chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 12 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-NOV-2017, the patient was vaccinated with the improperly stored doses of GARDASIL 9 (dose and route of administration were not reported) (lot # N020352 and expiration date: 10-APR-2010) for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit or colder for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1711USA011244: US-009507513-1711USA011245: US-009507513-1711USA011243.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Seizure
Clinical narrative: This spontaneous report was received from a 21 year old female patient regarding herself, who was involved in Research. Information regarding her medical history, concomitant medications and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with GARDASIL (strength, dose, frequency, route of administration, lot# and expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced negative side effects (adverse event), including seizures. Outcome of the events were unknown. Causality assessment was not provided. Reporter considered the events to be medically significant. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1711USA008974.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 11 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-NOV-2017, the patient was vaccinated with the improperly stored doses of GARDASIL 9 (dose and route of administration were not reported) (lot # N020352 and expiration date: 10-APR-2010) for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit or colder for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1711USA011244: US-009507513-1711USA011245: US-009507513-1711USA003900.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of personal independence in daily activities, Musculoskeletal pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: Really sore shoulder, arm. Cannot lift anything with arm, dress easily. Has been taking NORCO 5-325 for pain. Will see Dr. next week to evaluate. No site inflammation, redness, etc.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 6 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-NOV-2017, the patient was vaccinated with the improperly stored doses of ROTATEQ (dose and route of administration were not reported) (lot # N014980 and expiration date: 16-NOV-2018) for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit or colder for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of 4 reports received from the same reporter.; Sender's Comments: US-009507513-1711USA003900: US-009507513-1711USA011245: US-009507513-1711USA011243:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 12 weeks old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-NOV-2017, the patient was vaccinated with the improperly stored doses of ROTATEQ (dose and route of administration were not reported) (lot # N014980 and expiration date: 16-NOV-2018) for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit or colder for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of 4 reports received from the same reporter.; Sender's Comments: US-009507513-1711USA011244: US-009507513-1711USA003900: US-009507513-1711USA011243:
Sex: U
Vaccine: PNC13
Symptoms: Meningitis pneumococcal
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 13-month-old patient of an unspecified gender, race and ethnicity received three doses of PREVNAR 13, all on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pneumococcal meningitis. Clinical outcome was unknown at time of this report. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative serotype results and vaccination schedule are needed for full medical assessment.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable physician (patient's parent). An 18-year-old female patient of an unspecified ethnicity received the second dose of TRUMENBA, via an unspecified route of administration on 17Nov2017 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced injection site reaction five inches by three inches in size, with redness, induration, and warmth to touch. The physician inquired if should be concerned about such a large and severe reaction. Outcome of the events was unknown. Information on lot number and expiration date of the vaccine has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist  reported similar events for two patients (husband and wife). This is the 2nd of two reports (referred to the wife). This female patient of an unspecified age, race and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced localized redness and swelling that lasted a few days. Patient referred to Urgent Care physician office and she was treated with diphenhydramine hydrochloride (BENADRYL).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017502081 same reporter/drug/event, different patient.
Sex: F
Vaccine: PNC13
Symptoms: Biopsy skin abnormal, Dermatitis contact, Rash
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program received from a non-contactable consumer (reporting for herself). A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 20Oct2017 at a single dose for pneumonia. The patient's medical history was and concomitant medications were not reported. On an unspecified date, the patient experienced rash underneath her breasts. They took biopsy and said it was contact dermatitis. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a Spontaneous report based on the information received by Pfizer from Merck & Co., Inc. [Case Number: 00645621]. A non- contactable female nurse (reporting for herself). A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 08Nov2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 08Nov2017, the patient felt pain as pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) was being injected. On 09Nov2017, the patient continued to feel pain in the injection area and it appeared as a red swollen circle about 2 inches in diameter. The site was still painful the next day, 10Nov2017. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. A 7-decade-old female patient of an unspecified ethnicity received PREVNAR 13 , via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported back to her doctor that after receiving her pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) shot, that she ran a fever and was nauseous on an unspecified date. Outcome of the events was unknown. The information on the batch number and expiration date has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Headache, Muscle tightness
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (Case number # 00658249). A contactable Female consumer reported that: Description: The primary reporter is the patient (Name) at (Phone number) (Full demographics not provided). The patient mentioned that she is experiencing headaches and her "muscles are tight" after receiving PREVNAR 13. The patient mentioned that the tightness transitions throughout the body. The patient stated she had two shots administered; the first shot on 21Sep2016 and a second shot on 28Oct2017. No PQC involved. No additional AE information provided. Product: Product: Prevnar Product Circular # Not Applicable Lot Number: Unknown by Reporter Expiration Date: Unknown by Reporter Dose/Frequency: Unknown by Reporter/See AE description Manufacturer (if available). The information listed above is all data we have received. Please do not contact Merck & Co., Inc. for additional information. Any follow-up information received by Merck & Co., Inc. regarding this case will be forwarded to you upon receipt. Please note that this information has not been reported to the FDA. Information regarding batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration in the arm, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced behind the arm it was red swollen and in pain. It lasted about a week.
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report  obtained from a contactable pharmacist through a Pfizer sales representative. This pharmacist reported the same adverse event for three patients. This is the first of three reports. A female patient of an unspecified age, race and ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain and soreness of the arm where the vaccine was injected. Clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017505508 Same reporter/drug/event, different patients;US-PFIZER INC-2017505482 Same reporter/drug/event, different patients.
Sex: M
Vaccine: PNC13
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report  obtained from a contactable pharmacist through a Pfizer sales representative. This pharmacist reported the same adverse event for three patients. This is the third of three reports. A male patient of an unspecified age, race and ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain and soreness of the arm where the vaccine was injected. Clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017505508 Same reporter/drug/event, different patients;US-PFIZER INC-2017505472 Same reporter/drug/event, different patients.
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report  obtained from a contactable pharmacist through a Pfizer sales representative. This pharmacist reported the same adverse event for three patients. This is the second of three reports. A female patient of an unspecified age, race and ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain and soreness of the arm where the vaccine was injected. Clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017505472 Same reporter/drug/event, different patients;US-PFIZER INC-2017505482 Same reporter/drug/event, different patients.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Biopsy skin abnormal, Dermatitis, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old Caucasian female patient received the first dose of PREVNAR 13, via an unspecified route of administration on 29Oct2017 at single dose in upper right arm for immunisation. Medical history included hypertension, thyroid disorder and gastrooesophageal reflux disease. Concomitant medication included oral metoprolol succinate (TOPROL XL, tablet, 50 mg) 50 mg for hypertension, oral triamterene (TRIAMTERENE, tablet, 37.5 mg), 37.5 mg every other day, for hypertension, oral thyroid (ARMOUR THYROID, tablet, 1 g) 1 g, once a day for thyroid disorder, oral pantoprazole (unknown manufacturer, tablet, 40 mg) 40 mg daily, oral progesterone (unknown manufacturer, 100 mg, capsules capsule) 100 mg, daily as hormone therapy. The patient experienced rash underneath breast on 30Oct2017 with outcome of not recovered, it just won't go away and it hurts with the vengeance and dermatitis both on an unspecified date in 2017 with outcome of unknown. The patient thought that Rash was a yeast infection but turned out it was not. So the patient treated rash by applying on it Nystatin cream 30 g twice daily, Vusion Ointment 50 g, twice a day, Hydrocortisone 0.2 percent twice daily for 4 days, Hydrocortisone 0.5 percent one time a day, Eucrisa and Ketoconazole Cream 2 percent, twice a day but none of these creams have worked. The patient took also a tablet of fluconazole just once, as she reported that's all you required if you have a yeast infection apparently. But then she took them also two weeks after. Furthermore she orally took a dose pack of Methylprednisolone, Methylprednisolone 4 mg dose pack 21 tablets. The patient did a biopsy in 2017 to make sure it was not something weird, it just said dermatitis.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Injection site pain, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 71-year-old female patient received PREVNAR 13 as Pneumonia prevention on 17Nov2017 at single dose in the left arm via unspecified route. Concomitant medications included omega-3-acid ethyl ester (LOVAZA) for High cholesterol and high triglycerides at 1000mg, capsule, takes two capsules in the morning total dose of 2,000mg, pravastatin to control high cholesterol at 80mg, lithium carbonate for Bipolar disorder at 300 mg, lamotrigine for depression 200 mg, Levothyroxine for low thyroid and for depression at 25 ug, linaclotide (LINZESS) for  constipation 145 ug, plantago ovata (METAMUCIL) to prevent colon cancer and to fight constipation, docusate sodium (COLACE) for Constipation 100mg twice a day, ascorbic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate  (SUPER B COMPLEX) to keep her brain healthy so antidepressants work better, xantofyl (LUTEIN) 25 plus and Xanthan for Eye health, Glucosamine Hydrochloride, Chondroitin Sulfate Sodium for Sore knees, Calcium with Vitamin D and Minerals to prevent osteoporosis,  Magnesium acetylsalicylic acid (BABY ASPIRIN).  Relevant medical history included High cholesterol diagnosed about 10 or more years ago, High triglyceride diagnosed about 10 or more years ago, bipolar disorder diagnosed around 5 years, depression (From: 1999) Hospitalized in 1965 but it was not called depression, the patient was probably depressed since being a preteen, it has been a long standing problem, Low thyroid (From: May 2017), Constipation diagnosed when she was in college, Sore knees, Osteoporosis  diagnosed about 15 years ago with osteoporosis, has received shot that helped reverse it, the patient was on Forteo for 2 years, which reversed osteoporosis to osteopenia at the end of the shots of Forteo. It has stayed stable to osteopenia, Lymphedema (From: Jan 2001) and the patient had two Staph infections. One in May2017 or Jun2017, she had to go to wound care to clear it up. Before this in Mar2017 until Jun2017 the Staph infections required 2 hospitalizations. On 21Nov2017 the patient experienced pain in the injection with outcome of not recovered, he had mild systemic problems from 17Nov2017 to 18Nov2017 with outcome of recovered, small bruise on 21Nov2017 with outcome of recovering and Vaccination site warmth on 21Nov2017 with outcome of not recovered.
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Rash
Clinical narrative: Rash at or around injection site area and traveled up around neck. Patient's daughter notified us on 11-16-17.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Left arm swelling, redness and warm and pain. These symptoms started with in 6 hours after she was given PPV23. Patient was advised to take BENADRYL 50mg-4 x's a day.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Pallor
Clinical narrative: Shortly after flu vaccine was administered, pt turned pale white and passed out. Recovered but stated she was dizzy and labored breathing as well could answer basic question somewhat. After 3-4 min, condition worsened and BP was checked and found to be 53/37. Epinephrine 0.3 mg was administered and pt recovered quickly. EMS arrived 10 min later and took to hospital.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site bruising, Vaccination site nodule, Vaccination site rash
Clinical narrative: Redness, rash, bruising and a knot in her arm where she received the vaccine that lasted a week.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site reaction in an unspecified number of patients who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to Flu trivalent vaccine. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that she was not sure, but there might had been an increased rate of localized injection site reactions at her facility with quadrivalent FLUARIX in patients compared to trivalent flu vaccines. The reporter stated that she was not sure of how many patients may had been affected. This case is linked with US2017GSK180863, as reported by same reporter for different suspect.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Encephalitis autoimmune, Headache, Laboratory test, Malaise, Tension headache
Clinical narrative: Patient received a flu shot on 9/22/17 at approximately 10am. She began to feel ill the next day. On 9/26 she came to the office with headache-for 4 days on top of head and behind eyes; worse at night. She was diagnosed with acute non-intractable tension headache. NSAID and FLEXERIL were prescribed. On 9/28 the headaches worsened to severe. Patient was seen in the ER and given IV fluid, MOTRIN and BENADRYL (per the husband). She was released home. The next morning patient was not responsive, not alert to person place or time at home and an ambulance was called. She was hospitalized at hospital in the Infectious Disease ward (per the husband). He stated that many tests were performed. High dose steroids and antibiotics were prescribed and slow recovery occurred over 7 days. The patient was recently released from the hospital and is following up with a neurologist. The discharge papers stated the diagnosis was autoimmune encephalitis related to vaccination.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Unresponsive to stimuli, Vaccination complication
Clinical narrative: Patient received a flu shot on 9/22/17 at approximately 10am. She began to feel ill the next day. On 9/26 she came to the office with headache-for 4 days on top of head and behind eyes; worse at night. She was diagnosed with acute non-intractable tension headache. NSAID and FLEXERIL were prescribed. On 9/28 the headaches worsened to severe. Patient was seen in the ER and given IV fluid, MOTRIN and BENADRYL (per the husband). She was released home. The next morning patient was not responsive, not alert to person place or time at home and an ambulance was called. She was hospitalized at hospital in the Infectious Disease ward (per the husband). He stated that many tests were performed. High dose steroids and antibiotics were prescribed and slow recovery occurred over 7 days. The patient was recently released from the hospital and is following up with a neurologist. The discharge papers stated the diagnosis was autoimmune encephalitis related to vaccination.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Crying, Decreased appetite, Insomnia, Irritability, Pyrexia
Clinical narrative: Fever for 2-3 days (101.7*), fussiness - didn't sleep for more than 5 minute increments for 2 nights (fun), Poor appetite, vomit (once), non-stop crying for 3 hours from 7-11 pm and then broken sleep through the morning.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Fever for 2-3 days (101.7*), fussiness - didn't sleep for more than 5 minute increments for 2 nights (fun), Poor appetite, vomit (once), non-stop crying for 3 hours from 7-11 pm and then broken sleep through the morning.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Skeletal injury, Syringe issue, Wrong technique in product usage process
Clinical narrative: Pharmacist went to give injection and the plunger would not depress, pharmacist then stated that he would get another injection and pulled the needle out and Pharmacist got another injection and then continued with new injection. The patient then said that the new injection hurt at which time the pharmacist replied I think it hit the bone. The patient now states it hurts to raise her arm above her shoulder.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Pain
Clinical narrative: Bad Headache and body aches the night of vaccine. Felt a bit better the next day but still lingering headache.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, stomach pain reported by mother and patient. Patient directed to exam room. Notified doctor who advised for monitoring. Obtained vital signs which were within normal limits. Gave Gatorade, crackers. Monitored patient for 30 minutes. After monitoring patient stated that he felt better, symptoms where no longer present. Allowed to leave facility with mom.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given vaccines on 11/22/2017, and came in for check up on 11/24/17 indicating that her left arm started swelling and becoming red the following day. Patient had also indicated that the right arm was very painful. Exam revealed that the left medial upper arm was noted to have a 4-5 cm circular, red warm swollen area. The left bicep was measured and noted to be 14 inches in circumference while the right bicep measures 13.5 inches in circumference. Left arm has mild pain on palpation. Right arm has no erythema and no pain noted. Diagnosed with cellulitis of left arm and given script for cephalexin 500 mg one tablet twice a day for 10 days and to return to the office on Monday 11/27/17 for recheck. Patient was seen 11/27/17 and there was improvement noted. Patient is to finish the antibiotics and call if problems reoccur or become worse.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient was given vaccines on 11/22/2017, and came in for check up on 11/24/17 indicating that her left arm started swelling and becoming red the following day. Patient had also indicated that the right arm was very painful. Exam revealed that the left medial upper arm was noted to have a 4-5 cm circular, red warm swollen area. The left bicep was measured and noted to be 14 inches in circumference while the right bicep measures 13.5 inches in circumference. Left arm has mild pain on palpation. Right arm has no erythema and no pain noted. Diagnosed with cellulitis of left arm and given script for cephalexin 500 mg one tablet twice a day for 10 days and to return to the office on Monday 11/27/17 for recheck. Patient was seen 11/27/17 and there was improvement noted. Patient is to finish the antibiotics and call if problems reoccur or become worse.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: I'm unsure of the maker/type of flu vaccine I was given. However, when the vaccine was placed I could immediately tell something was wrong. Working in a hospital, I have to get these every year. This time the injection was excruciatingly painful and I could tell it was not placed properly. Subsequent to the vaccination, I have experienced pain in my shoulder with decreased range of motion. It is almost 2 months post injection and I am still experiencing these symptoms.
Age: 28.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Acne, Injection site pain
Clinical narrative: Pimple-like bumps on both sides of the face and on chin, consistent dull pain on exactly the same spot the shot was given.
Age: 28.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Pain in extremity
Clinical narrative: Pimple-like bumps on both sides of the face and on chin, consistent dull pain on exactly the same spot the shot was given.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a physician and described the occurrence of injection site reaction in a patient who received KINRIX (batch number 74G79, expiry date unknown). On an unknown date, the patient received KINRIX (intramuscular). On an unknown date, unknown after receiving KINRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to KINRIX. Additional details were provided as follows: This case was previously reported to manufacturer. The age at vaccination was not reported. The patient did not received any other vaccinations 4 weeks prior to the date. The patient did not had illness at the time of vaccination. The patient had no preexisting physician diagnosed allergies, birth defects and medical conditions. The patient experience severe local reaction.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Burning sensation, Feeling hot, Lip erythema, Lip swelling
Clinical narrative: No local rxn of site of injection - 11/10 next day 2:30-Whole body burning, heat, achy requiring a cool shower - lip swelling and red - jaw discomfort sinus pressure - 11/27 GI upset, jaw discomfort still - Patient has been in contact w/Dr sine 11/10.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in jaw, Paranasal sinus discomfort
Clinical narrative: No local rxn of site of injection - 11/10 next day 2:30-Whole body burning, heat, achy requiring a cool shower - lip swelling and red - jaw discomfort sinus pressure - 11/27 GI upset, jaw discomfort still - Patient has been in contact w/Dr sine 11/10.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Patient came in office with red reaction 3 inch wide 4 inch long.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Fever. This case was reported by a consumer via other manufacturer and described the occurrence of fever in a female patient who received BEXSERO.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Heart rate increased, Lip swelling, Listless, Nausea
Clinical narrative: Listlessness, nausea/diarrhea, fast pulse, these lasted about 4 days, on the 5th day my lips swelled up a bit.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest X-ray abnormal, Pneumonia
Clinical narrative: Patient diagnosed with pneumonia after X-ray diagnosis. Patient had complete physical when administered. Health excellent. Flu vaccine given at same time.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, pain and redness from shoulder to elbow.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypoaesthesia, Injection site pain, Injection site warmth, Neuralgia, Pain in extremity
Clinical narrative: Received shot in left arm, more pain than usual at shot site, shot site hot, couple hours later my index and middle finger went numb, arm started to hurt, next day whole arm was numb! I'm assuming this was because he hit a nerve. I called pharmacy and reported it to the Dr. Also, called the insurance Nurse. She recommended I go to emergency care. I did not. The third day my arm felt almost normal. Fourth day arm was back to normal. I feel compelled to report this so it doesn't happen to anyone else.
Age: 45.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Cough, Joint range of motion decreased, Malaise, Pyrexia, Rash
Clinical narrative: Patient reported on 11/20/17 to clinic that on 11/8/17 after receiving vaccines she began to feel ill. By 11/10/17 she had a 101 degree fever and increased to 103 over the next 3 days. She reported having a cough, rash with spots on her body, and could not move her joints. She reported taking ibuprofen and fever went down. By 11/18 her spots/rash had almost disappeared and no report of fever. Patient did not see a healthcare provider.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site discomfort, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Patient has had continual pain, discomfort, inflammation and redness at injection site since the vaccination date.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site reaction, Injection site swelling, Injection site urticaria, Local reaction
Clinical narrative: Local site reaction, large welt and swelling.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site joint pain, Injection site pain, Insomnia
Clinical narrative: Normal injection type pain-within 1 hr difficulty raising arm- pain in shoulder. Within 2 hrs can't shift pain increases going down arm. TYLENOL-can't sleep-pain, numbness, tingling down to finger tips. Ice packs, pain pill at 2 am. Can't use arm-extreme shoulder pain. Ache all down arm. Started to get some use of arm back Day 4. Still pain and limited use. Sometimes burning pain-sometimes ache. 11/26 I got this shot on 11/15-It is 11/26. I am still having pain in my shoulder and elbow joints and upper arm muscle. I cannot sleep on my right side as it hurts too much. The pain isn't as severe but it is still painful. This is so not right-what has happened to my shoulder and arm?
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Normal injection type pain-within 1 hr difficulty raising arm- pain in shoulder. Within 2 hrs can't shift pain increases going down arm. TYLENOL-can't sleep-pain, numbness, tingling down to finger tips. Ice packs, pain pill at 2 am. Can't use arm-extreme shoulder pain. Ache all down arm. Started to get some use of arm back Day 4. Still pain and limited use. Sometimes burning pain-sometimes ache. 11/26 I got this shot on 11/15-It is 11/26. I am still having pain in my shoulder and elbow joints and upper arm muscle. I cannot sleep on my right side as it hurts too much. The pain isn't as severe but it is still painful. This is so not right-what has happened to my shoulder and arm?
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 02-NOV-2017, the patient was vaccinated with an expired dose of M-M-R II lot # L041456 (expiration date: 22-OCT-2017) (route of administration and frequency were not reported) for prophylaxis. No adverse effects were reported.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram head abnormal, Disorientation, Hypoaesthesia, Motor dysfunction, Muscular weakness
Clinical narrative: 3 hours after administration of the influenza vaccine, experienced onset of right hand numbness and sensation and weakness. Traveled to right arm. Over next 36 hours had numbness and sensitivity spread to upper chest, upper back, across entire chin (left ear to right ear), down left arm and left hand. Had decrease in spatial awareness but no impairment. Problems with finger grasping thin objects such as a piece of paper. Admitted to hospital S/P abnormal brain CT. Brain MRI revealed hyperintensity lesions. Further assessment in progress to assess for demyelination. Waiting for neurology appt. 11/30.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal, Sensory disturbance
Clinical narrative: 3 hours after administration of the influenza vaccine, experienced onset of right hand numbness and sensation and weakness. Traveled to right arm. Over next 36 hours had numbness and sensitivity spread to upper chest, upper back, across entire chin (left ear to right ear), down left arm and left hand. Had decrease in spatial awareness but no impairment. Problems with finger grasping thin objects such as a piece of paper. Admitted to hospital S/P abnormal brain CT. Brain MRI revealed hyperintensity lesions. Further assessment in progress to assess for demyelination. Waiting for neurology appt. 11/30.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: Diffuse papular erythematous rash on face and body, itchy. No fever.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: PATIENT'S HUSBAND CAME TO PHARMACY AND SAID THE SHOT WAS GIVEN IN BURSA OF SHOULDER, ONLY ONE FINGER DOWN FROM SHOULDER INSTEAD FOR 3 FINGERS DOWN. HE SAID SHE HAD BEEN IN PAIN SINCE THE SHOT AND WANTED RELIEF FROM THE PAIN. SHE IS NURSE AND SAID HER RESEARCH RECOMMENDED A STEROID SHOT. SHE IS GOING TO DOCTOR FOR STEROID SHOT TODAY.
Age: 76.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: 1-2 hours after administration there was warmth and redness at the injection site. Later that evening the area became more inflamed and began to itch the only relief came from icing the area. As of 11/10/17 the area was better but still slightly red and itchy. As of today reaction has resolved.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: The patient called the pharmacy on 11-27-17. She said she has experience severe pain and stiffness in her right arm since receiving PNEUMOVAX. She also received the flu shot in her left arm on the same day and has no complaints. I recommended taking TYLENOL (she cannot take NSAIDs due to kidney problems) and ice. I told her to contact her primary care provider for further care.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Pain in shoulder, unable to lift arm above head.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: During the vaccination noted that the vaccine burned similarly to antibiotic injection and there was a sensation of receiving vaccination in multiple sites on the upper arm. Normal pain in upper arm following vaccination, but the pain did not subside rather increased until I was feeling pain down the back of my arm, through my elbow and wrist and down through my left ring finger. Pain is not constant but present when I try to reach above my shoulder or behind and to my left as in reaching onto the backseat of a car to pick something up. It is consistent when I try to sleep on my left side. Some days are definitely worse than others.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Fatigue, Full blood count normal, Hypersomnia, Irregular breathing
Clinical narrative: On 10/28/17 at 8:45 am, my son received the flu shot. On 10/29/17 at 7:30 am, we woke to my son convulsing and having erratic breathing. The seizure lasted about 2 minutes. After the seizure, he lost consciousness for about 3 minutes. During the seizure, we called 911. The paramedics arrived a minute into him going unconscious. When he regained consciousness, his eyes were focused in one area for long periods of time. He did not register anyone or respond to my voice or his father's. The paramedics took his vitals upon arrival and they were normal. We were taken to the emergency room. They took his temperature and it was 102 degrees F. They gave him children's TYLENOL rectally. They also did blood work. Everything came back normal. We stayed there for about 5 hours so they could monitor him. His fever went down to normal after 30 minutes and he went back to his normal self. He was very tired and slept most of the time at the hospital. After leaving the hospital, he developed a cough and a cold which lasted about a week. He had a fever on and off for 3 days. We continued giving him TYLENOL every 5-6 hours for 3 days.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Nasopharyngitis, Pyrexia, Seizure, Staring
Clinical narrative: On 10/28/17 at 8:45 am, my son received the flu shot. On 10/29/17 at 7:30 am, we woke to my son convulsing and having erratic breathing. The seizure lasted about 2 minutes. After the seizure, he lost consciousness for about 3 minutes. During the seizure, we called 911. The paramedics arrived a minute into him going unconscious. When he regained consciousness, his eyes were focused in one area for long periods of time. He did not register anyone or respond to my voice or his father's. The paramedics took his vitals upon arrival and they were normal. We were taken to the emergency room. They took his temperature and it was 102 degrees F. They gave him children's TYLENOL rectally. They also did blood work. Everything came back normal. We stayed there for about 5 hours so they could monitor him. His fever went down to normal after 30 minutes and he went back to his normal self. He was very tired and slept most of the time at the hospital. After leaving the hospital, he developed a cough and a cold which lasted about a week. He had a fever on and off for 3 days. We continued giving him TYLENOL every 5-6 hours for 3 days.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: On 10/28/17 at 8:45 am, my son received the flu shot. On 10/29/17 at 7:30 am, we woke to my son convulsing and having erratic breathing. The seizure lasted about 2 minutes. After the seizure, he lost consciousness for about 3 minutes. During the seizure, we called 911. The paramedics arrived a minute into him going unconscious. When he regained consciousness, his eyes were focused in one area for long periods of time. He did not register anyone or respond to my voice or his father's. The paramedics took his vitals upon arrival and they were normal. We were taken to the emergency room. They took his temperature and it was 102 degrees F. They gave him children's TYLENOL rectally. They also did blood work. Everything came back normal. We stayed there for about 5 hours so they could monitor him. His fever went down to normal after 30 minutes and he went back to his normal self. He was very tired and slept most of the time at the hospital. After leaving the hospital, he developed a cough and a cold which lasted about a week. He had a fever on and off for 3 days. We continued giving him TYLENOL every 5-6 hours for 3 days.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint crepitation, Joint lock, Pain in extremity
Clinical narrative: Patient said after a week the  arm he received the vaccination in was sore and was told to watch arm and report back if any problems. Called back and was told to see his physician in case he had a reaction to the shot. Patient stated he we went to have the arm massaged and is still having problems with arm. States that arm is locking and making a clicking sound and going to doctor for an MRI to see what is the problem.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Adverse reaction, Biopsy, Blood thyroid stimulating hormone, Constipation, Diet refusal
Clinical narrative: Patient's upper right thigh, where the vaccines were administered, was damaged immediately. The indent has since "grown" to become deeper and has turned a deep blue in her leg. This is because the fatty tissue was damaged and dissolved at time of vaccination. She has not been able to build any muscle in this limb, due to the pain and discomfort of the injury. This has affected her mobile development. After the vaccination, patient developed a severe aversion to eating in all forms (breastfeeding, would refuse all bottles and supplementation and supplementation efforts, including pumped breast milk and several formulas, and later would refuse all solid food until about 9 months of age). She would eat just barely enough to survive, hence, she fell off the growth chart and stopped gaining weight for several months. She developed severe gastrointestinal issues, including reflux, slow stomach, etc. She stopped having bowel movements and has had adverse reactions to 4 common allergens.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Differential white blood cell count, Endoscopy upper gastrointestinal tract, Food aversion, Full blood count, Gastric emptying study
Clinical narrative: Patient's upper right thigh, where the vaccines were administered, was damaged immediately. The indent has since "grown" to become deeper and has turned a deep blue in her leg. This is because the fatty tissue was damaged and dissolved at time of vaccination. She has not been able to build any muscle in this limb, due to the pain and discomfort of the injury. This has affected her mobile development. After the vaccination, patient developed a severe aversion to eating in all forms (breastfeeding, would refuse all bottles and supplementation and supplementation efforts, including pumped breast milk and several formulas, and later would refuse all solid food until about 9 months of age). She would eat just barely enough to survive, hence, she fell off the growth chart and stopped gaining weight for several months. She developed severe gastrointestinal issues, including reflux, slow stomach, etc. She stopped having bowel movements and has had adverse reactions to 4 common allergens.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Gastric hypomotility, Gastrointestinal disorder, Gastrooesophageal reflux disease, Immediate post-injection reaction, Immunoglobulins
Clinical narrative: Patient's upper right thigh, where the vaccines were administered, was damaged immediately. The indent has since "grown" to become deeper and has turned a deep blue in her leg. This is because the fatty tissue was damaged and dissolved at time of vaccination. She has not been able to build any muscle in this limb, due to the pain and discomfort of the injury. This has affected her mobile development. After the vaccination, patient developed a severe aversion to eating in all forms (breastfeeding, would refuse all bottles and supplementation and supplementation efforts, including pumped breast milk and several formulas, and later would refuse all solid food until about 9 months of age). She would eat just barely enough to survive, hence, she fell off the growth chart and stopped gaining weight for several months. She developed severe gastrointestinal issues, including reflux, slow stomach, etc. She stopped having bowel movements and has had adverse reactions to 4 common allergens.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site atrophy, Injection site discolouration, Injection site discomfort, Injection site indentation, Injection site injury
Clinical narrative: Patient's upper right thigh, where the vaccines were administered, was damaged immediately. The indent has since "grown" to become deeper and has turned a deep blue in her leg. This is because the fatty tissue was damaged and dissolved at time of vaccination. She has not been able to build any muscle in this limb, due to the pain and discomfort of the injury. This has affected her mobile development. After the vaccination, patient developed a severe aversion to eating in all forms (breastfeeding, would refuse all bottles and supplementation and supplementation efforts, including pumped breast milk and several formulas, and later would refuse all solid food until about 9 months of age). She would eat just barely enough to survive, hence, she fell off the growth chart and stopped gaining weight for several months. She developed severe gastrointestinal issues, including reflux, slow stomach, etc. She stopped having bowel movements and has had adverse reactions to 4 common allergens.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site pain, Lipase, Metabolic function test, Mobility decreased, Red blood cell sedimentation rate
Clinical narrative: Patient's upper right thigh, where the vaccines were administered, was damaged immediately. The indent has since "grown" to become deeper and has turned a deep blue in her leg. This is because the fatty tissue was damaged and dissolved at time of vaccination. She has not been able to build any muscle in this limb, due to the pain and discomfort of the injury. This has affected her mobile development. After the vaccination, patient developed a severe aversion to eating in all forms (breastfeeding, would refuse all bottles and supplementation and supplementation efforts, including pumped breast milk and several formulas, and later would refuse all solid food until about 9 months of age). She would eat just barely enough to survive, hence, she fell off the growth chart and stopped gaining weight for several months. She developed severe gastrointestinal issues, including reflux, slow stomach, etc. She stopped having bowel movements and has had adverse reactions to 4 common allergens.