chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: FLU4, HEP, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: After administration of HPV, patient became dizzy and proceeded to faint. Pt was in this state for about 20 seconds. After laying down for 20 minutes and several cups of water patient was able to sit up. After sitting for about 5 minutes, patient was able to stand and walk around exam room without dizziness. Patient was with complete resolution of symptoms upon leaving clinic.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Nodule, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Right Arm very tender to the touch, very painful, swollen, has a knot in the center.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Decreased appetite, Headache, Injection site erythema, Injection site pain
Clinical narrative: I received the shot around 3:00pm on Friday, by 8:00pm I was not feeling well. The next day I had a fever of 101, headache, chills, no appetite, spent the day in bed. The injection site was a red, slightly swollen, sore area that measured about two inchs by three inches. By Sunday I felt better, not 100 percent, but the fever and headach were gone. By Monday was ok, injection site the same, though now itchy too.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: I received the shot around 3:00pm on Friday, by 8:00pm I was not feeling well. The next day I had a fever of 101, headache, chills, no appetite, spent the day in bed. The injection site was a red, slightly swollen, sore area that measured about two inchs by three inches. By Sunday I felt better, not 100 percent, but the fever and headach were gone. By Monday was ok, injection site the same, though now itchy too.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Headache, Pain, Pain in extremity
Clinical narrative: I received the shot around 3:00pm on Friday, by 8:00pm I was not feeling well. The next day I had a fever of 101, headache, chills, no appetite, spent the day in bed. The injection site was a red, slightly swollen, sore area that measured about two inchs by three inches. By Sunday I felt better, not 100 percent, but the fever and headach were gone. By Monday was ok, injection site the same, though now itchy too.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: I received the shot around 3:00pm on Friday, by 8:00pm I was not feeling well. The next day I had a fever of 101, headache, chills, no appetite, spent the day in bed. The injection site was a red, slightly swollen, sore area that measured about two inchs by three inches. By Sunday I felt better, not 100 percent, but the fever and headach were gone. By Monday was ok, injection site the same, though now itchy too.
Age: 19.0
Sex: M
Vaccine: HEP, HEPA, HPV9, MENB, MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No symptoms reported via Clinic. Patient was given the adult dose of Hep B prior to 20th birthday at the age of 19.
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Rash generalised
Clinical narrative: 3 weeks after vaccination, Patient presented with mild rash all over her body starting at the head and running down to her body over the course of 5 days. At the end of 5 days, the rash disappeared.
Age: 72.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Joint swelling, Lymph node pain, Pain, Pain in extremity
Clinical narrative: Ten days after immunization, patient stated she had generalized aching for 2 days & thought it was due to fibromyalgia. Had light rash on neck and chest and sore glands at base of neck 2 to 4 days later (14-16 days after injection). Next day (day 17 after injection) knee was swollen and painful for a few hours, then pain resolved. Next day (day 18 after injection) both hands were painful for a few hours, then pain resolved. Approximately a week later, she had mild "pins and needles" tingling. Tingling is much less now, but still exists off and on (has been 33 days since injection).  Stated she got a cortisone injection 1-2 days after pain in knee for tendonitis.
Age: 72.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Paraesthesia, Rash, Tendonitis
Clinical narrative: Ten days after immunization, patient stated she had generalized aching for 2 days & thought it was due to fibromyalgia. Had light rash on neck and chest and sore glands at base of neck 2 to 4 days later (14-16 days after injection). Next day (day 17 after injection) knee was swollen and painful for a few hours, then pain resolved. Next day (day 18 after injection) both hands were painful for a few hours, then pain resolved. Approximately a week later, she had mild "pins and needles" tingling. Tingling is much less now, but still exists off and on (has been 33 days since injection).  Stated she got a cortisone injection 1-2 days after pain in knee for tendonitis.
Age: 72.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Joint swelling, Lymph node pain, Pain, Paraesthesia
Clinical narrative: Ten days after immunization, patient stated she had generalized aching for 2 days & thought it was due to fibromyalgia. Had light rash on neck and chest and sore glands at base of neck 2 to 4 days later (14-16 days after injection). Next day (day 17 after injection) knee was swollen and painful for a few hours, then pain resolved. Next day (day 18 after injection) both hands were painful for a few hours, then pain resolved. Approximately a week later, she had mild "pins and needles" tingling. Tingling is much less now, but still exists off and on (has been 33 days since injection).  Stated she got a cortisone injection 1-2 days after pain in knee for tendonitis.
Age: 72.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Rash, Tendonitis
Clinical narrative: Ten days after immunization, patient stated she had generalized aching for 2 days & thought it was due to fibromyalgia. Had light rash on neck and chest and sore glands at base of neck 2 to 4 days later (14-16 days after injection). Next day (day 17 after injection) knee was swollen and painful for a few hours, then pain resolved. Next day (day 18 after injection) both hands were painful for a few hours, then pain resolved. Approximately a week later, she had mild "pins and needles" tingling. Tingling is much less now, but still exists off and on (has been 33 days since injection).  Stated she got a cortisone injection 1-2 days after pain in knee for tendonitis.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient complains of intense pain going down her left arm inhibiting her from using her arm in any capacity.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Eczema, Impaired work ability, Insomnia, Pain
Clinical narrative: The day after immunization, from head to toe broke out in painful, itchy rash. Eczema on my hands flared ten times worse than before. These symptoms lasted for three weeks. I missed work for three weeks, was unable to sleep and pain scale was 10/10.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash generalised, Rash pruritic, Skin test
Clinical narrative: The day after immunization, from head to toe broke out in painful, itchy rash. Eczema on my hands flared ten times worse than before. These symptoms lasted for three weeks. I missed work for three weeks, was unable to sleep and pain scale was 10/10.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Neck pain
Clinical narrative: Continued pain at injection site from the 2nd SHINGRIX given on 1/31/19. Complains on 02/25/2019 pain is now shooting up to his neck and down to his elbow.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye pruritus, Pruritus, Rash
Clinical narrative: Patient states few days after immunization had chills and face and eyes became itchy. Took ZYRTEC to help with itching. Noticeable rash appeared next day on cheeks. Very itchy.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Rash erythematous
Clinical narrative: The patient stated that she experienced increasing redness and swelling around the injection site beginning after she received the vaccine. She developed red bumps that a physician family member told her look like cellulitis. I advised her to follow up with her PCP for diagnosis and treatment.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Dyspnoea, Haematochezia, Paraesthesia, Pyrexia, Rash generalised
Clinical narrative: Within 1 hour, she had trouble breathing and was wheezing. Fever of 100*, full body rash (small pin pricks from head to toe), bloody stool.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wheezing
Clinical narrative: Within 1 hour, she had trouble breathing and was wheezing. Fever of 100*, full body rash (small pin pricks from head to toe), bloody stool.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cold sweat, Decreased appetite, Immediate post-injection reaction, Loss of consciousness, Malaise
Clinical narrative: Immediately after vaccination pt had a vasovagal episodes and lost consciousness for less than 10 seconds, he recovered and after 10-15 mins left the office. Later that evening, about 3 hours after vaccination pt reported loss of appetite, nausea and not feeling well. No fever. His dad woke checked on him a few times in the night and he remained alert, but early in the night he still felt unwell, dad reported he was clammy but never had any shortness of breath or further symptoms. By morning he had returned to his usual state of good health.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Nausea, Presyncope
Clinical narrative: Immediately after vaccination pt had a vasovagal episodes and lost consciousness for less than 10 seconds, he recovered and after 10-15 mins left the office. Later that evening, about 3 hours after vaccination pt reported loss of appetite, nausea and not feeling well. No fever. His dad woke checked on him a few times in the night and he remained alert, but early in the night he still felt unwell, dad reported he was clammy but never had any shortness of breath or further symptoms. By morning he had returned to his usual state of good health.
Age: 9.0
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Blood creatine phosphokinase, Blood thyroid stimulating hormone, C-reactive protein increased, Fatigue, Full blood count
Clinical narrative: Father called on 02/22/2019 to report his daughters arm hurt (unknown arm), fatigue, and generalized muscle pain. PHN suggested father call health care provider.
Age: 9.0
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Father called on 02/22/2019 to report his daughters arm hurt (unknown arm), fatigue, and generalized muscle pain. PHN suggested father call health care provider.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood bilirubin increased, Blood glucose, Electrocardiogram normal, Eye movement disorder
Clinical narrative: Very sore, hot arm at point of injection (later, also red rash on bicep). Very tired, fever of 100 degrees. Went to bed at 8:30 PM after supper about 7 PM. The next morning, feverish, tingling skin, tired, weak and unsteady. Sitting in chair in kitchen and fainted. My husband said my head fell back. Eyes rolled back and I was unconscious for about a minute to 90 seconds. My husband called 911 and EMT came, checked pulse, blood pressure and blood sugar. They recommended that I be transported to the hospital by ambulance. My husband drove me to the hospital. EKG and  X-Rays and blood work at ER. There was not anything out of the ordinary according to ER MD. My bilirubin was 2.7 (higher than normal). Fever into the evening and overnight. My husband also had a fever and painful arm. We had the shots at the same time. My arm continued to swell, be hot and a rash continued until today (4-5 days). Arm is still tender and I am tired and don't feel quite right. I'm trying to make an appointment with a doctor for follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Gait disturbance, Increased tendency to bruise, Injection site pain
Clinical narrative: Very sore, hot arm at point of injection (later, also red rash on bicep). Very tired, fever of 100 degrees. Went to bed at 8:30 PM after supper about 7 PM. The next morning, feverish, tingling skin, tired, weak and unsteady. Sitting in chair in kitchen and fainted. My husband said my head fell back. Eyes rolled back and I was unconscious for about a minute to 90 seconds. My husband called 911 and EMT came, checked pulse, blood pressure and blood sugar. They recommended that I be transported to the hospital by ambulance. My husband drove me to the hospital. EKG and  X-Rays and blood work at ER. There was not anything out of the ordinary according to ER MD. My bilirubin was 2.7 (higher than normal). Fever into the evening and overnight. My husband also had a fever and painful arm. We had the shots at the same time. My arm continued to swell, be hot and a rash continued until today (4-5 days). Arm is still tender and I am tired and don't feel quite right. I'm trying to make an appointment with a doctor for follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Loss of consciousness, Paraesthesia, Peripheral swelling
Clinical narrative: Very sore, hot arm at point of injection (later, also red rash on bicep). Very tired, fever of 100 degrees. Went to bed at 8:30 PM after supper about 7 PM. The next morning, feverish, tingling skin, tired, weak and unsteady. Sitting in chair in kitchen and fainted. My husband said my head fell back. Eyes rolled back and I was unconscious for about a minute to 90 seconds. My husband called 911 and EMT came, checked pulse, blood pressure and blood sugar. They recommended that I be transported to the hospital by ambulance. My husband drove me to the hospital. EKG and  X-Rays and blood work at ER. There was not anything out of the ordinary according to ER MD. My bilirubin was 2.7 (higher than normal). Fever into the evening and overnight. My husband also had a fever and painful arm. We had the shots at the same time. My arm continued to swell, be hot and a rash continued until today (4-5 days). Arm is still tender and I am tired and don't feel quite right. I'm trying to make an appointment with a doctor for follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Posture abnormal, Pyrexia, Rash erythematous, Syncope, X-ray normal
Clinical narrative: Very sore, hot arm at point of injection (later, also red rash on bicep). Very tired, fever of 100 degrees. Went to bed at 8:30 PM after supper about 7 PM. The next morning, feverish, tingling skin, tired, weak and unsteady. Sitting in chair in kitchen and fainted. My husband said my head fell back. Eyes rolled back and I was unconscious for about a minute to 90 seconds. My husband called 911 and EMT came, checked pulse, blood pressure and blood sugar. They recommended that I be transported to the hospital by ambulance. My husband drove me to the hospital. EKG and  X-Rays and blood work at ER. There was not anything out of the ordinary according to ER MD. My bilirubin was 2.7 (higher than normal). Fever into the evening and overnight. My husband also had a fever and painful arm. We had the shots at the same time. My arm continued to swell, be hot and a rash continued until today (4-5 days). Arm is still tender and I am tired and don't feel quite right. I'm trying to make an appointment with a doctor for follow up.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site warmth, Malaise, Rash erythematous, Rash macular
Clinical narrative: Pt called the pharmacy on 2/25/19 stating that her arm had a red, warm, blotchy rash. She stated this rash was not directly at the injection site but surrounding. She stated that the rash traveled up to her shoulder and underneath her arm pit. She stated she was not feeling well but was unsure if she had a fever.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Concussion, Fall, Head injury, Syncope, Vomiting
Clinical narrative: Patient took the first dose on 02/20/2019 with no adverse reactions. She took her second dose on 02/23/2019 in the early morning and approximately 2-3 hours later, she vomited and had a syncopal episode and fell hitting her head and went to the emergency room and was diagnosed with a concussion.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Muscular weakness
Clinical narrative: Uncontrollable full body shivering and muscle weakness 24 hours after injection.
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: 03/31/2014: vaccination date; 04/08/2014: fever; 04/12/2014: atypical measles rash.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Malaise, Nausea, Rash
Clinical narrative: Starting the following morning, patient experienced a rash starting on her chest and neck and then traveling to her shoulders, back, stomach, and legs. Had nausea, diarrhea, and general malaise.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Cognitive disorder, Computerised tomogram, Dysarthria
Clinical narrative: Wife states that about 8 days after the SHINGRIX shot, her husband started slurring his words. She called 911 and they did a CAT scan. He was physically and cognitively "out of it," and remains not back to normal per the wife. Doctors think it may be a TIA or something related.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Headache, Paraesthesia
Clinical narrative: Headache, chills, chest pain, tingling.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Swollen upper leg. Red and itchy, warm to touch. Began within hours of vaccine. Now end of day 4 and is still itchy and red.
Age: 69.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Asthenia, Limb discomfort, Neuralgia, Paraesthesia, Product administered at inappropriate site
Clinical narrative: Both shots administered in the left arm. Pt came in on 2/17/19 and complained that when she was immunized, the shot given on the top (which one it was is not documented) caused a sort of electrical shock sensation that went down her arm. After going home she continued to feel discomfort in her left arm including nerve pain and loss of strength in that arm. Upon seeing her doctor, she stated that the doctor treating her told her that the shot was administered too high (possibly in a tendon) resulting in a "pocket" of some kind (her description). At the time of the conversation she said she is doing better, but she wanted us to know that the person administrating the immunization should be notified and be educated in proper administration technique.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Developed a rash at 9:30 the next day. Grew to 10 cm in 6 hours very red and hot. In the next 23 hours was as big as an adult hand.
Age: 67.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blood glucose, Cold sweat, Decreased appetite, Dizziness, Echocardiogram
Clinical narrative: 2/22/19 Light headed throughout the day, very tired, lack of appetite. I laid down until it passed over. 2/23/19 I went to a tiling class at 10:00 am. I became hot, clamy, light headed. I fainted and fell face first into a tile display and then onto the floor. After lying there a few minutes I got up and 10 seconds later I fainted again, falling to the floor, 911 was called and paramedics did some tests, finding nothing, and sent me to ER. I was admitted to Hospital.
Age: 67.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Face injury, Fall, Fatigue, Feeling hot, Laboratory test normal
Clinical narrative: 2/22/19 Light headed throughout the day, very tired, lack of appetite. I laid down until it passed over. 2/23/19 I went to a tiling class at 10:00 am. I became hot, clamy, light headed. I fainted and fell face first into a tile display and then onto the floor. After lying there a few minutes I got up and 10 seconds later I fainted again, falling to the floor, 911 was called and paramedics did some tests, finding nothing, and sent me to ER. I was admitted to Hospital.
Age: 67.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Syncope
Clinical narrative: 2/22/19 Light headed throughout the day, very tired, lack of appetite. I laid down until it passed over. 2/23/19 I went to a tiling class at 10:00 am. I became hot, clamy, light headed. I fainted and fell face first into a tile display and then onto the floor. After lying there a few minutes I got up and 10 seconds later I fainted again, falling to the floor, 911 was called and paramedics did some tests, finding nothing, and sent me to ER. I was admitted to Hospital.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site rash, Malaise, Pain in extremity
Clinical narrative: Patient felt unwell ("flu-like" symptoms) on day 2-3 post-injection with some arm soreness. Patient felt better on day 3, but noticed a slight rash and dull pain at the base of the deltoid muscle (much lower than injection site) a few days ago. He said the area did not itch, arm movement was not restricted or limited, no pain upon touching the area. He also said the area did not feel warm to the touch. He was just concerned about the light rash and dull pain since it has been 2 weeks post-injection.
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swollen arm, red, warm to touch.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV1
Symptoms: Extra dose administered
Clinical narrative: None. ROTARIX 3rd dose given oral GlaxoSmithKline lot 374XB.
Age: 24.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Eye movement disorder, Feeling abnormal, Injection site pain, Posture abnormal
Clinical narrative: After the 1st injection patient complained of burning pain at the injection site but was ok to received the 2nd vaccine and had asked for it in the same arm. Seconds after the 2nd vaccine patient said he felt weird, his eyes started to roll up and his head tilted back. I had 911 be called, colleague came in we were asking Alert and Oriented x3 questions and kept him talking until EMT came in and took over. Lapsed time 5min.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 3 inch red, swollen area, hot to the touch.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Pt felt feverish on 2-21-19 and when she woke up on 2-22-19, had a temp of 100.3 along with N/V.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling in upper arm, then was worse on the next day. Swelling down Rt arm. Pt was given Doxycycline Monohydrate.
Age: 11.0
Sex: M
Vaccine: FLUC4, HEP, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented to the clinic on 2/22/19 with redness and swelling to left deltoid. Dr. gave verbal order to send patient to ER for further eval and TX.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Dehydration, Diarrhoea, Laboratory test, Nausea
Clinical narrative: Nausea, extreme diarrhea, vomiting, swollen stomach, dehydrated, etc. Hospitalized from 2/13 (4AM) to 2/15/19.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Scan, Vomiting
Clinical narrative: Nausea, extreme diarrhea, vomiting, swollen stomach, dehydrated, etc. Hospitalized from 2/13 (4AM) to 2/15/19.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Asthenia, Dizziness, Headache, Malaise, Nausea
Clinical narrative: Mom said Patient reported feeling "really sick" in the car when leaving. She called 1 hr later saying child had nausea, headache, dizziness and was "weak in the knees" and said they were going to doctor. I told her Hep A went in the upper arm and the HPV in the lower (as it tends to hurt more) when she asked. Mom said that Patient was fine today, but she was still ill on Saturday and her arm hurt too much to help with chores. Mom said the doctor noted that the veins in the right arm were larger but he did not know why. He also noted that she was not short of breath and did not have a rash so he released her to home. Patient said she was ill for a day following the first and 2nd doses also. (mostly nausea).
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Pain in extremity
Clinical narrative: Mom said Patient reported feeling "really sick" in the car when leaving. She called 1 hr later saying child had nausea, headache, dizziness and was "weak in the knees" and said they were going to doctor. I told her Hep A went in the upper arm and the HPV in the lower (as it tends to hurt more) when she asked. Mom said that Patient was fine today, but she was still ill on Saturday and her arm hurt too much to help with chores. Mom said the doctor noted that the veins in the right arm were larger but he did not know why. He also noted that she was not short of breath and did not have a rash so he released her to home. Patient said she was ill for a day following the first and 2nd doses also. (mostly nausea).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Mobility decreased, Musculoskeletal pain, X-ray limb
Clinical narrative: The following day (after) the shot, I had a welt with a red circle on my shoulder at the spot where I had the shot. I also found that I could not raise my arm at all - my shoulder hurt but it was also locked (wouldn't move).
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Neck pain, Pyrexia, Vaccination site induration, Vaccination site swelling
Clinical narrative: (L) arm swelling at vaccine site began within 12 hrs. No erythema rash. 6cm swelling and induration. Pt Tx with CLARITIN and ice, ASA, Ibu, TYLENOL. No SOB. Neck sore. Feverish
Age: 6.0
Sex: F
Vaccine: DTAP, FLUC4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented to the clinic on 2/22/19 with redness and swelling to right deltoid. Dr. gave verbal order to send patient to ER for further eval and TX.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: Patient developed Bell's Palsy.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Borrelia test negative, Facial paralysis, Hypoaesthesia, Injection site pain, Lacrimation increased
Clinical narrative: Patient developed Bell's Palsy.
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Information has been received on 15-FEB-2019 from a lawyer regarding a case in litigation concerning a 65 year old male patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 09-JAN-2015, the patient was administered the ZOSTAVAX vaccine by a pharmacist (lot# and route unknown). On an unspecified date the patient was treated by a healthcare provider for post herpetic neuralgia as a result of vaccination with ZOSTAVAX. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Hypoaesthesia, Influenza like illness, Swelling, Swelling face
Clinical narrative: Day 2 and 3 (after receiving vaccine) I felt like I had the flu with aching. Day 4 - numbness and swelling to the side of neck and face (same side of body shot was given). Was given steroids, anti-inflammatory and pain medication via IV.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 14-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional by phone. This case is linked to cases 2018SA396614 and 2018SA396624 (same reporter). This case involves a six-months-old male patient who was vaccinated with a one dosage form of HEPATITIS B VACCINE (batch number: GX4X5), PREVENAR 13 (batch number: X35262) via intramuscular route in the right thigh, ROTATEQ (Batch number: R015607) via oral route, PENTACEL (batch number: UJ06MDA) and FLUZONE QUADRIVALENT (batch number: UT6315RA) via intramuscular route in the left thigh on 21-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of actual medication error due to product storage error because the refrigerator went down to 29 degree Fahrenheit for 1 hour. The patient did not experience any adverse event. Corrective action: patient was revaccinated. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Immediate post-injection reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 2nd dose of SHINGRIX (subcutaneous). In February 2019, less than a week after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the adverse drug reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was suspicion that my latest SHINGRIX shot was administered incorrectly. The patient noticed that SHINGRIX was supposed to be injected intramuscularly into the deltoid muscle while the old vaccine, ZOSTAVAX, was subcutaneous into the upper tricep area. When she had the first SHINGRIX shot it was injected into the top front of shoulder. The shot the patient got Wednesday was injected into the back upper fleshy part of my arm. The pharmacist even said it was a subcutaneous shot, which led to incorrect route of vaccine administration. It seems like that was the wrong way to do it. The patient asked that was this going to mess up the effectiveness of the shot, would I have to have it again. The patient asked that was this causing all side effects. The patient had been having many side effects.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 2nd dose of SHINGRIX (subcutaneous). In February 2019, less than a week after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the adverse drug reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was suspicion that my latest SHINGRIX shot was administered incorrectly. The patient noticed that SHINGRIX was supposed to be injected intramuscularly into the deltoid muscle while the old vaccine, ZOSTAVAX, was subcutaneous into the upper tricep area. When she had the first SHINGRIX shot it was injected into the top front of shoulder. The shot the patient got Wednesday was injected into the back upper fleshy part of my arm. The pharmacist even said it was a subcutaneous shot, which led to incorrect route of vaccine administration. It seems like that was the wrong way to do it. The patient asked that was this going to mess up the effectiveness of the shot, would I have to have it again. The patient asked that was this causing all side effects. The patient had been having many side effects.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction, Incorrect route of product administration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 2nd dose of SHINGRIX (subcutaneous). In February 2019, less than a week after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the adverse drug reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was suspicion that my latest SHINGRIX shot was administered incorrectly. The patient noticed that SHINGRIX was supposed to be injected intramuscularly into the deltoid muscle while the old vaccine, ZOSTAVAX, was subcutaneous into the upper tricep area. When she had the first SHINGRIX shot it was injected into the top front of shoulder. The shot the patient got Wednesday was injected into the back upper fleshy part of my arm. The pharmacist even said it was a subcutaneous shot, which led to incorrect route of vaccine administration. It seems like that was the wrong way to do it. The patient asked that was this going to mess up the effectiveness of the shot, would I have to have it again. The patient asked that was this causing all side effects. The patient had been having many side effects.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Lethargy, Listless, Pyrexia
Clinical narrative: Inconsolable crying lasting 2 days. Fever of 104*F for 2 days. Lethargic. Listless.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Delirium, Fatigue, Palpitations
Clinical narrative: Heart palpitations, confusion, delirium, fatigue.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: She ran 103-104 fever and was throwing up. Something was not right. It was the evening after she had received her vaccinations that day. We contacted the on call nurse and have told her doctor of her reactions. Not sure if she has any long term effects at this point.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Throbbing pain in tricep and spread into lat area. Felt feverish and tired. Administered two Tylenol Extra Strength about 18:00. Felt better. Woke up about 1:45AM shivering and feeling feverish. Took oral temperature and got 100.2 Administered 400mg Ibuprofen 02:00.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness. Fever 100.6. Muscle aches.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Antinuclear antibody, Blood uric acid, Full blood count, Injection site pain, Muscular weakness
Clinical narrative: L shoulder pain at site of injection ongoing for 12 days. No improvement. Weakness in Left arm and pain with movement. She is taking ibuprofen without relief.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: L shoulder pain at site of injection ongoing for 12 days. No improvement. Weakness in Left arm and pain with movement. She is taking ibuprofen without relief.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain
Clinical narrative: L shoulder pain at site of injection ongoing for 12 days. No improvement. Weakness in Left arm and pain with movement. She is taking ibuprofen without relief.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Rash erythematous, Rash macular
Clinical narrative: Noted dizziness night of injection followed by fatigue the next 2 days. On third day (2/25/2019) noted red raised blotchy rash from the neck down to waist sparring the extremities with pruritis. No vesicles.  No shortness of breath or swelling. Pt relates reaction is similar to that experienced with her other drug allergies. Advised by PCP to use benadryl and to not get the second in series of SHINGRIX over the next 2-6 mths. Of note pt relates a new medication to treat chronic migraines (ajovy) of which she had her first injection on 02/07/2019). As of this writing, rash has spread somewhat to scalp. Feels benadryl is helping. Has received no other vaccines previous month.
Sex: F
Vaccine: HPVX
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: This spontaneous report was received from a nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of unidentified Merck hpv vaccine (reported as "either GARDASIL or GARDASIL 9") (name, strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced symptoms described as postural orthostatic tachycardia syndrome (POTS). The outcome of POTS was unknown. The causality assessment between POTS and unidentified Merck hpv vaccine was not reported.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 08-FEB-2019, the patient was vaccinated with PROQUAD, subcutaneous, for prophylaxis and M-M-R II (indication, strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis.
Sex: F
Vaccine: VARZOS
Symptoms: Arthropathy, Blister, Cough, Epstein-Barr virus infection, Fatigue
Clinical narrative: Information has been received from an approximately 59 years old female patient. The patient had no pertinent medical history, concomitant medications nor concurrent conditions. The patient stated that she had "a strong immune system" prior to vaccination. In 2014, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date not reported), 1 dosage form in the muscle for the prevention of shingles. After receiving ZOSTAVAX, the patient developed a blister like rash on her left ankle around November of 2014. She stated that it later developed on her right arm as a cluster of fine blister. She was prescribed cortisone but that it did not work. The patient further stated that her throat started to become swollen, her joints started giving her problems, felt like everything was wearing her down, and she developed a cough that kept coming back. She was prescribed an unspecified antibiotic. In 2018 (reported as "about 8-9 months ago"), the patient was diagnosed with "Epstein Barr Syndrome". At the time of the report, the patient had not recovered from "Epstein Barr syndrome". The causal relationship between Epstein Barr syndrome and therapy with ZOSTAVAX was not reported. Upon internal review, the "Epstein Barr syndrome" was considered as a medically significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal oedema, Rash vesicular
Clinical narrative: Information has been received from an approximately 59 years old female patient. The patient had no pertinent medical history, concomitant medications nor concurrent conditions. The patient stated that she had "a strong immune system" prior to vaccination. In 2014, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date not reported), 1 dosage form in the muscle for the prevention of shingles. After receiving ZOSTAVAX, the patient developed a blister like rash on her left ankle around November of 2014. She stated that it later developed on her right arm as a cluster of fine blister. She was prescribed cortisone but that it did not work. The patient further stated that her throat started to become swollen, her joints started giving her problems, felt like everything was wearing her down, and she developed a cough that kept coming back. She was prescribed an unspecified antibiotic. In 2018 (reported as "about 8-9 months ago"), the patient was diagnosed with "Epstein Barr Syndrome". At the time of the report, the patient had not recovered from "Epstein Barr syndrome". The causal relationship between Epstein Barr syndrome and therapy with ZOSTAVAX was not reported. Upon internal review, the "Epstein Barr syndrome" was considered as a medically significant event.
Age: 3.0
Sex: M
Vaccine: FLUX, HEPA
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Tremor, Vaccination complication
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 3-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-FEB-2019, the patient was vaccinated for the first time with VAQTA, (reported as "Hep A manufactured by Merck"), (dose, frequency, lot # and expiration date were not reported) for prophylaxis. On the same date, the patient was vaccinated with an unspecified influenza virus vaccine. On 14-FEB-2019, shortly after receiving the vaccines, the patient experienced a reaction to vaccines and developed redness and swelling at the injection site, trouble breathing and tremors. The patient sought medical attention. He was taken to an unspecified urgent care, and at the time of the report, was under medical care for the symptoms. The outcome of tremors, trouble breathing, redness and swelling at the injection site was reported as not recovered. The reporter considered the events to be related to VAQTA and influenza virus vaccine.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Peripheral swelling, Vaccination failure
Clinical narrative: Information has been received from an other health professional via other company (2018526629) referring to a 69 year old female patient. The patient's medical history, current condition and concomitant therapy were unknown. On an unknown date in 2006, the patient was vaccinated with PNEUMOVAX 23 (dose, strength, route, batch/lot number and expiration date were not provided) for prophylaxis. On an unknown date in 2006, the patient reacted to PNEUMOVAX 23 when last immunized. Response to PNEUMOVAX 23 , the patient had been shortness of breath (Vaccination failure) and swellin in her arm. The outcome of the events was unknown. The causality assessments between the events and PNEUMOVAX 23 was considered as responsible by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation concerning a 71 year old female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-AUG-2013, a pharmacist administered the ZOSTAVAX vaccine by a pharmacist. In 2014, the patient was treated by a healthcare provider for shingles as a result of her vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation concerning a 69 year old female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2017, the patient was administered the ZOSTAVAX by a pharmacist. Later in 2017, the patient was treated by a healthcare provider for shingles as a result of her vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation concerning a 71 year old female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2015, the patient was administered the ZOSTAVAX by a pharmacist. In 2017, the patient was treated by a physician for shingles as a result of her vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 13-NOV-2014, the patient was administered ZOSTAVAX (lot# and route not specified) by a pharmacist. On an unspecified date the patient was treated by a healthcare provider at a hospital for pneumonia as a result of her vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2009, the patient was administered the ZOSTAVAX by a pharmacist. On an unspecified date, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning a 68 year old female patient There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 14-APR-2011, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. In July 2015, the patient was treated by the patient's healthcare provider at a medical center for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-FEB-2019 regarding a case in litigation concerning a 77 year old male patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2015, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a pharmacist. In 2016, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.