chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Physical disability, Quality of life decreased, Rash vesicular
Clinical narrative: Information was received 06-SEP-2017 from a lawyer regarding a case in litigation concerning a female plaintiff of unspecified age. It was claimed the plaintiff was inoculated with ZOSTAVAX on or about 07-SEP-2007, administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused her to contract a persistent strain of herpes zoster. On or about 20-JUN-2012, the plaintiff was treated by a different physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. It was claimed that as a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. It was claimed that as a direct result of the vaccine, the plaintiff suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition. The plaintiff suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events of caused her to contract a persistent strain of herpes zoster / severe vesicular eruption accompanied by weakened immune symptoms diagnosed as severe herpes zoster, or shingles were considered disabling. Additional information was requested.
Sex: U
Vaccine: PNC13
Symptoms: Asthenia, Dizziness
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales Representative. This Physician reported similar events for 3 patients. This is 3rd of 3 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lightheadedness/dizziness on an unspecified date with outcome of recovered, weakness on an unspecified date with outcome of recovered. Event was described as lightheadedness, dizziness and weakness lasting 2-3 minutes after injection, resolved by lying down, given fluids and glucose tablet. Sender's Comments: Linked Report(s): US-PFIZER INC-2017379704 different patient, same product, same event; US-PFIZER INC-2017379977 different patient, same product, same event.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13; (Lot Number: R56671; Expiration Date: Apr 2018; NDC number: 00005-1971-02) intramuscularly in the left arm on 25Aug2017 at about 3:20 PM at a single dose for immunization when the patient was 65-years-old. The patient did not receive any other vaccinations within four weeks. It was reported that the patient had no adverse events following prior unspecified vaccinations. Medical history was reported as none. There were no concomitant medications. Family medical history relevant to the event was unknown. The vaccine was given under protocol; there was no prescribing healthcare professional to provide. On 30Aug2017, the patient experienced reaction on her arm, redness, swelling, and warmth just below the site of injection. The reaction was probably the entire length of her left upper arm. There were no relevant tests. The patient did not seek treatment from an emergency room or a physician office. The action taken in response to the events for the vaccine was not applicable. The clinical outcome for the events of reaction on her arm, redness, swelling, and warmth just below the site of injection was not recovered. Causality was assessed between the vaccine and the event of reaction on her arm by the reporting pharmacist as related.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13; (Lot Number: R56671; Expiration Date: Apr 2018; NDC number: 00005-1971-02) intramuscularly in the left arm on 25Aug2017 at about 3:20 PM at a single dose for immunization when the patient was 65-years-old. The patient did not receive any other vaccinations within four weeks. It was reported that the patient had no adverse events following prior unspecified vaccinations. Medical history was reported as none. There were no concomitant medications. Family medical history relevant to the event was unknown. The vaccine was given under protocol; there was no prescribing healthcare professional to provide. On 30Aug2017, the patient experienced reaction on her arm, redness, swelling, and warmth just below the site of injection. The reaction was probably the entire length of her left upper arm. There were no relevant tests. The patient did not seek treatment from an emergency room or a physician office. The action taken in response to the events for the vaccine was not applicable. The clinical outcome for the events of reaction on her arm, redness, swelling, and warmth just below the site of injection was not recovered. Causality was assessed between the vaccine and the event of reaction on her arm by the reporting pharmacist as related.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer reported for his wife. A 67-year-old female patient received the first dose of PREVNAR 13 via intramuscular route in the left arm, for immunisation at 0,5ml single dose on 31Aug2017. On the same date the patient received also influenza vaccine via intramuscular route in the right arm, she has had it every year for the past 15 years. On 01Sep2017 the patient experienced who she has not been feeling well since she had the injection, on 31Aug2017 the site of injection was swollen, red, and very warm and on unknown date the patient experienced tiredness and dizziness. The outcome of the events tiredness and dizziness was unknown while the outcome of the other adverse events was not recovered.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer reported for his wife. A 67-year-old female patient received the first dose of PREVNAR 13 via intramuscular route in the left arm, for immunisation at 0,5ml single dose on 31Aug2017. On the same date the patient received also influenza vaccine via intramuscular route in the right arm, she has had it every year for the past 15 years. On 01Sep2017 the patient experienced who she has not been feeling well since she had the injection, on 31Aug2017 the site of injection was swollen, red, and very warm and on unknown date the patient experienced tiredness and dizziness. The outcome of the events tiredness and dizziness was unknown while the outcome of the other adverse events was not recovered.
Age: 77.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Discomfort
Clinical narrative: This is a spontaneous report from a contactable consumer reported for himself. A 77-year-old male patient received the first dose of PREVNAR 13 via intramuscular route in the left arm, for immunization at single dose on 31Aug2017. On the same date the patient received also influenza vaccine via intramuscular route in the right arm, he has had it every year for the past 15 years. He received a pneumonia vaccine perhaps 5 years ago. Relevant medical history included elevated blood pressure and high cholesterol, both ongoing. Concomitant medications included doxazosin. On 01Sep2017 the patient experienced discomfort. The outcome of the event was recovered on 03Sep2017.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer (husband). A female patient of unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration, on an unspecified date, single dose, for immunization. Relevant medical history and concomitant medications were not reported. The patient had a reaction to pneumococcal 13-val conj vac (dipht crm197 protein) on an unknown date (yesterday) also reported as severe reactions of the shot received last week. The injection site was red, very warm to touch and it sores. Outcome of the events was not recovered.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Next day pain in arm began, two days later went to urgent care with severe pain in left shoulder (bursitis like), 102F fever, body aches, flu-like symptoms, some hives near injection site.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Next day pain in arm began, two days later went to urgent care with severe pain in left shoulder (bursitis like), 102F fever, body aches, flu-like symptoms, some hives near injection site.
Sex: U
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Was seen 9/5/17 for well care. Had HPV, MENVEO in left arm, Tdap and FLULAVAL in right arm. Mom noticed redness and swelling last night 9/6/17 in left upper arm. Was tender and itchy this morning 9/7/17. Site red and warm to the touch. 9/7/17 School nurse marked it at around 12:00, redness grew outside the lines when we saw it around 2:30PM. Felt dizzy and nauseous while in school nurses office, had resolved by the time she came in for her appointment. No fever or chills, able to move arm. Diagnosed with local reaction to immunization. Advised by Dr to continue to apply ice 3-4 times per day and use BENADRYL every 6 hours as needed. Instructed to call if any increased tenderness, pain, fever. streaking or chills.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Chest pain, Dizziness, Electrocardiogram
Clinical narrative: As soon as I received injection I felt dizzy, a very weird different feeling hard to explain. My breathing changed and pain on my chest and side from front to back...as time passed I got so weak I couldn't walk and I had fever 103 to be exact verified by the hospital I went to emergency room because I couldn't take it anymore. I went through so much pain like I never experienced. I was sick for about a full week before I even felt a little better.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, X-ray
Clinical narrative: As soon as I received injection I felt dizzy, a very weird different feeling hard to explain. My breathing changed and pain on my chest and side from front to back...as time passed I got so weak I couldn't walk and I had fever 103 to be exact verified by the hospital I went to emergency room because I couldn't take it anymore. I went through so much pain like I never experienced. I was sick for about a full week before I even felt a little better.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Itching, redness, swelling, pain, rash at the site. It started itching before bedtime on the day the vaccine was given. Patient sought emergency treatment since her Dr or urgent care were not open. They gave her pain medication and a BENADRYL.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis, Erythema, Pain, Skin infection, Skin warm
Clinical narrative: Large red area on skin, warm to touch, painful to patient.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Peripheral swelling, Rash
Clinical narrative: Swelling in leg and rash.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Condition aggravated, Dyskinesia, Dysphemia, Migraine, Muscle twitching
Clinical narrative: Patient is a 13 yo female with PMHx of migraine who presents for ER followup. Patient was last seen in office on 9/5/17 for her WCC. Patient was in her usual state of health. Patient received her HPV vaccine during that visit. She later went to cheerleading practice with no issues. Later that day, she developed a migraine. She took Imitrex but had several bouts of emesis. Mother reports she had 12 episodes of vomiting within an hour period, mucous, nonbilious, nonbloody. Patient then around 10pm developed whole body jerking, trouble speaking, and not responding verbally. Denies bowel or bladder incontinence. Parents called 911. Patient was taken to Hospital ED.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Photophobia, Speech disorder, Vomiting
Clinical narrative: Patient is a 13 yo female with PMHx of migraine who presents for ER followup. Patient was last seen in office on 9/5/17 for her WCC. Patient was in her usual state of health. Patient received her HPV vaccine during that visit. She later went to cheerleading practice with no issues. Later that day, she developed a migraine. She took Imitrex but had several bouts of emesis. Mother reports she had 12 episodes of vomiting within an hour period, mucous, nonbilious, nonbloody. Patient then around 10pm developed whole body jerking, trouble speaking, and not responding verbally. Denies bowel or bladder incontinence. Parents called 911. Patient was taken to Hospital ED.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Dyskinesia, Fatigue, Headache, Hyperacusis, Pain
Clinical narrative: Patient is a 13 yo female with PMHx of migraine who presents for ER followup. Patient was last seen in office on 9/5/17 for her WCC. Patient was in her usual state of health. Patient received her HPV vaccine during that visit. She later went to cheerleading practice with no issues. Later that day, she developed a migraine. She took Imitrex but had several bouts of emesis. Mother reports she had 12 episodes of vomiting within an hour period, mucous, nonbilious, nonbloody. Patient then around 10pm developed whole body jerking, trouble speaking, and not responding verbally. Denies bowel or bladder incontinence. Parents called 911. Patient was taken to Hospital ED.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Pain in extremity, Photophobia, Seizure, Vomiting
Clinical narrative: Patient is a 13 yo female with PMHx of migraine who presents for ER followup. Patient was last seen in office on 9/5/17 for her WCC. Patient was in her usual state of health. Patient received her HPV vaccine during that visit. She later went to cheerleading practice with no issues. Later that day, she developed a migraine. She took Imitrex but had several bouts of emesis. Mother reports she had 12 episodes of vomiting within an hour period, mucous, nonbilious, nonbloody. Patient then around 10pm developed whole body jerking, trouble speaking, and not responding verbally. Denies bowel or bladder incontinence. Parents called 911. Patient was taken to Hospital ED.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Peripheral swelling, Somnolence
Clinical narrative: Patient felt she may faint Monday night, felt very tired and fell asleep. She awoke on Tuesday morning and left arm was swollen, red and warm to touch. Swelling has finally decreased as of 09/07/2017.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Pain, Photophobia, Pyrexia
Clinical narrative: Patient experienced headache, body aches, fever and photophobia. Symptoms relieved with Ibuprofen and symptoms would recur.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Nervousness, Tension
Clinical narrative: Prior to giving vaccines and discussing aftercare, I asked whether the client had eaten and had fluids, and his mother said he had just eaten half an hour prior. After instructing client to relax his arms and breathe normally, I administered the vaccines. The client began to tense up and become nervous. I asked him to let me know if he became dizzy, and he did (within a few minutes). I notified (Supervisor) and we administered the ice pack to his forehead and back of neck, moved him to a flat bed in the wheelchair and took his vitals. 12:47 pm BP 98/51 P 57 R 18 T 96.6 F. He remained lying down for about 10-15 minutes and raised his legs by bending his knees in the supine position. He stated he was beginning to feel better. 12:56 pm BP 109/60 P 63 R 16. He sat up on the side of the bed for a few minutes before standing. We had him drink a bottle of cold water and eat some crackers. Had him sit in the lobby while his mother paid at the checkout and stay until they were sure he was ok.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Gait inability, Injection site urticaria
Clinical narrative: Wheal/flare 4-5 cm in diameter at injection site. Coughing/SOB that worsened to point the patient was unable to speak.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Vaccination site erythema, Vaccination site oedema, Vaccination site warmth
Clinical narrative: Increased edema to the vaccine site with erythema. The area was also warm to the touch. Advised to continue cool compresses, and elevation of the affected limb. Recommended antibiotic therapy if s/s worsen in 2 days.
Age: 4.0
Sex: M
Vaccine: IPV, MMRV
Symptoms: Varicella post vaccine
Clinical narrative: PATIENT RECEIVED PROQUAD ON 8/11/17 AND VARIVAX ON 4/2/15. THE PATIENT NOW HAS CHICKENPOX 9/7/17.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Approximately 12 hours after receiving vaccine, patient's face had a rash on it. Later on that day, patient's rash progressed to her arms and legs. Pt was given ZYRTEC on 9/7/17 in the morning. She was advised by provider to take BENADRYL or other antihistamine.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information had been received on 01-SEP-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 22-MAY-2016 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-JUN-2016, patient was treated by nurse practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. Patient has been prescribed VALTREX, gabapentin and triamcinolone for management of her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information had been received on 01-SEP-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 20-NOV-2013 at a county health department, as recommended for routine adult health maintenance and for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUN-2016, patient was treated by physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine (lot number, dosage, and route of administration not provided) on or about 01-OCT-2015, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 10-SEP-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. The patient was prescribed antiviral therapies (unspecified) for management of her painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient has red circle on left thigh the size of a quarter. The area is warm to the tough and painful to patient. Patient will start Cephalexin 250mg/5ml he will take 3 ml by mouth 3 times a day for 10 days. Also he will take Benadryl 2.5 ml by mouth every 6 hours as needed for 3 days.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash all over arms, abd.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: HPV-9 vaccine administered into the Right Deltoid, 30 minutes later patient c/o warm- swollen mid thigh. Dr. saw patient right leg and applied a cold compress, swelling went down. Dr. examined patient leg and reapplied cold compress. Patient mother denied pain medication and Benadryl. Pt was examined for 20 minutes  by Dr. following her exam of the right leg.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dermatitis, Erythema, Infection
Clinical narrative: ON THE SAME ARM AS INJECTION, NOT AT INJECTION SITE. PATIENT'S ARM BECAME VERY RED AND INFLAMED. WENT TO DR AND THEY THINK IT IS INFECTED AND GAVE PT ANTIBIOTICS.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure increased, Chest discomfort, Feeling abnormal, Flushing, Hypoaesthesia
Clinical narrative: Today I gave a Tdap vaccine to a 24 year old regular patient of pharmacy. About 15 minutes later he returned to the counter stating that he "felt funny". Specifically his head and vaccination arm felt numb. Convinced him to stay in our lounge area with his grandmother who was with him. I checked his blood pressure every 10-15 minutes for about an hour. He maintained a flushed appearance and had a slightly elevated BP. (145/95 ish when he typically runs a little low normally). At one point he mentioned a sore throat and chest tightness, but denied any swelling or SOB. We discussed calling a squad and he wanted to give it a few more minutes. I was personally on the border of calling 911, but decided to give it 5-10 more minutes per his request, and I did not feel it was an emergency at that point. At that point it did start to subside. About 1 hour later his color suddenly returned to normal. I checked his BP and it was down to 130/90 mmHg. He reported numbness, sore throat, and chest tightness were gone. He went home with his grandmother with instructions to call 911 if symptoms returned, especially if SOB occurred.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Oropharyngeal pain
Clinical narrative: Today I gave a Tdap vaccine to a 24 year old regular patient of pharmacy. About 15 minutes later he returned to the counter stating that he "felt funny". Specifically his head and vaccination arm felt numb. Convinced him to stay in our lounge area with his grandmother who was with him. I checked his blood pressure every 10-15 minutes for about an hour. He maintained a flushed appearance and had a slightly elevated BP. (145/95 ish when he typically runs a little low normally). At one point he mentioned a sore throat and chest tightness, but denied any swelling or SOB. We discussed calling a squad and he wanted to give it a few more minutes. I was personally on the border of calling 911, but decided to give it 5-10 more minutes per his request, and I did not feel it was an emergency at that point. At that point it did start to subside. About 1 hour later his color suddenly returned to normal. I checked his BP and it was down to 130/90 mmHg. He reported numbness, sore throat, and chest tightness were gone. He went home with his grandmother with instructions to call 911 if symptoms returned, especially if SOB occurred.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin test, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Pt developed active varicella infection 16 days s/p vaccine administration. Pt had vesicular lesions over her body and was admitted to the hospital. Her hospital course was complicated by other medical conditions including the need for a renal biopsy for a pre-existing renal mass and the need to wait for resolution of lesions to perform the biopsy.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Lung disorder, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Pt developed a varicella infection. The pt was hospitalized with a hospital course complicated by multiple pulmonary issues.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, warmth and induration 3 cm below injection site in 4 cm x 10 cm area over the right upper inner arm. Treated with nsaid and Benadryl, cold compresses.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Eye swelling, Hyperhidrosis, Injection site swelling, Swelling face
Clinical narrative: Sometime that evening, patient reported: difficulty breathing, profuse sweating, swelling at injection site, swelling of face, and eyes (swollen shut). Patient reports being treated with steroids and antihistamines at hospital.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Starting about 24 hours after the vaccine, the patient developed a generalized confluent erythematous rash that affected the entirety of the abdomen, the central chest, the entirety of the neck, the lower back and the upper back. Rash was mildly pruritic, no hives. No airway involvement, no wheezing, no arthralgias. She stated that she develops a similar rash frequently with illnesses. The rash did not respond to oral diphenhydramine therapy.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Dizziness, Dysstasia, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Event: Patient had 3 vaccines (flu, BOOSTRIX, and PNEUMOVAX) on 9/6/2017 around 4:30pm. At 8pm 9/6/17 patient called to report that her arm was swollen, itchy and red at the injection site. On 9/7/2017 at 9am, the pharmacist followed up with the patient again. The patient reported that the redness and swelling still persisted. The swelling was spreading from the injection site to her upper shoulder. Patient also reported dizziness and that she was not able to wake up and stand up from her bed. Treatments: The on-duty pharmacist recommended the patient to call 911 or seek medical attention should life threatening situation occurred. The pharmacist also recommended patient to take allergy medication, ibuprofen, and put ice pack on the injection site. Patient's husband was with the patient when the event was happening. The pharmacist will continue to call patient every 2-3 hrs by the end of 9/7/2017. Patient reported to her primary care provider as well. Outcomes: Around 2 pm 9/7/2017, the pharmacist called the patient again. The swelling and redness were still the same, but she could stand up, walk and eat. She said that she would be ok without going to the emergency room.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Mobility decreased
Clinical narrative: Event: Patient had 3 vaccines (flu, BOOSTRIX, and PNEUMOVAX) on 9/6/2017 around 4:30pm. At 8pm 9/6/17 patient called to report that her arm was swollen, itchy and red at the injection site. On 9/7/2017 at 9am, the pharmacist followed up with the patient again. The patient reported that the redness and swelling still persisted. The swelling was spreading from the injection site to her upper shoulder. Patient also reported dizziness and that she was not able to wake up and stand up from her bed. Treatments: The on-duty pharmacist recommended the patient to call 911 or seek medical attention should life threatening situation occurred. The pharmacist also recommended patient to take allergy medication, ibuprofen, and put ice pack on the injection site. Patient's husband was with the patient when the event was happening. The pharmacist will continue to call patient every 2-3 hrs by the end of 9/7/2017. Patient reported to her primary care provider as well. Outcomes: Around 2 pm 9/7/2017, the pharmacist called the patient again. The swelling and redness were still the same, but she could stand up, walk and eat. She said that she would be ok without going to the emergency room.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient started to itch on Sept 3rd and notice welts. Started BENADRYL on Sept 5th and itching and welts have improved.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Pain in extremity, Peripheral swelling, Vaccination complication
Clinical narrative: Patient's husband called pharmacy @ approximately 10:30 am on 9/7/17 to report that the patient's arm was "swollen and sore from the bicep to elbow". This began approximate 1:00 pm on 9/6/17. Husband stated that they had been using ice during the afternoon and evening and the morning of the call. Pharmacist recommended continuing with intermittent ice and stated that she would call and check on the patient in the early afternoon today. When I called, the husband stated that they had gone to urgent care between the time of their call to the pharmacy and the pharmacist's early afternoon call to the patient. The husband stated that Dr had diagnosed patient with an allergic reaction to the PNEUMOVAX 23 injection and that he had seen many of these reactions in the past. Dr recommended BENADRYL and continued ice, stating that the condition would take approximately 24-48 hours to resolve (per patient's husband). Pharmacist asked how patient was doing after taking the BENADRYL and was told that patient was napping. Pharmacist made another follow-up call at approximately 5:10pm the same day. Patient's husband stated that his wife's arm swelling had subsided slightly and was still sore.
Age: 47.0
Sex: M
Vaccine: YF
Symptoms: Chills, Dizziness, Headache, Influenza virus test negative, Mononucleosis heterophile test negative
Clinical narrative: Symptoms started 9/1/17, c/o body aches, fever, chills, headache, lightheadedness, sore throat.
Age: 47.0
Sex: M
Vaccine: YF
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Streptococcus test negative
Clinical narrative: Symptoms started 9/1/17, c/o body aches, fever, chills, headache, lightheadedness, sore throat.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pyrexia
Clinical narrative: PT SAID THAT SHE DEVELOPED CELLULITIS IN HER LEFT ARM AFTER GETTING THE FLU VACCINATION FROM THE DR AND PNEUMOVAX 23 FROM PHARMACY. VACCINATIONS WERE GIVEN IN THE SAME ARM. PT SAID SHE DEVELOPED A FEVER THAT WENT AWAY. DR PRESCRIBED AUGMENTIN FOR PT TO CELLULITIS (PT WAS ALREADY TAKING AUGMENTIN FOR UNRELATED SINUS INFECTION). PT SHOWED ME HER ARM WHICH WAS RED. PT SAID IT WAS GETTING BETTER.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Carpal tunnel decompression, Musculoskeletal pain, Pain
Clinical narrative: After receiving the flu shot, the patient experienced pain on 09/04/17 the day after. The pain persisted to the point where the patient called the pharmacy in tears because of the shoulder pain. The pain still persists even today (09/07/17). Since the patient underwent carpal tunnel surgery in the right hand, the patient mentioned that she will take her pain medications while she recovers and hopefully the pain will subside by next week.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea and some dizziness. Onset was at 15 minutes and lasted about 10 minutes. Patient was given 50 mg of BENADRYL as a precaution. Felt better after 10 minutes and left feeling better. Felt like she needed something to eat.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Vomited twice 6 hours after vaccine given.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Headache
Clinical narrative: Patient initially stated that she felt dizzy and her head hurt to which her husband sat her down and came to get us. When we arrived she was very weak and having trouble responding but coherent. Gave her some water and an ice pack. Injection site was unremarkable, tongue and lips appeared to have no swelling. She slowly progressed and eventually said she needed to lay in the floor so we we eased her down and propped up her legs. She started to complain of her chest hurting and having trouble breathing slightly before we sat her down and she stated that again after we got her down and then she became unresponsive. We administered one Epinephrine 0.3 mg injection and within 30 seconds she became very alert and said she was feeling better. EMS arrived and took over from there.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Hyporesponsive to stimuli, Unresponsive to stimuli
Clinical narrative: Patient initially stated that she felt dizzy and her head hurt to which her husband sat her down and came to get us. When we arrived she was very weak and having trouble responding but coherent. Gave her some water and an ice pack. Injection site was unremarkable, tongue and lips appeared to have no swelling. She slowly progressed and eventually said she needed to lay in the floor so we we eased her down and propped up her legs. She started to complain of her chest hurting and having trouble breathing slightly before we sat her down and she stated that again after we got her down and then she became unresponsive. We administered one Epinephrine 0.3 mg injection and within 30 seconds she became very alert and said she was feeling better. EMS arrived and took over from there.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV1
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: Fever of 102.1, Crabby and crying baby (unusual for this infant).
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Abnormal behaviour, Chest X-ray normal, Diet refusal, Fatigue, Hyperhidrosis
Clinical narrative: To clarify the vaccincations listed above, I know our son received HepA, Hib, MMR, &Varicella on 8/28/17. I'm not certain which Hep A, Hib, etc each of the shots was as identified above. The information the clinic gave us did not specify those details. Our son received his vaccinations at his one year check up on 8/28/17 in the morning. On 8/30/17 he woke up after having been put to bed, covered in sweat. We turned a fan on him, opened his window, and checked him again in an hour and saw he was still sweating heavily. We took him to the ER and were told it was probably just a reacation to his vaccinations but that he looked fine.  He was fine the following day (8/31), however that night he was up every hour to hour and a half screaming (he typically sleeps through the night without waking).  I woke up with him at 5 am on 9/1 and realized at that time he had a fever. We started to give him Tylenol and coninued throughout the day on Friday.  He was crabby, tired, and not himself all day.  Whenever the Tylenol wore off, his fever came back.  This continued through Friday night and into Saturday.  Saturday afternoon (9/2) he woke up from a nap with a fever that was over 104 degrees. We immediately gave him more Tylenol, but it didn't bring the fever down.  We called an on call nurse and were advised to bring him back to urgent care/ER.    Upon arrival, we were told that the fever was too high to be a reaction to a vaccine. They checked our son over (eyes, ears, nose, listened to his chest and heart, etc).  They couldn't see anything so they ordered chest x-rays and a strep test.  Everything came back clear so we were told it was a reaction to one of the live immunizations he received on Monday.  All day Sunday (9/3) he was tired, crabby, and refused to eat or drink.  On Monday morning (9/4) he started to eat and play again, however he also broke out in a rash on the back of his neck.  The rash spread to his head, stomach, and back over the course of the next two days.  Finally on Wed, (9/6) we started to see the rash go away and his attitude, appetite, etc all returned to normal.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash, Screaming, Streptococcus test negative
Clinical narrative: To clarify the vaccincations listed above, I know our son received HepA, Hib, MMR, &Varicella on 8/28/17. I'm not certain which Hep A, Hib, etc each of the shots was as identified above. The information the clinic gave us did not specify those details. Our son received his vaccinations at his one year check up on 8/28/17 in the morning. On 8/30/17 he woke up after having been put to bed, covered in sweat. We turned a fan on him, opened his window, and checked him again in an hour and saw he was still sweating heavily. We took him to the ER and were told it was probably just a reacation to his vaccinations but that he looked fine.  He was fine the following day (8/31), however that night he was up every hour to hour and a half screaming (he typically sleeps through the night without waking).  I woke up with him at 5 am on 9/1 and realized at that time he had a fever. We started to give him Tylenol and coninued throughout the day on Friday.  He was crabby, tired, and not himself all day.  Whenever the Tylenol wore off, his fever came back.  This continued through Friday night and into Saturday.  Saturday afternoon (9/2) he woke up from a nap with a fever that was over 104 degrees. We immediately gave him more Tylenol, but it didn't bring the fever down.  We called an on call nurse and were advised to bring him back to urgent care/ER.    Upon arrival, we were told that the fever was too high to be a reaction to a vaccine. They checked our son over (eyes, ears, nose, listened to his chest and heart, etc).  They couldn't see anything so they ordered chest x-rays and a strep test.  Everything came back clear so we were told it was a reaction to one of the live immunizations he received on Monday.  All day Sunday (9/3) he was tired, crabby, and refused to eat or drink.  On Monday morning (9/4) he started to eat and play again, however he also broke out in a rash on the back of his neck.  The rash spread to his head, stomach, and back over the course of the next two days.  Finally on Wed, (9/6) we started to see the rash go away and his attitude, appetite, etc all returned to normal.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Vaccination complication
Clinical narrative: To clarify the vaccincations listed above, I know our son received HepA, Hib, MMR, &Varicella on 8/28/17. I'm not certain which Hep A, Hib, etc each of the shots was as identified above. The information the clinic gave us did not specify those details. Our son received his vaccinations at his one year check up on 8/28/17 in the morning. On 8/30/17 he woke up after having been put to bed, covered in sweat. We turned a fan on him, opened his window, and checked him again in an hour and saw he was still sweating heavily. We took him to the ER and were told it was probably just a reacation to his vaccinations but that he looked fine.  He was fine the following day (8/31), however that night he was up every hour to hour and a half screaming (he typically sleeps through the night without waking).  I woke up with him at 5 am on 9/1 and realized at that time he had a fever. We started to give him Tylenol and coninued throughout the day on Friday.  He was crabby, tired, and not himself all day.  Whenever the Tylenol wore off, his fever came back.  This continued through Friday night and into Saturday.  Saturday afternoon (9/2) he woke up from a nap with a fever that was over 104 degrees. We immediately gave him more Tylenol, but it didn't bring the fever down.  We called an on call nurse and were advised to bring him back to urgent care/ER.    Upon arrival, we were told that the fever was too high to be a reaction to a vaccine. They checked our son over (eyes, ears, nose, listened to his chest and heart, etc).  They couldn't see anything so they ordered chest x-rays and a strep test.  Everything came back clear so we were told it was a reaction to one of the live immunizations he received on Monday.  All day Sunday (9/3) he was tired, crabby, and refused to eat or drink.  On Monday morning (9/4) he started to eat and play again, however he also broke out in a rash on the back of his neck.  The rash spread to his head, stomach, and back over the course of the next two days.  Finally on Wed, (9/6) we started to see the rash go away and his attitude, appetite, etc all returned to normal.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain
Clinical narrative: The patient reports pain in the deltoid area of the left arm and pain with movement of the shoulder. The patient did not report the pain to the medical provider after the vaccination in February and had not been back in clinic for an appointment until September 6th when she mentioned the symptom to the medical provider during an exam.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: PNEUMOVAX 23 reaction: Pain where shot was given; redness and swelling where shot was given; irritation at shot site; felt tired and weak next morning; muscle pain. Arm much better after 3-4 days.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Myalgia
Clinical narrative: PNEUMOVAX 23 reaction: Pain where shot was given; redness and swelling where shot was given; irritation at shot site; felt tired and weak next morning; muscle pain. Arm much better after 3-4 days.
Age: 55.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Chills, Diarrhoea, Pruritus, Rash, Urticaria
Clinical narrative: 1 day after FLUZONE, Tdap-had chills, diarrhea. Went away. 2 day-broke out rash neck, chest, R side face, hives to ear lobes. No SOB. No cardiac issues. Itching.
Age: 78.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Loss of consciousness, Syncope
Clinical narrative: The day after the patient received the vaccines he fainted or passed out at his optometrist office. The office personnel called me to ask which vaccines he had received in case they were related to his fainting. I was told he was being transported to the hospital. I do not know what treatment he received or the outcome at this time. Per my company policy I submitted an incident report and the VAERS form to insure proper documentation.
Age: 0.17
Sex: F
Vaccine: HEP, IPV, PPV, RV1, TDAP
Symptoms: Lethargy, Pyrexia, Screaming
Clinical narrative: Fever of 100.1. Extreme lethargy for 2 days. High pitch scream for 2 days.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: Swollen arm/underneath radiating to shoulder and elbow pain/soreness.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Excessive itching/redness/injection site swelling/painful.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal disorder, Nerve conduction studies, Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: I was given flue shot in the left arm after the shot my arm kept hurting and I got where I could not used my arm. My finger started hurting felt like I was picking up broken glass.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen area around where got shot. Received shot 9/1/17 showed me on 9/5/17. She took BENADRYL.
Age: 0.83
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting (symptoms lasted less than a day) with leg swelling. Treatment-Fever resolved 8-25-17 at 10am and was able to keep down food. TYLENOL or ibuprofen as needed per pain, and if not feeling better to let us know and to go to ER.
Age: 15.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Live vaccines given prior to positive pregnancy test done.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: PNEUMOVAX 23 - 9/6/17 - 9/7/17 - 1/2 upper arm red, edema, sl. warm to touch, aches. Given AUGMENTIN, MEDROL DOSEPAK, cool compresses, ADVIL.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Large raised red rash on left deltoid swelling at injection site.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a 50-year-old female patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult. On an unknown date, the patient received ENGERIX B adult and ENGERIX B adult at an unknown dose. On an unknown date, unknown after receiving ENGERIX B adult and ENGERIX B adult, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to ENGERIX B adult and ENGERIX B adult. Additional details were provided as follows: The age at vaccination was not reported. In 1991, the patient received a complete hepatitis B series and in 1992, the patient received a booster dose. On an unknown date, recent the patient underwent for laboratory test which showed low titer for hepatitis B (decreased therapeutic response) and subsequently the healthcare professional intended to vaccinate the patient with a booster dose of ENGERIX-B, but the vaccine was not yet been administered. The healthcare professional did not had specific patient information.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient vaccinated by pharmacist and under 18 years old.