chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from a lawyer, and a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-OCT-2012, at age 65, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from a lawyer, and a female patient of unknown age.  No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2010, at age approximately 62, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine
Clinical narrative: This spontaneous report was received from a physician, via company representative, referring to a child of unknown gender and unknown age (age reported between 2 to 3-year-old). Information regarding the patient's medical history, concurrent conditions or concomitant medications was unknown. On an unknown date, the patient was vaccinated with the first dose of M-M-R II for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date in 2019 (reported as within the last two weeks), after receiving M-M-R II the patient developed measles. It was unknown if medical attention was sought, if any laboratory diagnostic was performed or if the patient received treatment. At the time of the report, the outcome of measles was unknown. The reporter did not provide causality assessment between the events and vaccination with M-M-R II. Upon internal review the event measles was determined to be medically significant.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: bad reaction; This spontaneous report as received from a other health professional via Pfizer regarding to a 55 year old female patient. The patient's medical history included extensive nerve damage, concurrent condition and concomitant medications were not reported. On an unknown date, (also reported as patient inn her 30's) the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route, lot#  and expiry were not reported) for prophylaxis. The reporter described that, the patient had a really bad reaction (adverse reaction) to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). The outcome of adverse reaction was unknown. The reporter considered adverse reaction to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).; Sender's Comments:  US-PFIZER INC-2018352490:
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included ZOSTAVAX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of SHINGRIX on unknown arm. The patient had 2nd dose of SHINGRIX over two months ago and at the time of reporting experiencing pain in the arm she received the injection. The patient could not lift her arm over a 30 degree angle without pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Decreased appetite, Nausea, Pyrexia
Clinical narrative: Severe stomach pain, nausea, low grade fever. Pain was 10 on a 1-10 scale for 2 full days. Pain tapered off over the next 3 days. No appetite for several days. Stayed in bed 2 full days.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong technique in product usage process
Clinical narrative: Pt was given the pediatric dose instead of the adult dose, but was give 2 pediatric doses to equal the Adult dose that was needed.
Age: 59.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: weakness, dizziness, shivering, fatigue Began when I got out of bed at 7am. Continued throughout the day.  First day after vaccine, so I don't know if it will continue tomorrow.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: RASH ON RIGHT ARM, AND RIGHT SIDE OF TRUNK.
Age: 55.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Headache, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Athough I also had headaches chills they went away after a couple days but pain in arm still persists  as to where I have a hard time functioning cant carry heavy objects ibuprofen seems to take the edge off but concerned about long term effects of eating ibuprofen called clinic for follow up got put on phone with pharmacist who seems clueless any assistance on what to do to fix this would be highly appreciated . today makes 11 days did not check temperature when had headache
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 year old given the influenza immunization for 3 and older
Age: 1.58
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: Pt. developed a rash on right thigh at the injection site. PCP diagnosed as cellulitis. Treated with antibiotics. Rash resolved 4/15/19
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Body temperature increased, Dizziness, Fatigue, Lymphadenopathy, Paraesthesia
Clinical narrative: 5 days after the vaccination, patient experienced painful lymphadenopathy to left side of neck.  She also had some tingling sensations to the area. Patient was seen in the office on 4/9/19, when she was prescribed AUGMENTIN and prednisone. Patient called office on 4/16/19 and reported that the lymph node is decreasing in size, and is no longer painful. She is no longer experiencing  tingling in the area.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Tinnitus
Clinical narrative: 5 days after the vaccination, patient experienced painful lymphadenopathy to left side of neck.  She also had some tingling sensations to the area. Patient was seen in the office on 4/9/19, when she was prescribed AUGMENTIN and prednisone. Patient called office on 4/16/19 and reported that the lymph node is decreasing in size, and is no longer painful. She is no longer experiencing  tingling in the area.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain, Injection site paraesthesia, Lymph node pain, Lymphadenopathy, Neck pain
Clinical narrative: 5 days after the vaccination, patient experienced painful lymphadenopathy to left side of neck.  She also had some tingling sensations to the area. Patient was seen in the office on 4/9/19, when she was prescribed AUGMENTIN and prednisone. Patient called office on 4/16/19 and reported that the lymph node is decreasing in size, and is no longer painful. She is no longer experiencing  tingling in the area.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Swelling
Clinical narrative: 5 days after the vaccination, patient experienced painful lymphadenopathy to left side of neck.  She also had some tingling sensations to the area. Patient was seen in the office on 4/9/19, when she was prescribed AUGMENTIN and prednisone. Patient called office on 4/16/19 and reported that the lymph node is decreasing in size, and is no longer painful. She is no longer experiencing  tingling in the area.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Irritability, Pyrexia, Rash generalised
Clinical narrative: Patient's mother called with concerns of child developing a rash at the injection site of MMR that was given 9 days previously. She states that the rash spread to her entire body was followed by low grade fever and fussiness. She called the office on 4/16 for an apt and was seen the same day.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: Patient stated that her feet swelled up on the night after receiving the vaccine. She stated that the swelling subsided by the next day.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Cardiac arrest, Cyanosis, Dyspnoea, Endotracheal intubation, Infantile apnoea
Clinical narrative: Per hospital records- on 4/2/19 patient was found at home by mother unconscious in crib with cyanosis, then called EMS C/O apneic episode. Another hospital note states mother found patient "gasping for air" then she called 911. Once EMS arrived, CPR was performed. Patient was taken to ER, arrived in ER at 1949 for cardiac arrest. Per mother last PO intake was 1500 that day. Patient became apenic then was intubated and admitted to PICU. On 4/11/19 patient was transferred to main campus for ECMO.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intensive care, Loss of consciousness, Resuscitation
Clinical narrative: Per hospital records- on 4/2/19 patient was found at home by mother unconscious in crib with cyanosis, then called EMS C/O apneic episode. Another hospital note states mother found patient "gasping for air" then she called 911. Once EMS arrived, CPR was performed. Patient was taken to ER, arrived in ER at 1949 for cardiac arrest. Per mother last PO intake was 1500 that day. Patient became apenic then was intubated and admitted to PICU. On 4/11/19 patient was transferred to main campus for ECMO.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Patient had rash on both arms from shoulders to forearm. She did not report any pain, just itching.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Left inner arm redness, axillary to olecranon
Age: 61.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Chills, Constipation, Decreased appetite, Headache, Lethargy
Clinical narrative: 4/9/19 - woke up with headache, chills, lethargy, nausea, loss of appetite, left arm was extremely sore where vaccination was administered. Took ZOFRAN and ibuprofen, left work early, had only a cup of chicken soup that day, tried to rest/sleep. 4/10/19 - same signs as 4/9/19 without chills, continued ZOFRAN, ibuprofen, still no appetite, tried to rest, sleep. 4/11/19 - headache gone, still some nausea and lethargy, sore arm, but was able to eat a little more than the previous 2 days. Took ZOFRAN and rested. 4/12/19 - felt pretty much fully recovered, able to go back to work but constipated. 4/13/19 - still dealing with constipation. 4/14/19 - constipation resolved, fully recovered.
Age: 61.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Nausea, Vaccination site pain
Clinical narrative: 4/9/19 - woke up with headache, chills, lethargy, nausea, loss of appetite, left arm was extremely sore where vaccination was administered. Took ZOFRAN and ibuprofen, left work early, had only a cup of chicken soup that day, tried to rest/sleep. 4/10/19 - same signs as 4/9/19 without chills, continued ZOFRAN, ibuprofen, still no appetite, tried to rest, sleep. 4/11/19 - headache gone, still some nausea and lethargy, sore arm, but was able to eat a little more than the previous 2 days. Took ZOFRAN and rested. 4/12/19 - felt pretty much fully recovered, able to go back to work but constipated. 4/13/19 - still dealing with constipation. 4/14/19 - constipation resolved, fully recovered.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 08-FEB-2017, the patient was inoculated with ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). One day after receiving ZOSTAVAX vaccine, the patient experienced Herpes zoster and was later diagnosed with post herpetic neuralgia. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient experienced serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the use of ZOSTAVAX, the patient has suffered and incurred damages including medical expenses; loss of accumulations; and other economic and noneconomic damages. Treatment of Herpes zoster and post herpetic neuralgia was unknown.  Outcome of Herpes zoster and post herpetic neuralgia was not recovered. Causality assessment was related. Herpes zoster and post herpetic neuralgia were considered to be disabling. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from a lawyer, and a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On and unknown date in 2014, at age 67, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from a lawyer, and  female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2014, at age 73, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a nurse practitioner for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Adverse event, Product contamination chemical, Product quality issue
Clinical narrative: unspecified number of MMR II doses have been sent to unspecified independent laboratories and have been found to contain glycosates, "which are toxins"; the worst chronic (unspecified) conditions in children; product quality complaint; This spontaneous report was received from a consumer refers to an unknown number of childrens of unknown ages and genders. The patients historical condition, concomitant medications and drug reactions or allergies were not reported.       On an unknown date, the patient s were vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) reconstitute with sterile diluent for prophylaxis(dosage schedule, route, anatomical location, lot number and expiration date were not reported).      Consumer stated that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine has produced the worst chronic (unspecified) conditions in children (adverse event). Additionally, stated that an unspecified number of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses have been sent to unspecified independent laboratories and have been found to contain "glycosates" which are toxins (product contamination chemical )(product quality issue).   The outcome of product contamination chemical, product quality issue and adverse event was unknown.  At the time of the report, the causality between the aforementioned events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was not provided.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 11 year old patient.    On 15-APR-2019 the patient was vaccinated with GARDASIL 9 lot # R025155 dose 2, 1 dosage form for prophylaxis. On 15-APR-2019, 1 year 21 days after onset of therapy the patient experienced inappropriate schedule of product administration. On an unknown date the patient experienced no adverse event.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 55-year-old female patient who received SHINGRIX (batch number 3NY5G, expiry date 7th March 2019) for prophylaxis. On 10th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 10th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling (serious criteria clinically significant/intervention required), fever (serious criteria clinically significant/intervention required), facial flushing (serious criteria clinically significant/intervention required), injection site warmth (serious criteria clinically significant/intervention required) and injection site pain. On 13th September 2018, the patient experienced injected limb mobility decreased. The patient was treated with ibuprofen (Motrin), paracetamol (Tylenol), medication unknown (Ice Pack (Nos)) and non-drug therapy (Heating Therapy). On an unknown date, the outcome of the injection site swelling, fever, injection site warmth, injection site pain and injected limb mobility decreased were recovered/resolved and the outcome of the facial flushing was unknown. It was unknown if the reporter considered the injection site swelling, fever, facial flushing, injection site warmth, injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a nurse practitioner. The patient received dose of SHINGRIX in her left arm. The nurse practitioner reported that her arm hurt following dose 2 of SHINGRIX. By that night she developed a fever of 102, her arm was swollen and hot to the touch. Her face and body were flushed. By the third day, the patient went to the doctor. It hurt to raise her arm up. The patient rotated taking Tylenol and Motrin and cycled with ice and heat and by the fourth day , that night, her symptoms resolved. The patient consented to follow up. The nurse practitioner thought expiration date of vaccine was correct.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 55-year-old female patient who received SHINGRIX (batch number 3NY5G, expiry date 7th March 2019) for prophylaxis. On 10th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 10th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling (serious criteria clinically significant/intervention required), fever (serious criteria clinically significant/intervention required), facial flushing (serious criteria clinically significant/intervention required), injection site warmth (serious criteria clinically significant/intervention required) and injection site pain. On 13th September 2018, the patient experienced injected limb mobility decreased. The patient was treated with ibuprofen (Motrin), paracetamol (Tylenol), medication unknown (Ice Pack (Nos)) and non-drug therapy (Heating Therapy). On an unknown date, the outcome of the injection site swelling, fever, injection site warmth, injection site pain and injected limb mobility decreased were recovered/resolved and the outcome of the facial flushing was unknown. It was unknown if the reporter considered the injection site swelling, fever, facial flushing, injection site warmth, injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a nurse practitioner. The patient received dose of SHINGRIX in her left arm. The nurse practitioner reported that her arm hurt following dose 2 of SHINGRIX. By that night she developed a fever of 102, her arm was swollen and hot to the touch. Her face and body were flushed. By the third day, the patient went to the doctor. It hurt to raise her arm up. The patient rotated taking Tylenol and Motrin and cycled with ice and heat and by the fourth day , that night, her symptoms resolved. The patient consented to follow up. The nurse practitioner thought expiration date of vaccine was correct.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: After 4 days receiving vaccine pt has rash and itching at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Insomnia, Pain
Clinical narrative: 10:30 body aches, 11:00 chills, fever. By midnight throwing up. Dry heaves rest of the night, fever, major chills, shaking, can't get warm, no sleep all night. In the morning took compazine, later some liquids, an Advil, feverish all 2nd day, continued Advil, slept all day.  3rd day - still very tired, body aches, soft diet.   1st dose of Shringrix side effects the same. Administered with pneumonia vaccine, doctor thought it was due to taking two vaccines at same time.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Retching, Somnolence, Tremor, Vomiting
Clinical narrative: 10:30 body aches, 11:00 chills, fever. By midnight throwing up. Dry heaves rest of the night, fever, major chills, shaking, can't get warm, no sleep all night. In the morning took compazine, later some liquids, an Advil, feverish all 2nd day, continued Advil, slept all day.  3rd day - still very tired, body aches, soft diet.   1st dose of Shringrix side effects the same. Administered with pneumonia vaccine, doctor thought it was due to taking two vaccines at same time.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain, Pyrexia
Clinical narrative: Low grade fever, body aches more than 30 hours, spent the day on the couch, feeling lousy.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient complains of redness at site that is over 2 inches circumference and soreness at the site. Adverse events occurred immediately during the administration of the vaccination. The arm continues to feel sore when certain movements occur, such as arm bending towards the back.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient had symptoms of shingles on 4-13-2019 and Dx confirmed on 4/16/2019.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Headache, Injection site pain, Insomnia, Malaise
Clinical narrative: After 5 hours, severe pain at injection site. Continued all night so I didn't sleep at all. Felt nauseated and faint. Sick the entire day after with arm pain, nausea, dizziness and headache. Arm pain lasted a couple more days but all other symptoms were gone.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity
Clinical narrative: After 5 hours, severe pain at injection site. Continued all night so I didn't sleep at all. Felt nauseated and faint. Sick the entire day after with arm pain, nausea, dizziness and headache. Arm pain lasted a couple more days but all other symptoms were gone.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: I got the Recombinant Zoster (Shingle) Vaccine, RZV. I'm not sure if that is the one I selected above. The muscle of the injection site got moderately sore. And is still mildly sore today. I also had moderate Headache, muscle aches, fever, shivering and fatigue. Those symptoms lasted at the moderate level for two days, then went away, leaving me feeling exhausted/fatigued to this day.  On 04/12/2019 a red rectangle about 2 inches by four inches appeared around the injection site.  No additional pain/soreness and no itching. This is gone now.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: I got the Recombinant Zoster (Shingle) Vaccine, RZV. I'm not sure if that is the one I selected above. The muscle of the injection site got moderately sore. And is still mildly sore today. I also had moderate Headache, muscle aches, fever, shivering and fatigue. Those symptoms lasted at the moderate level for two days, then went away, leaving me feeling exhausted/fatigued to this day.  On 04/12/2019 a red rectangle about 2 inches by four inches appeared around the injection site.  No additional pain/soreness and no itching. This is gone now.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever and chills and fatigue. In bed for over a day.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Mother believes that the rash began after receiving the Hep B immunization. No bleeding or pus. Afebrile, not acutely ill.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Significant redness, itching, with swelling on left deltoid 10x5cm.
Age: 0.42
Sex: F
Vaccine: DTAP, IPV
Symptoms: Crying, Screaming
Clinical narrative: BABY STARTED SCREAMING AND CRYING, AND STOPPED TAKING HER BOTTLE. THIS CARRIED ON FOR 2 WEEKS STRAIGHT.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in arm that received vaccine. Numbness traveled to leg on the same side of body. Patient went to emergency room. She was sent home and her symptoms resolved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Myalgia, Nausea
Clinical narrative: 7 hours after injection she developed pain and redness at the injection site, nausea, myalgias and fatigue.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient presented to pharmacy approximately 28 hours post-injection and showed me that her left arm had a light pink circle around the injection site approximately 2 inches wide. Area shown did not appear red as a rash would. Patient says it was a little sore but pink area (not red) has not spread out. I recommended the patient to use 1% hydrocortisone to reduce the pinkness of the area and to report to her physician in 24 hours if the symptoms don't decrease. Patient was well and alert; no limitation of arm movement. This was patient's 2nd vaccination of SHINGRIX to complete the series.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Patient described limited range in motion and bruising/pain of shoulder that had lasted over a week.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Warm, red, swollen and tender arm at injection site. Sore, achy muscles no joints. Headache and chills. Arm is still red, warm, tender and slightly swollen almost 36 hours later.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia
Clinical narrative: Warm, red, swollen and tender arm at injection site. Sore, achy muscles no joints. Headache and chills. Arm is still red, warm, tender and slightly swollen almost 36 hours later.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia
Clinical narrative: Chills, joint and muscle aches.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysuria, Micturition urgency, Urinary tract infection
Clinical narrative: Urinary tract infection. Urgency, burning, frequent small amounts of urine with pain.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Hypersensitivity, Throat irritation
Clinical narrative: Patient said that just a few minutes after leaving the store her throat began itching and she recongized the signs of an allergic reaction. Her husband took her immediately to the emergency room where she was treated and released. She has an allergy to sugar, which she did report to the pharmacy, however the pharmacist did not realize sucrose was in the vaccine as a stabilzer. Pharmacist called the patient once made aware and the patient was appreciative for the call, but still upset, as she should be, that this could be prevented.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Fatigue, Myalgia, Nuclear magnetic resonance imaging brain
Clinical narrative: Decreased upper body strength, arm sore, hard time taking deep breath, extreme fatigue, increased myalgia.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Scan with contrast
Clinical narrative: Decreased upper body strength, arm sore, hard time taking deep breath, extreme fatigue, increased myalgia.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Blood glucose normal, Generalised tonic-clonic seizure, Postictal state
Clinical narrative: After vaccine given & nurse left room, mom called out for help. NP walked into room and patient was having seizure tonic-clonic lasting < 30 seconds. Patient was post-ictal for several minutes and then recovered to normal behavior.
Age: 27.0
Sex: U
Vaccine: HPV9
Symptoms: Rash pustular, Skin discolouration
Clinical narrative: Possible pustular skin reaction over lower extremities. Patient reported this started after GARDASIL injection. No other new medications or changes. Seen by Dr. in office today. Rash/bumps noted in various stages of healing. Patient reported they were "bumps with white stuff coming out of them". No pain or itching. Darkened skin changes noted. 6/11/2019: Follow up received: Specific reaction date and time are not available. Patient presented to office on 4/4/19 for 2nd GARDASIL injection and reported "blistered" bumps that started "after 1st GARDASIL". Patient saw physician for office visit and assessment on 4/16/19 (declined visit on 4/4/19) and bumps were noted "in varying degrees of healing" per MD.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Patient with rash and whelps intermittent.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Pruritus, Urticaria
Clinical narrative: UrticariaPruritus
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: None, dose expired on 4/14/2019, given on 4/16/2019. Given in error, no harm done.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got small case (few small patches) of shingles.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Swelling of left arm pain/burning Fever
Age: 1.33
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: erythema & swelling at site of injection (i.e. right arm)
Age: 11.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Erythema, Pruritus, Pyrexia
Clinical narrative: Looked like a mosquito bite with larger red ring on right forearm, about 2" diameter, site itchy. Low grade fever. Appeared next day after visit and immunizations.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site urticaria
Clinical narrative: Had reaction to MMR, Varicella and PCV-13 immediate redness and hives around injection site of all vaccines. Given Benadryl and observed for 20m. Redness decrease and hives gone after 20m.
Age: 47.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Full blood count normal, Immediate post-injection reaction, International normalised ratio normal, Laboratory test normal, Malaise
Clinical narrative: felt feverish and illx2 dys immed after vaccine then morbilliform rash (B) forelegs and forearms (none on face or trunk)
Age: 47.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Pyrexia, Rash, Rash morbilliform, Red blood cell sedimentation rate normal
Clinical narrative: felt feverish and illx2 dys immed after vaccine then morbilliform rash (B) forelegs and forearms (none on face or trunk)
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site pain, Muscular weakness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 715399) on 31-JAN-2018 and 25-FEB-2019. This spontaneous report as received from a regulatory authority refers to a 26-year-old non pregnant female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 13-SEP-2017 the patient was vaccinated with the first dose of GARDASIL 9 injection (exact dose was not provided, lot # N013276, expiration date: 21-JAN-2020) intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced immediate post-injection reaction, muscular weakness and injection site pain. Soreness to site began immediately. Patient attempted ibuprofen for first few days, then stopped (did not want to take medication routinely). Patient contacted health clinic that morning (29-SEP-2017) reporting continued moderate soreness (not severe) and some weakness to left hand (described as similar to the weakness after it fell asleep and began to wake (no tingling/ prickling feeling). The outcome of immediate post-injection reaction, muscular weakness and injection site pain was reported as not recovered/not resolved. The causality between the events and the suspect therapy was not provided. Follow-up information has been received from the nurse on 16-APR-2019. The nurse was unable to identify the patient and hence no additional information was provided at the time of call.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Arthroscopy, Asthenia, Bursitis, Feeling hot, Gastrointestinal disorder
Clinical narrative: When receiving influenza vaccine at workplace clinic on 9/14/2018, no unusual pain was noted at the time of injection, however, the nurse administering the vaccine noted that it was "hard to inject". Pain was noted later in the afternoon, similar to other previous vaccines, however, difficulty raising arm above shoulder level was also experienced. Symptoms initially improved after 36 hours, then worsened after the subsequent week and the injury was reported to the Health at Work office. Pain, strength and range of motion (ROM) continued to worsen, in spite of increasing doses of ibuprofen to 600mg every 6 hrs (unable to tolerate this dose for long due to GI symptoms). Referral was made to orthopedic surgeon with the following treatments: o Tramadol 50 mg at bedtime as needed (used intermittently since 10/5/2018) o Flexeril 5mg at bedtime as needed (used intermittently since 10/5/2018) o Acetaminophen 1g 2-3 x/day (intermittently prior to surgery, daily through March 2019, currently as needed) o Diclofenac gel topically twice daily (10/2018  ongoing, as needed) o Meloxicam 15mg (11/14/2018-ongoing)  now on 7.5mg daily since 3/19/2019 o Steroid injections x 2: 10/5/2018 (relief of pain x 2 days, improved ROM x 6 days) and 11/14/2018 (decrease in pain, but not eliminated) o Physical therapy twice weekly (10/10/2018  11/6/2018 and 1/15/2019  4/15/2019)  exercises, myofascial release, iontophoresis (total of 6, last done in January), TENS/IFT, dry needling, kinesiology taping, joint mobilization, ultrasound x1 o Application of cold packs 2-3 times daily (October-February; currently as needed) o 1/3/2019 - arthroscopic shoulder surgery at Hospital  left shoulder arthroscopic debridement foreign body bursitis and partial-thickness rotator cuff tear; left shoulder subacromial decompression. Initial course following vaccination: Periods of slight improvement followed by worsening episodes, unrelated to activity, etc. Worsening episodes associated with increased pain, sensation of feeling hot (without fever) and popping/crunching in the joint. Resting pain was as low as 1-2/10, up to 6/10; most days had constant resting pain. Frequent sharp pains (7/10) with almost every arm movement. Multiple distinct areas of pain involving shoulder (anterior and posterior), various locations on the upper arm and extending to the elbow, as well as subscapularis region. Minimal impact at work, mostly sedentary deskwork as Clinical Research Nurse. Significant impact on ADLs including cooking, cleaning, laundry, grocery shopping, driving/travel and sleeping  improved by mid-late February 2019. After initial post-op period, had gradual improvement in pain and function. By late February, ROM and strength almost back to normal but have continued to have persistent, intermittent episodes of pain with movement as well as pain at rest, lasting 1-6 hrs; occasional days with little to no pain. Released by surgeon on 4/10/2019 with a permanent partial disability rating of 10% for the left upper extremity.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Rotator cuff syndrome, Tendon disorder, Ultrasound scan
Clinical narrative: When receiving influenza vaccine at workplace clinic on 9/14/2018, no unusual pain was noted at the time of injection, however, the nurse administering the vaccine noted that it was "hard to inject". Pain was noted later in the afternoon, similar to other previous vaccines, however, difficulty raising arm above shoulder level was also experienced. Symptoms initially improved after 36 hours, then worsened after the subsequent week and the injury was reported to the Health at Work office. Pain, strength and range of motion (ROM) continued to worsen, in spite of increasing doses of ibuprofen to 600mg every 6 hrs (unable to tolerate this dose for long due to GI symptoms). Referral was made to orthopedic surgeon with the following treatments: o Tramadol 50 mg at bedtime as needed (used intermittently since 10/5/2018) o Flexeril 5mg at bedtime as needed (used intermittently since 10/5/2018) o Acetaminophen 1g 2-3 x/day (intermittently prior to surgery, daily through March 2019, currently as needed) o Diclofenac gel topically twice daily (10/2018  ongoing, as needed) o Meloxicam 15mg (11/14/2018-ongoing)  now on 7.5mg daily since 3/19/2019 o Steroid injections x 2: 10/5/2018 (relief of pain x 2 days, improved ROM x 6 days) and 11/14/2018 (decrease in pain, but not eliminated) o Physical therapy twice weekly (10/10/2018  11/6/2018 and 1/15/2019  4/15/2019)  exercises, myofascial release, iontophoresis (total of 6, last done in January), TENS/IFT, dry needling, kinesiology taping, joint mobilization, ultrasound x1 o Application of cold packs 2-3 times daily (October-February; currently as needed) o 1/3/2019 - arthroscopic shoulder surgery at Hospital  left shoulder arthroscopic debridement foreign body bursitis and partial-thickness rotator cuff tear; left shoulder subacromial decompression. Initial course following vaccination: Periods of slight improvement followed by worsening episodes, unrelated to activity, etc. Worsening episodes associated with increased pain, sensation of feeling hot (without fever) and popping/crunching in the joint. Resting pain was as low as 1-2/10, up to 6/10; most days had constant resting pain. Frequent sharp pains (7/10) with almost every arm movement. Multiple distinct areas of pain involving shoulder (anterior and posterior), various locations on the upper arm and extending to the elbow, as well as subscapularis region. Minimal impact at work, mostly sedentary deskwork as Clinical Research Nurse. Significant impact on ADLs including cooking, cleaning, laundry, grocery shopping, driving/travel and sleeping  improved by mid-late February 2019. After initial post-op period, had gradual improvement in pain and function. By late February, ROM and strength almost back to normal but have continued to have persistent, intermittent episodes of pain with movement as well as pain at rest, lasting 1-6 hrs; occasional days with little to no pain. Released by surgeon on 4/10/2019 with a permanent partial disability rating of 10% for the left upper extremity.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Aching in upper arm and shoulder. Instead of getting better, pain and stiffness continued to get worse until, after two months, I could no longer raise my arm over head, nor could I move arm behind my back, as in trying to do a zipper. Now, this pattern continues, so I have lost much mobility in left arm, and I am left-handed. Also, at times there is a throbbing pain in my upper arm muscles, both bicep and tricep. Two rounds of physical therapy have done nothing to alleviate this condition. I might add that the injection itself was extremely painful and delivered high on my arm, above the muscle belly and closer to the rotator cuff of my shoulder.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Aching in upper arm and shoulder. Instead of getting better, pain and stiffness continued to get worse until, after two months, I could no longer raise my arm over head, nor could I move arm behind my back, as in trying to do a zipper. Now, this pattern continues, so I have lost much mobility in left arm, and I am left-handed. Also, at times there is a throbbing pain in my upper arm muscles, both bicep and tricep. Two rounds of physical therapy have done nothing to alleviate this condition. I might add that the injection itself was extremely painful and delivered high on my arm, above the muscle belly and closer to the rotator cuff of my shoulder.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Aching in upper arm and shoulder. Instead of getting better, pain and stiffness continued to get worse until, after two months, I could no longer raise my arm over head, nor could I move arm behind my back, as in trying to do a zipper. Now, this pattern continues, so I have lost much mobility in left arm, and I am left-handed. Also, at times there is a throbbing pain in my upper arm muscles, both bicep and tricep. Two rounds of physical therapy have done nothing to alleviate this condition. I might add that the injection itself was extremely painful and delivered high on my arm, above the muscle belly and closer to the rotator cuff of my shoulder.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 71-year-old male patient who received SHINGRIX (batch number ER5ZB, expiry date 9th June 2020) for prophylaxis. On 6th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th March 2019, 3 days after receiving SHINGRIX, the patient experienced hives and rash. On an unknown date, the outcome of the hives was recovered/resolved and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the hives and rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist called on behalf of a patient. The patient received SHINGRIX on left arm. The rash was located on the patient's trunk, groin, leg, flank and injected arm (left).
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 71-year-old male patient who received SHINGRIX (batch number ER5ZB, expiry date 9th June 2020) for prophylaxis. On 6th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th March 2019, 3 days after receiving SHINGRIX, the patient experienced hives and rash. On an unknown date, the outcome of the hives was recovered/resolved and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the hives and rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist called on behalf of a patient. The patient received SHINGRIX on left arm. The rash was located on the patient's trunk, groin, leg, flank and injected arm (left).
Age: 21.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Generalised erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: LARGE (.10 CM) RED WELTS AT INJECTION SITE AND CHEST,BACK.LEGS WITH  ITCHING
Age: 21.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pain in extremity, Pruritus generalised
Clinical narrative: LARGE (.10 CM) RED WELTS AT INJECTION SITE AND CHEST,BACK.LEGS WITH  ITCHING
Age: 21.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: LARGE (.10 CM) RED WELTS AT INJECTION SITE AND CHEST,BACK.LEGS WITH  ITCHING
Age: 4.0
Sex: U
Vaccine: TDAP
Symptoms: Agitation, Crying, Decreased appetite, Dyspnoea, Insomnia
Clinical narrative: Vaccine given: Diphtheria, Tetanus, Pertussis ( VIS edition 1/2012 provided) symptoms: hard to breath, stopped eating, lost 10pounds on 2 weeks, swallow face, specially around the mouth, rush around the mouth, crying, not sleeping, agitate, etc.