chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: This spontaneous report was received from a consumer referring herself as a female patient of currently 80 years old. The patient concurrent conditions included shingles, high blood pressure and hypothyroidism. The patient's medical history was not reported. The patient was allergic to latex and penicillin. The patient's concomitant medication included losartan and levothyroxine. On an unknown date, approximately back in 2006 to 2007, the patient was vaccinated with ZOSTAVAX (0.65 ml, frequency not reported) (lot# and expiration date not reported) subcutaneously. On an unknown date, reported as within a year of getting vaccination, the patient experienced dizzy spells (dizziness), blood pressure went up like crazy (blood pressure increased) and had pins and needles in both of feet, middle of back and down of arms and hands. It was also reported that, the patient was in constant pain and reported that it was been horror (pain). The patient have seen multiple neurologists and given with couple of unspecified shots in back to numb it, but patient was suffering. The patient received tramadol for pain, but patient got violently ill with vomiting and dizziness and stopped taking it. Patient also stated that, unspecified blood tests and echocardiogram were performed to the patient, but results were not provided. The patient was not recovered from the events. The reporter did not provide the causal relationship for the events with suspect therapy ZOSTAVAX. No product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Pruritus
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning 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 inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about June 2014 at her primary care physician's office for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent and severe strain of herpes zoster. In approximately June 2014 [reported as shortly after receiving the ZOSTAVAX], the patient developed severe and painful itching on her back. Thereafter, the patient presented to her primary care physician and was diagnosed with shingles on her back and left forearm. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of adverse event in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse who was reporting for herself stated that the pharmacist who administered the SHINGRIX vaccine to her told her that he had 2 patients who had to go to the emergency room after receiving the vaccine. She stated they were not admitted and they did not die. This was all the information she provided. This case was linked to the case US2018071812 and US2018GSK075872, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gastroenteritis viral, Headache, Pyrexia, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a 69-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). On 23rd April 2018 13:39, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, several hours after receiving SHINGRIX, the patient experienced vomiting, chills, headache, fever and stomach virus. On an unknown date, the outcome of the vomiting, chills, headache, fever and stomach virus were recovering/resolving. It was unknown if the reporter considered the vomiting, chills, headache, fever and stomach virus to be related to SHINGRIX. Additional information was reported as follow: The healthcare professional reported that, the patient received the SHINGRIX vaccine one day before the day of reporting and on the day of reporting called the pharmacist and stated that they had symptoms that started overnight. The patient vomited 4 times and experienced severe chills, and headache. The patient had body temperature of 101 degree F. The patient called their doctor and was waiting for a call back from the on-call physician since their doctor was away. It didn't seem that the symptoms were improving. The healthcare professional stated she wasn't sure if this was due to the vaccine or if the patient picked up a stomach bug or a virus. The healthcare professional also stated that, the patient was very healthy when she received the vaccine.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Electroencephalogram normal, Nuclear magnetic resonance imaging brain normal, Seizure
Clinical narrative: Received vaccine 3/27/18, had seizure 3/28/18.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt experiencing swelling and redness, on side of bicep (left).
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX. On 12th April 2018, the patient received SHINGRIX. On 12th April 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. On 13th April 2018, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the injected limb mobility decreased was unknown. The reporter considered the pain in arm and injection limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The pain was really bad for the patient about 5 days and was getting better but still there at the time of reporting. One day after receiving SHINGRIX, the patient was unable to use the arm. The patient had consulted the pharmacist for more information.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX. On 12th April 2018, the patient received SHINGRIX. On 12th April 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. On 13th April 2018, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the injected limb mobility decreased was unknown. The reporter considered the pain in arm and injection limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The pain was really bad for the patient about 5 days and was getting better but still there at the time of reporting. One day after receiving SHINGRIX, the patient was unable to use the arm. The patient had consulted the pharmacist for more information.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Insomnia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of insomnia in a elderly male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced insomnia, injection site pain, injection site erythema and injection site discomfort. On an unknown date, the outcome of the insomnia, injection site pain, injection site erythema and injection site discomfort were unknown. The reporter considered the insomnia to be related to SHINGRIX. The reporter considered the injection site pain, injection erythema and injection site discomfort to be almost certainly related to SHINGRIX. The additional details were provided as follows: The age at vaccination was not reported. The patient experienced insomnia the night after vaccination with SHINGRIX, he also experienced injection site redness and discomfort. The health care professional called to report the insomnia. The patient felt it was related. The health care professional had not spoken to the patient since the initial report and was unsure if symptoms had resolved.
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Dyspnoea, Electrocardiogram, Fatigue, Migraine
Clinical narrative: My daughter has played every sport every year after getting her 2nd dose of GARDASIL she started having vision problems, started having breathing problems, very bad migraines, is so tired all the time, she really never had any of these problems until she received her 2nd dose of GARDASIL and is currently being seen for her symptoms.
Sex: F
Vaccine: HPV4
Symptoms: Visual impairment
Clinical narrative: My daughter has played every sport every year after getting her 2nd dose of GARDASIL she started having vision problems, started having breathing problems, very bad migraines, is so tired all the time, she really never had any of these problems until she received her 2nd dose of GARDASIL and is currently being seen for her symptoms.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a registered nurse and family nurse practitioner student, they noted a patient who received SHINGRIX and was diagnosed with shingles within the same week she received the vaccine, no exact date was provided. Hospitalization was not noted for treatment of shingles. The date of birth of the patient, initials of patient, pharmacy that administered SHINGRIX, anatomical location of injection, lot number and expiration date, dose administered, date of vaccination, concomitant vaccines, concomitant medications, outcome of diagnosis details were not known.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local reaction, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of local reaction in a 78-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local reaction, pain, erythema and induration. On an unknown date, the outcome of the local reaction, pain, erythema and induration were unknown. It was unknown if the reporter considered the local reaction, pain, erythema and induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient developed a local reaction after receiving a dose of SHINGRIX and symptoms reported were pain, redness, area of induration 5 inches in diameter. The healthcare professional reported that the patient was actually not her patient but a patient of her husbands; husband was also a doctor. The HCP stated they do not have further address details or information of facility in which the patient received the vaccine. No further information was available at the time of report.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old male patient who received SHINGRIX. Concurrent medical conditions included diabetes. On 31st March 2018, the patient received the 1st dose of SHINGRIX. On 23rd April 2018, 23 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced painful rash, skin warm and pain in arm. On an unknown date, the outcome of the shingles and painful rash were not recovered/not resolved and the outcome of the skin warm and pain in arm were recovered/resolved. It was unknown if the reporter considered the shingles, painful rash, skin warm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by wife of the patient. The patient was continuing immunosuppressant and diabetic medication. Less than a week after receiving SHINGRIX, the patient experienced arm achiness and warm to touch which resolved within a week of vaccination. Less than a month after receiving SHINGRIX, the patient experienced rash described as achy and pinpoint in size. This is 1 of the 2 cases reported by same reporter.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Eye swelling, Eyelid oedema, Swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of periocular swelling in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced periocular swelling and periorbital pain. On an unknown date, the outcome of the periocular swelling was recovered/resolved and the outcome of the periorbital pain was unknown. It was unknown if the reporter considered the periocular swelling and periorbital pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced swelling around both eyes and forehead between eyes for 2 to 3 days, with some pain. The physician asked the patient if she had eaten any new food or used any new products on skin and the answer was no. The physician thought that it might had been reaction to vaccine, but the physician was not sure. The reporter agreed to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of adverse event in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse who was reporting for herself stated that the pharmacist who administered the SHINGRIX vaccine to her told her that he had 2 patients who had to go to the Emergency room after receiving the vaccine. She stated they were not admitted and they did not die. This was all the information she provided. This case was linked to the case US2018071812 and US2018GSK075873, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Pain, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling, felt faint and pain. On an unknown date, the outcome of the swelling, felt faint and pain were unknown. It was unknown if the reporter considered the swelling, felt faint and pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional stated that, he had a lots of patients, who experienced swelling (more than usual), pain and feeling of pain, after vaccinating with SHINGRIX. The reporter did not spoke to the healthcare professional himself. The adverse events were reported to the reporter by the inside sales department. The reports were send to the Regulatory Authority by the reporter.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 78-year-old male patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020). On 19th April 2018, the patient received SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain. On 23rd April 2018, the patient experienced shoulder pain. In April 2018, the outcome of the muscle pain was recovered/resolved. On an unknown date, the outcome of the shoulder pain was not reported. The reporter considered the muscle pain and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of their patient received the SHINGRIX vaccine. On 23rd April 2018, in morning, 4 days after receiving vaccination, the patient complained of extreme shoulder pain, which the patient associated to the SHINGRIX.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of rash in a 64-year-old female patient who received SHINGRIX. On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th April 2018, less than a day after receiving SHINGRIX, the patient experienced rash, fever and erythema. On an unknown date, the outcome of the rash, fever and erythema were unknown. It was unknown if the reporter considered the rash, fever and erythema to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that patient received SHINGRIX on right deltoid and developed events within 24 hours of the dose. The health care professional stated that the patient required a physician visit because she went in to see the physician on 16th April 2018 due to these adverse events. The health care professional was not sure how the patient was doing and they would be calling the patient later on the day of reporting. The reporter did not collect vaccine lot number and expiry date.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of rash in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced rash, injection site pain and injection site induration. On an unknown date, the outcome of the rash, injection site pain and injection site induration were unknown. It was unknown if the reporter considered the rash, injection site pain and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient developed rash around neck and shoulder within 24 hours of getting SHINGRIX along with pain induration at injection site. All questions were asked to reporter but provided limited information. The GlaxoSmithKline field representative gave permission to contact primary reporter for further details.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache, fatigue, feeling cold and shivering. On an unknown date, the outcome of the pain in arm, headache, fatigue, feeling cold and shivering were unknown. It was unknown if the reporter considered the pain in arm, headache, fatigue, feeling cold and shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist told the patient that her arm would be sore and the patient stated that it was sore but she also experienced other side effects like headache, fatigue, and feeling very cold or shivery that night when she went to bed. The reporter stated that she knew these were listed as side effects but she want to be sure there was no contraindication for her to get the 2nd dose of SHINGRIX in 2 months.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Lymphadenopathy, Pyrexia
Clinical narrative: Low grade fever, shivering, exhaustion, swollen lymph nodes, very painful injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient has soreness and tenderness at the site of injection, which started on 5/2/18. The injection site is also red and warm to the touch, which started today 5/3/18.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Patient states symptoms of swelling, redness, and welts on the left arm at site of injection
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Patient received vaccine at approximately 2:00p on Tuesday, May 1, 2018. She reports on Wednesday, May 2, 2018, that she experienced a severe headache, muscle aches, fever, shivering, and fatigue that afternoon. Symptoms resolved by today, Thursday, May 3, 2018.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Malaise, Pyrexia, Rash
Clinical narrative: Painful rash, joint pain, fever, chills, malaise.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Exposure during pregnancy
Clinical narrative: Pt found out wife was pregnant (8 weeks pregnant) at time of vaccination. Did not inform staff until after administration.
Age: 1.58
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Adverse reaction
Clinical narrative: Mom called to clinic on 12/15/17 and reported reaction inside area of quarter to half-dollar size and outside is size of Mom's hand. Patient not seen in clinic. Mom is an LPN.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dysstasia, Feeling abnormal, Injection site pain, Myalgia
Clinical narrative: Started same evening after receiving vaccine. Woke up chattering and had difficulty standing. Pain in most muscles. Did not feel right the next day. One day later felt normal again. Injection site tender for 4 days without redness or rash.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, MMRV, PNC13
Symptoms: Pyrexia, Rash generalised, Rash macular
Clinical narrative: Fever Low grade temp, rash all over bumpy with bright red splotches.  Lasted 1 week.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Clostridium test, Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting and diarrhea soon after administration of the vaccine. Previously was feeling fine.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Fatigue, Pruritus, Swelling, Urticaria
Clinical narrative: URTICARIA- bilateral arms started 2 May. Patient received Vaccinations to Typhod, Anthrax, Small pox approx 27 Apr. Reports itching swelling, fatigue.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Peripheral swelling, Tenderness
Clinical narrative: ARM SWELL, EXTREMELY PAINFUL TO TOUCH, RED, HEADACHE.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Pain
Clinical narrative: Red sore arm approximately 4 inches below the injection site. Hot red circle diameter 3 to 4 inches. Throbbing sensation and itching sensation. Lasted 1 week after injection.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Headache, Hyperhidrosis
Clinical narrative: Patient received immunization at approximately 11:00am. Per patient, around 12:00am she began is develop a pounding headache, nausea, vomiting, diarrhea, chills, fever, sweats, body aches, general weakness, redness and swelling of injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: Patient received immunization at approximately 11:00am. Per patient, around 12:00am she began is develop a pounding headache, nausea, vomiting, diarrhea, chills, fever, sweats, body aches, general weakness, redness and swelling of injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: Patient received immunization at approximately 11:00am. Per patient, around 12:00am she began is develop a pounding headache, nausea, vomiting, diarrhea, chills, fever, sweats, body aches, general weakness, redness and swelling of injection site.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: This spontaneous report has been received from a nurse practitioner referring to a 4 month old male patient. The patient did not have pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications. On 07-APR-2018, the patient was vaccinated with the second dose of ROTATEQ by oral route (strength, dose, lot number and expiration date were not provided) for vaccination. Approximately on 16-APR-2018 (reported as "one week after the first twin showed symptoms"), the patient developed a milder case of "bloody streak in his stool, which was very mucous-like" (haematochezia). Although medical attention was sought, none laboratory studies were performed and no treatment was given. The outcome of haematochezia was reported as not resolved. The causality assessment between therapy with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) and the event was not reported. Upon internal review, haematochezia was determined to be medically significant. This is one of two cases from the same reporter.; Sender's Comments: US-009507513-1804USA012023:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth, Pain
Clinical narrative: Stated that when she was going to bed noticed a small, hard lump where vaccine was given and that it was slightly painful. She then woke up in the middle of the night because it had become extremely painful. The next morning the bump was larger and still painful. Now, (2 days later) the bump is still large and painful. She states that it is not red or really hot, but is slightly warm. I suggested she take motrin/aleve for the pain and put an ice pack on it but to go to the dr if it becomes red, hot, or swollen.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: ARM PAIN, HEADACHE, NAUSEA.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Metabolic function test normal, Monocyte count increased, Neutrophil count increased, Pyrexia, Streptococcus test negative
Clinical narrative: According to parents, near-immediate onset of fever. Fever up to 103F. Intermittent vomiting. Persisted until May 2nd (6 days). Pt was brought to ER twice, 4/29 and 5/1. Hydration status was maintained. Fever treated with acetaminophen. No tenderness at injection sites. No other symptoms.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Urine analysis normal, Vomiting, White blood cell count increased
Clinical narrative: According to parents, near-immediate onset of fever. Fever up to 103F. Intermittent vomiting. Persisted until May 2nd (6 days). Pt was brought to ER twice, 4/29 and 5/1. Hydration status was maintained. Fever treated with acetaminophen. No tenderness at injection sites. No other symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Fatigue, Influenza like illness
Clinical narrative: Wide awake all night long. Pulse seemed normal and body was tired but mind was busy and awake all night. Then early morning started feeling nauseous and threw up bile (nothing in stomach) and then had diarrhea. Achy in stomach and back (flu like) still at 2PM.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Wide awake all night long. Pulse seemed normal and body was tired but mind was busy and awake all night. Then early morning started feeling nauseous and threw up bile (nothing in stomach) and then had diarrhea. Achy in stomach and back (flu like) still at 2PM.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: Wide awake all night long. Pulse seemed normal and body was tired but mind was busy and awake all night. Also sore around injection site but nothing unusual.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Myalgia
Clinical narrative: 2 days ago she received the pneumococcal 23 valent vaccine to the right deltoid. About 7 hours later she developed pain at the injection site. 10 hours later hours later she developed generalized myalgias. No fever, headache, or nuchal rigidity. Since, the myalgias have improved and she is feeling better. Last night she noted a red rash at the injection site. The injection site remains painful, but is much improved over the day of the injection. No other symptoms. No generalized rash. No GI symptoms.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Lip erythema, Lip oedema
Clinical narrative: TOP LIP EDEMA WITH INCREASED REDDNESS, DR. ORDERED 3.5ML CHILDREN'S BENADRYL EVERY 6 HOURS AS NEEDED, IF NO IMPROVEMENT AT 2 DOSE TO RETURN TO OFFICE.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Pt presents with red, swollen deltoid, warm to the touch.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Flushing, Headache, Myalgia
Clinical narrative: Facial flushing, chills, myalgia, fatigue, headache - relatively mild (4out of 10).
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Patient describes severe muscle pain and aches for 3 to 4 days after receiving vaccinations. Pain was constant and worse after the first shot. Patient tried OTC pan relievers with no relief. Pain went away after 5 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Peripheral swelling, Swelling
Clinical narrative: She received tdap and polio together in one shot. I noticed that her arm started to swell and become hot in the evening. She went to bed and when she woke up it was worse and as the day continued became worse. I took her to the doctor again and they said it was a localized swelling. I have pictures, it doesn't seem localized to me.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Headache, Loss of personal independence in daily activities, Nausea
Clinical narrative: Headache, fatigue, nausea, shakiness, fever max 100, localized warmth and tenderness to left arm. Out of work for 2 days due to symptoms currently.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tenderness, Tremor
Clinical narrative: Headache, fatigue, nausea, shakiness, fever max 100, localized warmth and tenderness to left arm. Out of work for 2 days due to symptoms currently.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis patient given Ibuprofen and Cephalexin 500mg.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Large knot came up at sight of injection. Lasted about 1 week and was about 1 1/2 inches in diameter. Was very painful as well. no fever/no redness.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This vaccine was administered by her GI clinic today due to her having Ulcerative colitis and being immunocompromised. Came to Urgent Care for evaluation due to swelling, redness, pain of her left upper arm where site of injection. Symptoms progressing. No airway compromised. She applied BENADRYL cream prior to her visit at the Urgent Care and TYLENOL. She has had PPV13 3/2018 with no problem.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Decreased appetite, Diarrhoea, Dyspnoea, Headache
Clinical narrative: Shortness of breath, stiff neck, headache, nausea, vomiting, diarrhea, fever (102.4F), aching all over, no appetite, increase in blood glucose (over 200).
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Shortness of breath, stiff neck, headache, nausea, vomiting, diarrhea, fever (102.4F), aching all over, no appetite, increase in blood glucose (over 200).
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: Patient is complaining of high fever that started yesterday after vaccine. Not relieved with Tylenol or Ibuprofen.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea
Clinical narrative: The following day after receiving the vaccine the patient started having episodes of shivering and nausea. Patient reported going to doctor and was prescribed ondansetron.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt presents 5/3/18 for Hives that started the day she got her immunizations. Started with a band around her arm the day she got her imms-hives developed that day. Has been giving BENADRYL twice in the past 4 days - hives had been on chest, neck, back, now on face and whole body. Worsened after getting hot (running outside, sleeping wrapped in blankets). Itchy, not painful. No SOB, no runny/stuffy nose, NOS. Eats, milk, eggs, and gelatin products without problems.
Age: 28.0
Sex: F
Vaccine: MNQ
Symptoms: Condition aggravated, Seizure
Clinical narrative: Patient had a seizure lasting about 1 minute. After a short rest she was ambulatory and left on her own.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Atypical.... sore arm shortly after injection. Next day, achey muscles, headache, fatigue. Ibuprofen seems to somewhat ease muscle aches. Not bad enough to seek further help.  Just for informational purposes.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Serum sickness
Clinical narrative: Developed rash on 4/27 - progressed, Fever on 4/29. Seen at medical associates on 4/29 - Dx with serum sickness. Seen at ED on 4/29 - dx with serum sickness - given Rx for oral steroids. Seen at medical associates on  4/30 - improved, on oral steroids
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Hypersensitivity, Nausea, Swelling
Clinical narrative: Swelling, headache, nausea vomiting, diarrhea.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Swelling, headache, nausea vomiting, diarrhea.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient stated that since 4/10/18 she has been experiencing  paresthesias in bilateral hands/forearms which she attributes to the SHINGRIX vaccine she received on 3/22/18.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Inflammation, Joint range of motion decreased, Pain
Clinical narrative: I was contacted by his attorney on 5/3/18 that his client, is experiencing limited range of motion on his shoulder, pain and inflammation. He is currently being treated by an orthopedic.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: I was contacted by his attorney on 5/3/18 that his client, is experiencing limited range of motion on his shoulder, pain and inflammation. He is currently being treated by an orthopedic.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Chills, exhaustion, whole body achiness, headache, upset stomach, redness at injection site, pain at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Chills, exhaustion, whole body achiness, headache, upset stomach, redness at injection site, pain at injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Paraesthesia, Pruritus
Clinical narrative: Patient received vaccine on 5/1/18. On 5/3/18 patient returned to pharmacy and complained of arm redness and itching and "tingling around the head". Redness was visualized about 4 inches from site of injection. Patient was advised to take an oral antihistamine (either Claritin or Benadryl) and to go to urgent care/doctor visit. No update from patient as of yet.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Headache, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Pt called at day 9 to say that he was still feeling body aches and malaise. From the first day or two he noticed site soreness and swelling. Then headache (muscular type/scalp pain) started, but has now stopped. No fever but some chills. Alternating Ibuprofen/Tylenol seems to be helping. But still muscle aches upon awakening and in the evening. Also complained of "gait disturbances" that seem to originate from his sternum/back. RPh advised pt to follow up with physician.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Pt called at day 9 to say that he was still feeling body aches and malaise. From the first day or two he noticed site soreness and swelling. Then headache (muscular type/scalp pain) started, but has now stopped. No fever but some chills. Alternating Ibuprofen/Tylenol seems to be helping. But still muscle aches upon awakening and in the evening. Also complained of "gait disturbances" that seem to originate from his sternum/back. RPh advised pt to follow up with physician.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Shaking chills, muscle aches, bone ache, sweats, nausea, severe headache, sore arm.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Tremor
Clinical narrative: Shaking chills, muscle aches, bone ache, sweats, nausea, severe headache, sore arm.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Fatigue, Headache, Vomiting
Clinical narrative: Fatigued started in morning  (he felt as if he couldn?t push a door open) in the afternoon came the  headache and vomiting towards  the early evening.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersomnia, Injection site pain, Lethargy
Clinical narrative: Profound lethargy lasting 24 hours. Slept most of day following administration of the vaccine. Also had pain at injection site which I understand to be common. Had pain with the first dose, as well, but did not have the lethargy.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm has not gone away after 6 months.
Age: 41.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Swollen arm, could not move arm, pain, symptoms stared within a few hours.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (R) thigh red area 4 x 5 cm with warmth to touch. No drainage or tenderness.
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Administered 2nd MMR and Varicella to child under age 4yrs.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: L arm cellulitis at injection site and persistent fever.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 10 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated that she gave 20 doses of SHINGRIX so far and 1 patient had flu-like symptoms that came on 10 hours after administration of the vaccine. The adverse event reported to reporter by Inside Sales. The reporter did not speak with the health care professional himself.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle tightness, Peripheral swelling, Rash, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 62-year-old female patient who received SHINGRIX (batch number X3M27, expiry date 29th August 2020). On 21st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 5 min after receiving SHINGRIX, the patient experienced swelling arm, skin warm, rash and muscle tightness. On an unknown date, the outcome of the swelling arm, skin warm, rash and muscle tightness were recovered/resolved. The reporter considered the swelling arm, skin warm, rash and muscle tightness to be probably related to SHINGRIX. Additional details were provided as follows: The health care professional stated that the patient experienced swelling in arm, warm to touch, rash around neck and lip got tight 5 minutes after receiving the SHINGRIX vaccine and all of it subsided 1 day later.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Heart rate increased, Pain in extremity, Pruritus, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX. Concurrent medical conditions included neuromuscular disorder nos and Globulins deficiency. Concomitant products included amitriptyline, levothyroxine, Mesalamine and ranitidine. On 20th April 2018, the patient received the 1st dose of SHINGRIX. On 20th April 2018. several hours after receiving SHINGRIX, the patient experienced pain in arm, erythema, swelling and skin warm. On 21st April 2018. the outcome of the heartbeats increased. On 25th April 2018, the patient experienced itchy upper limbs. In April 2018, the outcome of the heartbeats increased was recovered/resolved. On an unknown date, the outcome of the pain in arm, erythema, itchy upper limbs, swelling and skin warm were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, erythema, heartbeats increased, itchy upper limbs, swelling and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient was vaccinated in the morning and reported that she started to feel pain in the left arm a few hours after the vaccination. A red, raised area which was hot to the touch also presented a few hours following the vaccination and had not resolved. The next day after vaccination she began to experience a fast heart beat. It measured 111 to 112 beats per min. This symptom resolved by that evening at 8:00 pm. The night before the day of reporting the area on her left arm started to feel itchy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX. Concurrent medical conditions included neuromuscular disorder nos and Globulins deficiency. Concomitant products included amitriptyline, levothyroxine, Mesalamine and ranitidine. On 20th April 2018, the patient received the 1st dose of SHINGRIX. On 20th April 2018. several hours after receiving SHINGRIX, the patient experienced pain in arm, erythema, swelling and skin warm. On 21st April 2018. the outcome of the heartbeats increased. On 25th April 2018, the patient experienced itchy upper limbs. In April 2018, the outcome of the heartbeats increased was recovered/resolved. On an unknown date, the outcome of the pain in arm, erythema, itchy upper limbs, swelling and skin warm were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, erythema, heartbeats increased, itchy upper limbs, swelling and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient was vaccinated in the morning and reported that she started to feel pain in the left arm a few hours after the vaccination. A red, raised area which was hot to the touch also presented a few hours following the vaccination and had not resolved. The next day after vaccination she began to experience a fast heart beat. It measured 111 to 112 beats per min. This symptom resolved by that evening at 8:00 pm. The night before the day of reporting the area on her left arm started to feel itchy.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in an elderly female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site rash and injection site swelling. The patient was treated with BENADRYL and Ice Pack (Nos). On an unknown date, the outcome of the injection site erythema, injection site rash and injection site swelling were unknown. The reporter considered the injection site erythema., injection site rash and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient developed a reddish rash and local swelling around the injection site after receiving SHINGRIX. The patient called to physician about the reaction and the physician recommended ice and BENADRYL. The patient received SHINGRIX from different the health care professional and did not have any vaccine information. The physician reported only limited details about the adverse event.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Pt. felt flu-like symptoms, fever a couple hrs after shot that lasted for about 36 hours.
Age: 82.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Nausea, Partial seizures, Tremor, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient experience partial seizure activity. She was slumped over and unresponsive with right side shaking. Patient also experienced nausea/vomiting.