chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: F
Vaccine: IPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Immunization given too early, invalid dose.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Incorrect diluent used.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Day after administration of seasonal influenza vaccine, employee reported to Employee Health Nurse with red and inflamed skin running from right side of neck to right elbow. Employee reported it started approximately 5-6 hours after vaccination. When she presented to Employee Health, it was no longer spreading per employee. Recommended anti-histamine. Resolved within a few days.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Electroencephalogram normal, Seizure
Clinical narrative: Mother of infant states infant received vaccines 7/11/2017 around noon and she had been giving her Tylenol every 4 hours until she fell asleep for the night. She woke up at 2 am infant was having seizure and her temp was 106, she called PCP, who instructed her to take infant to ER. She stayed in ER until temp was down to 102 and then was sent home to be taken to other hospital on 7/12/2017. States hospital did testing, observed the infant and EEG for 48 hours. Hospital informed her that there was no abnormal brain activity and no further seizures noted.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Injection site erythema, Injection site reaction, Rash pruritic
Clinical narrative: Patient woke up Saturday morning after receiving the flu shot with her left arm bruised with some redness and an itchy rash that wnt down her entire left arm.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: No immediate reaction. 2 days after injection client noted red, swollen area at injection site. Client sates this has never happened before. Client states she will send pic of it to telehealth provider for her employer if it does not resolve today.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Contusion, Erythema, Pain, Skin mass
Clinical narrative: Pain, redness, knot under skin, warmth, bruise and temp 100.7.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Pain, redness, knot under skin, warmth, bruise and temp 100.7.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: After receiving the vaccine on Friday, the patient broke out in hives on Saturday evening on her arms and chest. She reported some itching, but no trouble breathing was noted. She used diphenhydramine and a few unknown anti-itch lotions with only marginal effect.
Age: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Erythema, Laboratory test, Pain, Skin test, Swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient of an unspecified ethnicity received PREVNAR 13 (lot number: S58702, expiry date: Aug2019, NDC number: 00005197102), intramuscular in the right deltoid at a single dose for immunization, and influenza vaccine (FLU SHOT), via an unspecified route of administration, dose, frequency and indication, both vaccines administered on 12Oct2017. Vaccines were administered in the pharmacy/drug store. Medical history included asthma that was diagnosed 5 years ago, unspecified allergy, and stomach issues described as stomach issues as far as acid that started one year ago. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) inhaler (strength: 200/25 unit not provided) for asthma. The next day after vaccination (13Oct2017), the patient was a little sore but it was not red or swollen. The day after (14Oct2017), it started swelling and getting really red, it was about 3 by 3, the size of the area. The outcome of the events was not recovered and it was reported that the events worsened. No treatment reported for the events. The patient did a skin test and some kind of lab work to find out if she was allergic to Penicillin. The test was about a week ago and the patient had not received the result yet.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Febrile convulsion
Clinical narrative: This is a spontaneous report from a contactable consumer. A 15-month-old female patient of an unspecified ethnicity received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration, in 2017, as single dose for immunization and influenza vaccine (MANUFACTURER UNKNOWN), via an unspecified route of administration, in 2017, as single dose for immunization. The patient's medical history and concomitant medications were not reported.  On the same day as the immunization, later that night the patient experienced febrile seizure in 2017.  The mother of the patient stated that her daughter was fine after her temperature came down. The clinical outcome of febrile seizure was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Cough, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer reported for himself. This 65-year-old male patient received in Mar2017 a single dose of PREVNAR 13 as injection in the left arm since had a cough and thought would help. Medical history included ongoing diabetes since 2015, ongoing blood pressure high since 2017, ongoing high cholesterol and high triglycerides since 2010 and sleep disorder. Concomitant medications included ongoing gemfibrozil and metformin for diabetes, ongoing atorvastatin calcium, ongoing lisinopril, zolpidem tartrate (AMBIEN) for sleep disorder, ongoing glimepride and insulin. The patient reported that in Mar2017 when he got the injection he had severe pain in the left arm where the injection site was which has continued up until now. Within 24hrs he had pain in joints and muscles. His left arm now hurts severely in the evenings from his joints down from his shoulder to fingers. It hurts in his wrist and shoulder. It continued to hurt at the site of injection. He has limited arm motion with left arm. He cannot use the left arm to reach up when in the grocery store. The pain has radiated from the shoulder to finger tips. He has had X-Rays of the arm (date not reported) and he will have a CAT scan of the left arm. He has never had pain like this. He had soreness and redness on injection. No longer has the redness. It went away a few weeks (unknown date in 2017). All events started within 24HRS of receiving the vaccine (Mar2017). Completely recovered from the redness. All other events were not recovered.
Sex: M
Vaccine: PNC13
Symptoms: Myalgia, Pain in extremity, X-ray limb
Clinical narrative: This is a spontaneous report from a contactable consumer reported for himself. This 65-year-old male patient received in Mar2017 a single dose of PREVNAR 13 as injection in the left arm since had a cough and thought would help. Medical history included ongoing diabetes since 2015, ongoing blood pressure high since 2017, ongoing high cholesterol and high triglycerides since 2010 and sleep disorder. Concomitant medications included ongoing gemfibrozil and metformin for diabetes, ongoing atorvastatin calcium, ongoing lisinopril, zolpidem tartrate (AMBIEN) for sleep disorder, ongoing glimepride and insulin. The patient reported that in Mar2017 when he got the injection he had severe pain in the left arm where the injection site was which has continued up until now. Within 24hrs he had pain in joints and muscles. His left arm now hurts severely in the evenings from his joints down from his shoulder to fingers. It hurts in his wrist and shoulder. It continued to hurt at the site of injection. He has limited arm motion with left arm. He cannot use the left arm to reach up when in the grocery store. The pain has radiated from the shoulder to finger tips. He has had X-Rays of the arm (date not reported) and he will have a CAT scan of the left arm. He has never had pain like this. He had soreness and redness on injection. No longer has the redness. It went away a few weeks (unknown date in 2017). All events started within 24HRS of receiving the vaccine (Mar2017). Completely recovered from the redness. All other events were not recovered.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: Diagnosed with bells palsy.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Dysarthria, Electrocardiogram normal, Eyelid function disorder
Clinical narrative: Diagnosed with bells palsy.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis, X-ray normal
Clinical narrative: Diagnosed with bells palsy.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site joint pain, Limb injury
Clinical narrative: Patient immediately had soreness and pain in the R shoulder joint which is constant and only minimally responds to ibuprofen. Has had the pain for a month at this point. Pain started immediately. Suspicion for SIRVA because vaccine was administered high in the arm.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Heart rate increased
Clinical narrative: I went in for my flu shot and a MMR titer on 10/18/2017 at 9:00 am at Health Clinic. I received my flu shot at about 9:15 am and within a minute to two minutes, my heart rate jumped through the roof and I started feeling dizzy. I asked the doctor if this was normal and she replied that it can be. She instructed me just to take some deep breaths and then left it alone. When I got home and looked up side effects from the flu shot it said that a fast heartbeat was a severe allergic reaction and to report it. When I talked to the doctor about it, she said that allergic reactions only happen on the skin and that it had to be anxiety, but my vitals were all normal right before I received the flu shot. When I talked to the office today 10/19/2017 they told me that the severe side effects only pertain to people who are getting the flu shot for the first time in their life and that it was probably anxiety.
Age: 38.0
Sex: M
Vaccine: RAB
Symptoms: Headache, Laboratory test, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: The patient is a 38 yo male with a history of MS. He reports He received post exposure rabies vaccine on 20 Dec 2016 due to puncture wounds from a cat attack. He states he did not have a bite, but had multiple claw wounds to his right bicep area. He had been wearing long sleeves. He was treated with rabies immunoglobulin (RIG) and received rabies vaccine #1 in addition to antibiotic. About 12 hours later he developed a profoundly severe headache 'worst of his life.' He was released from work to his room, and went to sleep. He self-treated with ibuprofen which did not help. He states the duration was about 24 hours and then symptoms resolved. He states he had the same headache experience after each subsequent rabies vaccine dose with the same 12 hour onset, profound severity and 24 hour duration, and only effective treatment was sleep. The pt reported his events to our clinic due to clinical onset of MS 76 days post vaccine receipt. It is unlikely his MS is vaccine related due to limited evidence in the literature associating MS with vaccine receipt and delay in onset is not consistent.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives starting the evening of the vaccine.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Dizziness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling in upper R arm, redness, very warm feeling as described by patient, pt felt weak and dizzy as if she were going to faint.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: The vaccination was given on 10/17/17 and reported to the pharmacy on the morning of 10/18/17.   The patient said that her left arm was sore, swollen, would not move, and that she had a fever. The patient was told to contact her doctor, and to go to the emergency room for treatment. The pharmacy contacted her doctor directly to make sure they followed up with her. She was told to take benadryl by her doctor, and if no improvement to go to the emergency dept. The patient reported later that day that it had improved somewhat, and that she was not going to the ED or her doctor.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: RED, SWOLLEN, SORE AND HOT- REPORTED  4 DAYS AFTER SHOT.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: No adverse reactions noted at clinic visit 8/9/17. Patient found unresponsive; deceased on 8/11/17.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified amount of patients of unknown age and gender. On an unknown dates between 07-AUG-2017 and 19-SEP-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX (doses, route of administration and indication were not reported, lot# M035147 exp. 25-OCT-2017; M034765 exp. 25-OCT-2017). Concomitant therapies included properly stored sterile diluent. No adverse effects were reported. Data logger involved (6°F to 14°F for 16 hours). Previous temperature excursion reported (6°F to 14°F for 16 hours). This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1710USA009683.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified amount of patients of unknown age and gender. On an unknown dates between 07-AUG-2017 and 19-SEP-2017, the patients were vaccinated with impropely stored doses of VARIVAX (doses, route of administration and indication were not reported, lot# M049126 exp 15-DEC-2018; M028551 exp 07-JUN-2018). Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. Data logger involved ( 6°F to 14°F for 16 hours). Previous temperature excursion reported ( 6°F to 14°F for 16 hours). This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1709USA010341:
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable medical assistant calling on behalf of a nurse. An 18-year-old female patient of an unspecified ethnicity received TRUMENBA, (lot number: R56652, expiry date: 30Sep2017, NDC number of TRUMENBA: 00005010010), in the physician's office via an unspecified route of administration at right deltoid on 06Oct2017 16:23 at a single dose as needed vaccine for college. Medical history included mild asthma, anemia, chronic tinnitus and tonsillectomy. Concomitant medication included 8th dose of influenza vaccine (manufacturer: GlaxoSmithKline, Lot Number:PN75E; Expiry Date:31May2018) intramuscular at left deltoid. On 06Oct2017, TRUMENBA that had been expired for 6 days was given to a patient. A day after the vaccination, on 07Oct2017, the patient experienced headache and slight fever (described as the patient was warm). The outcome of the events was unknown.
Sex: U
Vaccine: PPV
Symptoms: Dizziness, Feeling abnormal, Gastrooesophageal reflux disease
Clinical narrative: This is a spontaneous report from a non-contactable consumer who reported for oneself. A patient of unspecified age, ethnicity, and gender received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein), via an unspecified route of administration on an unspecified date at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient received the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) at around 5' o clock in the afternoon and at 12 midnight the patient felt like he/she was drugged up. The patient did not throw up but just acid came out of the mouth and the patient felt dizzy. The patient wanted to know if that was any kind of adverse reaction. The patient had not taken any kind of medication not even an acetaminophen (TYLENOL). The outcome of the events was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has submitted the same report to the regulatory authorities. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site swelling, Injection site vesicles
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program "SNOW Patient Testimonial Recruitment", from a contactable consumer reporting for herself. A female patient of an unspecified age and ethnicity started to receive PREVNAR 13, via an unspecified route of administration, on 16Oct2017, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced very tired, the injection site was swollen and had a blister all on an unspecified date with outcome of unknown.
Age: 85.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site swelling
Clinical narrative: Patient received both BOOSTRIX and FLUZONE IM in left bicep- Pt has baseball sized swelling at injection site.
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure fluctuation, Dysphagia, Hyperchlorhydria, Malaise, Palpitations
Clinical narrative: This case was reported by a consumer and described the occurrence of blood pressure fluctuation in a female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced blood pressure fluctuation, palpitation, unwell, unable to swallow and hyperacidity. On an unknown date, the outcome of the blood pressure fluctuation, palpitation, unwell, unable to swallow and hyperacidity were unknown. It was unknown if the reporter considered the blood pressure fluctuation, palpitation, unwell, unable to swallow and hyperacidity to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. Colleague reported that she was informed of an adverse event with a flu vaccine by her sister-in-law, who herself was informed by the patient (who was also her sister, living in another country). On the reporting date, the patient had to go to the physician because she could not swallow any food anymore. The physician prescribed something for acid in the stomach and if it was not going better, then the patient had to go back the next week. The patient was not well. The patient experienced heart palpitations and varying blood pressure. The patient wanted to know whether a flu vaccine can give such adverse events, because according to her everything started after administration of the flu vaccine. She had mailed some general information regarding flu vaccine to her sister as well. The colleague stated that the patient did not want to give any further information to GSK. The reporter only had the data mentioned in her mail and did not know which flu vaccine was concerned and did not have any details about the doctor.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site joint pain, Injection site pain, Injection site swelling
Clinical narrative: Patient reported by phone and email red bump at site of flu vaccine and sore arm/shoulder joint four days post-injection. She denied limited mobility. She was encouraged to apply warm packs but stated she could not do so during work hours. At her pre-arranged PCP visit on October 12, she stated most of the redness was gone except the one small red spot. She stated that her PCP did not feel it looked bad enough to send a report to the Clinic. Patient remained concerned and consequently a VAERS report was offered by the Clinic.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Tremor
Clinical narrative: Patient developed sudden onset of upper extremity tremors, shaking, and anxiety at 3:25 pm and reported to ED for evaluation at 4:25 pm.
Age: 84.0
Sex: F
Vaccine: FLUA3
Symptoms: Cardiac monitoring normal, Lumbar puncture normal, Muscular weakness, Nuclear magnetic resonance imaging normal, Presyncope
Clinical narrative: Pt got shot on 9-1. On 9-11 pt was standing and all of the sudden pt collapsed (legs felt weak). Pt went to hospital. Hospital said was vasovagal and discharged pt. Pt went to cardiologist and was on a heart monitor for a week. Pt went to see md, doctor said heart is fine, call primary because patient said had flu shot recently. PCP called pt, said think having a reaction to flu shot, and sent pt to neurologist. Pt went to neurologist, and collapsed twice in office and was sent to hospital. was there 6 days, Had 2 MRI, spinal tap, all came back ok. Hospital said mild reaction to flu shot. Pt sent to rehab for 2 weeks. Home now and getting therapy at home.
Age: 84.0
Sex: F
Vaccine: FLUA3
Symptoms: Syncope, Vaccination complication
Clinical narrative: Pt got shot on 9-1. On 9-11 pt was standing and all of the sudden pt collapsed (legs felt weak). Pt went to hospital. Hospital said was vasovagal and discharged pt. Pt went to cardiologist and was on a heart monitor for a week. Pt went to see md, doctor said heart is fine, call primary because patient said had flu shot recently. PCP called pt, said think having a reaction to flu shot, and sent pt to neurologist. Pt went to neurologist, and collapsed twice in office and was sent to hospital. was there 6 days, Had 2 MRI, spinal tap, all came back ok. Hospital said mild reaction to flu shot. Pt sent to rehab for 2 weeks. Home now and getting therapy at home.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Crying, Dyskinesia, Irritability, Loss of consciousness, Pyrexia
Clinical narrative: Patient received vaccine Monday, October 16th, 2017 at 4 PM, and the following day patient had upper and lower extremity jerking and was unresponsive for 3min. She spontaneously regained consciousness but felt sleepy and slept for 20 to 25 min. Mother notice that patient had 102 F temperature and gave her ibuprofen oral. After six hours her fever was 102.5 and she another episode that lasted less than 5 minutes. She had a large wet diaper. She was irritable and cried for several minutes. She came to the ER where she was admitted.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Somnolence, Unresponsive to stimuli
Clinical narrative: Patient received vaccine Monday, October 16th, 2017 at 4 PM, and the following day patient had upper and lower extremity jerking and was unresponsive for 3min. She spontaneously regained consciousness but felt sleepy and slept for 20 to 25 min. Mother notice that patient had 102 F temperature and gave her ibuprofen oral. After six hours her fever was 102.5 and she another episode that lasted less than 5 minutes. She had a large wet diaper. She was irritable and cried for several minutes. She came to the ER where she was admitted.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Dizziness, nausea, fatigue.
Age: 72.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Skin abrasion
Clinical narrative: Red, Swollen, and warm to the touch halfway down patient upper arm lasting 2 days. Limited loss of motion for 2 days which came back on 3rd day. Patient said arm feels normal now and no treatment was needed.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer's mother refers to a 18 year old male patient. In April 2017, the patient was vaccinated with first dose of GARDASIL 9 (unspecified dose administered intramuscularly for an unknown indication). The second dose was administered in August 2017. No adverse effect reported. Additional information is not expected. The reporter did not wish to be contacted.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Injection site mass, Mass excision
Clinical narrative: This spontaneous report was received from a male patient of unknown age, who was reporting on himself. The patient's pertinent medical history was memory, spasm and prostate (as reported). He had no drug reactions or allergies. On an unknown date in July 2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming units (PFU) (dose, route of administration, lot# and expiration date were not provided) which was reconstituted with sterile diluent (manufacturer unknown) (strength, dose, frequency, route of administration, lot# and expiration date were not reported) in the back part on an unspecified arm, for prevention of shingles. Concomitant therapies included hydrochlorothiazide, carvedilol, ELIQUIS, digoxin, LIPITOR, PROSCAR, timolol maleate (manufacturer unknown), latanoprost, NAMENDA, primidone and losartan (manufacturer unknown). On an unknown date in 2017 (reported as "few weeks ago"), the patient noticed a bump where he received the vaccine. He went to an unspecified dermatologist on an unspecified date after he noticed the bump. The bump was removed by the dermatologist on an unspecified date. The dermatologist took a biopsy of the bump after the bump was removed and sent it for testing on an unknown date. At the time of the report, the patient was waiting for the results of the biopsy. He also reported that the bump was currently barely visible and the bump's spot was covered with a Band-Aid. The outcome of the event and the relatedness between the event and the suspect therapies were not provided.
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Cellulitis, Injection site cellulitis, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 70 year old female patient. The patient's historical drugs included PREVNAR at least 1 year ago. The patient's had no allergies. On 06-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, intramuscularly (also reported as subcutaneously), in the left deltoid, lot # N019348 with expiration date 08-Feb-2019, for vaccination (route of administration was not reported). Other suspect therapies included FLUAD, in the opposite arm. The patient's concomitant medications (reported as "a ton of medications) included budesonide, formoterol fumarate(SYMBICORT), unspecified blood pressure medication and unspecified eye drops for glaucoma. On 08-OCT-2017, the patient presented to the pharmacy with a cellulitis type reaction described as swelling and a wet, blistery, awful looking rash from the site of injection on the left deltoid down to or past her elbow (injection site cellulitis). It was stated that the patient was referred to her physician or hospital but the pharmacist was unsure if she went or not. It was reported as a "horrifying reaction" with "really bad symptoms". At the time of reporting, the outcome of the adverse event was reported as not recovered. The causality assessment between cellulitis type reaction and PNEUMOVAX 23 was not provided. The reporting pharmacist considered cellulitis type reaction as medically significant event. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1710USA005880:
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Peripheral swelling, Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 70 year old female patient. The patient's historical drugs included PREVNAR at least 1 year ago. The patient's had no allergies. On 06-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, intramuscularly (also reported as subcutaneously), in the left deltoid, lot # N019348 with expiration date 08-Feb-2019, for vaccination (route of administration was not reported). Other suspect therapies included FLUAD, in the opposite arm. The patient's concomitant medications (reported as "a ton of medications) included budesonide, formoterol fumarate(SYMBICORT), unspecified blood pressure medication and unspecified eye drops for glaucoma. On 08-OCT-2017, the patient presented to the pharmacy with a cellulitis type reaction described as swelling and a wet, blistery, awful looking rash from the site of injection on the left deltoid down to or past her elbow (injection site cellulitis). It was stated that the patient was referred to her physician or hospital but the pharmacist was unsure if she went or not. It was reported as a "horrifying reaction" with "really bad symptoms". At the time of reporting, the outcome of the adverse event was reported as not recovered. The causality assessment between cellulitis type reaction and PNEUMOVAX 23 was not provided. The reporting pharmacist considered cellulitis type reaction as medically significant event. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1710USA005880:
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient had a history of splenectomy. The patient's concurrent conditions, concomitant medications and drug reactions or allergies were not specified. On an unknown date, the patient was vaccinated with a properly stored PNEUMOVAX 23 lot # N013521, expiration date 23-JAN-2019, one dose (route of administration not specified) for prophylaxis. On an unknown date, the patient experienced swelling, itchiness and redness migrating down the arm. The patient did not seek any medical attention. The reporter requested checking the lot # B013521 of PNEUMOVAX 23. The outcome of the events was reported as recovered. The relatedness between PNEUMOVAX 23 and the events was not specified. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA005621: Original Case : 1710USA005621 US-009507513-1710USA007749:
Sex: U
Vaccine: PNC13
Symptoms: Asplenia
Clinical narrative: This is a spontaneous report form a contactable Physician via Pfizer sales representative through medical information team. A patient of unspecified age ethnicity and gender 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 became asplenic on an unspecified date with outcome of unknown. The physician wanted to know if the patient need a booster dose. Sender's Comments: Based on the information currently available, being asplenic is not related to the use of PREVNAR 13 but represents the patient's underlying medical condition.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age and race/ethnicity received PREVNAR 13 (Lot number S51635, Expiry date Oct 2018, NDC number 00005197101), via an unspecified route of administration at single dose in the right arm on 13Oct2017 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling of the right arm on 15Oct2017 with outcome of unknown.
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: This is a spontaneous report from a contactable pharmacist reporting for two patients (husband and wife). This is the first of two reports (wife). An elderly (reported as over 65-year-old) female patient received on 16Oct2017 PREVNAR 13, intramuscular in deltoid at single dose, and FLUZONE (Lot UI890AA, exp date 05Jun2018) in the same arm of pneumococcal 13-val conj vac (dipht crm197 protein), both for immunisation. Medical history and concomitant medications were not reported. The patient experienced redness, itching and soreness all in Oct2017 with outcome of not recovered. The reporter did not know if the events were related to pneumococcal 13-val conj vac because the reporter also gave influenza vaccine in the same arm as the pneumococcal 13-val conj vac injection. The reporter didn't know if the reaction happened because of the combination of giving both products.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017452872 same reporter/drug/event, different patient.
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: This is a spontaneous report from a contactable pharmacist reporting for two patients (Husband and Wife). This is the second of two reports (husband). An elderly male patient of an unspecified age received on 16Oct2017 PREVNAR 13, intramuscular in deltoid at single dose, and FLUZONE (Lot UI890AA, exp date 05Jun2018), both for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness, itching and soreness all on 17Oct2017 with outcome of not recovered. The reporter did not know if the events were related to pneumococcal 13-val conj vac because he also gave influenza vaccine, he wanted to get it in the same arm as the pneumococcal 13-val conj vac injection. The reporter didn't know if the reaction happened because of the combination of giving both products.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017452856 same reporter/drug/event, different patient.
Age: 75.0
Sex: U
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Pain
Clinical narrative: Pt. reports skin pinched right medial deltoid lateral side and needle inserted quickly. That night pain started - pain stil there since 10/9/17 when vaccine given. So bad pt. not using arm at all. Pt. has tried NSAIDS, heat, ice and rubbing it but not getting any better. No fevers, no erythema, discharge, no nausea/vomiting, no respiratory issues.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Pruritus, Swelling
Clinical narrative: After receiving the flu vaccine at 0800 on 10/18/17 Pt. stated that same day at approximately 1800, she started to flush from chest up to entire face, was started to swell, felt itchiness to feet than hands. She took two OTC BENADRYL which alleviated the symptoms.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: On September 21, 2017 I got a TD, after getting my allergy shots on 9/20/17. Then on the 9/22/17 my forearm began swelling and hurting. As of 10/11/17 it still swelling and hurt. No am on prednisone and on prednisone until 10/20. As of 10/10/17 no allergy shot. On September 20, 2017 at 3:45 PM I went and got my allergy shot in both arms from Dr. Then on September 21, 2017, I went to clinic and got a TD, because mine had expired. After the shot, my right arm began swelling and hurting in my forearm. I am unable to bend it all the way down. I received a check-up on October 10, 2017 by Dr. and was started on prednisone due to me now being unable to take my allergy shots until my check up on October 20, 2017.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Bedridden, Chills, Erythema, Feeding disorder
Clinical narrative: This patient received a flu vaccine and a pneumonia vaccine in the same arm. She immediately noticed severe swelling in her arm, pain, and she started to feel sick. By that evening she was bedridden with flu-like symptoms,complaining of flu like symptoms with fever and chills and aches all over her body. She could not eat or drink for several days. On Monday she presented back to the pharmacy, looked very weak and pale and her arm was still red, rashy and swollen. I advised her step over to her physician's office to make sure she was going to be okay, and to try to get some liquids in her.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fluid intake reduced, Influenza like illness, Malaise, Pain, Pallor
Clinical narrative: This patient received a flu vaccine and a pneumonia vaccine in the same arm. She immediately noticed severe swelling in her arm, pain, and she started to feel sick. By that evening she was bedridden with flu-like symptoms,complaining of flu like symptoms with fever and chills and aches all over her body. She could not eat or drink for several days. On Monday she presented back to the pharmacy, looked very weak and pale and her arm was still red, rashy and swollen. I advised her step over to her physician's office to make sure she was going to be okay, and to try to get some liquids in her.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: This patient received a flu vaccine and a pneumonia vaccine in the same arm. She immediately noticed severe swelling in her arm, pain, and she started to feel sick. By that evening she was bedridden with flu-like symptoms,complaining of flu like symptoms with fever and chills and aches all over her body. She could not eat or drink for several days. On Monday she presented back to the pharmacy, looked very weak and pale and her arm was still red, rashy and swollen. I advised her step over to her physician's office to make sure she was going to be okay, and to try to get some liquids in her.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema multiforme, Injection site erythema, Injection site induration, Injection site swelling, Urticaria
Clinical narrative: Left deltoid swollen, hard and red 5 hours post vaccination. Developed hives all over body. Seen by PA on 10/18/2017 diagnosed with Erythema Multiforme.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Injection site pain, Oedema peripheral
Clinical narrative: The firefighter noticed swelling and pain to his right axilla approximately 15 hours after administer of the vaccine. He also reported soreness to the right deltoid, but no redness to the site.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Neck pain, Swelling
Clinical narrative: Employee stated he began to experience left sided neck pain and swelling,  and headache. Presented to Urgent Care Center after neck pain persisted, was seen and given a muscle relaxer. Stated he took the medication for 4 days, alleviated neck pain. States he feels ok this week, no pain or swelling.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Heart rate increased, Skin mass, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to touch, rapid heartrate, knot under skin.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm was swollen, red, and hot. The area was about the size of a palm 4 x 4 inches. No treatment was given to the patient.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Amnesia, Asthenia, Dizziness, Headache, Loss of consciousness
Clinical narrative: Minor patient taken by her mother for a routine family medicine visit. Patient was seen by herself without mother present. Physician was told by patient that mother was in the lobby. Physician then counseled patient to receive HPV and influenza vaccine. Patient at this time had signs of illness (cold, congested and runny nose). Vaccine information sheet for both vaccines not given to patient. Patient not asked about allergies or medical condition. Consent for flu vaccine not obtained from mother. Mother left in the lobby for the whole time without being brought back to have discussion with anyone about flu vaccine nor to be given VIS. Patient agreed to vaccines at physician recommendations. Was given both vaccines in different deltoids. After administration, patient was sent out to the waiting room immediately and not monitored for 15 minutes as recommended for HPV vaccines (due to the potential for unconciousness etc.). She was there was less than 10 minutes and then promptly had a partial seizure in mother's arms. Patient was eased to the floor where she was unconscious and nonresponsive for between 1-2 minutes. Patient awoke and was slowly oriented but experiencing weakness, dizziness, headaches, neck pain, memory loss and nausea. Memory loss has improved. Patient still weak, dizzy, with neck pain and overall body pain as of 10/19/2017.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Nail discolouration, Nausea, Pain, Partial seizures, Unresponsive to stimuli
Clinical narrative: Minor patient taken by her mother for a routine family medicine visit. Patient was seen by herself without mother present. Physician was told by patient that mother was in the lobby. Physician then counseled patient to receive HPV and influenza vaccine. Patient at this time had signs of illness (cold, congested and runny nose). Vaccine information sheet for both vaccines not given to patient. Patient not asked about allergies or medical condition. Consent for flu vaccine not obtained from mother. Mother left in the lobby for the whole time without being brought back to have discussion with anyone about flu vaccine nor to be given VIS. Patient agreed to vaccines at physician recommendations. Was given both vaccines in different deltoids. After administration, patient was sent out to the waiting room immediately and not monitored for 15 minutes as recommended for HPV vaccines (due to the potential for unconciousness etc.). She was there was less than 10 minutes and then promptly had a partial seizure in mother's arms. Patient was eased to the floor where she was unconscious and nonresponsive for between 1-2 minutes. Patient awoke and was slowly oriented but experiencing weakness, dizziness, headaches, neck pain, memory loss and nausea. Memory loss has improved. Patient still weak, dizzy, with neck pain and overall body pain as of 10/19/2017.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Gait disturbance, Muscle spasms
Clinical narrative: Today while at recess- student says he was playing soccer though only walking at the time and his lower back cramped up; he did not fall, did not lose consciousness but walked hunched over and teacher called school nurse (the reporter); school nurse arrived student sitting able to move his legs and back- student was able to talk. Transported via golf cart to the nurse's office. Afebrile, 84/62, pulse 72. Was given a heating pad (low). Began feeling a little better says his back loosened up- felt best laying down or with knees up; student also said he was dizzy; mother arrive to see student; student able to sit up- take ADVIL. Had student drink water- dizzy feeling subsided and he returned to class accompanied by his mother (also a teacher at the school); mother called physician's office (put on a long hold) but since student was feeling better will call back later as needed.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Influenza, Injected limb mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Patient was given the IM shot high on their arm. The Pharmacist removed the needle and reinserted the needle lower into their deltoid. Patient called the next week complaining of obtaining the flu over the weekend from the shot and that her arm still hurt 2-3 days after the shot. Patient was told that's not out of the norm and to continue to monitor. Today, 10/19/17, patient came back into pharmacy to again state that she cannot lift her arm due to tenderness.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient presented 8 hours after vaccination with erythema and swelling around injection site on right arm despite premedication prior to vaccination and at home. Redness and swelling appears to be approximately the size of a baseball. Patient treated with Acetaminophen 500 mg and BENADRYL 50 mg and instructed to continue with cold compress recommended. Patient presented 20 hours after vaccination with feverish, erythema, and swelling around injection site on right arm that had not subsided with prior treatment course and reported chills and pain during the night. Redness and swelling still appeared to be approximately the size of a baseball, with slight increase in size. Primary Care Physician's office notified by phone of AE. Patient given Acetaminophen 1000 mg and BENADRYL 50 mg in pharmacy and cold compress applied for approximately 20 minutes for observation. No change in reaction, but patient did not have any pain or chills. Patient was instructed to continue Acetaminophen Q4hours and alternate with NSAID Q6hours, continue cold compress PRN, and BENADRYL 50 mg Q4-6hours PRN. She was instructed to come back in for reassessment if the reaction continued throughout the day.
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Skin warm
Clinical narrative: PATIENT CALLED THE NEXT DAY 10/15/2017 TO REPORT THAT HER ARM HAD SWELLED FROM HER SHOULDER TO HER ELBOW APPROXIMATELY 1/2 HOUR AFTER THE VACCINE WAS ADMINISTERED. SHE REPORTED THAT HER ARM WAS HOT TO THE TOUCH BUT NOT RED. SHE JUST APPLIED ICE AND THE SWELLING WENT DOWN. SHE ALSO RECEIVED HER FLU VACCINE AT THE SAME TIME, BUT IN THE LEFT ARM. THE FLU VACCINE SHE RECEIVED WAS AFLURIA QUAD
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Cough, Injection site pain, Painful respiration
Clinical narrative: 10 minutes after receiving vaccine developed right upper sternal discomfort/chest pain. Denied shortness of breath, itchy swelling of throat, hives, dizziness, headaches, or even sore arm. Ibuprofen 600 mg taken that evening and subsequent evening was ineffective relief. Deep breath causes increased pain to site. Rare occasional dry cough.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site pain, Vertigo
Clinical narrative: Pain from vaccination site spread to under arm then got vertigo. Did not respond to a Medical location. Did not seem to be life threatening.
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: Dyspnoea
Clinical narrative: After vaccine, complained of shortness of breath. He was taken to the ER.
Age: 40.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient has localized redness, swelling, and tenderness on right deltoid at injection site.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Nervousness, Pallor
Clinical narrative: Approx 21/2 hrs after flu vac C/O feeling shaky, pale, sweaty, VS 140/97 HR 120-130 - EE sent home by manager - states symptoms resolved after 45 min. Seen by this Nurse today (98.4, 110/74 HR 100 10-19-2017) denied any complaints today "I feel fine" R-16.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Injection site discolouration, Injection site swelling
Clinical narrative: Swelling, discoloration (yellow), black/blue where injection was administered, dizziness, area or discoloration is 2.5 inch diameter. Swelling and discoloration still present almost 6 days after injection. Dizziness still present.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Expired product administered
Clinical narrative: PREVNAR 13 given 2 days after expiration date.