chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report has been received from a medical assistant referring to a 37 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not reported. Concomitant therapies included anti-rh gamma globulin(RHOGAM (ANTI-RH GAMMA GLOBULIN)) and iron (unspecified), minerals (unspecified), vitamins (unspecified)(IRON (UNSPECIFIED) (+) MINERALS (UNSPECIFIED) (+) VITAMINS (UNSPECIFIE). On 21-JUN-2018, a pregnant patient was vaccinated with GARDASIL 9, intramuscularly (strength, dose, frequency, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Age: 37.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Fatigue, Ultrasound scan, Urine analysis, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report has been received from a medical assistant referring to a 37 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not reported. Concomitant therapies included anti-rh gamma globulin(RHOGAM (ANTI-RH GAMMA GLOBULIN)) and iron (unspecified), minerals (unspecified), vitamins (unspecified)(IRON (UNSPECIFIED) (+) MINERALS (UNSPECIFIED) (+) VITAMINS (UNSPECIFIE). On 21-JUN-2018, a pregnant patient was vaccinated with GARDASIL 9, intramuscularly (strength, dose, frequency, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a physician referring to his 16 year old male patient son. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 20-JUN-2018 (reported as "two days ago"), the patient was vaccinated with GARDASIL 9 (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. On an unknown date, the physician stated that the patient had a huge 15 cm localized site reaction, red, swollen, sore, and with fever. At the time of the report, the outcome of  localized site reaction, red, swollen, sore, and with fever, was unknown. The physician did not mention the causality assessment between the events and GARDASIL 9 vaccination.
Age: 26.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 26 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-JUN-2018, the patient was vaccinated with a dose of PROQUAD subcutaneously lot number N020011 and expiration date of 13-JAN-2018 for prophylaxis (dose was not reported). No adverse effects were reported in the patient.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Oral administration complication, Vomiting
Clinical narrative: This spontaneous report was received from a physician assistant referring to a 2 month old female patient. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 26-JUN-2018, the patient was vaccinated with a dose of ROTATEQ orally (strength, dose, frequency, lot # and expiration date were not reported) for prophylaxis. On 26-JUN-2018, the patient vomited immediately after receiving the first dose of their ROTATEQ vaccination series . The physician assistant reported that the patient recovered completely with no treatment on an unknown date in 2018. No additional information was provided. The reporter did not assess a causal relationship between the aforementioned event and ROTATEQ.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 23-MAR-2018, the patient was vaccinated with improperly stored PROQUAD (dosing details were not reported) (lot # N028444, expiry date: 09-APR-2019) for prophylaxis the vaccine was administered with properly stored sterile diluent (MERCK). The vaccine was stored at a temperature of  14 degree Celsius to -10 Celsius (-9.9 degree Celsius) for 17 hours and 11 minutes. No previous temperature excursions reported. No adverse effects reported. No product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA007217: US-009507513-1804USA007886.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included pravastatin sodium (Pravastatin). On 29th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than an hour after receiving SHINGRIX, the patient experienced injection site pain. On 11th June 2018, the patient experienced raised rash, itching, rash and redness. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the raised rash, itching, rash and redness were unchanged. The reporter considered the injection site pain to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the raised rash, itching, rash and redness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient experienced pain at the injection site approximately within 15 minutes of receiving the vaccine. The pain at the injection site lasted for about two to three days, and was resolved at the date of reporting. 13 days after receiving SHINGRIX, the patient experienced rash associated with redness, itching and bumps on her thigh. The patient stated that the rash appears in 9 to 10 different patches on her thigh, and it was spreading. The patient had denied permission to contact their physician. No further details were provided, all questions were asked.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Laboratory test normal, Nausea, Neuralgia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of nausea in a 77-year-old male patient who received SHINGRIX (batch number 5ny3B, expiry date 13th July 2020) for prophylaxis. On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th May 2018, less than a day after receiving SHINGRIX, the patient experienced nausea, vomiting, pain in arm, chills and nerve pain. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the nausea, vomiting, pain in arm, chills and nerve pain were recovered/resolved. The reporter considered the nausea, vomiting, pain in arm and chills to be related to SHINGRIX. It was unknown if the reporter considered the nerve pain to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. The reporter declined to provide routine concomitant medications, but said there had been no changes to his routine concomitant medications or additions of any new concomitant medications when symptoms started. No other vaccinations besides SHINGRIX were administered or within four weeks prior. At 2:45 pm, the patient was administered SHINGRIX vaccine. On 30th May 2018, the symptoms of nausea, vomiting, and chills without fever started within 2 hours of receiving the vaccination. On the same day, the nerve pain started around the same time as the other symptoms and was tolerable, but the patient went to the emergency room the next day because of the other symptoms. The patient had nerve pain on the same arm as the vaccination. The pain radiating to the wrist area had a pain level of 3 to 2.5. As of 20th June 2018,  about 99 percent of the pain was gone. On 31st May 2018, the next day the patient went to the emergency room. The reporter described the other symptoms as disabling because those symptoms had required an emergency room visit.  The patient was jeopardized only because the patient had to go to the Emergency room for the symptoms. The patient was not admitted overnight to the hospital and was given Intravenous Zofran at the emergency room which relieved his symptoms of vomiting and nausea. All symptoms were resolved at the time of reporting, on 22nd June 2018 and the patient was no longer complaining of any pain. The emergency room performed a full laboratory work-up and all of his labs were normally described by the patient to the pharmacist as having checked out. The reporter granted permission to be contacted with any further related questions.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of nausea in a 77-year-old male patient who received SHINGRIX (batch number 5ny3B, expiry date 13th July 2020) for prophylaxis. On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th May 2018, less than a day after receiving SHINGRIX, the patient experienced nausea, vomiting, pain in arm, chills and nerve pain. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the nausea, vomiting, pain in arm, chills and nerve pain were recovered/resolved. The reporter considered the nausea, vomiting, pain in arm and chills to be related to SHINGRIX. It was unknown if the reporter considered the nerve pain to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. The reporter declined to provide routine concomitant medications, but said there had been no changes to his routine concomitant medications or additions of any new concomitant medications when symptoms started. No other vaccinations besides SHINGRIX were administered or within four weeks prior. At 2:45 pm, the patient was administered SHINGRIX vaccine. On 30th May 2018, the symptoms of nausea, vomiting, and chills without fever started within 2 hours of receiving the vaccination. On the same day, the nerve pain started around the same time as the other symptoms and was tolerable, but the patient went to the emergency room the next day because of the other symptoms. The patient had nerve pain on the same arm as the vaccination. The pain radiating to the wrist area had a pain level of 3 to 2.5. As of 20th June 2018,  about 99 percent of the pain was gone. On 31st May 2018, the next day the patient went to the emergency room. The reporter described the other symptoms as disabling because those symptoms had required an emergency room visit.  The patient was jeopardized only because the patient had to go to the Emergency room for the symptoms. The patient was not admitted overnight to the hospital and was given Intravenous Zofran at the emergency room which relieved his symptoms of vomiting and nausea. All symptoms were resolved at the time of reporting, on 22nd June 2018 and the patient was no longer complaining of any pain. The emergency room performed a full laboratory work-up and all of his labs were normally described by the patient to the pharmacist as having checked out. The reporter granted permission to be contacted with any further related questions.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, rigors, vomiting and nausea. On an unknown date, the outcome of the pain, rigors, vomiting and nausea were unknown. The reporter considered the pain, rigors, vomiting and nausea to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain, rigors overnight, then vomiting and nausea. The physician and nurse believed it was related to SHINGRIX. The physician would return after July 5. The reporter agreed to be followed up.
Age: 19.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Periarthritis
Clinical narrative: This is a spontaneous report from a contactable Pediatrician reported for her son. A 19-year-old male patient received TRUMENBA at single dose via unspecified route at the left arm on 22Jun2018 14:45. On the same date the patient also received the second dose of MENACTRA via unspecified route at the right arm. The patient had no medical history. On the same date the patient progressively worsening stiffening of the shoulder joint and pain, frozen shoulder and had severe limitation of the active lifting; Limitation of external rotation. Treatment of shoulder pain was "MOTRIN or TYLENOL." The outcome of the events was not recovered. The pediatrician stated that he had no doubt that the events are related to the vaccine. They are a very acute injury.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Myalgia, Nausea, Neck pain
Clinical narrative: Fever 99.9. Severe muscle pain. Bad Headache. Dizziness. Nauseous. Neck pain.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 99.9. Severe muscle pain. Bad Headache. Dizziness. Nauseous. Neck pain.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Musculoskeletal pain, Pain
Clinical narrative: Patient reported shooting and stabbing shoulder pain significantly impairing activities of daily living approximately 3 hours after administration. Patient denied swelling and redness. Patient reported symptom improvement after taking NSAID.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Computerised tomogram head, Dyspnoea, Electroencephalogram, Full blood count, Metabolic function test normal
Clinical narrative: Patient had a 20-30 second episode of stiffening with difficulty breathing followed by 30min of sleepiness. She was admitted to hospital and labs and EEG were obtained and normal. Neurology was consulted and felt with history this was a seizure episode secondary to pertussis vaccine.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Musculoskeletal stiffness, Seizure, Somnolence
Clinical narrative: Patient had a 20-30 second episode of stiffening with difficulty breathing followed by 30min of sleepiness. She was admitted to hospital and labs and EEG were obtained and normal. Neurology was consulted and felt with history this was a seizure episode secondary to pertussis vaccine.
Age: 75.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration, Vaccination site warmth
Clinical narrative: About 3-4 days after vaccination site became reddened, warm, hard, itchy. Pt. to use cool compresses, benedry, and ibuprofen.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Eyelid oedema, Injection site erythema, Injection site pain, Injection site warmth, Swelling face
Clinical narrative: Vaccine administered 6/25/18 at approximately 10:30am. Upon waking 6/27/18 approx. 6am the employee had facial swelling on left side of forehead, left upper eye lid, and top of left shoulder (near clavicle). Left shoulder was warm to touch and red with tenderness....not at the injection site. Sent to clinic for evaluation and it was determined employee had a adverse reaction to the Hep B vaccine. OTC Benadryl 50mg at HS and Claritin 10mg daily were advised. Ice X3 days, elevate HOB and APAP for pain. No NSAID HX gastric sleeve.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Testicular swelling
Clinical narrative: Vaccine administered 6/25/18 at approximately 10:30am. Upon waking 6/27/18 approx. 6am the employee had facial swelling on left side of forehead, left upper eye lid, and top of left shoulder (near clavicle). Left shoulder was warm to touch and red with tenderness....not at the injection site. Sent to clinic for evaluation and it was determined employee had a adverse reaction to the Hep B vaccine. OTC Benadryl 50mg at HS and Claritin 10mg daily were advised. Ice X3 days, elevate HOB and APAP for pain. No NSAID HX gastric sleeve.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nasopharyngitis, Neck pain, Tremor
Clinical narrative: Patient experienced severe cold chills, was shaking, had severe headache and neck hurt.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Dizziness, Fatigue, Headache, Muscular weakness
Clinical narrative: Severe headaches at 5:30pm that evening I received the shot. I woke up on 6/27 with extreme fatigue, severe muscle weakness, a temp of 101.8. As the day went on, by mid morning, I was also experiencing nauseous, dizziness, and tingling down my legs. My temp last until about 9:30pm with all the other symptoms listed. On 6/28, I woke up with a severe headache and severe muscle weakness in my hands. By 8:30AM, all symptoms had subsided.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Paraesthesia
Clinical narrative: Severe headaches at 5:30pm that evening I received the shot. I woke up on 6/27 with extreme fatigue, severe muscle weakness, a temp of 101.8. As the day went on, by mid morning, I was also experiencing nauseous, dizziness, and tingling down my legs. My temp last until about 9:30pm with all the other symptoms listed. On 6/28, I woke up with a severe headache and severe muscle weakness in my hands. By 8:30AM, all symptoms had subsided.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Insomnia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Later in the day of vaccination, patient's arm started swelling at location of vaccination. The area has been red and sore and swollen ever since that evening, resulting in loss of sleep for the patient.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Impaired work ability, Lethargy
Clinical narrative: Nausea, Headache, Fever - 101.2°F, Chills, Lethargy, extremely painful arm - Started approximately 10 hours after vaccination. Stayed home from work following day. Fever broke at 1:00 AM on Wednesday. Returned to work on Wednesday with headache and painful arm. By the end of Wednesday the headache declined and energy began to return.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Nausea, Headache, Fever - 101.2°F, Chills, Lethargy, extremely painful arm - Started approximately 10 hours after vaccination. Stayed home from work following day. Fever broke at 1:00 AM on Wednesday. Returned to work on Wednesday with headache and painful arm. By the end of Wednesday the headache declined and energy began to return.
Age: 10.0
Sex: F
Vaccine: MENB
Symptoms: Wrong drug administered
Clinical narrative: PATIENT IS 12 YEARS OLD. WAS SUPPOSED TO RECEIVE A Tdap SHOT. INSTEAD SHE RECEIVED A BEXSERO.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness, Seizure, Syncope, Tremor
Clinical narrative: After vaccines patient had syncopal episode on examination table and a momentary seizure with right arm and leg shaking. This lasted seconds and she came to immediately afterward. Never happened before.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: CHILLS, FEVER STARTING WITHIN FEW HOURS, SORE RED, WARM INJECTION SITE LASTED 2-3 DAYS. NEXT DAY MALAISE, FATIGUE, LOSS OF APPETITE. SPENT 2 DAYS ON COUCH, WRAPPED IN BLANKET.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Pyrexia
Clinical narrative: CHILLS, FEVER STARTING WITHIN FEW HOURS, SORE RED, WARM INJECTION SITE LASTED 2-3 DAYS. NEXT DAY MALAISE, FATIGUE, LOSS OF APPETITE. SPENT 2 DAYS ON COUCH, WRAPPED IN BLANKET.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Pt had fever on 6/26/18, ended up in the ER on 6/27/18. In ER pt was treated for cellulitis with Keflex. Area where immunization was given on L thigh was red, raised and hard measuring 3 cm in diameter  with 3 additional smaller firm red raised bumps.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Pt had fever on 6/26/18, ended up in the ER on 6/27/18. In ER pt was treated for cellulitis with Keflex. Area where immunization was given on L thigh was red, raised and hard measuring 3 cm in diameter  with 3 additional smaller firm red raised bumps.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Neuropathy peripheral, Petechiae, Rash, Rash pruritic
Clinical narrative: Initially noted on May 22nd  moderate hives on both lower legs. After 7 days developed into a petechial rash approximately 15 x 6 cm left calf and 18 x 8 cm on the right. Rash slowly resolved over the following 7-10 days. Not painful or very pruritic but patient does have neuropathy.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Initially noted on May 22nd  moderate hives on both lower legs. After 7 days developed into a petechial rash approximately 15 x 6 cm left calf and 18 x 8 cm on the right. Rash slowly resolved over the following 7-10 days. Not painful or very pruritic but patient does have neuropathy.
Age: 17.0
Sex: F
Vaccine: HEP, JEV1
Symptoms: Incorrect dose administered
Clinical narrative: Given the adult dose (1ml) instead of the pedi dose (0.5 ml) of ENGERIX only. There was no error with the Japanese Encephalitis vaccine.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Diarrhoea, Erythema, Headache
Clinical narrative: Headache, chills, diarrhea, muscle soreness, soreness under right arm, redness.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Headache, chills, diarrhea, muscle soreness, soreness under right arm, redness.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Rash
Clinical narrative: Systemic rashes and left sided chest pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Fever of 100.6. Body aches. Flu like symptoms. Extreme swelling and redness/tenderness at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 100.6. Body aches. Flu like symptoms. Extreme swelling and redness/tenderness at injection site.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Swelling/ redness on right thigh; 99.1 temperature; fussiness.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Middle insomnia, Musculoskeletal stiffness
Clinical narrative: This is what I wrote to my Dr.:  I was able to get a shingles vaccine yesterday. Everything went smoothly except I got a rxn during the night. I got very fatigued (went to sleep 9:30) and around 11p I started to get the shivers. I tried to go back to sleep but around midnight the shivering woke me up again. I couldn't stop. I put on more clothes and returned to bed. I woke several times during the night and by 4a I had pretty much stopped. I took off the clothes that I put on earlier because I was getting warm. This morning I feel only only slight residual shivering. My arm with the injection is much stiffer that yesterday but I don't think it is serious. I am letting you know because I plan to report this to VAERS. I don't think this is enough to prevent me from getting the second vaccine.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Vomiting
Clinical narrative: Pt called Dr. last night (06/27/18) with vomiting but no abdominal pain or fever. She had the SHINGRIX vaccine #2 yesterday. The vomiting has stopped but she has diffuse muscle aches today. No fever.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: Intussusception.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Feeling cold, Influenza like illness
Clinical narrative: Arm developed some soreness on 6/18/18. On 6/19/18, I hurt all over, low grade fever 100.2 that increased to 101.8 (on TYLENOL) felt like I had the flu. Eyes buried, my tinnitus double or tripled, loss of appetite, chills, (L) arm hurt from just under (L) ear to my elbow. Body felt so cold I had to still tired. I've had sore arms before from vaccinations but never has one done.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity, Pyrexia, Tinnitus
Clinical narrative: Arm developed some soreness on 6/18/18. On 6/19/18, I hurt all over, low grade fever 100.2 that increased to 101.8 (on TYLENOL) felt like I had the flu. Eyes buried, my tinnitus double or tripled, loss of appetite, chills, (L) arm hurt from just under (L) ear to my elbow. Body felt so cold I had to still tired. I've had sore arms before from vaccinations but never has one done.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vision blurred
Clinical narrative: Arm developed some soreness on 6/18/18. On 6/19/18, I hurt all over, low grade fever 100.2 that increased to 101.8 (on TYLENOL) felt like I had the flu. Eyes buried, my tinnitus double or tripled, loss of appetite, chills, (L) arm hurt from just under (L) ear to my elbow. Body felt so cold I had to still tired. I've had sore arms before from vaccinations but never has one done.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dizziness, Feeling cold, Headache, Malaise
Clinical narrative: Arm developed some soreness on 6/18/18. On 6/19/18, I hurt all over, low grade fever 100.2 that increased to 101.8 (on TYLENOL) felt like I had the flu. Eyes buried, my tinnitus double or tripled, loss of appetite, chills, (L) arm hurt from just under (L) ear to my elbow. Body felt so cold I had to still tired. I've had sore arms before from vaccinations but never has one done.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm developed some soreness on 6/18/18. On 6/19/18, I hurt all over, low grade fever 100.2 that increased to 101.8 (on TYLENOL) felt like I had the flu. Eyes buried, my tinnitus double or tripled, loss of appetite, chills, (L) arm hurt from just under (L) ear to my elbow. Body felt so cold I had to still tired. I've had sore arms before from vaccinations but never has one done.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: RED BUMP BELOW INJECTION SITE THAT WAS RAISED, WARM, AND ITCHY.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Induration, redness, warmth at vaccine site.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Orthopaedic examination, Rotator cuff syndrome, Ultrasound scan
Clinical narrative: Torn rotator cuff right arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Formication, Headache
Clinical narrative: Fatigue, headache, shivering, skin crawling.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported her arm being swollen, red and sore. She says at this time she is just going to monitor the site. If it gets worse or it does not improve she will seek medical attention. It started 6/26 the day after the injection, got worse on 6/27 and is about the same today 6/28.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture, Erythema, Mobility decreased, Myalgia, Pain
Clinical narrative: First reactions: unable to raise arm without assistance from other arm, pain, fevers, day 2 of reactions rash, myalgia, post-tussive emesis, tenderness, swelling, itchy, redness, warmth, unable to make move arm.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Post-tussive vomiting, Pruritus, Pyrexia, Rash, Skin warm
Clinical narrative: First reactions: unable to raise arm without assistance from other arm, pain, fevers, day 2 of reactions rash, myalgia, post-tussive emesis, tenderness, swelling, itchy, redness, warmth, unable to make move arm.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Tenderness
Clinical narrative: First reactions: unable to raise arm without assistance from other arm, pain, fevers, day 2 of reactions rash, myalgia, post-tussive emesis, tenderness, swelling, itchy, redness, warmth, unable to make move arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Lethargy, Myalgia, Nausea
Clinical narrative: Pain in arm, generalized muscle aches, nerve ending tingling especially head and neck, lethargy, nausea & vomiting, chills, headache.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Vomiting
Clinical narrative: Pain in arm, generalized muscle aches, nerve ending tingling especially head and neck, lethargy, nausea & vomiting, chills, headache.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Decreased appetite, Headache, Vomiting
Clinical narrative: Had vomiting a day after TRUMENBA vaccine (but reports also has vomiting when she does not take Doxycyline with food, however the vomiting she had the after the vaccine was not related to Doxycyline). Also had decrease in appetite (was skipping meals and eating less) and increase in headache frequency. Headaches were improving when I saw her.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Erythema, Hyperhidrosis, Pain
Clinical narrative: Hurts to lift arm, excessive sweating, redness, swelling, warm to the touch, tightness of arm, very pruritic, lightheaded, new diarrhea.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Skin tightness, Skin warm, Swelling
Clinical narrative: Hurts to lift arm, excessive sweating, redness, swelling, warm to the touch, tightness of arm, very pruritic, lightheaded, new diarrhea.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient's arm (deltoid muscle) where injection was given is very swollen, red, and tender. Swelling/redness is about the entire size of the patient's deltoid muscle. She ahs been icing the area to help with the pain and swelling so far.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site swelling, Pyrexia
Clinical narrative: Slight fever of 99.6, extreme tiredness 3-4 days with continued tiredness for 2 weeks. Arm swollen  1 1/2 inches diameter at shot location for several days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site swelling, Pyrexia
Clinical narrative: Fever of 101, extreme tiredness 3-4 days with continued tiredness for 2 1/2 weeks, severe chills by 3 AM June 9 2018 (lasted off and on for 2 days).  Arm swollen 3 inches diameter at shot location for 5 days.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Asthenia, Blood test normal, Body temperature increased, Diarrhoea, Electroencephalogram normal
Clinical narrative: Seizure 10 hrs after vaccine, sleep apnea, muscle spasms /100° temp. forty-eight hrs later for 48 hrs, weakness, soreness, vomiting diarrhea/injection site redness, swelling, lump/muscle spasms for app. 1 week following/injection site lump for over 1 month afterward.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Injection site erythema, Injection site mass, Injection site reaction, Injection site swelling, Muscle spasms
Clinical narrative: Seizure 10 hrs after vaccine, sleep apnea, muscle spasms /100° temp. forty-eight hrs later for 48 hrs, weakness, soreness, vomiting diarrhea/injection site redness, swelling, lump/muscle spasms for app. 1 week following/injection site lump for over 1 month afterward.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Pain, Seizure, Sleep apnoea syndrome, Vomiting
Clinical narrative: Seizure 10 hrs after vaccine, sleep apnea, muscle spasms /100° temp. forty-eight hrs later for 48 hrs, weakness, soreness, vomiting diarrhea/injection site redness, swelling, lump/muscle spasms for app. 1 week following/injection site lump for over 1 month afterward.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient came in on June 26.2018 and showed a red area around the shot area. Pain said felt warm.  Size was about 3 to 4 inches in diameter.
Age: 8.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 8 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 23-JUN-2018 (also reported as 23-JUN-2019), the patient was vaccinated with a dose of GARDASIL 9, 1 injection (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. No adverse effects reported. No further information provided.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Tonic clonic movements
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 16 year old female patient. The patient had no concurrent conditions, medical history, drug reactions/allergies and concomitant therapy. On 21-JUN-2018, the patient received the first dose of GARDASIL 9 (lot # N026812 and expiration date 22-JUN-2020) (dose unknown) via intramuscular route for human papilloma virus (HPV vaccination). On the same day, the patient experienced tonic-clonic movements which lasted for 30 seconds. No other side effects were reported. It was reported that no treatment was given for the event tonic-clonic movements and no lab tests were performed. The outcome of the event tonic-clonic movements was recovered on 21-JUN-2018. The casual relationship between the event tonic-clonic movements and GARDASIL 9 was not reported. No product quality complaint was reported. Upon internal review, the event of tonic clonic movements was considered as medically significant.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: PT STATES HER ARM BEGAN TO SWELL THE NEXT DAY AFTER VACCINE, PT MADE APPT TO SEE DR ON 6/28/18. LEFT ARM RED, SWOLLEN, ITCHING AND WARM TO TOUCH . DR PRESCRIBED OTC BENADRYL.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Bursitis, Chills, Dyspnoea, Gait disturbance
Clinical narrative: About 45 minutes after vaccine was administered, patient reported severe muscle pain in her left arm (injection site arm). The pain became so intense that patient couldn't breathe  well (pain was taking her breath away) and made it difficult to walk. She also reported elevated heart rate and blood pressure along with shaking/shivering. No redness and moderate swelling  at injection site was also reported. The reaction was severe enough that she went to urgent care.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site reaction, Injection site swelling, Myalgia, Tremor
Clinical narrative: About 45 minutes after vaccine was administered, patient reported severe muscle pain in her left arm (injection site arm). The pain became so intense that patient couldn't breathe  well (pain was taking her breath away) and made it difficult to walk. She also reported elevated heart rate and blood pressure along with shaking/shivering. No redness and moderate swelling  at injection site was also reported. The reaction was severe enough that she went to urgent care.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: Approximately 48 hours after vaccination developed rash on left side of chest, rash eventually spread under arm to back. Diagnosed as shingles by same practitioner who prescribed SHINGRIX.  Rash is painful, burning.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Approximately 7 hours after receiving the vaccine, I had severe muscle aches throughout my body, and headache, fever and chills.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 56-year-old female patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) for prophylaxis. On 13th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema was not recovered/not resolved and the outcome of the pain was recovering/resolving. The reporter considered the erythema and pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient received Shingrix in left arm. The soreness was resolving 1 week after injection, however, redness was still there, it was a 2 by 4 square.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included sulfonamide allergy (severe reaction). Concomitant products included losartan potassium (Losartan). On 20th March 2018, the patient received SHINGRIX (intramuscular). On 20th March 2018, immediately after receiving SHINGRIX, the patient experienced pain, fever and swelling. The patient was treated with ibuprofen (Thyroid Medicaiton). On 30th March 2018, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the fever and swelling were recovered/resolved. The reporter considered the pain, fever and swelling to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain upon vaccination. The pain was intense for 3 days and lasted to a lesser degree for another week. The patient received Ibuprofen 800 mg about 3 hours and continued to take it for 3 days. The patient noted that the Ibuprofen masked a fever of 3 degrees above normal. The patient had a good pain tolerance otherwise and rarely gets sick. The patient had denied permission to contact their physician.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was patient's wife and declined to provide date of birth of the patient. The age at vaccination was not reported. The patient's wife reported that her husband experienced soreness after receiving the SHINGRIX. This case was linked with US2018GSK115151, US2018109093 and US2018109097, reported by the same reporter.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin irritation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 14th June 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In June 2018, less than a week after receiving SHINGRIX the patient experienced rash and skin irritation. On an unknown date, the outcome of the rash and skin irritation were unknown. It was unknown if the reporter considered the rash and skin irritation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in an unknown deltoid. After receiving SHINGRIX, the patient experienced localized spot of irritation on her lower armpit of unknown arm. The reporter did not know the exact timeline for how soon after the second dose in the series was received and the symptom start. The patient called GlaxoSmithKline to inquire if this symptom could be related or not to the SHINGRIX and mentioned time constraints. The general phone number to GlaxoSmithKline's medical information team was provided. The call somehow was disconnected before the transfer to the GlaxoSmithKline medical information team could be completed. Two outbound attempts were made to the pharmacy, but there was a busy signal and no way to leave a message. It was okay to contact the reporter. No further information was provided beyond what was documented above.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 85-year-old female patient who received SHINGRIX for prophylaxis.  On 16th June 2018, the patient received the 1st dose of SHINGRIX. On 18th June 2018, 2 days after receiving SHINGRIX, the patient experienced injection site inflammation and injection site erythema. On an unknown date, the outcome of the injection site inflammation and injection site erythema were recovering/resolving. It was unknown if the reporter considered the injection site inflammation and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient left voicemail and reported that experienced inflammation and redness just beneath the injection site that is about 2 to 4 inches in size and was very red. Upon callback to the patient on 19th June 2018, the patient reported that she applied ice pack to the area and that it was improving. The patient stated that she was late for appointment and unable to answer further questions for the report. The patient filed limited report and demographics for pharmacy and physician were not obtained before caller ended the call.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Flank pain, Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of flank pain in a 50-year-old male patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received SHINGRIX. In June 2018, 2 days after receiving SHINGRIX, the patient experienced flank pain and shingles. On an unknown date, the outcome of the flank pain and shingles were unknown. It was unknown if the reporter considered the flank pain and shingles to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that 2 to 3 days after vaccination, the patient developed left flank pain. One week later the patient developed shingles on his left flank described as a 3 by 6 cm lesion. The reporter had no other information about the lot number or expiration date.  The adverse event was collected via chat.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Redness at the injection site for two days. Patient wearing arm sling to minimize movement of the left shoulder, limited ROM d/t pain. No palpable abnormalities and no associated rash or edema or induration. Injection site at the superior medial deltoid.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Serum sickness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in a 72-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities and serum sickness. On an unknown date, the outcome of the erythema of extremities and serum sickness were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and serum sickness to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced arm erythema and what he described it as "serum sickness" for a week. The healthcare professional was inquiring if it was safe for the patient to received the 2nd dose of SHINGRIX vaccine. The patient was not immunosuppressed. Information was provided to the healthcare professional from the FAQs (were there more local reactions seen with the second dose than with the first dose) and he was alss informed that the call would be transferred over to medical information as he was not happy with the response. The healthcare professional was in a rush and very adamant about speaking to someone further about his inquiry and therefore he was not probe any further.
Sex: F
Vaccine: VARZOS, FLU4, TDAP
Symptoms: Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Previously administered products included DPT with an associated reaction of urticaria (received in 2000, see case US2018GSK115151) and Influenza vaccine with an associated reaction of urticaria (received in 2000, see case US2018GSK115151). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and activities of daily living impaired. On an unknown date, the outcome of the injection site pain, injection site swelling and activities of daily living impaired were unknown.  It was unknown if the reporter considered the injection site pain, injection site swelling and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient declined to provide date of birth. The age at vaccination was not reported. The patient reported that they experienced a painful area at the injection site, and swelling, further described as a deep arm pain, after receiving SHINGRIX. The patient reported that they could not do a lot for a few days. This case was linked with US2018GSK115151, US2018109095 and US2018109097 reported by the same reporter.