative: During a "wellness check up phone call" on 5/28, patient reported an increasing stiffness, pain near the injection site. Patient denied any itching, rash, discoloration, bruising or fever or general malaise. Patient reported he noticed the expected discomfort (2nd of the series) on Day 2, but that by the morning of Day 3, 5/28, upon awakening he was in considerable pain in the injection arm, but noted that the pain had subsided considerably after moving the arm and exercising.  Patient was advised to continue to move the arm as he was comfortable, take acetaminophen if desired, and report any ongoing issues.  Over the course of the next several days, via a couple of phone calls, the patient continued to report discomfort and patient was advised that the Pharmacist would consult with the manufacturer vaccine medical department for advice and that he might consider being seen by a physician is needed. Patient continued to state that the pain was the most intense early morning and subsided later in the day.  On or about 6/1 or 2, the Pharmacist did call GlaxoSmithKline and after conversation with the representative, and a review of patient symptoms, the representative advised that the symptoms were unremarkable per the drug profile and that in some cases the symptoms could remain ongoing for at least 90 days, per literature.  It was also discussed that the patient should seek other medical advice if he felt warranted.  Patient was called, information was shared and the patient seemed acceptable of the advice. There was no more report from the patient until the evening of 7/29, when the spouse of the patient reported that symptoms continued to linger and that patient had been seen and taken 2 courses of steroids, which relieved while medication was being taken but that symptoms returned after discontinuation of steroid.  Patient requested that the Pharmacist perhaps speak to the physician who was treating at present and the Pharmacist agreed to do so
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Symptoms started at 3:30 the day after when I started to have body aches and headache.  This then became chills and fatigue.  I started to get sick to my stomach and about 11:30 pm I vomited.  I had chills on and of the next 24 hours with feverish periods.  Finally started to feel a little better 55 hours post shot
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Symptoms started at 3:30 the day after when I started to have body aches and headache.  This then became chills and fatigue.  I started to get sick to my stomach and about 11:30 pm I vomited.  I had chills on and of the next 24 hours with feverish periods.  Finally started to feel a little better 55 hours post shot
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Muscle spasms, Pyrexia
Clinical narrative: fever of 100.6, muscle cramp in calves, headache, chills, tiredness
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: pt began experiencing red area warm to the touch beginning 7-28-20 but not sore.  at time of phone conversations she estimated the size to be about 5in long and 2.5 in wide.  has gotten better today per pt (7-29-20)
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Herpes zoster
Clinical narrative: Patient mentioned that they had shingles like symptoms. Particularly a sore on her upper lip.
Age: 54.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Fatigue, Headache, Muscle fatigue, Myalgia, Pyrexia
Clinical narrative: Low Grade Fever: 99-100' F, muscle fatigue, tiredness, muscle aches, headache
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Seizure
Clinical narrative: Patient felt lightheaded then lost consciousness and began convulsing. This lasted approximately 20-30 seconds. Patient regained consciousness but was not able to recall what happened. Stated she felt "like she went to sleep". Patient denied any difficulty breathing and no other symptoms presented after. Patient was examined by clinic provider and placed under observation for approximately 15-20 minutes then discharged.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Cognitive disorder, Computerised tomogram head, Confusional state, Facial paresis
Clinical narrative: Guillain-Barre Syndrome; Lower extremity weakness/weakness of arm; weakness of face; trouble speaking; trouble walking/Gait dysfunction; loss balance; numbness of lower extremities; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix (intravenous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  The initial information was received on 21 July 2020 via medical record.(Case medically confirmed). The Patient was admitted to hospital on 10 February 2018 and discharged on 09 March 2018 with discharged diagnosis Guillaine Barre syndrome(GBS), Numbness and weakness of the face , arm ,leg,Confusion or trouble speaking or understanding , Trouble walking, loss balance. CT of brain was performed on 12 February 2018. On 19 February 2018 the patient reported Lower extremity weakness. The patient had psuedohyponatremia as a result of presence of IV immunoglobulins being administered for treatment of GBS. The patient with GBS received IVIG treatment. The patient with GBS secondary to herpes zoster vaccination being evaluated for hyponatremia. The patient diagnosed with numbness of the lower extremities and gait dysfunction. The patient had BLE weakness.
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Guillain-Barre Syndrome; Lower extremity weakness/weakness of arm; weakness of face; trouble speaking; trouble walking/Gait dysfunction; loss balance; numbness of lower extremities; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix (intravenous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  The initial information was received on 21 July 2020 via medical record.(Case medically confirmed). The Patient was admitted to hospital on 10 February 2018 and discharged on 09 March 2018 with discharged diagnosis Guillaine Barre syndrome(GBS), Numbness and weakness of the face , arm ,leg,Confusion or trouble speaking or understanding , Trouble walking, loss balance. CT of brain was performed on 12 February 2018. On 19 February 2018 the patient reported Lower extremity weakness. The patient had psuedohyponatremia as a result of presence of IV immunoglobulins being administered for treatment of GBS. The patient with GBS received IVIG treatment. The patient with GBS secondary to herpes zoster vaccination being evaluated for hyponatremia. The patient diagnosed with numbness of the lower extremities and gait dysfunction. The patient had BLE weakness.
Sex: F
Vaccine: VARZOS
Symptoms: Pseudohyponatraemia, Speech disorder
Clinical narrative: Guillain-Barre Syndrome; Lower extremity weakness/weakness of arm; weakness of face; trouble speaking; trouble walking/Gait dysfunction; loss balance; numbness of lower extremities; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix (intravenous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  The initial information was received on 21 July 2020 via medical record.(Case medically confirmed). The Patient was admitted to hospital on 10 February 2018 and discharged on 09 March 2018 with discharged diagnosis Guillaine Barre syndrome(GBS), Numbness and weakness of the face , arm ,leg,Confusion or trouble speaking or understanding , Trouble walking, loss balance. CT of brain was performed on 12 February 2018. On 19 February 2018 the patient reported Lower extremity weakness. The patient had psuedohyponatremia as a result of presence of IV immunoglobulins being administered for treatment of GBS. The patient with GBS received IVIG treatment. The patient with GBS secondary to herpes zoster vaccination being evaluated for hyponatremia. The patient diagnosed with numbness of the lower extremities and gait dysfunction. The patient had BLE weakness.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: Rash / Not only at the injection site; Rash over her body / On her arm and chest; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2020, the patient received the 1st dose of Shingrix. On 8th July 2020, 7 days after receiving Shingrix, the patient experienced injection site rash and generalized rash. On an unknown date, the outcome of the injection site rash and generalized rash were recovering/resolving.   It was unknown if the reporter considered the injection site rash and generalized rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had presented a rash over her body.  It was not only at the injection site, but also on her arm and chest and it had remained for two weeks which seemed unusual. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Rash / Not only at the injection site; Rash over her body / On her arm and chest; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2020, the patient received the 1st dose of Shingrix. On 8th July 2020, 7 days after receiving Shingrix, the patient experienced injection site rash and generalized rash. On an unknown date, the outcome of the injection site rash and generalized rash were recovering/resolving.   It was unknown if the reporter considered the injection site rash and generalized rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had presented a rash over her body.  It was not only at the injection site, but also on her arm and chest and it had remained for two weeks which seemed unusual. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chest discomfort, Chest pain, Chills, Disturbance in attention
Clinical narrative: I had typical side effects the day of the vaccine-chills, fever, pain at injection site. I was very tired for the next few days, had trouble focusing my eyes. I felt a dry, scratchy feeling in my chest. The feeling of being ill, dry, scratchy chest, dizziness and exhaustion went on for a few weeks when I sought care from my primary care physician in March 2020. In April, the scratchy feeling in my chest became chest pain and difficulty breathing. I went back to my primary care and also made 4 visits to the emergency room.  The first ER visit I thought I might be having a food allergy but it did not resolve. Currently, I still have pain in the center of my chest and the right side both front near the sternum and back along the thoracic vertebrae. I still have difficulty pulling in a full breath sometimes and have a scratchy feeling in my chest. I break out in a sweat during pain/breathing difficulties.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dysphagia, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: I had typical side effects the day of the vaccine-chills, fever, pain at injection site. I was very tired for the next few days, had trouble focusing my eyes. I felt a dry, scratchy feeling in my chest. The feeling of being ill, dry, scratchy chest, dizziness and exhaustion went on for a few weeks when I sought care from my primary care physician in March 2020. In April, the scratchy feeling in my chest became chest pain and difficulty breathing. I went back to my primary care and also made 4 visits to the emergency room.  The first ER visit I thought I might be having a food allergy but it did not resolve. Currently, I still have pain in the center of my chest and the right side both front near the sternum and back along the thoracic vertebrae. I still have difficulty pulling in a full breath sometimes and have a scratchy feeling in my chest. I break out in a sweat during pain/breathing difficulties.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Immunology test, Oxygen saturation increased, SARS-CoV-2 test negative, Sinus pain
Clinical narrative: I had typical side effects the day of the vaccine-chills, fever, pain at injection site. I was very tired for the next few days, had trouble focusing my eyes. I felt a dry, scratchy feeling in my chest. The feeling of being ill, dry, scratchy chest, dizziness and exhaustion went on for a few weeks when I sought care from my primary care physician in March 2020. In April, the scratchy feeling in my chest became chest pain and difficulty breathing. I went back to my primary care and also made 4 visits to the emergency room.  The first ER visit I thought I might be having a food allergy but it did not resolve. Currently, I still have pain in the center of my chest and the right side both front near the sternum and back along the thoracic vertebrae. I still have difficulty pulling in a full breath sometimes and have a scratchy feeling in my chest. I break out in a sweat during pain/breathing difficulties.