chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Feeling abnormal, Hypoaesthesia, Injection site pain, Mobility decreased
Clinical narrative: Patient stated that she has never had an issue with any flushot in the past, but this vaccine affected her within minutes of being administered.  She stated she had no injection site reaction, but very shortly after receiving the vaccine felt really dizzy and weird.  She stated she had to sit down for about 10 additional minutes.  She stated the next morning, she could barely stand to raise her arm due to the pain in her deltoid area that was radiating down to her last two fingers in her hand causing some numbness and tingling.  She stated it made her feel like her bones in her arm were aching as well.   She stated that she is still having these issues a full month later.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Paraesthesia
Clinical narrative: Patient stated that she has never had an issue with any flushot in the past, but this vaccine affected her within minutes of being administered.  She stated she had no injection site reaction, but very shortly after receiving the vaccine felt really dizzy and weird.  She stated she had to sit down for about 10 additional minutes.  She stated the next morning, she could barely stand to raise her arm due to the pain in her deltoid area that was radiating down to her last two fingers in her hand causing some numbness and tingling.  She stated it made her feel like her bones in her arm were aching as well.   She stated that she is still having these issues a full month later.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever, severe body ache, headache. From about 6 pm the day of vaccination, to noon the next day.
Age: 68.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Chills, Cough, Headache, Insomnia, Myalgia
Clinical narrative: Dry cough, throat closing/swelling, fever, severe chills, headache, muscle aches, frequent urination, unable to sleep
Age: 68.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Pharyngeal swelling, Pollakiuria, Pyrexia, Throat tightness
Clinical narrative: Dry cough, throat closing/swelling, fever, severe chills, headache, muscle aches, frequent urination, unable to sleep
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pt states was administered Anthrax while known to be pregnant via home pregnancy test.  Pt states they questioned technician if appropriate to receive Anthrax vaccine while pregnant.  Pt states they were 4-5 weeks at time of injection. Pt states and medical record supports miscarriage on/about 20 December 2018.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: SWOLLEN, WARM TO TOUCH, SORE TO TOUCH, SORE WITH MOVEMENT
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Swelling face
Clinical narrative: Swelling of lips and right side of the face. Patient went to emergency room for treatment. Patient was prescribed Prednisone 50mg once daily for 5 days
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Peripheral swelling, Tenderness
Clinical narrative: swelling and redness through out the arm(upper arm) hard and tenderness
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: redness and a bump
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Awoke 10/12/19 with hives all over body - itching, burning.  Then went to the ER was given prednisone. followed up with primary MD who advised to not get vaccinated for flu in the future.
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: My daughter went to the clinic and received her flu vaccine on 10-21-19. It was given right by the bony prominence of her shoulder instead of in the deltoid muscle. She is having shoulder and arm pain. I have contacted the clinic about improper vaccine administration techniques as I am a nurse myself.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Hyperhidrosis, Injection site discomfort
Clinical narrative: Woke up approx. 2:00 am on 5/22/19 after receiving first Shingrix injection (thru Pharmacy), 5/21/19 @ 4:54 pm with extreme injection site discomfort/hardness/warmth. Headache, body aches, low-grade fever, sweats/chills, nausea, diarrhea. Severity of listed symptoms lasted approx. 12 hours with mild, lingering symptoms continued another 12 hours. Injection site pain lasted for several days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site warmth, Nausea, Pain
Clinical narrative: Woke up approx. 2:00 am on 5/22/19 after receiving first Shingrix injection (thru Pharmacy), 5/21/19 @ 4:54 pm with extreme injection site discomfort/hardness/warmth. Headache, body aches, low-grade fever, sweats/chills, nausea, diarrhea. Severity of listed symptoms lasted approx. 12 hours with mild, lingering symptoms continued another 12 hours. Injection site pain lasted for several days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Woke up approx. 2:00 am on 5/22/19 after receiving first Shingrix injection (thru Pharmacy), 5/21/19 @ 4:54 pm with extreme injection site discomfort/hardness/warmth. Headache, body aches, low-grade fever, sweats/chills, nausea, diarrhea. Severity of listed symptoms lasted approx. 12 hours with mild, lingering symptoms continued another 12 hours. Injection site pain lasted for several days.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: I became extremely achey over my whole body, got a headache and felt very fatigued. This started to develop about 4-5 hours after I got the vaccine. The next morning, I developed a fever of 100 degrees and got the chills. I did not work or do much other than stay in bed for the day following the vaccine. I felt much better the next morning - so adverse effects lasted about 24 hours total.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Hyperhidrosis, Myalgia, Nasopharyngitis
Clinical narrative: Severe cold, shivering, fever, severe sweating, muscle aches, fatigue
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Severe cold, shivering, fever, severe sweating, muscle aches, fatigue
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Feeding disorder, Tremor
Clinical narrative: Patient shaking non stop, she can't even eat, because of the shaking the whole body, the symptoms last for around six hours.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Abdominal pain, Computerised tomogram normal, Lipase increased, Liver function test normal, Pancreatitis
Clinical narrative: 14 days after immunizations, patient developed abd pain, was found to have pancreatitis - lipase > 2000, and was hospitalized for IV fluids.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Ultrasound abdomen normal
Clinical narrative: 14 days after immunizations, patient developed abd pain, was found to have pancreatitis - lipase > 2000, and was hospitalized for IV fluids.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema
Clinical narrative: 3-4 in area erythemia at injection site
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Injection site discolouration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: PATIENT REACTED TO FLUZONE HD - ARM (RIGHT) SWOLLEN AND DARK COLURATION. SHE HAD CHILLS AND FEVER. SYMPTOM SUBSIDED BUT AREA STILL HAD SEVERE DICOLURATION AT INJECTION SITE AND STILL PAINFUL. PATIENT DID NOT NOTIFY HER DOCTOR AND DID NOT WANT US NOTIFYING DOCTOR.
Age: 47.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Injection site rash, Rash
Clinical narrative: rash at both sites, rash on face, rash on right leg
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: redness, swelling and itching above elbow on same arm as injection. Patient took 1 dose of benadryl which seemed to help but condition later progressed. pt saw doctor on morning of 10/23 and was diagnosed with possible infection and prescribed 7 day course of doxycycline.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Contusion, Fall, Headache, Loss of consciousness
Clinical narrative: Vaccine was administered in the left outer upper arm area by MA while mom was in the room.  Patient was sitting on the exam table.  As she left the room mom shouted and when I entered the room patient had fallen to the ground forward and lost consciousness for a brief period (2-3 seconds) and slowly regained the color and consciousness.  No vomiting or any seizure and observed in the office and he wanted to go home after 30 minutes.  On examination noted to have a small bump on the right fore head and bruise on his left knee.  Pupils were equal and reactive and no headache or any focal signs.  He felt OK and wanted to go home and left the office just after 4 PM.  Mom was advised to take him to ER if any headache, seizures, vomiting or any focal signs or any concerns.   I called to check on him on 10/23/19: he went to school and had a short day till 11 AM.  Mild headache and left knee pain persists but improving with Tylenol and ice application.  Mom was again requested to take him to ER for evaluation is she has any concerns.  Likely he had a vaso-vagal incident.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Presyncope, Swelling, Swelling face
Clinical narrative: Vaccine was administered in the left outer upper arm area by MA while mom was in the room.  Patient was sitting on the exam table.  As she left the room mom shouted and when I entered the room patient had fallen to the ground forward and lost consciousness for a brief period (2-3 seconds) and slowly regained the color and consciousness.  No vomiting or any seizure and observed in the office and he wanted to go home after 30 minutes.  On examination noted to have a small bump on the right fore head and bruise on his left knee.  Pupils were equal and reactive and no headache or any focal signs.  He felt OK and wanted to go home and left the office just after 4 PM.  Mom was advised to take him to ER if any headache, seizures, vomiting or any focal signs or any concerns.   I called to check on him on 10/23/19: he went to school and had a short day till 11 AM.  Mild headache and left knee pain persists but improving with Tylenol and ice application.  Mom was again requested to take him to ER for evaluation is she has any concerns.  Likely he had a vaso-vagal incident.
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Cold sweat, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: I administered these vaccines to patient. Afluria in right arm and Shingrix in left arm. The patient walked up to front of store when she felt very hot and lightheaded. She was leaning on counter and sitting on the floor when I reached her. I helped her to lie down flat on the floor. She was very cold to touch, clammy and sweating profusely. We called 911 but patient began to feel better and she refused the ambulance to come. Patient was talking and said now she was feeling cold but stopped sweating. We helped her off the floor and she sat in a chair and drank gatorade. Patient never lost consciousness. Afterwards, she said that she had radiation therapy this morning also and that she suffers from hot flashes.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Left arm pain 8/10 (with 10 being the most painful) started at the injection site radiating  to the left shoulder on Saturday 10/5/19, increasing on Sunday 10/6/19  to 10/10 pain level. Pain occurs with every movement. Also, loss of range of motion with each attempt to move arm forward, backward, or upward . Can't lay on left side when sleeping; and pain continues as described to this day.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles soon after Shingrix vaccine on 10/6/2019. This was the second dose of the series. The first dose was given on 5/6/2019 at medical office.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Verbalized she feels her right arm swollen from elbow to hand.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Nerve injury, Paraesthesia, Paralysis
Clinical narrative: No adverse event was reported until now when the law office file a motion for intention to file a law suit stating pt suffer, pain, loss of amenity,guillain-barre syndrome, paresthesia, severe sensorimotor polyneuropahty, numbness, paralysis, sensory and motor nerve damage. Patient never reach out to us.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral sensorimotor neuropathy
Clinical narrative: No adverse event was reported until now when the law office file a motion for intention to file a law suit stating pt suffer, pain, loss of amenity,guillain-barre syndrome, paresthesia, severe sensorimotor polyneuropahty, numbness, paralysis, sensory and motor nerve damage. Patient never reach out to us.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Pyrexia, Retching
Clinical narrative: spouse phoned pharmacy stating patient was having dry heaves, sweating and low grade fever
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling around upper arm
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Extra dose administered, Pain
Clinical narrative: The patient came to our pharmacy to receive the Shingrix vaccine, which she was given. We also asked her if she would like get her flu shot. she said yes and filled out all corresponding forms. Then on 1023 the patient called us stating she never asked to get her flu shot she already got it from he dr's office. She is having side effects with the shot such as soreness, feeling weak, and asked us to write a report
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Right arm.....Large local reaction with redness, swelling and warmth to touch
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt has experienced pain in arm since injection on 10.4.19 (date today upon report of issue from patient is 10/23/19)- reports pain upon raising shoulder that sometimes feels like shooting pain. Cannot take NSAIDS due to low kidney function, but has reported using heating pad to try and relieve pain.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: the patient experienced a rash all the way around her left arm down to her elbow; patient was seen in the office on 08-OCT-2019 for an unspecified reason; This spontaneous report was received from a medical assistant via company representative, referring to a 70-year-old female patient. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were unknown.     On 09-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in left deltoid for prophylaxis (strength and dose were not reported, lot number S009238 has been verified to be a valid number; and expiration date 11-FEB-2021).   On an unknown date, the patient experienced a rash all the way around her left arm down to her elbow. The patient did not seek medical attention, the rash lasted a couple days and was resolved on an unspecified date..  It was also reported that on 08-OCT-2019, the patient was seen in the office for an unspecified reason (adverse event). The outcome for of adverse event was unknown. It was reported no treatment was given to the patient nor laboratory diagnostics or studies was performed.   The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administration, and the events was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; the patient was administered an improperly stored dose; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.  On 13-AUG-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# S002874, expiration date 29-JAN-2021) (exact dose, route, site of administration were not reported) for prophylaxis. Administered dose was stored in a temperature of 7.64 Fahrenheit degrees (F) for 20 minutes. Previous temperature excursion was 19.34 F for 34 minutes. Sterile diluent used to reconstitute the administered vaccine was properly stored. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; he administered a pediatric dose of VAQTA [...] instead of an adult dose; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.   On 10-OCT-2019, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA), lot # S002506, expiration date 04-APR-2020 (exact dose and route of administration were not reported) for prophylaxis. The pharmacist reported that he administered the pediatric dose of hepatitis a vaccine, inactivated (VAQTA) instead of an adult dose. No adverse effects reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; The patient inadvertently received a dose of PNEUMOVAX 23 Pre-filled Syringe, after the labeled expiration date (Lot: N025656; Exp: 04/19/2019); This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies.  On 09-OCT-2019, the patient inadvertently received a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe for prophylaxis, after the labeled expiration date lot number N025656, expiration date 19-APR-2019 (dosage schedule, anatomical location and route of administration were not reported) (expired product administered).    No adverse effects reported.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; the patient received an improperly stored dose of VARIVAX; This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-OCT-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # S005078, expiration date 19-FEB-2019, for prophylaxis (dose, frequency and route of administration were not provided), which was reconstituted with a sterile diluent (lot #, expiration date and route of administration were not provided). The vaccine was exposed to a temperature of -14 degrees Celsius for 45 minutes and -9 to 8 degrees Celsius for 75 minutes. There were no previous temperature excursion. The call was made because of digital data logger. There were no adverse effects reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; the patient received an improperly stored dose of VARIVAX; This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-OCT-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # S005078, expiration date 19-FEB-2019, for prophylaxis (dose, frequency and route of administration were not provided), which was reconstituted with a sterile diluent (lot #, expiration date and route of administration were not provided). The vaccine was exposed to a temperature of -14 to 10 degrees Celsius for 45 minutes and -9 to 8 degrees Celsius for 75 minutes. There were no previous temperature excursion. The call was made because of digital data logger. There were no adverse effects reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse eveent; improperly stored doses of rotateq administered; This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. The medical assistant described on 17-OCT-2019, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R035369 and expiry date 10-OCT-2020, (strength, dose, route were not reported) for prophylaxis (product storage error). No adverse effects reported and no product quality complaint. It was reported that the vaccine was stored 6 hours 48 minutes at temperature below 36 degree Fahrenheit (33.8 F), there was no previous temperature excursion. It was stated that call was placed because of data logger.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Inappropriate schedule of product administration, Incorrect route of product administration, Pruritus, Rash erythematous
Clinical narrative: Inappropriate route of vaccination; cellulitis/ cellulitis from the injection site down to the antecubital fossa; swelling; rash look like cellulitis-red; minimal itch; Drug dose administration interval too long; This case was reported by a physician via call center representative and described the occurrence of cellulitis of arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (received 1st dose in March 2019).   On 1st October 2019, the patient received the 2nd dose of Shingrix. On 1st October 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 4th October 2019, the patient experienced cellulitis of arm (serious criteria GSK medically significant), swelling, red rash and pruritus. On an unknown date, the patient experienced intramuscular formulation administered by other route. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the cellulitis of arm, swelling, red rash and pruritus were recovered/resolved and the outcome of the intramuscular formulation administered by other route and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the cellulitis of arm and swelling to be related to Shingrix. The reporter considered the red rash and pruritus to be related to Shingrix.  Additional details were provided as follows: The rash started day 3 after shot and it was extended to shot site to elbow. The patient had no pain but had minimal itch. The patient received 2nd injection with similar reaction but less intense. The reporter stated that vaccine was not administered by them either time.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Vaccine positive rechallenge
Clinical narrative: Inappropriate route of vaccination; cellulitis/ cellulitis from the injection site down to the antecubital fossa; swelling; rash look like cellulitis-red; minimal itch; Drug dose administration interval too long; This case was reported by a physician via call center representative and described the occurrence of cellulitis of arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (received 1st dose in March 2019).   On 1st October 2019, the patient received the 2nd dose of Shingrix. On 1st October 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 4th October 2019, the patient experienced cellulitis of arm (serious criteria GSK medically significant), swelling, red rash and pruritus. On an unknown date, the patient experienced intramuscular formulation administered by other route. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the cellulitis of arm, swelling, red rash and pruritus were recovered/resolved and the outcome of the intramuscular formulation administered by other route and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the cellulitis of arm and swelling to be related to Shingrix. The reporter considered the red rash and pruritus to be related to Shingrix.  Additional details were provided as follows: The rash started day 3 after shot and it was extended to shot site to elbow. The patient had no pain but had minimal itch. The patient received 2nd injection with similar reaction but less intense. The reporter stated that vaccine was not administered by them either time.
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Malaise, Pain, Pyrexia
Clinical narrative: Body aches; Fever; Feel really sick / feel very poorly; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 30-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced general body pain, fever and sickness. On an unknown date, the outcome of the general body pain, fever and sickness were unknown.   It was unknown if the reporter considered the general body pain, fever and sickness to be related to Flu vaccine.  Additional details were provided as follows: The patient received flu vaccines and had body aches, fever and to feel sick afterward. The reporter stated they were all years ago, from hospitals and during Army enlistment. The reporter stated would previously receive flu vaccines and the night of and for a few days after feeling very poorly and then the symptoms would resolve. The reporter did not consent to follow up. The reporter has no other information for this case. No consent to follow up. This case linked with US2019187025, reported by same reporter.
Age: 27.0
Sex: M
Vaccine: HEPA
Symptoms: Angioedema, Dysphagia, Dysphonia, Lip swelling, Oropharyngeal discomfort
Clinical narrative: Angioedema in face and arms; Strange feeling in throat and voice; Difficulty swallowing saliva/ Strange feeling in throat and voice; Swollen tongue; Lip swelling; This case was reported by a physician via call center representative and described the occurrence of angioedema in a 27-year-old male patient who received HAV (Havrix) (batch number 2AD47, expiry date 31st January 2022) for prophylaxis.   On 3rd October 2019, the patient received Havrix. On 13th October 2019, 10 days after receiving Havrix, the patient experienced throat discomfort, swallowing difficult, swollen tongue and lip swelling. On an unknown date, the patient experienced angioedema (serious criteria GSK medically significant). The patient was treated with antihistamine, epinephrine and prednisone. On 1st October 2019, the outcome of the angioedema was recovered/resolved. On an unknown date, the outcome of the throat discomfort, swallowing difficult, swollen tongue and lip swelling were unknown.   It was unknown if the reporter considered the angioedema, throat discomfort, swallowing difficult, swollen tongue and lip swelling to be related to Havrix.  Additional details were provided as follows: The physician reported that the patient was administered hepatitis A vaccine on unknown arm and had possible angioedema on two separate occasions. Approximately 48-72 hours later following vaccination, it was reported that the patient had angioedema in face and arms. The physician mentioned that the patient may not have given it much attention and reaction may started prior to patient seeking medical help and first occurrence was resolved. The physician reporter that saw the patient on 8th October 2019 and also noted first occurrence resolved. During consultation the patient reported to the physician that he was not any other medications. On 13th October 2019, the physician reports patient woke up very early in morning during sleep due to strange feeling in throat and voice, difficulty swallowing saliva, and swollen tongue. The nurse evaluation was significant for tongue and lip swelling, and the patient was given an antihistamine and subcutaneous epinephrine. The patient was then transported to an emergency room at approximately 4 AM on 13th October 2019 and then transported to a second emergency room due to physician's preference for an available ENT specialist in the event intubation was required. At the second facility, patient underwent an upper airway examination and was later discharged on a tapering dose of prednisone and antihistamines. The physician reports symptoms resolved by the time patient was returned to the detention center. The physician mentions he had requested medical records for upper airway examination and he also ordered a test for complement levels and was willing to provide this information when available during follow-up. Emergency visit was required.
Age: 27.0
Sex: M
Vaccine: HEPA
Symptoms: Swollen tongue
Clinical narrative: Angioedema in face and arms; Strange feeling in throat and voice; Difficulty swallowing saliva/ Strange feeling in throat and voice; Swollen tongue; Lip swelling; This case was reported by a physician via call center representative and described the occurrence of angioedema in a 27-year-old male patient who received HAV (Havrix) (batch number 2AD47, expiry date 31st January 2022) for prophylaxis.   On 3rd October 2019, the patient received Havrix. On 13th October 2019, 10 days after receiving Havrix, the patient experienced throat discomfort, swallowing difficult, swollen tongue and lip swelling. On an unknown date, the patient experienced angioedema (serious criteria GSK medically significant). The patient was treated with antihistamine, epinephrine and prednisone. On 1st October 2019, the outcome of the angioedema was recovered/resolved. On an unknown date, the outcome of the throat discomfort, swallowing difficult, swollen tongue and lip swelling were unknown.   It was unknown if the reporter considered the angioedema, throat discomfort, swallowing difficult, swollen tongue and lip swelling to be related to Havrix.  Additional details were provided as follows: The physician reported that the patient was administered hepatitis A vaccine on unknown arm and had possible angioedema on two separate occasions. Approximately 48-72 hours later following vaccination, it was reported that the patient had angioedema in face and arms. The physician mentioned that the patient may not have given it much attention and reaction may started prior to patient seeking medical help and first occurrence was resolved. The physician reporter that saw the patient on 8th October 2019 and also noted first occurrence resolved. During consultation the patient reported to the physician that he was not any other medications. On 13th October 2019, the physician reports patient woke up very early in morning during sleep due to strange feeling in throat and voice, difficulty swallowing saliva, and swollen tongue. The nurse evaluation was significant for tongue and lip swelling, and the patient was given an antihistamine and subcutaneous epinephrine. The patient was then transported to an emergency room at approximately 4 AM on 13th October 2019 and then transported to a second emergency room due to physician's preference for an available ENT specialist in the event intubation was required. At the second facility, patient underwent an upper airway examination and was later discharged on a tapering dose of prednisone and antihistamines. The physician reports symptoms resolved by the time patient was returned to the detention center. The physician mentions he had requested medical records for upper airway examination and he also ordered a test for complement levels and was willing to provide this information when available during follow-up. Emergency visit was required.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: swelling, warmth, erythema to (L) deltoid region cool compresses, benadryl
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Swelling
Clinical narrative: Swelling within 24hr. Pain within 8 hr.
Age: 52.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Blister, Pruritus, Rash pruritic, Skin swelling, Skin warm
Clinical narrative: Sat AM (10-19-19) woke up with itchy (L) collar bone - progressed to neck, back, and chest with no abdomen. (+) shoulders, no face (+) chin. hives->hot, itchy bumps with fluid - skin swollen.- still has itchy chest; (L) collar bone today - hives mostly gone. Took Benadryl Sat and Sun and Sun, didn't relieve sx. No PCP seen.
Age: 52.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Urticaria
Clinical narrative: Sat AM (10-19-19) woke up with itchy (L) collar bone - progressed to neck, back, and chest with no abdomen. (+) shoulders, no face (+) chin. hives->hot, itchy bumps with fluid - skin swollen.- still has itchy chest; (L) collar bone today - hives mostly gone. Took Benadryl Sat and Sun and Sun, didn't relieve sx. No PCP seen.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Pain and swelling, small vesicle near site occurred within 24 hrs.
Age: 2.5
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 8cmx8cm warmth, redness, induration 6cmx6cm to left deltoid cool compresses, benadryl
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: prolonged severe crying x 12hrs
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Paraesthesia oral, Pruritus, Tongue discomfort, Tremor
Clinical narrative: Itching all over, tongue felt funny and tingly lips felt puffy. Felt shaky all over. Took Benadryl for 2 days.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Circadian rhythm sleep disorder, Laboratory test, Scan brain, Syncope
Clinical narrative: patient says she was fine after the injection but later on that night fainted. she went to the emergency room and says the doctor ran a bunch of tests and did scan of her brain with no conclusive results as to what caused the syncope.  patient was then traveling for 2 weeks and just returned to contact pharmacy. still does not feel like "herself" but does report also being jet lag. it was recommended that she follow up with her primary doctor
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Febrile convulsion
Clinical narrative: febrile seizure
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Lymphadenopathy, Pain
Clinical narrative: headaches, body aches, extreme fatigue, upset stomach, fever, swollen gland still suffering after 5 days
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: headaches, body aches, extreme fatigue, upset stomach, fever, swollen gland still suffering after 5 days
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: chills and tired up to 36-48 hrs.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: In the evening started to become sore at sight. Then developed aches and pains throughout body and chills. No fever. By the next morning had swelling and redness at sight of injection. The redness spread to approximately 3 inches wide and 3 inches long. It was warm to touch and swollen. Continuous chills throughout the day as well as joint pain. I am reporting this 2 days after receiving vaccine. Chills have stopped. Aching is subsiding but redness and swelling and warmth at sight continue. Called the pharmacist who gave me the vaccine and said they were reactions he had seen commonly and if anything changes to call him. Recommended Benedetto or Claritin or Motrin.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain
Clinical narrative: In the evening started to become sore at sight. Then developed aches and pains throughout body and chills. No fever. By the next morning had swelling and redness at sight of injection. The redness spread to approximately 3 inches wide and 3 inches long. It was warm to touch and swollen. Continuous chills throughout the day as well as joint pain. I am reporting this 2 days after receiving vaccine. Chills have stopped. Aching is subsiding but redness and swelling and warmth at sight continue. Called the pharmacist who gave me the vaccine and said they were reactions he had seen commonly and if anything changes to call him. Recommended Benedetto or Claritin or Motrin.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Limb discomfort, Muscular weakness, Throat tightness
Clinical narrative: Client presented for first ever flu shot.  VIS and possible side affects including possibility of allergic reaction reviewed. Client was self reported as very anxious prior to vaccination.  Vaccinated without incident and declined staying near nurse after vaccination for 15 minutes. Returned about 10-15 minutes later complaining of tightness in throat but could breathe okay.  Also had cold sweats and complaint of weakness/heaviness in both arms. BP 138/80; P 80 and R 20 and regular. No shortness of breath. Lungs clear bilaterally with no wheeze present.  Client denied itching, rash, hives or redness on skin. No tongue or lip swelling..  Skin was cool and damp to touch. Denied dizziness. Client talked with nurse about psychological fright versus anaphylaxis and she agreed that her symptoms were from being so anxious.  By the time she left the area, she did not have any complaint of tightness in throat.  Nurse recommended she seek medical attention if symptoms returned.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Malaise, Pain, Pain in extremity
Clinical narrative: RT ARM AND SHOULDER VERY PAINFUL....TOP OF SHOULDER PAINFUL TO TOUCH.  ENTIRE UPPER ARM  PAINFUL AND PAINFUL TO MOVE.   INJECTION SITE IS NORMAL.   GENERAL FEELING OF MALAISE.  EVEN TWO DAYS POST VACCINATION.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: Severe muscle pain all over body with fever, unable to function. Now has lasted fro one week and still continuing
Age: 59.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Injection was ordered as subcutaneous injection but given as intramuscular injection by error. No treatment necessary. Provider and patient were informed.
Age: 65.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site pruritus, Rash, Varicella post vaccine
Clinical narrative: 4 cm rash, are vesicle, left arm skin over deltoid with itching. Likely mild Varicella
Age: 69.0
Sex: F
Vaccine: HPV9
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Blood culture, C-reactive protein increased
Clinical narrative: headache, vomiting, body aches, fever and shivering four hours after injection. Unable to do any daily activities for 4 days (fever continued until day 3 and returned on day60. On 6th day developed aching wrist joints and rash with swelling from foot to buttock area bi-laterally. Sent by PC doctor to ER for work-up for rash. Chest X-ray, blood cultures, lab tests were taken. ESR and C-reactive protein tests were high. Diagnosis was made of leukocytoclastic vasculitis. Rash began to resolve by 5 days after onset. PC did follow-up labs that showed continued inflammation.
Age: 69.0
Sex: F
Vaccine: HPV9
Symptoms: Chest X-ray normal, Chills, Headache, Hypersensitivity vasculitis, Inflammation
Clinical narrative: headache, vomiting, body aches, fever and shivering four hours after injection. Unable to do any daily activities for 4 days (fever continued until day 3 and returned on day60. On 6th day developed aching wrist joints and rash with swelling from foot to buttock area bi-laterally. Sent by PC doctor to ER for work-up for rash. Chest X-ray, blood cultures, lab tests were taken. ESR and C-reactive protein tests were high. Diagnosis was made of leukocytoclastic vasculitis. Rash began to resolve by 5 days after onset. PC did follow-up labs that showed continued inflammation.
Age: 69.0
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test, Loss of personal independence in daily activities, Metabolic function test abnormal, Pain, Peripheral swelling
Clinical narrative: headache, vomiting, body aches, fever and shivering four hours after injection. Unable to do any daily activities for 4 days (fever continued until day 3 and returned on day60. On 6th day developed aching wrist joints and rash with swelling from foot to buttock area bi-laterally. Sent by PC doctor to ER for work-up for rash. Chest X-ray, blood cultures, lab tests were taken. ESR and C-reactive protein tests were high. Diagnosis was made of leukocytoclastic vasculitis. Rash began to resolve by 5 days after onset. PC did follow-up labs that showed continued inflammation.
Age: 69.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate increased, Vomiting
Clinical narrative: headache, vomiting, body aches, fever and shivering four hours after injection. Unable to do any daily activities for 4 days (fever continued until day 3 and returned on day60. On 6th day developed aching wrist joints and rash with swelling from foot to buttock area bi-laterally. Sent by PC doctor to ER for work-up for rash. Chest X-ray, blood cultures, lab tests were taken. ESR and C-reactive protein tests were high. Diagnosis was made of leukocytoclastic vasculitis. Rash began to resolve by 5 days after onset. PC did follow-up labs that showed continued inflammation.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity
Clinical narrative: on 10/21, received flu shot; that evening, patient woke up with pain in arm. By morning, arm had gotten "fire red", hurt. Throughout the day and evening, she used ice pack, which helped. On morning of 10/23, painhad gone down considerably. We told her that if it doesn't get better, or gets worse, to let her dr know.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Feeling abnormal, Lip swelling, Swelling of eyelid, Urticaria
Clinical narrative: The patient's lips were extremely swollen and was complaining about his hands feeling funny and they were red the night following vaccination. Patient also had hives, and his eyelids were swollen as well. The patient went to the ER. The patient was given Benadryl in the ER and was prescribed prednisone. Patient is on maintenance medications for chronic migraines. The course of the reaction was 3 days and patient is well.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Flushing, Visual impairment
Clinical narrative: Dizziness, flushing, vision change
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Pain
Clinical narrative: (L) shoulder pain begin approximately 24hr after vaccine. Pain with MVT shoulder.  Tx - sling, ice, ibuprofen, Physical Therapy
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Palpable area (2 cm) at injection site that is subcutaneous and tender. No change in size from initial vaccination 8/29/19
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: swelling, warmth, tenderness to left upper arm from deltoid to elbow starting evening of day vaccine given. Seen in office 2 days later. Advised cool compressed & benadryl
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Patient had swelling at injection site immediately after the injection. He was given 1 (one) tablet of Benadryl 25 mg and an ice pact to hold over injection site. He was observed for 25 minutes in store. No other symptoms. He was contacted again in 1 hour still no other symptoms. Swelling went down.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Nodule, Skin warm
Clinical narrative: Baseball size knot with redness & warm to touch after receiving Fluv acc. @ school Base clinic. Seen & given Benadryl & Hydrocortison 1% topical cream
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Pharyngeal swelling, Swollen tongue, Throat tightness
Clinical narrative: 12:30 Tongue and throat began to swell and throat began to close off. Pt administered Epi pen 12:40 injection into right thigh and drove herself to Emergency room for further treatment. Some symptoms still 24hrs later.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Cough, Eczema, Rhinorrhoea, Urticaria, Vomiting
Clinical narrative: 16m. old boy come for 3 shots: Flulaval (R thigh) & DTaP & Pedvax Hib (L thigh). Developing hives (1 lesion) mild, check 5 minutes after given shots, no other local Reaction or systemic Reaction. Given Benadryl & Ibuprofen, pt vomited right away. Redo Benadryl, pt's Rash improved after 30 minutes Here for 15 month exam.Mother concerns about allergies due to cough and runny nose also eczema concerns -ma Dental referral list given to call and schedule appointment. Patient presents today for routine health maintenance with his mother.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: patient developed hives to arms, torso and legs following administration of vaccine, no other symptoms reported; Benadryl administered x2 (25mg @ 8:28 AM and 25mg @ 9:11 AM). Patient observed for 1.5 hours after start of reaction with no additional symptoms noted. Patient's mother aware, left in care of school nurse after observation period.
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Circumstance or information capable of leading to medication error, Mass
Clinical narrative: patient jumped while being injected a lump formed afterward
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Paraesthesia, Paraesthesia oral
Clinical narrative: Community Influenza Clinic on 10/22/2019 Patient received her annual influenza immunization at approximately 11:00am without immediate adverse effect.  She returned to the clinic area at approximately 11:25am with complaints of "tingling" sensations in the left side of her mouth and both of her hands.  She told staff, "I really don't feel well at all".  Patient was alert and oriented; she was able to follow all staff directives. No facial drooping, slurred speech, diaphoresis, ataxia or signs of respiratory distress noted.  Patient denied loss of consciousness.She was assisted to a seated position with her head down; an ice pack was applied to the back of her neck; emotional support was given.  Vital Signs, as follows:  * 11:30am:  BP=160/100, AP=134 (1+,reg), R=16 (unlabored)  * 11:35am:  BP=160/100, AP=137 (1+,reg), R=16 (unlabored)    (911/EMS activated at 11;35am, per patient request and because her vital signs were significantly elevated)  * 11:40am:  BP 154/88, AP=128 (1+, reg), R=20 (unlabored)  Patient denied difficulty breathing, throat or mouth edema/swelling or other signs/symptoms of anaphylaxis.    EMS arrived at the scene at 11:45am.  Patient walked independently to the ambulance; no ataxia noted.   They monitored her for an unknown amount of time before patient refused transport. and signed off; it is unknown what occurred in the ambulance to make patient change her mind about going to the hospital.   At approximately 12:45pm; she reported that the left side of her mouth was still "tingling", but that she felt better; she was advised by RN staff to follow-up with her Primary Care Provider.  On 10/23/19, patient was called by Public Health Staff.  Patient reported having the "tingling" sensations until "later in the day" yesterday,  but feels much better today.