chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Capillaritis, Chronic pigmented purpura, Erythema, Glucose tolerance impaired, Mood swings
Clinical narrative: Red patches on right leg. From the sole of feet up to butt cheek. The discoloration patches spread and darkened over a few months period. Also mood swings.
Age: 8.0
Sex: F
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Purpura, Skin discolouration
Clinical narrative: Red patches on right leg. From the sole of feet up to butt cheek. The discoloration patches spread and darkened over a few months period. Also mood swings.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Malaise
Clinical narrative: OVERALL MALAISE, THEN RED, IRRITATED AREA LARGER THEN TENNIS BALL IN CIRCUMFERENCE AT INJECTION SITE.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Expired product administered, Headache, Intensive care, Malaise, Pain in extremity
Clinical narrative: DON phoned patient's mother on 6/12/18 to notify her that patient had received an expired dose of Tdap (BOOSTRIX, Lot#393D9, Exp 5/28/18). Mother reported she was just returning home with patient from Hospital following patient being hospitalized for a seizure. Patient received vaccinations on 6/1/18. Mom reports patient complained of his arms being sore, runny nose and generalized malaise on Sunday, 6/3/18. On Friday, 6/8/18 at 12:46pm patient had a seizure. Mom reports patient was awake and responsive following the seizure. He took TYLENOL for a headache following the seizure and fell asleep. Family was later unable to awaken him and called 911. Patient was taken to Medical Center by EMS and then transferred by ground unit to another Hospital where he was admitted to ICU. Patient remained unresponsive and in ICU from Friday evening, June 8th through Sunday morning, June 10th. Patient was transferred to a regular floor on Sunday evening, June 10th and discharged to home on Tuesday, June 12th. Mom reports he is feeling better each day. Mom reports patient has a follow up appointment schedule with Neurology Clinic on Thursday, June 28th. She reports they have been advised to not receive any further doses of HPV vaccination.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rhinorrhoea, Seizure, Unresponsive to stimuli
Clinical narrative: DON phoned patient's mother on 6/12/18 to notify her that patient had received an expired dose of Tdap (BOOSTRIX, Lot#393D9, Exp 5/28/18). Mother reported she was just returning home with patient from Hospital following patient being hospitalized for a seizure. Patient received vaccinations on 6/1/18. Mom reports patient complained of his arms being sore, runny nose and generalized malaise on Sunday, 6/3/18. On Friday, 6/8/18 at 12:46pm patient had a seizure. Mom reports patient was awake and responsive following the seizure. He took TYLENOL for a headache following the seizure and fell asleep. Family was later unable to awaken him and called 911. Patient was taken to Medical Center by EMS and then transferred by ground unit to another Hospital where he was admitted to ICU. Patient remained unresponsive and in ICU from Friday evening, June 8th through Sunday morning, June 10th. Patient was transferred to a regular floor on Sunday evening, June 10th and discharged to home on Tuesday, June 12th. Mom reports he is feeling better each day. Mom reports patient has a follow up appointment schedule with Neurology Clinic on Thursday, June 28th. She reports they have been advised to not receive any further doses of HPV vaccination.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Altered state of consciousness, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Pt's mother called and stated pt became dizzy, nauseated, diaphoretic, and then vomited. She presented to the office with more vomiting, very pale. Vitals taken and stable. She became dizzy in office and felt like she may pass out. Mother called her pediatrician and after pt began to feel a little better was going to take her to the ER. Pt after approx 30 minutes walked s difficulty and normal gait out to her car accompanied by mother and a friend.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Pt's mother called and stated pt became dizzy, nauseated, diaphoretic, and then vomited. She presented to the office with more vomiting, very pale. Vitals taken and stable. She became dizzy in office and felt like she may pass out. Mother called her pediatrician and after pt began to feel a little better was going to take her to the ER. Pt after approx 30 minutes walked s difficulty and normal gait out to her car accompanied by mother and a friend.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: Approximately 1 week after receiving vaccine patient  noticed a itchy/sore rash across back of neck. He assumed it was from poison ivy or brown tail moth so had been treating otc. He went to doctor this week (about 3 weeks after rash originally began) and doctor diagnosed as shingle rash.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 2nd June 2018, the patient received SHINGRIX (intramuscular) .5 ml. In June 2018, less than a day after receiving SHINGRIX, the patient experienced shingles and feels awful. On an unknown date, the outcome of the shingles and feels awful were recovering/resolving. It was unknown if the reporter considered the shingles and feels awful to be related to SHINGRIX. Additional details were provided as follows: After receiving the SHINGRIX, the patient was very unpleasant in the first 36 hours and had some rashes as if they were shingles. Already at 48 hours, the rashes had been reduced enough but the reporter would follow up with the patient to see if she had improved. The reporter agreed for follow up.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Acne, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report was received from 25 year old female consumer, reporting on herself. The patient's concurrent conditions included irritable bowel syndrome and colitis. The patient did not have any allergies. There was no reported information on the patient's pertinent medical history or concomitant medications. On 22-MAY-2018, the patient was vaccinated with a dose of GARDASIL 9 for prophylaxis, (product circular # uspi-v503-i-1802r007) (dose, route of administration, lot number and expiration date were not reported), and on an unspecified date in May 2018, reported as "a few days after the injection", the patient noticed soreness and redness around the injection site (Injection site pain, Injection site erythema); the patient also noted "a small bump" at the injection site that "looked almost like a pimple" (Injection site mass). She saw her health care provider and was advised to "monitor and have ice applied to the area". There was no additional information provided. It was reported that, there were no laboratory diagnostics or studies performed, and there was no need for hospitalization for the event. At the time of the report, the patient had not yet recovered from the events. The reporter did not provide a causal assessment between the therapy with GARDASIL 9 and the events.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In June 2011, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-AUG-2011, the patient was treated by a nurse practitioner at a health system for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and PERCOCET for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-SEP-2015, the patient was treated at urgent care for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-OCT-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), (by an unspecified healthcare professional) at a healthcare facility/office, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 21-NOV-2012, the patient was treated by a nurse practitioner, for a blistering vesicular eruption, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, MEN
Symptoms: Fatigue, Headache, Lymph node pain, Mononucleosis heterophile test negative, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 17-year-old female patient who received Havrix (batch number B2JH7, expiry date 6th June 2020) for prophylaxis. On 22nd May 2018, the patient received Havrix .5 ml. In May 2018, 4 days after receiving Havrix, the patient experienced neck pain, fatigue, fever, general body pain, lymph node pain and headache. On an unknown date, the outcome of the neck pain, fatigue, fever, general body pain, lymph node pain and headache were recovering/resolving. It was unknown if the reporter considered the neck pain, fatigue, fever, general body pain, lymph node pain and headache to be related to Havrix. Additional details were provided as follows: The reporter is the patient's father. The patient received Havrix in the right deltoid. On the same day, the patient also received Meningococcal vaccine (unspecified) concomitantly. The reporter noted, the patient received three additional vaccines two days after receiving Havrix. Vaccine names were not provided. Adverse events were improving since they began. The patient was taken to her doctor's office and tested for mono (mononucleosis), test results were negative. The patient was not hospitalized for treatment of any of the reported events. The contact details of the physician were provided. No additional information was provided. No further information would be available for the reported suspect vaccine and adverse event 'off label use'. The reported suspect vaccine (Twinrix) was changed to Havrix as per the batch number B2JH7. Lab Comments: On an unknown date, the patient underwent Mononucleosis (mono) test, which found as negative.
Age: 17.0
Sex: F
Vaccine: HEPA, MEN
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 17-year-old female patient who received Havrix (batch number B2JH7, expiry date 6th June 2020) for prophylaxis. On 22nd May 2018, the patient received Havrix .5 ml. In May 2018, 4 days after receiving Havrix, the patient experienced neck pain, fatigue, fever, general body pain, lymph node pain and headache. On an unknown date, the outcome of the neck pain, fatigue, fever, general body pain, lymph node pain and headache were recovering/resolving. It was unknown if the reporter considered the neck pain, fatigue, fever, general body pain, lymph node pain and headache to be related to Havrix. Additional details were provided as follows: The reporter is the patient's father. The patient received Havrix in the right deltoid. On the same day, the patient also received Meningococcal vaccine (unspecified) concomitantly. The reporter noted, the patient received three additional vaccines two days after receiving Havrix. Vaccine names were not provided. Adverse events were improving since they began. The patient was taken to her doctor's office and tested for mono (mononucleosis), test results were negative. The patient was not hospitalized for treatment of any of the reported events. The contact details of the physician were provided. No additional information was provided. No further information would be available for the reported suspect vaccine and adverse event 'off label use'. The reported suspect vaccine (Twinrix) was changed to Havrix as per the batch number B2JH7. Lab Comments: On an unknown date, the patient underwent Mononucleosis (mono) test, which found as negative.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pain, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included carvedilol, rosuvastatin calcium (Crestor), colecalciferol (Vitamin D3), ascorbic acid + carotenoids nos + copper + tocopherol + zeaxanthin + zinc (Areds 2), azilsartan medoxomil + chlortalidone (Edarbyclor) and acetylsalicylic acid (Low Dose Aspirin). On 2nd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd June 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain. On 4th June 2018, the patient experienced local swelling, localized erythema and pain localized. On 3rd June 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the local swelling, localized erythema and pain localized were unchanged. The reporter considered the injection site pain, local swelling, localized erythema and pain localized to be related to SHINGRIX. Additional details were provided as follows: At 15:00, the patient received SHINGRIX on the left arm. The patient reported that, on the day of vaccination, in the evening, he noticed soreness at the injection site. At the time of this report, 2 days after receiving Shingrix, the patient after getting back from work, noticed that on the back of his biceps he had big red bump which was painful and it was about the size of 3 inches in width and 5 inches in height. The patient had denied permission to contact their physician. All questions were asked however no further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. Concurrent medical conditions included allergy (Macrolide). On 31st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced headache, swelling arm, chills and fever. On an unknown date, the outcome of the headache, swelling arm, chills and fever were unknown. The reporter considered the headache, swelling arm, chills and fever to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that she was not aware of any other medication or medical history of the patient because the patient did not usually went to their pharmacy. The reporter declined to give other patient information. The reporter did not have any other information regarding outcome of adverse events at time of call.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included salbutamol sulphate (Albuterol), diazepam, lorazepam, omeprazole, ranitidine hydrochloride (Ranitidine), buspirone, budesonide + formoterol fumarate (Symbicort), tramadol and trazodone.  On 16th May 2018 14:30, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a day after receiving SHINGRIX, the patient experienced fever and chills. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever and chills were recovered/resolved. The reporter considered the fever and chills to be related to SHINGRIX. Additional information was reported as follows: The patient stated that he experienced fever and chills at midnight on the day of vaccination. The events fever and chills were intense for about 8 hours, and then he took Tylenol to help with his symptoms. The symptoms completely resolved within 2 days after receiving the vaccination. The patient gave permission to contact his physician.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 69-year-old female patient who received Shingrix (batch number AS9CM, expiry date 25th April 2020) for prophylaxis. On 31st May 2018 13:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 5 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. The reporter considered the rash to be possibly related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient was well and had no history of issues with prior vaccinations. The patient experienced a rash under her armpit between her trunk and groin 5 days after receiving her first Shingrix vaccination. The rash resolved within 1 day with no treatment required.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 75-year-old female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a month after receiving Shingrix, the patient experienced abdominal pain, general body pain and headache. On an unknown date, the outcome of the abdominal pain, general body pain and headache were unknown. It was unknown if the reporter considered the abdominal pain, general body pain and headache to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter indicated that she believes that her mother received the Shingrix vaccine approximately two weeks ago. The patient had been in the emergency room on three separate occasions since getting the vaccination. The first time she went to the emergency room she was experiencing a headache and body aches. On the date of reporting, the third visit to the emergency room and the patient was experiencing abdominal pain.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Decreased appetite, Injection site warmth, Malaise, Product quality issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 56-year-old female patient who received SHINGRIX) (batch number 32GR4, expiry date 4th July 2020) and (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. Concomitant products included ADACEL. On 26th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 26th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site warmth, appetite lost and feeling unwell. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site warmth, appetite lost, feeling unwell and pharmaceutical product complaint were unknown. The reporter considered the injection site warmth, appetite lost and feeling unwell to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on the right arm. The lot number of the adjuvant/liquid was D3L5G with an expiry of 11/29/2020. On the same day, the patient received the 1st dose of ADACEL on the left arm concomitantly. The patient experienced hot at injection site to touch, feeling sick, and loss of appetite after SHINGRIX vaccination. The pharmacist reported that he had been giving SHINGRIX injections since January 2018 and said that this last batch of SHINGRIX might be suspect. He reported that the patient experienced Adverse drug reactions (ADE's) unlike previous injections. The reporter did not have any product to return and was not seeking reimbursement. When asked, the pharmacist reported there was nothing unusual about the vials or the box. The side effect profile and percentages of ADEs experienced were reviewed. The pharmacist also reported via VAERS. This case is 1 of the 7 linked cases reported by the same reporter.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 81-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On 5th June 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 5th June 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 6th June 2018, the patient experienced injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and intramuscular formulation administered by other route were unknown. The reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was previouslly reported to physician. The reporter had a consumer that was administered the SHINGRIX vaccine subcutaneously instead of intramuscularly, which led to inappropriate route of vaccination. The day after receiving the SHINGRIX on 6th June 2018, the consumer experienced swelling, redness, and heat at the injection site. The information was transferred to the agency.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced chills and fatigue. On an unknown date, the outcome of the chills and fatigue were unknown. The reporter considered the chills and fatigue to be related to SHINGRIX. Additional details were provided as follows: Nurse reported to sales account manager that, she received SHINGRIX in the last couple of days and that evening of the vaccination she experienced chills that occurred again the following night. The patient also had fatigue. No further information available (all questions asked). This case has been linked with case US2018102548, reported by the same reporter.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Vertigo.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: PT RECEIVED FIRST DOSE AT MARCH AND STILL HAVE INJECTION SITE SWELLING.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Incomplete course of vaccination, Injection site pain, Pain, Pyrexia
Clinical narrative: Patient described she has been experiencing extreme soreness in the arm where shot was given, fever, chills, bodyaches for the last 2 days. I explained those can be side effects of SHINGRIX as stated in the on the vis. She stated that the reaction/side effects were so uncomfortable that she refuses to get the 2nd dose. I explained the importance of 2 doses, but stated that was ultimately her choice. I educated her that the side effects should go away on their own within 2-3 days, but that if they worsened or she developed any new symptoms to call her notify or seek medical care. She verbalized understanding, but again stated she would NOT be getting the 2nd dose. This is a newer vaccine, therefore I thought it important to share that this reaction from this client as you may still be collecting data on side effects, etc. and that people may refuse the 2nd dose if they experience those side effects.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Day one following injection, site looked like a big, bad bug bite. Day two was hard, red and HOT, and the size of a baseball. Day three was hard, red, hot and the size of a softball. Almost like it had a bulls eye around it. Day four was same size, however less intensity on redness and heat. It never really hurt him, just annoying. Day two we applied bentonite clay. Day three he took a bath with Epsom salts and a few oils. Day four he took the same bath with some bentonite clay added to it.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Pain
Clinical narrative: Patient entered pharmacy two days after vaccine. Symptoms described were body soreness and weakness. At injection site, redness presented about the an 2 inches in diameter around the injection site. Advised patient to see provider and watch for worsening symptoms. Two days later, patient returned to the pharmacy and site is still red and area of redness increased to about 3 inches. Advised patient again to go to provider.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient should have received pediatric dose and was administer adult dose. The patient didn't have an adverse reaction and no treatment was needed.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Swelling
Clinical narrative: Patient experienced severe local swelling, to the extent she could not put on a sleeve, redness and heat at the injection site. No throat invovement, or difficulty breathing. Patient was seen by her cardiologist for an unrelated issue, whom referred her immediately to her primary care provider.  Dr. diagnosed her as having cellulitis and prescribed an antibiotic.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site urticaria
Clinical narrative: Left upper arm urticaria at site, given in one arm due to struggle to give vaccines.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient reported Grade 3 arm pain lasting for approximately 1 month post vaccination. She described that she could not raise her arm up to comb her hair or over her head. The pain was severe and she needed assistance for activities of daily living. She did not report this to her medical provider and did not seek medical treatment. She described that it was worse in the morning and lessened by evening.  It is resolved for the most part as of today. She still has some pain when she raises it above her head but it is much less than her initial pain following the injection.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: Patient reported Grade 3 arm pain lasting for approximately 1 month post vaccination. She described that she could not raise her arm up to comb her hair or over her head. The pain was severe and she needed assistance for activities of daily living. She did not report this to her medical provider and did not seek medical treatment. She described that it was worse in the morning and lessened by evening.  It is resolved for the most part as of today. She still has some pain when she raises it above her head but it is much less than her initial pain following the injection.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient described Grade 3 arm pain lasting for approximately 1 month post vaccination. She was unable to perform activities of daily living such as combing her hair. She could not raise her arm up above her head. The pain was worse in the morning and subsided by the evening daily. She did not report this to her medical provider or seek medical attention. The pain has resolved almost completely but slightly painful to raise her arm over her head.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: Patient described Grade 3 arm pain lasting for approximately 1 month post vaccination. She was unable to perform activities of daily living such as combing her hair. She could not raise her arm up above her head. The pain was worse in the morning and subsided by the evening daily. She did not report this to her medical provider or seek medical attention. The pain has resolved almost completely but slightly painful to raise her arm over her head.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Injected limb mobility decreased, Injection site pain, Mobility decreased, Muscle spasms
Clinical narrative: First night, 3 different horrible leg cramps both legs, different sites. By am, both shoulders so sore couldn't raise my arms. Left shoulder hurt more than right. Also, really wierd ache in left side. Had to press in hard over heart, lung, to keep from hurting when walked. Stayed in a chair all day, didn't hurt to breath that way, or the minimal movement to read a book didn't hurt.  Next day, still couldn't raise arms  but didn't hurt as much, ditto with weird pain on left side. By 3rd day, still improving, but still couldn't easily brush hair, fasten hair back. Was 4th before was feeling ok to do normal routine.  Almost gone on 5th day, just twinges...md told me not to get 2nd shot...never had a reaction to one before.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: First night, 3 different horrible leg cramps both legs, different sites. By am, both shoulders so sore couldn't raise my arms. Left shoulder hurt more than right. Also, really wierd ache in left side. Had to press in hard over heart, lung, to keep from hurting when walked. Stayed in a chair all day, didn't hurt to breath that way, or the minimal movement to read a book didn't hurt.  Next day, still couldn't raise arms  but didn't hurt as much, ditto with weird pain on left side. By 3rd day, still improving, but still couldn't easily brush hair, fasten hair back. Was 4th before was feeling ok to do normal routine.  Almost gone on 5th day, just twinges...md told me not to get 2nd shot...never had a reaction to one before.
Age: 66.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm swelled from vaccinations site approx 2 inches below shoulder bone to elbow the following day (5/30/18). Symptoms include swollen, itchy, warm to touch. Treated with ice. The swelling has decreased since vaccination.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Feeding disorder, Hyperhidrosis
Clinical narrative: Patient experience burning during administration. For the 1st two days patient was weak and reported sleeping 15 to 16 hours per day while not being able to get out of bed. Patient had sweats, chills, nausea for 4 days and could not eat. In addition a migraine headache, upset stomach for 3 days and for a full 7 days the left side of the body hurt.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersomnia, Injection site pain, Migraine, Nausea, Pain
Clinical narrative: Patient experience burning during administration. For the 1st two days patient was weak and reported sleeping 15 to 16 hours per day while not being able to get out of bed. Patient had sweats, chills, nausea for 4 days and could not eat. In addition a migraine headache, upset stomach for 3 days and for a full 7 days the left side of the body hurt.
Age: 75.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain in extremity
Clinical narrative: Patient called on 06/14/2018 complaining of arm pain. Counseled patient to take otc pain meds until resolved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Malaise, Pyrexia
Clinical narrative: PATIENT IS A PHYSICIAN, AND SHE THOUGHT HER SIDE EFFECTS WERE SEVERE ENOUGH TO REPORT. PATIENT COMPLAINED OF SEVERE SWELLING AND REDNESS THAT WENT AROUND THE ENTIRE  CIRCUMFERENCE OF HER LEFT UPPER ARM. SHE ALSO EXPERIENCED EXTREME CHILLS AND FEVER AND SAID THAT IT TOOK HER SEVERAL HOURS TO GET COMFORTABLY WARM. SHE EXPERIENCED SEVERE MALAISE FOR SEVERAL DAYS AND WAS NOT ABLE TO DO ANYTHING AT HOME. HER SIDE EFFECTS WERE SEVERE ENOUGH TO LEAD HER TO QUESTION GETTING THE SECOND DOSE. SHE IS NOT SURE IF SHE WILL GET THE DOSE. AS A PHYSCIAN, SHE THOUGHT HER SIDE EFFECTS WERE MORE SEVERE THAN WHAT IS TYPICALLY EXPERIENCED AFTER A VACCINATION. SHE SELF-MONITORED HER SYMPTOMS UNTIL SHE RECOVERED AFTER A FEW DAYS.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, C-reactive protein, Differential white blood cell count, Dizziness, Full blood count
Clinical narrative: Patient started experiencing Headaches and dizziness and joint pain later in the day after vaccines.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Red blood cell sedimentation rate
Clinical narrative: Patient started experiencing Headaches and dizziness and joint pain later in the day after vaccines.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Intussusception, X-ray
Clinical narrative: Patient developed intussusception.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Viral titre increased
Clinical narrative: Sporadic fluid filled vesicles starting on head and moving down to torso.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pain in extremity, Pruritus generalised
Clinical narrative: Stinging sensation shortly after receiving injection. Next day symptoms evolved to include pruritus encompassing entire body, severe headache, severe arm pain.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: As of the morning of the day after vaccine was administered pt was with some 2cm indurated areas with superficial erythema over both thighs (antero lateral areas where imm were place yesterday). No fever. Mother to massage areas with cool compresses and administer TYLENOL PRN for pain.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Headache, Injection site pain, Malaise
Clinical narrative: Very sore arm at injection site almost immediately following vaccination. Soreness of muscles generally throughout my body the next day; even soreness of skin, akin to having the flu. Headache. "Wooziness."  Mild stomach upset. General malaise. Worst of the symptoms occurred beginning the morning of the day after vaccination and lasted approximately 2 days.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain of skin
Clinical narrative: Very sore arm at injection site almost immediately following vaccination. Soreness of muscles generally throughout my body the next day; even soreness of skin, akin to having the flu. Headache. "Wooziness."  Mild stomach upset. General malaise. Worst of the symptoms occurred beginning the morning of the day after vaccination and lasted approximately 2 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, MMRV
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Large area of redness and warmth at vaccine sites on left thigh. No induration, no signs of infection. Two injections were given in left thigh.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Arthralgia, Blood potassium increased, Diarrhoea, Dizziness
Clinical narrative: Nondescript symptoms including: stomach ache, fever, intermittent diarrhea, body aches, body rash, swelling of extremities, joint pain, feeling faint.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Peripheral swelling, Pyrexia, Rash generalised, White blood cell count decreased
Clinical narrative: Nondescript symptoms including: stomach ache, fever, intermittent diarrhea, body aches, body rash, swelling of extremities, joint pain, feeling faint.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Discomfort, Pruritus, Rash
Clinical narrative: 18 year old male presents today c/o rash on chest area that has been ongoing for the past 2weeks. Per pt states that he first noted the rash on the nipple and spread slightly to around the nipple area. Pt states that he has noted some itching, intermittent discomfort, however, denies any pain. Pt denies any fever, no body aches, no other lesions elsewhere. Pt did have varicella vaccine placed on 5/22 and about 1 week later rash was noted. Patient currently denies any other complaints or concerns.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site rash, Injection site warmth, Urticaria
Clinical narrative: PATIENT GOT A SMALL RASH AROUND THE INJECTION SITE THE DAY AFTER VACCINE WAS GIVEN, BUT ON 6/12/18 WENT TO THE DOCTOR AS THE RASH HAD GOTTEN TO BE AROUND 5 INCHES WIDE AND WAS WARM TO THE TOUCH. PATIENT ALSO REPORTED HIVES ALL OVER HER BODY AND CHILLS.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Dizziness, Panic attack
Clinical narrative: Dizziness followed by panic / anxiety attacks for about ten days. No history of anything related to panic / anxiety. Met with Doctors at Med. Center. Prescribed Ativan and Lexapro. Symptoms of anxiety alleviated but dizziness remains while driving auto.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: PT STATED THAT SHE DEVELOPED A RASH ON THE RIGHT ARM/BACK. SHE WENT TO HER PHYSICIAN AND WAS TOLD THAT IT WAS A MILD CASE OF SHINGLES. NO TREATMENT, MD TOLD PT THAT IT WAS GETTING BETTER.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient has a red mark on arm around the area of vaccine. Not painful, not itching but its noticable and it is rectangular in shape approzimately 3 inches in height and 5 inches in width going from outter arm diagnoally to inner arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient just reported arm pain that was "different" than what she has ever experienced with a vaccine.
Age: 70.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Patient developed a hot red rash over 1/3 of her arm from the HAVRIX immunization within one day. Reaction wasn't severe enough to seek medical attention.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itch, and soreness of left arm from shoulder to elbow starting the evening after receiving the SHINGRIX vaccine.
Age: 47.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Mobility decreased, Muscle tightness
Clinical narrative: Neck tightness, left and right trapezius tightness and inhibiting the movements. Took 2 tabs of Naproxen 220 mg.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling hot, Loss of consciousness, Tremor, Visual impairment
Clinical narrative: Within seconds of the fluid being released into my arm I starting having uncontrollable shaking in my legs and arms. I felt a rush of heat on my face and everything started to go black while my body was still jolting/shaking. It then followed by me losing consciousness. When I woke up I had no idea what had happened the last thing I remembered was the shaking and the darkness. The nurse told me I was almost going to fall off the bed.
Age: 5.0
Sex: M
Vaccine: TYP
Symptoms: Cough, Eye swelling
Clinical narrative: Within 40-50 min, pt was noted to have swollen left eye, cough, was advised to given EPIPEN JR and call 911 but 911 operator advised no EPIPEN JR. EMS gave 20 mg BENADRYL IM en route to ER, with resolution of symptoms while in the ER. No respiratory compromised, pt was discharged after 2 hr observation.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Insomnia, Nausea, Neck pain
Clinical narrative: Experienced nausea, excessive vomiting, HA and worsening of insomnia a week after vacc. In mid May, primary MD prescribed AMBIEN then later trazadone and assessed that vacc is culprit since there was no other change in medical profile. In June, severe dizziness and painful HA radiating from head to neck. Internist assessed vacc is cause of symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Experienced nausea, excessive vomiting, HA and worsening of insomnia a week after vacc. In mid May, primary MD prescribed AMBIEN then later trazadone and assessed that vacc is culprit since there was no other change in medical profile. In June, severe dizziness and painful HA radiating from head to neck. Internist assessed vacc is cause of symptoms.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Rash began 6-14-18. Vesicular, pruritic rash.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby
Clinical narrative: This serious clinical study case, received from other health professional on 31-May-2018, concerning a female infant subject whose mother (age: 29, body weight: 202 lbs, height: 62.2 inches, body mass index: 36.7) enrolled in study. The patient's mother had no history of pregnancies and family history had no congenital malformations. The patient's mother had no habit of tobacco, alcohol or illicit drug use. The history of the patient's mother included hypertension and concomitant medications included VITAFOL ONE for healthy pregnancy. The last menstrual period (LMP) of the patient's mother was reported as 20-Jul-2017. On 17-Oct-2017, the patient's mother was administered with Influenza vaccine (batch number: 00644623A, dose, route of administration, anatomical location and expiry date: not reported), at 12th week of pregnancy. On 17-Oct-2017, electrocardiogram (EKG) was performed and the result was normal (no major congenital malformations noted). On 24-Oct-2017, after 8 days of vaccination, the patient's mother was diagnosed with chronic hypertension. The patient's mother was treated with Labetalol (200 mg, twice daily via oral route since 08-Sep-2017) for chronic hypertension. On 24-Oct-2017, cystic fibrosis mutation analysis of the patient's mother was performed, the result was found to be normal (no major congenital malformations noted). On 25-Oct-2017, 1st trimester screen of the patient's mother was performed, the result was found to be normal (no major congenital malformations noted). The nature of pregnancy was reported as singleton. On 05-Dec-2017, the patient's mother had given the informed consent. On 20-Mar-2018, prenatal test of the patient's mother (Group B streptococcus agalactiae) was done which showed the result was normal (no major congenital malformation was noted). The estimated date of delivery (EDD) of the patient was 26-Apr-2018. In 2018, at 39.1 gestational age, the patient's mother gave birth to female infant (patient) of weight 2410 g (reported as low birth weight), length: 43.2 cm and head circumference was 34.0. Type of pregnancy was reported as caesarean. The APGAR (appearance, pulse, grimace, activity, and respiration) score at 1 minute was 7 and 5 minutes was 9. The patient had no pregnancy complications. This case was cross-linked to case 201703634 (mother case).