chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Pain in extremity, Skin abrasion, Skin laceration, Visual impairment
Clinical narrative: By the end of the day, the Bursa popped out of left posterior knee with swelling, joint clicking and severe pain. Conditions persists. The following evening I began to have excruciating pain in my upper back, shoulders, down my arms into my wrists and down to my fingertips. The pain was icy-hot and burning as well as throbbing. I take (Aleve) to help with the pain and purchased wrist braces which did not help. The pain is severe in my arms and my hands remain constantly numb. It has, also moved into my face, mouth, sinuses, eyes, and into my chest causing heavy breathing and chest pain similar to the arm pain.  I cannot properly perform my work duties, as my fingers are numb, preventing me from using the keyboard in my normal manner.  I tire easily and have great difficulty trying to find a position that I can sleep in comfortably. I wake approximately every two hours with my hands and  shoulders numb and painful. I also have difficulty with simple dexterity. Events such as holding a glass of water require concentration, because I cannot gauge how it feels.  I have had many cuts, bruises, scrapes, pinches and broken fingernails to my hands and arms because I cannot feel them. The numbness in my eyes causes vision problems. I drive one hour each way to and from work. The other problems are with heat and cold on my tongue and mouth, because they are numb and I cannot feel them either. When the hot/cold is exceptionally extreme in my hands and arms, my whole body gets the chills even when the temperatures are 80-100 degrees ( I live where the temperatures are typically in this range most of the day). This problem consumes my thoughts throughout the day due to it's annoying persistence. I cannot do any of the craft projects that would typically fill my off-time with because the senses I use to enjoy them are numbed. My greatest concern is that this will not go away. When I checked on the Clinic and hospital websites, it stated that the adverse reactions can last 1 to 2 years, or may be permanent.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Mobility decreased, Pain, Vomiting
Clinical narrative: about 2 hours after vaccine vomiting occurred, then patient was sick and everything hurt and couldn't lift her head off of the pillow. She felt like she couldn't move for two days.  this self resolved after 2 days.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash macular
Clinical narrative: Patient called me and told me that she got Shingrix shot from our pharmacy and she got the reaction of it. Her skin became sore, blouchy and painful to touch on the spot where she got the shot. I told her that she has to see the doctor for that. I don't know if she went to see the doctor or not yet.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose given on 5/29/19 in left delt, patient scheduled to come back in for adult dose on 7/3/19
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Severe pain, to the point the patient said they were debating whether or not to go to the emergency department. They are on oxycodone once daily as needed, they've used that as well as applied ice. Advised OTC acetaminophen, patient can not take NSAIDs. Advised patient to try to contact primary physician for a second opinion, if pain was the only concern may not require visit to emergency department. Discussed signs and symptoms of allergic reaction, doesn't sound like an allergic reaction upon talking with patient. Only severe pain.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Eye contusion, Gait disturbance, Injected limb mobility decreased, Malaise
Clinical narrative: Patient  woke up sick the following morning following her injection.  She ran a fever , 102.3 degrees for 48 hours and experienced weakness which caused her to stumble into a wall, giving her a black eye.  She also fainted briefly.  She had aches and pains--she stated she could not move her arm of the injection.  She states she has recovered now but wanted us to know about her response to this shot.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Syncope
Clinical narrative: Patient  woke up sick the following morning following her injection.  She ran a fever , 102.3 degrees for 48 hours and experienced weakness which caused her to stumble into a wall, giving her a black eye.  She also fainted briefly.  She had aches and pains--she stated she could not move her arm of the injection.  She states she has recovered now but wanted us to know about her response to this shot.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles on her forehead 4 days after the vaccine
Age: 32.0
Sex: F
Vaccine: RAB, UNK
Symptoms: Dyspnoea, Erythema, Hypopnoea, Pruritus, Vomiting
Clinical narrative: record reports pt. being readied for discharge when she c/o itching. Erythema without urticaria noted R shin, was in NAD and lungs were clear.  Oral benadryl planned, but pt. c/o difficulty breathing before receiving med.  Had emesis; lungs then noted with decreased air entry.  Continued observation, rec'd epinephrine IM, methylprednisolone and Ondansetron IV.  She responded to treatment and was discharged later that afternoon (~17:09 PM)
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site paraesthesia, Injection site pruritus, Injection site warmth
Clinical narrative: Pt experienced flu like symptoms on the evening of receiving the vaccine. On Thurs, the next day, she started to have tingling and itchiness at injection site. She went to bed and Friday morning when she awoke, the site was more red. hot to the touch. She called the pharmacy on Sat and was asked to draw a circle around the area to watch for spreading. She used ice topically and OTC steroid cream and took Benadryl qpm to stop reaction. The site continued to be red, and spread to the inside of her left arm.  When she reported to the pharmacy on Monday, July 1st, it was about 1.5 in by 3.5 in around. PCP was contacted and they agreed with continuing steroid cream, ice, and Benadryl and to watch for more spreading.  RPH at pharmacy drew circle around the area . Pt would return to pharmacy the next day if the site spread.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Crying, Dizziness, Musculoskeletal stiffness, Nausea
Clinical narrative: Crying, dizziness, nausea, chills, arm pain, stiffness, whole
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Crying, dizziness, nausea, chills, arm pain, stiffness, whole
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Back pain, Headache, Pyrexia, Tremor
Clinical narrative: Shaking, stomach pain, headache, backache, and fever of 101.2
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Electrocardiogram, Laboratory test, Pericarditis, Troponin increased
Clinical narrative: The patient experienced chest pain and was hospitalized June 29, 2019.  He went to ER.  Troponin was elevated and was transferred to another hospital so that Cardiology could see him.  Diagnosed with pericarditis.  Patient had received the Smallpox Vaccine June 18, 2019.  Pt has been referred to Cardiology and followed by PCM as well.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Dehydration, Diarrhoea, Dizziness
Clinical narrative: Next morning of receiving shot .. I had severe nausea, migraine headache, weakness, dizziness. Could not get out of bed for 3 straight days .. became dehydrated after vomiting and diarrhea .. water would not even stay on my stomach .. threw up the water .. started sipping Pedialite and other electrolytes .. too sick to go to the doctor was able to get enough fluids down  .. headache remained 5 days after shot in 4 days ate 1 piece of toast .. starting eating slowly on the 4th day after the shot, still not much appetite . A week into this shot I still feel  light headed and some dizziness and lots of weakness. My doctor's nurse (never got to talk personally to the doctor) says this shot shouldn't cause any thing like this -- WRONG!
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: Next morning of receiving shot .. I had severe nausea, migraine headache, weakness, dizziness. Could not get out of bed for 3 straight days .. became dehydrated after vomiting and diarrhea .. water would not even stay on my stomach .. threw up the water .. started sipping Pedialite and other electrolytes .. too sick to go to the doctor was able to get enough fluids down  .. headache remained 5 days after shot in 4 days ate 1 piece of toast .. starting eating slowly on the 4th day after the shot, still not much appetite . A week into this shot I still feel  light headed and some dizziness and lots of weakness. My doctor's nurse (never got to talk personally to the doctor) says this shot shouldn't cause any thing like this -- WRONG!
Age: 1.83
Sex: F
Vaccine: MMR
Symptoms: Culture, Lymphadenopathy, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: My daughter had developed a few bumps on her body specifically on the back of her lower legs and on the base of her neck on the upper part of her spinal cord, 8 days after the shot. We did not think it was anything harmful because she did not scratch it. On day 8 after the shot I noticed the occipital lymph node was very swollen at 3 pm that day. By that night at 9 pm she had a low fever of 99.9. We gave her medicine to treat it thinking it was due to teething. On day ten everything seemed normal except for the low temp but again was not concerned. Day 11 at 9 pm she developed a pink rash on the trunk of her body; light pink spots. same low grade temp. we had thought it might have been an allergy. and would wait to see how it developed or changed day 12 she awoke with no fever but a very distint rash all over her body the same pink spots that we had seen days prior seems to develop all over her body. starting from her trunk and become more spread out; randomly not in a  pattern. I called the nurse who gave her the vaccine shot (not putting the 2 together at the time) and sent her photos i had taken and a detailed timeline of the odd development. by day 12 she had no fever no itch no pain no other symptom other than a bunch of red to pink colored spots. she was happy and playing and didnt even take any notice to them. we discussed things it could be such as strep a viral infection side effect ect. and decided to keep an eye out for one more night. day 13 went to dr bc rash was all over face hands trunk feet no other side effects at all no medicine needed no issues asside from the strange spots all over that was at 10 am and now at 5 pm she is napping and seems to be fine. pink spots are seemingly fading from hands face and her leg under her knee
Age: 1.83
Sex: F
Vaccine: MMR
Symptoms: Streptococcus test negative
Clinical narrative: My daughter had developed a few bumps on her body specifically on the back of her lower legs and on the base of her neck on the upper part of her spinal cord, 8 days after the shot. We did not think it was anything harmful because she did not scratch it. On day 8 after the shot I noticed the occipital lymph node was very swollen at 3 pm that day. By that night at 9 pm she had a low fever of 99.9. We gave her medicine to treat it thinking it was due to teething. On day ten everything seemed normal except for the low temp but again was not concerned. Day 11 at 9 pm she developed a pink rash on the trunk of her body; light pink spots. same low grade temp. we had thought it might have been an allergy. and would wait to see how it developed or changed day 12 she awoke with no fever but a very distint rash all over her body the same pink spots that we had seen days prior seems to develop all over her body. starting from her trunk and become more spread out; randomly not in a  pattern. I called the nurse who gave her the vaccine shot (not putting the 2 together at the time) and sent her photos i had taken and a detailed timeline of the odd development. by day 12 she had no fever no itch no pain no other symptom other than a bunch of red to pink colored spots. she was happy and playing and didnt even take any notice to them. we discussed things it could be such as strep a viral infection side effect ect. and decided to keep an eye out for one more night. day 13 went to dr bc rash was all over face hands trunk feet no other side effects at all no medicine needed no issues asside from the strange spots all over that was at 10 am and now at 5 pm she is napping and seems to be fine. pink spots are seemingly fading from hands face and her leg under her knee
Age: 54.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Pharmacist realized that the vaccination was given intramuscularly instead of subcutaneously.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever  Uncontrollable shivering Headache  Weak  Body pain
Age: 71.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Abnormal faeces, Decreased appetite
Clinical narrative: Stomach ache and loss of appetite for 5 days after injection. Last 2 days of stomach ache and loss of appetite also had chalky stools, which returned to normal after the 2 days.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Full body hives
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Sibling and patient seen same day an order was given to MA and incorrect vaccines were given to patient.  Patient did receive catch up vaccines( DTap, Hib, Hep B, IPV, PCV),   but administered MMR and VZV as well.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration, Skin warm, Tenderness
Clinical narrative: Approximately 20 hours after receiving vaccine started to complain of tenderness, progressed over the next 24 hours to red, hot, hard and measured 15 cmx12.5 cm when seen in clinic 48 hours after given, on the day mom called about the reaction.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Myalgia, Nausea
Clinical narrative: Red arm 12 cm Nausea Fever to 100.5 Fatigue chills myalgia
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Red arm 12 cm Nausea Fever to 100.5 Fatigue chills myalgia
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Rash vesicular
Clinical narrative: chicken pox like rash confirmed by physician
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: Patient developed a non itchy rash on chest below neck and red blotches on body. It started a day or two after the vaccine patient doesn't remember doing anything else new at the time that they thought could cause this symptoms. Patient went to bed and rash was gone the next day. This was reported on day of second dose of shingrix
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Dizziness, Fall, Flushing, Syncope
Clinical narrative: AFTER VACCINE WAS ADMINISTERED, PATIENT WAS ASKED TO WAIT/SIT FOR 20MINS PER PROTOCOL. AFTER ABOUT 3-5MINS OF ADMIN, PATIENT WAS ON THE FLOOR AND THE PHARMACIST AND 2 OTHER STAFF RUSHED TO HER AID. UPON ASSESSMENT, WITHS SIGNS, FLUSH  ON FACE CLAMY BODY, ETC--SYNCOPE WAS CONFIRMED. HER LEGS WERE ELEVATED. NOT LONG SHESTARTED ASKING QUESTIONS ABOUT HER SITUATION AND EXPLAINED HOW SHE FELT A BIT DIZZY, CLOSED HER EYES AND FINALLY FELL ON THE FLOOR FROM HER CHAIR.   SHE WAS IN LYING POSITION FOR ABOUT 25MIN AND HER DAD CAME TO THE PHARMACY TO PICK HER UP. SHE WAS FINE . DAD AND DAUGHTER LAUGHED ABOUT THE WHOLE THING COS SHE HAS ALWAYS HAD THIS KIND OF EXPERIENCE BEFORE EVEN WITH LAB WORKS PER PATIENT.
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Vaccination complication
Clinical narrative: Child developed a fever as high as 104.3 degrees farenheit, along with localized redness and swelling of right thigh about 24 hours after vaccine administration. Mother called in to report this to the nurse on 6/27/19 and the child was scheduled to be seen the same day in office. Provider concluded that symptoms are due to vaccine reaction. Patient treated symptomatically with acetaminophen and ibuprofen for fever and pain relief.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Mastication disorder, Swelling face
Clinical narrative: Patient called call center number to reach provider to cancel appointment for second dose of MMR vaccine. Patient reports that on day 18 after receiving vaccine at the Clinic she developed right sided facial swelling with an enlarged and tender lymph node on that side, making it difficult to chew. Patient followed up with PCP and PCP reports that it may have been an adverse reaction to the vaccination and advised patient to not get second dose of vaccine. Patient reports symptoms have improved but have not gone away completely.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: PATIENT PRESENTED TODAY 67/1/19 WITH A LITTLE RASH IN HER RIGHT ARM, ACCORDING TO HER STARTED YESTERDAY. NO SWELLING, NO ITCHING
Age: 56.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: MILD ACHES, arthralgia , LOW GRADE FEVER, BILATERAL FEET PAIN, SWELLING
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Pyrexia, Skin warm
Clinical narrative: Patient had large bruises that were warm to the touch. One on bicep muscle and one on deltoid muscle. Patient also was running a fever on Wednesday after getting vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site abscess, Injection site pain, Injection site reaction, Staphylococcal infection
Clinical narrative: 1-Pain at site of injection. 2-Pain and redness about 3" under the injection site 3-about 2' diameter of redness 3" under the injection site. 4- Dr diagnosed it as staph infection as patient had staph infections before,. 5- Dr informed the patient that the infection was because of the injection. 6- Dr prescribed Bactrim DS (take one tablet twice daily for 10 days)
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperaesthesia, Injection site pain, Migraine
Clinical narrative: Patient described severe muscle soreness at site of injection, headache the developed into migraine, chills of body, and increased skin sensitivity.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Malaise, Pyrexia
Clinical narrative: Headache, chills, diarrhea, vomiting, fever, malaise
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Headache, chills, diarrhea, vomiting, fever, malaise
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Larger Red area around injection site. Approximately 3" x 2"
Sex: F
Vaccine: HPV9
Symptoms: Therapeutic product effective for unapproved indication
Clinical narrative: within two weeks, the tumors were half the original size and 9 months later there were no signs of HPV cancer; used GARDASIL 9 to treat HPV 16 cancer; The consumer reports that the patient also "had 3 additional doses injected directly into her tumors over an 8 month time period; This spontaneous report as received from an unspecified consumer refers to a female patient in her 90's. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (exact dose, lot# and expiration date were not provided) for human papillomavirus (HPV) 16 cancer (considered as product use in unapproved indication). The consumer reports that on unspecified dates, the ,,patient was given two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly 6 weeks apart". On an unknown dates, the patient also ,,had 3 additional doses injected directly into her tumors over an 8 month time period".   On an unspecified date, ,,within two weeks, the tumors were half the original size and 9 months later there were no signs of HPV cancer" and on an unspecified date, ,,2 years later, the patient had a follow up which showed zero histological signs of HPV" (considered as therapeutic product effective for unapproved indication). The outcome of the event was unknown.   The relatedness between the event of therapeutic product effective for unapproved indication and the suspect vaccine was not provided.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal disorder
Clinical narrative: RED; SORE; she can't lift it; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hashimoto's thyroiditis.   On 31st May 2019, the patient received the 1st dose of Shingrix .5 ml. On 1st June 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the injection site erythema, pain in arm and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The reporter was patient herself.   The patient received her first dose in the left arm. The next day, her arm was very red from the injection site down to an inch or two above her elbow.  The arm was sore to the point that she could not lift it. The patient consented to follow up. There is a discrepancy with respect to the outcome of the events injection site erythema and pain in arm. In source document, the outcome is reported as recovering/ resolving for all the symptoms, however as per narrative description it is not recovered/ not resolved. The outcome of all the symptoms retained as per the narrative description.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Pain in extremity
Clinical narrative: RED; SORE; she can't lift it; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hashimoto's thyroiditis.   On 31st May 2019, the patient received the 1st dose of Shingrix .5 ml. On 1st June 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the injection site erythema, pain in arm and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The reporter was patient herself.   The patient received her first dose in the left arm. The next day, her arm was very red from the injection site down to an inch or two above her elbow.  The arm was sore to the point that she could not lift it. The patient consented to follow up. There is a discrepancy with respect to the outcome of the events injection site erythema and pain in arm. In source document, the outcome is reported as recovering/ resolving for all the symptoms, however as per narrative description it is not recovered/ not resolved. The outcome of all the symptoms retained as per the narrative description.
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Hypersomnia, Pyrexia
Clinical narrative: Did not wake up to eat, slept over 24 hours, feverish
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient began experiencing pain and weakness in left arm within 1 day following vaccination and still having weakness in arm > 1 month from vaccination
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: 1:00 PM (07-01-2019) Injection site pain. Started to feel slightly dizzy, slightly weak, tired. These slowly increased as time passed. 12:00 AM (next day, 07-02-2019) Woke up with slightly above 100 degree fever, headache, elevated pulse rate (but usual, for me, blood pressure, which is slightly elevated) and generally not feeling well. Took 1,000 mg acetaminophen. 2:30 AM (07-02-2019) Feeling a little better, probably from acetaminophen, but cannot sleep because still not feeling well. So I researched side effects of Shingrix, found this website and decided to submit a report.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Malaise, Pyrexia
Clinical narrative: 1:00 PM (07-01-2019) Injection site pain. Started to feel slightly dizzy, slightly weak, tired. These slowly increased as time passed. 12:00 AM (next day, 07-02-2019) Woke up with slightly above 100 degree fever, headache, elevated pulse rate (but usual, for me, blood pressure, which is slightly elevated) and generally not feeling well. Took 1,000 mg acetaminophen. 2:30 AM (07-02-2019) Feeling a little better, probably from acetaminophen, but cannot sleep because still not feeling well. So I researched side effects of Shingrix, found this website and decided to submit a report.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever of 101.3, Myalgias, Cough, and Sore arm.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Muscle aches head to toe, headache, fatigue, nausea, loss of appetite. Symptoms persisted for two days, slightly less severe on day two. Patient completely recovered on day three. Patient did not seek medical treatment.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects.; a patient received a dose of M-M-R II (lot: N032748; expiration: 11/20/2019) that was prepared using an expired diluent (lot: M040792; expiration: 05/29/2019).; Information has been received from a pharmacist referring to a unknown gender patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On 01-JUN-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # N032748, expiration date: 20-NOV-2019, therapy type: rHA, dose, frequency were not reported) subcutaneously that was prepared using an expired sterile diluent (lot #: M040792, expiration date: 29-MAY-2019, strength, dose, frequency were not reported) (expired product administered). No known adverse effects.
Sex: M
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Oral administration complication, Vomiting
Clinical narrative: vomited immediately after receiving the ROTATEQ; vomited immediately after receiving the ROTATEQ; This spontaneous report was received from a nurse referring to a 2-month-old male patient. The patient's medical history included premature with 30-week-old gestation, apnoea at birth and hypoglycaemia at birth and the patient was fine at the time of this report. The patient had no concomitant medication or drug allergies.  On 06-JUN-2019 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ)( lot # R034878, expiration date 11-SEP-2020; strength and dose were not reported) in the series orally for prophylaxis. The patient vomited immediately after receiving rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (underdose). The events occurred during office visit. No treatment was given and no lab diagnostics or studies was performed.   Therapy with series of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was reported as continued. The outcome of vomiting was reported as recovered. The causality assessment was not provided by the reporter.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: confirmed case of mumps in an age-appropriately vaccinated student; Information has been received from a company representative referring to a child patient of unknown gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot# and expiration date were not reported) for prophylaxis.      On an unknown date, the patient experienced mumps (reported as a confirmed case of mumps in the age appropriately vaccinated student).  The outcome of mumps was unknown. The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: could not raise her arm because was in so much pain; could not raise her arm because was in so much pain; Information has been received from a physician via a field representative referring to a 26 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.  On 19-JUL-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (route, strength, dose, frequency, batch/lot # and expiration date were not reported) in the upper arm for prophylaxis (reported as human papilloma virus (HPV) prevention).         On the same date after administration, the patient "could not raise her arm because was in so much pain". Information about lab diagnostics/studies was unknown by the reporter. The patient went to physical therapy and received treatment for the events.   The outcome of both events was unknown. The causality was not reported.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass
Clinical narrative: the patient was noted to have a "cyst localized on the left upper limb"; the patient developed a "1.5 centimeter lump" at the injection site on an unspecified date.; Information has been received from a healthcare business professor(HBP), referring to a 17 years old female patient. Information of concomitant therapy and pertinent medical history was unknown. The patient was allergic to benzyl peroxide and minocycline (reported as monocycline).  On 06-MAY-2019, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot # R010596, expiration date: 11-DEC-2020, strength, dose, frequency and route were unknown) for prophylaxis.   On an unknown date in 2019, the patient developed a "1.5 centimeter lump" at the injection site. On 11-JUN-2019, the patient was noted to have a "cyst localized on the left upper limb" when seen by the physician. It was unknown if  treatments were given for the events. No lab diagnostics or studies were performed for the events. The outcome of the events was unknown. The causality assessment was not provided by the reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Retinal detachment, Vision blurred
Clinical narrative: retinal detachment with single break of the left; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions or concomitant medications.  On or around 25-JUN-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  In approximately June 2017 (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered blurry vision in the left eye and was diagnosed with retinal detachment with single break of the left eye. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product.  The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. The outcome of the event was not reported.  The event was considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event retinal detachment with single break of the left eye was determined to be medically significant.  Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; Expired vaccine used; This spontaneous report was received from a nurse refers to a 18 years old patient. The patient's concurrent condition, pertinent medical history, drug reactions/allergies were not reported.    On 27-JUN-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), vial (strength, dose was unknown) via intramuscular route, lot # r013858, expiration date of 27-JUN-2019 for prophylaxis. On 27-JUN-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (expired product administered). No adverse events were reported. No product quality complaint was involved. The outcome of expired product administered was unknown.  Lot No. r013858 has been verified to be a valid lot number for [hepatitis a vaccine, inactivated], expiration date reported as 27-JUN-2019, but upon internal validation established as 12-JUN-2019.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VAQTA on multiple dates; no adverse effect; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-MAR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-APR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-MAY-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-MAY-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-OCT-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R006209, expiry date 16-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-OCT-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R006209, expiry date 16-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VAQTA on multiple dates; no adverse effect; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-MAY-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VAQTA on multiple dates; no adverse effect; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-OCT-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VAQTA on multiple dates; no adverse effect; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-JAN-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VAQTA on multiple dates; no adverse effect; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JAN-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VAQTA on multiple dates; no adverse effect; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-FEB-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VAQTA on multiple dates; no adverse effect; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-FEB-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-OCT-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # N023953, expiry date 05-NOV-2018 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-OCT-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R006209, expiry date 16-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: nasty reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included drug allergy (Allergic to Maxitrol).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced nasty reaction. The patient was asking if they could take Tylenol for this. The pharmacist advised not to use it because it reduces vaccines effectiveness.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: redness; sore; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema and pain were unknown.   It was unknown if the reporter considered the erythema and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was not reported but was captured as adult as per vaccine indication. The healthcare professional (HCP) stated, the patients (no more than 2 or 3 patients) that experienced redness and were more sore after dose 1 of Shingrix then were just fine following dose 2. The reporter consented to follow up.  No additional details were available regarding the event.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Sluggishness
Clinical narrative: achy; tired; feeling draggy; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, tiredness and sluggishness. On an unknown date, the outcome of the pain, tiredness and sluggishness were unknown.   It was unknown if the reporter considered the pain, tiredness and sluggishness to be related to Shingrix.  Additional details were provided as follows: The reporting pharmacist was the patient. The age at vaccination was not reported but the patient could be 65 or 66 years old. The reporter reported that, he was achy, tired, and draggy after receiving a dose of Shingrix. The reporter reported his experience in passing after reporting his wife's experience. The reporter did not consent to follow up. This case was 1 of 3 cases, reported by same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb mass, Pain in extremity
Clinical narrative: SORE ARM; LUMP; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and mass. On an unknown date, the outcome of the pain in arm and mass were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and mass to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. After vaccination with dose of Shingrix, the patient developed a lump on their arm which was present and experienced soreness in the arm once and a while, at the time of reporting. The pharmacist was unsure when these symptoms started following vaccination. The event onset after vaccination with Shingrix was uknown. The batch number and expiry date of Shingrix was unknown. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Headache; Very tired; Fever/ fever of 102.9 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date in Jun2019 in the afternoon at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On a unspecified date in Jun2019, the reporter stated that her daughter woke up this morning and her arm was very sore, she had a headache, and was very tired. The reporter then further stated that her daughter has a fever of 102.9 degrees Fahrenheit. The reporter was querying if these could be side effects of meningococcal group b rlp2086. The outcome of arm was very sore, headache, was very tired and fever was unknown.  The following information on the batch number has been requested.