chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Mother contacted Dr. on the same day patient received her 2 mths scheduled vaccines. Rotavirus vaccine was administered at this time. Mother indicated patient had several stools with bright streaks of blood the evening after receiving her vaccines. Patient had never had this before. Patient had a max temp of 99.8. No vomiting or diarrhea. She was feeding well. Patient appeared comfortable per parent. Mother was instructed to monitor closely for changes in behavior or increased blood in stool through the evening. Dr. contacted family the following day and spoke to the father. Patient slept well and had 2 normal appearing stools, without blood. Feeding normally. Will continue to monitor.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Disturbance in attention, Feeling abnormal, Headache
Clinical narrative: Generalized weakness, headache, lack of energy, feeling like brain is in a fog, and difficulty concentrating
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Patient was put to bed at 10pm in his usual state of health.  Parents found him unresponsive at 1am when they went to check on him per family routine. EMS was called.   He was brought to the ER and was pronounced dead.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Cellulitis
Clinical narrative: Cellulitis
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports that  woke up today (10/29) with and area (15cm x 9cm) of mild  swelling,  redness, and warmth just below the injection site. The area is tender to touch.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Heart rate increased, Nausea, Vomiting
Clinical narrative: Rapid heart rate at 2 am in the morning. HR 150 but I was able to decrease the HR to 120 -130 after several minutes. ( I had a pulse Ox with me at my house.     No chest pain, no SOB,  no tightness in my chest.   I has nausea and vomitting at approx 11:00 pm. Still having shivers that started at 7 pm.
Age: 17.0
Sex: F
Vaccine: HEPA, MMR, MNQ, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient received an unnecessary dose (3rd dose) of varicella. Only one dose was recorded in CHIRP, but a second dose was listed on the patient's school immunization record. This second dose was not noticed until after the varicella vaccine was administered. The patient's parent was notified of the extra dose.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Paraesthesia, X-ray
Clinical narrative: Patient went to ER after experiencing numbness and tingling in hands, fingers and inability to raise arm over head.  She had an xray that showed nothing, was prescribed Ibuprofen and told to follow up with Primary care physician. She did that this week and he stated to stop ibuprofen due to high blood pressure and to follow up with him in 2 weeks if not resolved and he may prescribe physical therapy at that point. As of today the numbness and tingling is gone but still having issues raising her arm over head. She does have more mobility than earlier in the week. Seems to be improving at this point
Age: 25.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Headache, Peripheral swelling, Rash macular, Skin warm
Clinical narrative: Patient reports that arm became warm red and swollen approximately 1-1 1/2 hours after shot was given, redness continued to spread the following day with blotchiness on arms, patient also complained of a headache. Today 10/29 patient was seen in clinic,  and redness has decreased, no C/O headache.
Age: 39.0
Sex: F
Vaccine: FLUA4
Symptoms: Haematoma
Clinical narrative: Hematoma
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site dysaesthesia, Injection site pain
Clinical narrative: burning and dysthesia at injection site
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: RIGHT HAND NUMBNESS AND TINGLING FOR 3 DAYS
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine
Clinical narrative: Patient started to get a migraine approx. 3.5 hours after receiving the flu vaccine on 10/28/2020. Today(10/29/20) at 2:00pm, when she called to report her migraine, the migraine has only subsided a little.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Abdominal pain upper, Condition aggravated, Malaise, Sensation of foreign body, Tachycardia
Clinical narrative: rec High dose flu. 4 hours later started feeling ill. throat feeling like its about to close,swelling and lump in throat on right side. Tachycardia sever stomach pains. Called HCP and they stated they would give her a call back in 24 hours. Will be contacting CDC info for additional medical advice.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Throat tightness
Clinical narrative: rec High dose flu. 4 hours later started feeling ill. throat feeling like its about to close,swelling and lump in throat on right side. Tachycardia sever stomach pains. Called HCP and they stated they would give her a call back in 24 hours. Will be contacting CDC info for additional medical advice.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cough, Oropharyngeal pain, Pain, Tremor
Clinical narrative: Mid afternoon - sore throat and cough. 6:00 PM -  aches. 6:30 PM - uncontrollable shaking - lasted ten minutes, followed by aches and chills for rest of the night.  By morning, felt washed out with most of aches and chills subsided.
Age: 41.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Erythema, Pain in extremity, Skin swelling
Clinical narrative: IM Injection given, next day, on the am pt complains of sore arm, red, puffy. Pt immediately notified attending physician. He prescribed 1.) prednizone 2.) cephalexin.
Age: 41.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Erythema, Injection site urticaria, Myalgia, Pain, Swelling
Clinical narrative: IM Injection given, next day, on the am pt complains of sore arm, red, puffy. Pt immediately notified attending physician. He prescribed 1.) prednizone 2.) cephalexin.
Age: 41.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: IM Injection given, next day, on the am pt complains of sore arm, red, puffy. Pt immediately notified attending physician. He prescribed 1.) prednizone 2.) cephalexin.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Blood pressure increased, Blood test normal, Body temperature increased, Chest X-ray normal, Chills
Clinical narrative: A couple of hours after vaccination experienced chills and shaking. Covered up with blankets. A couple hours developed a temperature of 100.4. Blood pressure was elevated. Pulse 133. Called doctor. Nauseous. Went to ER and was given Tylenol. Fever subsided after releases from ER. Fever returned later that night. Still experiencing symptoms on today.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Electrocardiogram normal, Nausea, Pyrexia, Tremor, Urine analysis normal
Clinical narrative: A couple of hours after vaccination experienced chills and shaking. Covered up with blankets. A couple hours developed a temperature of 100.4. Blood pressure was elevated. Pulse 133. Called doctor. Nauseous. Went to ER and was given Tylenol. Fever subsided after releases from ER. Fever returned later that night. Still experiencing symptoms on today.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient arm became sore and red.  It stretched  down below the elbow.  Lasted two or three days and resolved
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Loss of consciousness, Pharyngeal swelling
Clinical narrative: Within 15 minutes of having the injection I noticed my throat was swelling--a first.  My breathing was labored & I had to not exert myself.  I did not go to the hospital.  The next morning I blacked out, too.  Again, I did not seek medical attention.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Erythema, Loss of consciousness
Clinical narrative: Patient was given Fluzone HD, he had experienced lightheadness but said he was fine and a baidaid was paced on his arm by pharmacist and turned to give his wife her immunization and after going back and forth with her as to which arm she wanted she noticed him getting red in the face and looked like he was having trouble breathing and was losing conscientiousness. The wife was asked if she ever experienced him like this before and she said no. Pharmacist went to call 911 and other staff got him a bottle of water and he came around and started to drink the water and looked fine at that point. EMTs arrived shortly and administered to the patient. They transported him to the hospital.
Age: 55.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Dyspnoea
Clinical narrative: a few hours after vaccine complained of shortness of breath and dizziness, lasted 2 days.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling injection site
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Feeling abnormal, Pain, Visual impairment
Clinical narrative: Pt stated she felt pain then begun feeling the room darkening and became dizzy. Pt felt she was dreaming and could hear her mother talking. When she came to she was aware of her surrounding but felt tired. BP 100/70 POX 99. Pt has h/o vasovagal episodes c/w vasovagal event
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Dizziness, Injection site pain, Paraesthesia, Pyrexia
Clinical narrative: On evening following injection, pt reported injection site pain / tingling, light-headed chills, fever.  Symptoms resolved approx. 36 hrs Covid-19 test negative. No other medical attention
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: SARS-CoV-2 test negative
Clinical narrative: On evening following injection, pt reported injection site pain / tingling, light-headed chills, fever.  Symptoms resolved approx. 36 hrs Covid-19 test negative. No other medical attention
Age: 73.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Induration, Nodule, Pain, Skin warm
Clinical narrative: Tuesday 10/27 patient noticed small knot + slight soreness; Wed (10/28) slightly redder + redness area about quarter size. Thurs (10/29) when patient woke up warm to touch; hard knot, redness area had double in size advised patient to call Primary care to make appt for today or go to urgent care
Age: 73.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Swelling
Clinical narrative: Tuesday 10/27 patient noticed small knot + slight soreness; Wed (10/28) slightly redder + redness area about quarter size. Thurs (10/29) when patient woke up warm to touch; hard knot, redness area had double in size advised patient to call Primary care to make appt for today or go to urgent care
Sex: U
Vaccine: VARZOS
Symptoms: Fibromyalgia, Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; fibromyalgia; herpes zoster; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 27-FEB-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After vaccination, the patient suffered from herpes zoster, postherpetic neuralgia (PHN) and fibromyalgia. As a result of those symptoms, the patient was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms had resulted in physical limitations not present prior to vaccination. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient 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, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered the herpes zoster, PHN and fibromyalgia to be disabling events.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; 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 2013, 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 hearing loss. 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 hearing loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, hearing loss was determined to be medically significant.
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. On or about 04-AUG-2009, 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 physician 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: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: blurry vision in one eye; This case was reported by a consumer via interactive digital media and described the occurrence of blurred vision in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2020, the patient received the 1st dose of Shingrix. On 24th October 2020, 2 days after receiving Shingrix, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was not recovered/not resolved.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.  Additional deatils were provided as follows: The reporter was patient wife. The age at vaccination was not reported. The patient was vaccinated with Shingrix on 22nd October 2020. On 24th October 2020 and 25th October 2020 patient had blurry vision in one eye. No further deatils were provided.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Muscle pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient reported experiencing muscle pain at the injection site after receiving 1st dose of the Shingrix vaccine back in July 2020. She stated that it went away in a day and a half. The reporter did not consent to follow up. Not all information was available. For tolerance after 2nd dose refer case US2020212920.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212920:2nd dose, same patient
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain in extremity
Clinical narrative: Shivering; Soreness at the injection site/ arm is very sore; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2020 14:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2020, 13 hrs after receiving Shingrix, the patient experienced shivering and pain in arm. On 23rd October 2020, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   The reporter considered the shivering and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported that he received his first Shingrix shot was administered at his MD office by the nurse who injected into the left shoulder (deltoid). The reporter said that he had since gotten over it and was fine at the time of reporting and did not had a fever. The reporter stated that the nurse warned him that his arm was going to be sore and he said that it was very sore. The soreness at the injection site had not resolved. The reporter did not see the lot or expiry date of the Shingrix but gave permission to contact his MD office. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Death
Clinical narrative: A patient was dead the next day after receiving the flu shot; Initial information was received on 25-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-healthcare professional via social media.  This case involves a female patient (age unspecified) who was dead the next day after receiving the INFLUENZA VACCINE (death).  Medical treatments, vaccinations, concomitant medications and family history were not provided.  At the time of death, the patient had ongoing medical problems with her legs (leg discomfort).  On an unknown date, the patient was in the hospital due to problems with her legs and received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient died the next day after receiving INFLUENZA VACCINE (death). This event was also assessed as medically significant.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment before death.  It was unknown if an autopsy was done.   The cause of death was not specified.  The information on batch number was requested for this case.   Sender's Comments:  This poorly documented social media case involves a female patient who died (death NOS) the next day after receiving the INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is compatible. At the time of death, she had ongoing problems with her legs. Additional information regarding medical history, concomitant medications, lab investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 1.0
Sex: M
Vaccine: IPV, PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 12 month old got Ipol vaccine instead of pneumonia vaccine, no AE; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case from other health professional.   This case involves a 1 years old male patient who was vaccinated with 0.5 ml of IPV (VERO) [IPOL] (fourth dose, batch numbers: R1B25 / QFAA2047 Expiration date: 13-Mar-2021 and 30-Jun-2021) vaccine instead of PNEUMOCOCCAL VACCINE (batch number and expiration date not reported), via intramuscular route in vastus lateralis for prophylactic vaccination on 19-Oct-2020 (PT: wrong product administered).  The patient's past vaccination  included IPOL on 19-DEC-2019 for prophylactic vaccination.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong vaccine administered (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: PENTACEL was prepared incorrectly.  Instead of mixing the powder with the liquid, Dtap and Polio and Act-Hib all separately, no AE; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves patient of unknown age who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number and expiration date not reported) that was prepared incorrectly, that is instead of mixing the powder with the liquid, DTaP and polio and Act-Hib all separately via unknown route in an unknown  administration site for prophylactic vaccination (PT: product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate reconstitution technique (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt Was given flu vaccine Right deltoid at 5:45 pm and 15 minutes later at 6:00 pm the Pt had adverse reaction what it appears as hives only 2 on each arm, 1 on the right lower leg, and 1 on right side of cheek. Pt was given 10 Ml of benadryl. Pt was monitored on the hour for 4 hours but no other symptoms appeared. Spoke with mother of child this morning 10/29/2020 8:13 am, stated that the hives are gone and no other symptoms appeared.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Oropharyngeal discomfort, Pharyngeal swelling
Clinical narrative: My husband sent a text to me at 1340 : "I think I had a bit of a reaction to the flu shot. Within minutes the back of my throat felt weird, swollen. It isn't getting worse so I guess I won't worry about it." I wrote back to go back into the clinic thinking he was at his PCP. However, he was at a Flu clinic set up for today at the university where he teaches. The nurses from clinic did not have an Epi Pen or Benedryl. My husband refused an ambulance. They monitored him for over 20 minutes. I called at 1407, he was talking and laughing with them. Said swelling was going down. His PCP was notified. RNs at the site suggested he take Benedryl at home. Was notified by RNs at site and his PCP by phone to pull over if difficulty breathing starts and call 911. He seems to be ok at this time.
Age: 37.0
Sex: F
Vaccine: FLUA3
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Nodule, Pain
Clinical narrative: Immediately experienced burning throughout upper arm. Subsided about 5 minutes. Soreness. 30 minutes after experienced hot, swelling, a knot, redness, and soreness. Caller has already notified health care provider.
Age: 37.0
Sex: F
Vaccine: FLUA3
Symptoms: Skin warm, Swelling
Clinical narrative: Immediately experienced burning throughout upper arm. Subsided about 5 minutes. Soreness. 30 minutes after experienced hot, swelling, a knot, redness, and soreness. Caller has already notified health care provider.
Age: 25.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Very large injection site reaction. I had a large red spot, covering most of my upper arm. I would say the size of the red patch was about 8x4 inches or so. I also experienced swelling and the spot was warm to the touch and mildly itchy. Treated with ice, ibuprofen and Benadryl for about four days. The injection site reaction got worse over about the first 36 hours from the time of the injection and then slowly improved. From the time of the injection to the time the reaction went away was about 5 days total.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram, Pain in extremity, Paraesthesia
Clinical narrative: When injection given felt intense pain down left arm (like hot lava being injected) arm was sore for a few days .. then arm began to have "pins and needle " feeling . Happened 1 year ago today .  HAs not improved.. has become more intense from shoulder to finger tips
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site streaking, Peripheral swelling
Clinical narrative: SWELLING OF ARM REDNESS/RED STRIPE ON ARM PAIN AT INJECTION SITE
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Syncope
Clinical narrative: Post vaccine syncopal event w/ onset approximately 1min post vaccine administration, lasting <10 seconds.  Accompanied by nausea.  Pt with known hx of similar post vaccine / needle events.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, UNK
Symptoms: Agitation, Electroencephalogram normal, Lethargy, Magnetic resonance imaging normal, Muscle twitching
Clinical narrative: fever, lethargy, severe rash on face and body, itching, facial twitching, seizure like activity, agitation
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, UNK
Symptoms: Pruritus, Pyrexia, Rash, Seizure like phenomena
Clinical narrative: fever, lethargy, severe rash on face and body, itching, facial twitching, seizure like activity, agitation
Age: 43.0
Sex: F
Vaccine: FLUR4
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Patient complained of vaccination administration too close to shoulder blade, resulting in loss of motion and pain.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Ear swelling, Lip swelling, Pruritus, Urticaria
Clinical narrative: Patient developed diffuse itchy hives and swelling of the upper lip, R eye, and R ear. Mom gave benadryl at home and then brought patient to urgent care, where patient received oral prednisolone. Patient was then sent home to complete 5 day course of oral prednisolone. Mom has continued to give patient oral benadryl and topical benadryl as needed, with improvement in sypmtoms.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pt complains of entire arm, shoulder to hand, aching and sore continuing to 15 days post vaccine. I examined arm and saw no bruising.  No pain at injection site per patient.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Blood pressure increased, Presyncope, Syncope
Clinical narrative: ALL ADVERSE REACTIONS WERE REPORTED BY PATIENT'S PARENT VIA PHONE. PATIENT'S MOTHER STATES PATIENT FELT FINE AFTER INJECTIONS, WENT TO LUNCH AND THEN BACK TO SCHOOL. SHE STATES THE SCHOOL NOTIFIED HER THAT THE PATIENT HAD HAD 2 SYNCOPAL/ NEAR SYNCOPAL EPISODES . THE PARENT WENT TO PICK HER UP AND SHE HAD ANOTHER NEAR SYNCOPAL EPISODE ON THE WAY TO THE CAR. THE PARENT TOOK HER TO HER PLACE OF EMPLOYMENT WHICH HAPPENS TO BE A NURSING FACILITY AND THEY DID VITAL SIGNS THAT REVEALED A SLIGHTLY ELVATED BLOOD PRESSURE AND  AN O2 SATURATION OF 89% AS WELL AS A PULSE OF 99. OUR OFFICE INSTRUCTED THE PARENT TO SEEK EMERGENCY CARE FOR THE PATIENT IMMEDIATELY.  SHE WAS GOING TO GO TO MEDICAL CENTER FOR EVALUATION.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: ADMINISTERED HD VACCINE TO PATIENT THAT WAS UNDER 65 YEARS OF AGE. PATIENT TO MY KNOWLEDGE HAS HAD NO KNOWN SIDE EFFECTS FROM THE VACCINE.
Age: 71.0
Sex: F
Vaccine: FLUA3, UNK
Symptoms: Asthenia, Memory impairment, Migraine, Nausea, Pain
Clinical narrative: Night of vax pt. awaken with pain, nausea, shaking, forgetful, memory delay, weak and swelling in the back of the head in the neck indentation with migraines and light sensitivity. Says swelling stayed 4 days. Pt. still having some symptoms of headaches and sensitivity to light as well as no energy and weakness. Pt. lives alone, she called dr. office 1 week after vax.
Age: 71.0
Sex: F
Vaccine: FLUA3, UNK
Symptoms: Photophobia, Swelling, Tremor
Clinical narrative: Night of vax pt. awaken with pain, nausea, shaking, forgetful, memory delay, weak and swelling in the back of the head in the neck indentation with migraines and light sensitivity. Says swelling stayed 4 days. Pt. still having some symptoms of headaches and sensitivity to light as well as no energy and weakness. Pt. lives alone, she called dr. office 1 week after vax.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Arthralgia, Asthenia, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Fever up to 101 degrees, Headaches, Muscle aches, joint aches, very tired, dizziness, weakness,  Nausea, Loss of appetite,
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever up to 101 degrees, Headaches, Muscle aches, joint aches, very tired, dizziness, weakness,  Nausea, Loss of appetite,
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was accidently given 2 influenza vaccines
Sex: F
Vaccine: UNK
Symptoms: Myalgia
Clinical narrative: Rec. 1st dose shingles vax and Flu. Does not know which vax brand received. Next morning after vax started having muscle aches. will be calling HCP for medical advise .
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis. Patient treated at Medical Center by M.D. Patient was given antibiotic Doxycyline on 10/25/20.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site haemorrhage, Vaccination site induration, Vaccination site pain
Clinical narrative: Flu vaccine site bled soon after needle was removed from arm after administration.  Bruise was almost immediately observed.  No tenderness to the site. By the next morning, she noticed site of BCG vaccine, inferior to the flu vaccine site was red and indurated and tender and warm.  No fever.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site warmth
Clinical narrative: Flu vaccine site bled soon after needle was removed from arm after administration.  Bruise was almost immediately observed.  No tenderness to the site. By the next morning, she noticed site of BCG vaccine, inferior to the flu vaccine site was red and indurated and tender and warm.  No fever.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Injection site bruising, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Next day 24 hours later/10/23/20 - Pain, oval shaped swelling extending completely across the top half of my arm and extending approximately half and  inch outward, with redness, and a thick lump in the center of my top  arm at the injection site. Used ice on 10/22/20-10/23/20.  Used ice and Extra strength Tylenol Days 2 and 3. 10/24/20  Same appearance but  now with bruising (a thin bluish line) under the complete half of the oval shaped swelling. An increasing feeling of being unwell. Not able to compare it to any other feeling. Have been resting as much as possible to help with lightheadness and sick feeling. 10/25/20  Same appearance with a slight lessening of the swelling and bruising  is disappearing. Now warmth is felt to the touch only at the injection site where the lump is.  Pain is continuing. 10/26/20  Requested an urgent care Follow up with the Doctor.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Next day 24 hours later/10/23/20 - Pain, oval shaped swelling extending completely across the top half of my arm and extending approximately half and  inch outward, with redness, and a thick lump in the center of my top  arm at the injection site. Used ice on 10/22/20-10/23/20.  Used ice and Extra strength Tylenol Days 2 and 3. 10/24/20  Same appearance but  now with bruising (a thin bluish line) under the complete half of the oval shaped swelling. An increasing feeling of being unwell. Not able to compare it to any other feeling. Have been resting as much as possible to help with lightheadness and sick feeling. 10/25/20  Same appearance with a slight lessening of the swelling and bruising  is disappearing. Now warmth is felt to the touch only at the injection site where the lump is.  Pain is continuing. 10/26/20  Requested an urgent care Follow up with the Doctor.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient has redness/erythema with swelling beginning a few inches BELOW the actual injection site and spreading around her arm and down to the crease of the elbow. Patient cannot take diphenhydramine due to excessive sedation it causes. Patient will apply cold compress for 20 minutes at a time several times per day. She will mark the borders of the redness so she can monitor for spread/recede and will contact her PCP if she notices spreading beyond current limits.
Age: 29.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, Hot to touch, Swelling
Age: 77.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site rash, Rash
Clinical narrative: The patient received her flu shot on 09/28/2020, and noticed a rash forming on 10/08/2020 around the injection site. The patient  started taking Benadryl on 10/08/2020, and went in to see her physician on 10/09/2020. She was given Prednisone 10mg #10 tablets 2 PO QD on 10/09/2020. On 10/12/2020 the rash started spreading from head to toe. Her physician instructed her to stop all maintenance medications and only continue on the Benadryl and the Prednisone. The patient started on Losartan in place of Diltiazem 180mg ER. The patient had an appointment with her dermatologist on 10/13. On 10/15 her dermatologist send in a new prescription for Prednisone 20mg #32 tablets for 21 days, and instructed patient to start taking Allegra as well as the Benadryl. As of today 10/29/2020 the patient is on the final week of Prednisone, and the rash is almost completely resolved.
Age: 52.0
Sex: F
Vaccine: FLUR4
Symptoms: Chills, Diarrhoea, Nausea
Clinical narrative: nausea, diarrhea, chills,
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Migraine
Clinical narrative: I am not sure that this was an adverse event as a result  of the flu but felt I should report it just in case it is.  I suffer from episodic migraines and one trigger can be long runs, and I did go for a long run on the morning of Oct 24th.  What was unusual was that I had three migraines in a row over three days after getting the flu shot (migraines on Sat, Sun and Mon night).
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: I, Pharm.D., gave Fluzone HD vaccine to the patient in the Deltoid muscle and a great deal of blood filled all the barrier bandage. I kept it on for a minute then took it off, the blood stopped coming out but it looked the area was swollen up under the skin, I placed a gauze pad with a gentle pressure for a minute in case more blood may start coming out but none came out and it was apparent at this point the area was swollen about 1.5 inches in diameter and 1 cm in height around the shot area. I kept the patient waiting for about 10 more minutes and asked him questions. He said that he never had allergic reaction to a shot before and he had a flu shot every year for decades. The skin color stayed the same for the entire period (normal skin color) and the swelling went down slightly after him being in the booth/kiosk for 15 minutes. Since he didn't have any concerns and was not feeling ill or dizzy, he was ok in leaving the pharmacy area. I called the patient 1.5 hours later and he said that he is still feeling fine and there are no concerning issues.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain
Clinical narrative: UPON INITIAL INJECTION, NO REDNESS, NO WARMTH, NO SWELLING NOTED.  DAY AFTER "USUAL" SORENESS FOR INFLUENZA INJECTION, BUT FOLLOWING DAYS HAD INCREASED PAIN TO LEFT SHOULDER.  DISCOMFORT HAS CONTINUED FOR OVER 4 WEEKS.  TENDER UPON PALPATION.  DENIES REDNESS, WARMTH, OR SWELLING.  INCREASED DISCOMFORT UPON MOVEMENT OR RAISING ARM OVER HEAD.  DESCRIBES AS "ACHING."  ADVISED TO SEEK TREATMENT AT PCP NOTED ABOVE.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Pain
Clinical narrative: A few hours after he received an injection he started getting a bull's-eye rash around that lasted for a few days then alarm crew and I got larger about the size of a quarter super hard super sore that's very painful for him to move his arm on day six he developed a fever of 101.4 which is where we are currently..
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Local reaction, Pyrexia, Rash, Scab
Clinical narrative: Local reaction where vaccine was administered.  Rash and scabbing. Fever the next day.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Local reaction, Malaise, Pyrexia
Clinical narrative: NO IMMEDIATE SYMPTOMS. FEVER/MALAISE/HEADACHE AROUND 16 HOURS AFTER VACCINATION. THEN ERYTHEMA OF LEFT DELTOID WITH LOCAL EDEMA AND TENDERNESS DEVELOPED. SHE REPORTED TENDERNESS ALL THE WAY TO THE ELBOW. THESE SYMPTOMS INCREASED OVER 24-48 HOURS BEFORE MOSTLY RESOLVED BY THE TIME SHE HAD CONTACTED ME - SHE HAD USED ASPIRIN AND TYLENOL AS NEEDED TO CONTROL LOCAL SYMPTOMS.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Tenderness
Clinical narrative: NO IMMEDIATE SYMPTOMS. FEVER/MALAISE/HEADACHE AROUND 16 HOURS AFTER VACCINATION. THEN ERYTHEMA OF LEFT DELTOID WITH LOCAL EDEMA AND TENDERNESS DEVELOPED. SHE REPORTED TENDERNESS ALL THE WAY TO THE ELBOW. THESE SYMPTOMS INCREASED OVER 24-48 HOURS BEFORE MOSTLY RESOLVED BY THE TIME SHE HAD CONTACTED ME - SHE HAD USED ASPIRIN AND TYLENOL AS NEEDED TO CONTROL LOCAL SYMPTOMS.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abscess drainage, Culture negative, Gram stain negative, Injection site abscess sterile
Clinical narrative: Sterile abscess developed at site of injection
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling, Pain
Clinical narrative: Severe pain, swelling at site, head and body aches
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient stated left arm was painful and numb. Went to doctor and doctor believed pharmacist may have hit a nerve. Last communication on 10/23 patient was still feeling the same issues of numbness and pain
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt says her arm started hurting right after vaccine administration. To this day, it hurst still every time she needs to use it to do her hair or put on her clothes.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Injection site pain, Injection site swelling, Paraesthesia oral, Swollen tongue
Clinical narrative: Worker states that she has had adverse reactions to flu shots containing preservative in 2015, 2016 and 2017 consisting of fever, metallic taste and red streaks on her arm. In 2018 and 2019 a preservative free flu vaccination was administered without any adverse reaction. Worker received the Seqirus Afluria preservative free vaccination ( left deltoid ) at 10:10 AM on 28OCT2020. Within 10 minutes she experienced a metallic taste, tingling lips and a feeling of the back of her tongue swelling. By 0800 PM she was aware of a swollen, tender area lower on her left arm than the injection site. Worker states upon experiencing the adverse effects, she took 50mg Benadryl and took another 25mg Benadryl 2 hours later as the symptoms were still present.  29OCT2020: worker still has a noticeably swollen area mid shaft anterior left arm which she states is only tender to palpation. Temp: 97.1, Pulse 71, Blood pressure 136/77.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Worker states that she has had adverse reactions to flu shots containing preservative in 2015, 2016 and 2017 consisting of fever, metallic taste and red streaks on her arm. In 2018 and 2019 a preservative free flu vaccination was administered without any adverse reaction. Worker received the Seqirus Afluria preservative free vaccination ( left deltoid ) at 10:10 AM on 28OCT2020. Within 10 minutes she experienced a metallic taste, tingling lips and a feeling of the back of her tongue swelling. By 0800 PM she was aware of a swollen, tender area lower on her left arm than the injection site. Worker states upon experiencing the adverse effects, she took 50mg Benadryl and took another 25mg Benadryl 2 hours later as the symptoms were still present.  29OCT2020: worker still has a noticeably swollen area mid shaft anterior left arm which she states is only tender to palpation. Temp: 97.1, Pulse 71, Blood pressure 136/77.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: MMRV and Varicella were given at the same time. PA, Health Dept. and Mom were all notified. Mom was told to call if child displays any unusual symptoms.
Age: 30.0
Sex: U
Vaccine: FLUC4, VARCEL
Symptoms: Influenza like illness, Pain, Pruritus, Pyrexia, Rash pustular
Clinical narrative: Patient had a fever of 101 and flu like symptoms. Pox started to appear across the forehead and then the entire body the day after the fever started. Pox proceeded to appear and become filled with fluid and were painful and itchy. 5-6 days after the pox appeared the fluid pox ruptured and scabbed over.  Those that did not have fluid disappeared with out filling with fluid.
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema
Clinical narrative: Patient stated that she had a red injection site reaction the day of vaccine on 10/27 but since vaccine injection site reaction has grown in size to about 4 to 5 inches wide. Told patient to keep an eye on injection site and treat any pain with a cold compress and pain reliever and to seek medical attention if it continues to spread. Patient is monitoring
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Swelling
Clinical narrative: Large bump  2 inches in diameter, warm to the touch ,  soft on top
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Dry mouth, Ear swelling, Erythema, Eye swelling
Clinical narrative: the evening of the vaccination, I began itchiness, which increased over the next day.  by day two  itchiness increased to uncomfortable levels; the  eyes,  face, neck, ears, chin, lips were swollen;  slightly red or blushed;  no hives or rash. mouth dryness. no response from primary physician on 10/8 and increased symptoms, I went to immediate care at 715-745pm.   * an allergic reaction was confirmed and I was given an hydration drip of three medications:  I think steroid, antihystimien, 3rd items; also prescribed a six  day  dose of METHYLPREDNISOLONE 4MG DOSE PK
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Lip swelling, Pruritus, Swelling, Swelling face
Clinical narrative: the evening of the vaccination, I began itchiness, which increased over the next day.  by day two  itchiness increased to uncomfortable levels; the  eyes,  face, neck, ears, chin, lips were swollen;  slightly red or blushed;  no hives or rash. mouth dryness. no response from primary physician on 10/8 and increased symptoms, I went to immediate care at 715-745pm.   * an allergic reaction was confirmed and I was given an hydration drip of three medications:  I think steroid, antihystimien, 3rd items; also prescribed a six  day  dose of METHYLPREDNISOLONE 4MG DOSE PK
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Energy increased, Pain, Palpitations, Panic reaction
Clinical narrative: pt states that about 5 minutes after receiving injection he got into his car and felt an intense knife-stabbing pain at L2 in his spine at the waist area. L2 was a site of a break 25 years ago. Pain lasted about 20 minutes and was immediately accompanied by an adrenaline-like surge and racing heart which subsided quickly. Pt states he felt fear and as if he was going to die, although he suggested it was a sense of panic that probably made him feel that way and it subsided as he began to relax.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Eye movement disorder, Gaze palsy, Hypotonia, Pyrexia, Seizure
Clinical narrative: Mother of child states that the child had a subjective fever on 10/26/2020, she did not take his temperature, but he felt hot to the touch. States she believed his was teething at the time, as he is cutting new teeth. 2 days later around dinner time (6:00pm) mother states child's eyes rolled into the back of his head, his eyes glassed over and his body was limp. States when she picked him up, his arms hung to the side. Mother estimates the seizure event last 10 minutes. She drove the child to the ER and by the time they got there he was his usual self.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Skin warm
Clinical narrative: Mother of child states that the child had a subjective fever on 10/26/2020, she did not take his temperature, but he felt hot to the touch. States she believed his was teething at the time, as he is cutting new teeth. 2 days later around dinner time (6:00pm) mother states child's eyes rolled into the back of his head, his eyes glassed over and his body was limp. States when she picked him up, his arms hung to the side. Mother estimates the seizure event last 10 minutes. She drove the child to the ER and by the time they got there he was his usual self.