chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pt reports receiving shot in her LD around noon on 01/09/2019, and pretty much on the dot at 3 PM 01/09/2019 she started getting an intense, "excruciating pain" building in her left arm. Within seconds, her pain level had reached a 9/10 on 0-10 pain scale and she felt weak, shaky and that she was going to pass out. She was at a local business, but had to lay on the floor and request help. They brought her water (she drank about 90 oz within a few minutes), gave her some ibuprofen and sat with her until a relative came. She thought about going to ER but says that after about one hour laying down there she felt okay to go to home. That evening, she developed some mild fever and chills. She reported minimal swelling at injection site and minimal redness but states she has very limited movement and strength in her arm. She describes it pretty much as an "arm paralysis". She denies any airway involvement nor rash. But even after two days (she reported to me on 01/11/2019) she still doesn't feel very good, still has little movement in her arm and almost no strength. She is taking ibuprofen 800 mg every six hours and Benadryl about the same schedule. She reports with medications, her pain is tolerable at a 2-3 pain level, but without medication and resting it is around a 4-5. If she tries to lift or move her arm, the pain quickly becomes 8-9 on 0-10 pain scale. I spoke with pt again on 01/14/19 and she feels she is on the mend but still only has about 80% normal range of motion and 60% strength in her arm. If she tries to lift her arm, it quickly becomes a 7-8 on pain scale. She spoke with a Dr. over the weekend who told her she likely had an anaphylactic reaction and should not receive any future doses. She spoke with an NP today and was Rx'd prednisone x 5 days to see if there was any benefit. Both providers agreed that she has nerve involvement from the inflammation process in her arm. She doesn't feel shaky, chilled or any other symptoms at this time besides her arm pain and limited movement. She does plan to potentially follow up with her PMD, Dr especially if no further improvement from the prednisone. Again, she denies any respiratory involvement, no rash, no major swelling or redness. Her arm is very tender to the touch at the injection site. Pt is a long practice RN who is a professor with local university nursing program, so does feel she has pretty good medical background. She reports she anticipated some pain and potential reaction, but nothing to this severity, length and involvement.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Flushing, Injection site erythema, Injection site pain
Clinical narrative: Fever spiked to 103*F by 11:00 pm the day after injection. Controlled with ibuprofen (400 mg) and acetaminophen (1000 mg), reduced to 1000 mg acetaminophen as needed at intervals of 4 hours or more. Fever persisted varying between 99*F and 102.5*F for the next 48 hours accompanied by chills, night sweats, joint pain expecially in hands, fingers, and toes, mild episodes of nausea, flushing of the face. Extreme soreness and swelling of injection site to the point of waking pain at night. Swelling is roughly 10 cm along the length of the arm and 5 cm wide, mild to dark red. Now 4 days after injection most symptoms still persist, mitigated by acetaminophen doses.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Nausea, Night sweats, Pyrexia, Sleep disorder
Clinical narrative: Fever spiked to 103*F by 11:00 pm the day after injection. Controlled with ibuprofen (400 mg) and acetaminophen (1000 mg), reduced to 1000 mg acetaminophen as needed at intervals of 4 hours or more. Fever persisted varying between 99*F and 102.5*F for the next 48 hours accompanied by chills, night sweats, joint pain expecially in hands, fingers, and toes, mild episodes of nausea, flushing of the face. Extreme soreness and swelling of injection site to the point of waking pain at night. Swelling is roughly 10 cm along the length of the arm and 5 cm wide, mild to dark red. Now 4 days after injection most symptoms still persist, mitigated by acetaminophen doses.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Paraesthesia
Clinical narrative: Patient bled at injection site (upper right arm) and was swabbed. By time Band-Aid was applied 15-20 seconds a grape sized raised area appeared at inj. site and site and surrounding area appeared red and Pt became light headed. 911 was called, but patient did not want this & called friends to come pick her up. I walked her over to waiting area where she sat and then Police arrived who subsequently called EMT who arrive 5 minutes later. Pt mentioned tingly hands and EMT check vitals which were normal. She refused to be brought to Hospital and signed out against medical advise. She left with friends who assisted her (she was a bit dizzy) about 30-40 minutes following the injection. We all cautioned her and I called her later in the day where she was doing fine. She was given Benadryl 25mg while at the pharmacy.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Herpes virus infection, Herpes zoster, Influenza like illness, Injection site pain
Clinical narrative: Typical flu-like aching reaction with injection site tenderness and swelling. Acute herpes zoster in C-2 distribution on Lt parietal scalp, starting Nov 22, ie 2 days after vaccination.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Typical flu-like aching reaction with injection site tenderness and swelling. Acute herpes zoster in C-2 distribution on Lt parietal scalp, starting Nov 22, ie 2 days after vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: PATIENT CAME IN THIS MORNING (1/14/19) STATING THAT SHE HAD A PAIN THAT SHOT DOWN HER ARM AND UP INTO THE SIDE OF HER HEAD AND HAD  NAUSEA AS WELL. SHE SAID IT LASTED FOR ABOUT 24 HOURS THEN WENT AWAY. SHE WAS UNABLE TO REALLY LEAVE THE HOUSE OR DO ANYTHING THE DAY AFTER THE SHOT DUE TO HOW IT MADE HER FEEL. SHE STATES SHE FEELS FINE NOW AND WILL STILL GET THE 2ND DOSE WHEN IT IS DUE.
Sex: U
Vaccine: FLU4, TD
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: He reports he received the seasonal influenza and Td vaccines and the following day developed pain and swelling affecting the lymph nodes of his left axilla which lasted for one week prior to resolving. No constitutional or systemic symptoms. He sought care in the ER where he was told to use cool compresses.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray, Dizziness, Electrocardiogram, Loss of consciousness, Pain in extremity
Clinical narrative: Patient received vaccine and about 3-4 hours later began having severe pain in the injected arm. Over the next 2 hours pain worsened and patient became lightheaded, which made her decide to go to the ER. In the ER patient reports experience "non-anaphylactic" shock and became unconscious. Treatment not noted, but patient was evaluated for heart attack due to pain in arm and lightheadedness. Patient regained consciousness in ER and was discharged once stable later the same evening. Patient followed up with on 1/14/19 and reports no systemic effects, but still has mild pain in injected arm. Has a follow-up scheduled with PCP for 1/16/2019.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Shock, X-ray limb
Clinical narrative: Patient received vaccine and about 3-4 hours later began having severe pain in the injected arm. Over the next 2 hours pain worsened and patient became lightheaded, which made her decide to go to the ER. In the ER patient reports experience "non-anaphylactic" shock and became unconscious. Treatment not noted, but patient was evaluated for heart attack due to pain in arm and lightheadedness. Patient regained consciousness in ER and was discharged once stable later the same evening. Patient followed up with on 1/14/19 and reports no systemic effects, but still has mild pain in injected arm. Has a follow-up scheduled with PCP for 1/16/2019.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Possible cellulitis -- clinic gave her antibiotics (cephalexin 500 mg QID X10 days) on 1/11/19.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient reported swelling around the injection site (about the size of a fist), but no redness. Patient reported that she could lift her arm above her shoulder but it was painful and with some difficulty. Instructed patient to take 600 mg of Ibuprofen OTC every 6 hours, continue to use cold pack to help with swelling. Patient did not feel that her reaction was life-threatening or warranted a hospital visit. Will f/u with patient tomorrow for progress report.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth, Peripheral swelling, Urticaria
Clinical narrative: Leg swollen, warm to touch, bruised. Hands and feet swollen with welts on day 3.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site pain, Injection site swelling, Pain
Clinical narrative: Injection site - swollen, sore  getting better after 2 full days; Shivering only on first night, extremely cold, required extra blankets; Fever-first night 101.5, second night 100.5, normal morning of third day Tylenol for fever and aching; Excedrine for fever; Third day mostly better with slight arm soreness and slight aching.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Injection site - swollen, sore  getting better after 2 full days; Shivering only on first night, extremely cold, required extra blankets; Fever-first night 101.5, second night 100.5, normal morning of third day Tylenol for fever and aching; Excedrine for fever; Third day mostly better with slight arm soreness and slight aching.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Pain
Clinical narrative: After receiving my Flu shot, I now have pain in my shoulder and elbow when moving my left arm.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Fever 104 resolved after 1 or 2 days. Injection site reaction with redness and warmth in the middle third of the arm. I confirmed with the patient the injections were given in the upper arm deltoid.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Chest pain, Chills, Feeling cold, Headache
Clinical narrative: I received the current flu vaccine that Pharmacy was administering on 1/3/19. Within 5 to 10 minutes while I was in my vehicle in the parking lot, I began to get sharp acute jolting pain emanating from my lower back and moving upward and around to my chest. The pain was a number 9 on a scale of 10 being the most severe. The jolting pain would come almost every 3 seconds. It was so severe I was moments from calling 911 for assistance. In about 12 to 15 minutes, the pain began to minimize. I then drove home where I immediately began to feel extremely cold to the point of uncontrollable shivers. I also began to develop a severe headache along with body aches and fever that lasted through the day and through the night. By 7:00 am the next morning the conditions began to subside. Two year ago I experienced the same flu conditions that lasted 3 days. I am clearly allergic to something in the injection cocktail.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: I received the current flu vaccine that Pharmacy was administering on 1/3/19. Within 5 to 10 minutes while I was in my vehicle in the parking lot, I began to get sharp acute jolting pain emanating from my lower back and moving upward and around to my chest. The pain was a number 9 on a scale of 10 being the most severe. The jolting pain would come almost every 3 seconds. It was so severe I was moments from calling 911 for assistance. In about 12 to 15 minutes, the pain began to minimize. I then drove home where I immediately began to feel extremely cold to the point of uncontrollable shivers. I also began to develop a severe headache along with body aches and fever that lasted through the day and through the night. By 7:00 am the next morning the conditions began to subside. Two year ago I experienced the same flu conditions that lasted 3 days. I am clearly allergic to something in the injection cocktail.
Age: 49.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Asthenia, Grip strength decreased, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Fever of 100.2 orally. Right deltoid mildly swollen, diffusely red and mildly warm, tender. Redness had slight turn towards the forearm of the deltoid. Reported numbness and weakness and wasn't able to fully squeeze (R) hand. Pt. given 60 mg TORADOL inj. in clinic. Sent home w/oral TORADOL, PERCOCET, prednisone, ZOFRAN.
Age: 49.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever of 100.2 orally. Right deltoid mildly swollen, diffusely red and mildly warm, tender. Redness had slight turn towards the forearm of the deltoid. Reported numbness and weakness and wasn't able to fully squeeze (R) hand. Pt. given 60 mg TORADOL inj. in clinic. Sent home w/oral TORADOL, PERCOCET, prednisone, ZOFRAN.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: Pain - limited arm movement.
Age: 30.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Electrocardiogram normal, Nausea, Pallor, Posture abnormal
Clinical narrative: At around 10:50 on 08/30/18 Patient had an abnormal reaction 2-3 minutes after receiving the vaccine. Patient slowly slumped over and slowly brought himself to the ground. RN called for help and Code Blue called. Patient appeared pale, and felt cold and clammy; reports feeling nauseous. No LOC noted; Patient did not hit his head or any other body part. VS.: 95/69; 55; 99%; resp 21. Pads placed on Patient for monitoring. Monitor showed NSR; Patient was A&O throughout the entire event and stated that he has had a similar reaction in the past after getting an injection. Code team arrived and assumed control of situation. Patient transported to the emergency room.
Age: 30.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: At around 10:50 on 08/30/18 Patient had an abnormal reaction 2-3 minutes after receiving the vaccine. Patient slowly slumped over and slowly brought himself to the ground. RN called for help and Code Blue called. Patient appeared pale, and felt cold and clammy; reports feeling nauseous. No LOC noted; Patient did not hit his head or any other body part. VS.: 95/69; 55; 99%; resp 21. Pads placed on Patient for monitoring. Monitor showed NSR; Patient was A&O throughout the entire event and stated that he has had a similar reaction in the past after getting an injection. Code team arrived and assumed control of situation. Patient transported to the emergency room.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Patient reported red, itchy rash around injection site started approximately 2 days after receiving PREVNAR 13 (received vaccine on 05/03/18. Patient went to ER on 05/10/18 with c/o rash and was not admitted. Discharged home with prescriptions for BENADRYL and prednisone with resolution of symptoms.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Injection site erythema, Irritability
Clinical narrative: Fussy the night of shots, woke in the am with redness at 3 sites (size of a nickel x 2; size of dime x 1).
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Bronchogram abnormal, Chest X-ray, Cough, Crying, Eye movement disorder
Clinical narrative: Febrile seizure at 12 hours after received, he had runny nose but no fever at visit (sibling had been ill with suspected RSV the previous week). Seizure resolved, no repeat but then progressed to continued fevers, cough. On 1/2/19 normal exam except slight nasal drainage. On 1/3 mom took him to ED for seizure (occurred just before midnight - no eval done in ED other than exam and TYLENOL). 1/4/19 came into clinic for eval with continued fevers, exam markedly different from 1/2 with copious nasal congestion, cough, fever on exam. (B) otitis media and concern for possible viral pneumonia (increased hilar markings with air bronchograms throughout - bronchiolitis vs. pneumonia). Mom described episode the evening of 1/2 - eyes rolled back, body stiffening for 20 no more than 30 seconds, breathing erratic. No color change and then stopped crying as soon as episode stopped - mom took him directly to ED - did not need to call 911.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Febrile convulsion, Irregular breathing, Musculoskeletal stiffness, Otitis media, Pyrexia
Clinical narrative: Febrile seizure at 12 hours after received, he had runny nose but no fever at visit (sibling had been ill with suspected RSV the previous week). Seizure resolved, no repeat but then progressed to continued fevers, cough. On 1/2/19 normal exam except slight nasal drainage. On 1/3 mom took him to ED for seizure (occurred just before midnight - no eval done in ED other than exam and TYLENOL). 1/4/19 came into clinic for eval with continued fevers, exam markedly different from 1/2 with copious nasal congestion, cough, fever on exam. (B) otitis media and concern for possible viral pneumonia (increased hilar markings with air bronchograms throughout - bronchiolitis vs. pneumonia). Mom described episode the evening of 1/2 - eyes rolled back, body stiffening for 20 no more than 30 seconds, breathing erratic. No color change and then stopped crying as soon as episode stopped - mom took him directly to ED - did not need to call 911.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Rhinorrhoea, Seizure
Clinical narrative: Febrile seizure at 12 hours after received, he had runny nose but no fever at visit (sibling had been ill with suspected RSV the previous week). Seizure resolved, no repeat but then progressed to continued fevers, cough. On 1/2/19 normal exam except slight nasal drainage. On 1/3 mom took him to ED for seizure (occurred just before midnight - no eval done in ED other than exam and TYLENOL). 1/4/19 came into clinic for eval with continued fevers, exam markedly different from 1/2 with copious nasal congestion, cough, fever on exam. (B) otitis media and concern for possible viral pneumonia (increased hilar markings with air bronchograms throughout - bronchiolitis vs. pneumonia). Mom described episode the evening of 1/2 - eyes rolled back, body stiffening for 20 no more than 30 seconds, breathing erratic. No color change and then stopped crying as soon as episode stopped - mom took him directly to ED - did not need to call 911.
Age: 46.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Feeling hot, Pruritus, Pyrexia, Rash, Rash erythematous
Clinical narrative: Red, raised spots all over face. Heated up and itchy, felt like sunburnt. Also a fever 100 degrees.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Chest pain, Cough, Dyspnoea, Pneumonia
Clinical narrative: This is a spontaneous case, initially received from other health professional on 25-Oct-2018, concerning a 45-year-old, adult, female patient. The patient's current condition included Still's disease for which the patient was taking methotrexate, once a week. On 19-Oct-2018, the patient was administered FLUCELVAX QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252234 and expiry date: 30-Jun-2019) for influenza prophylaxis. On an unspecified date in Oct-2018, within 24 hours of vaccination, the patient experienced symptoms of fever (greater than 101-degree F) for over 24 hours, chest pain, back pain, trouble in breathing and intense cough (wet). The patient was diagnosed with pneumonia and was subsequently hospitalized on 20-Oct-2018. Due to the onset of pneumonia, the doctor had advised the patient to interrupt methotrexate for a week and a half. It was reported that the diagnostic tests were not available as they were performed at the hospital. The patient was prescribed with azithromycin. On 23-Oct-2018, the patient was discharged from the hospital in febrile condition. The outcome of the events was recovered on an unspecified date. The patient was asymptomatic. The reporter assessed this case as serious due to hospitalization. Follow-up received from other health professional on 04-Dec-2018: Added current condition (still's disease) in patient's tab and concomitant medication (methotrexate) in the product's tab. The symptoms prior to hospitalization were fever (greater than 101-degree F) for over 24 hours, chest pain, back pain, trouble in breathing and intense cough (wet). The patient was treated with azithromycin and diagnostic tests were not available as they were performed in the hospital. All symptoms were resolved except cough which could last for one or 2 months. The narrative was amended accordingly. Follow-up received from other health professional on 04-Jan-2019: The outcome of the events cough and pneumonia was changed from not recovered to recovered in the event tab. It was reported that the patient was asymptomatic. The narrative was amended accordingly.; Reporter's Comments: A 45-year-old female patient with concomitant methotrexate therapy experienced fever, cough (wet), chest pain, back pain and trouble in breathing, within 24 hours after receipt of FLUCELVAX QIVc vaccine and was diagnosed with Pneumonia. Upon diagnosis patient was treated with Azithromycin. The event pneumonia can be alternately explained by infection (suspected bacterial) rather than the inactivated suspect vaccine. Hence, the company assessed the causality of the event as not related to suspect vaccine. Concomitant methotrexate therapy is considered as a known risk factor for pneumonia.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous case, initially received from other health professional on 25-Oct-2018, concerning a 45-year-old, adult, female patient. The patient's current condition included Still's disease for which the patient was taking methotrexate, once a week. On 19-Oct-2018, the patient was administered FLUCELVAX QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252234 and expiry date: 30-Jun-2019) for influenza prophylaxis. On an unspecified date in Oct-2018, within 24 hours of vaccination, the patient experienced symptoms of fever (greater than 101-degree F) for over 24 hours, chest pain, back pain, trouble in breathing and intense cough (wet). The patient was diagnosed with pneumonia and was subsequently hospitalized on 20-Oct-2018. Due to the onset of pneumonia, the doctor had advised the patient to interrupt methotrexate for a week and a half. It was reported that the diagnostic tests were not available as they were performed at the hospital. The patient was prescribed with azithromycin. On 23-Oct-2018, the patient was discharged from the hospital in febrile condition. The outcome of the events was recovered on an unspecified date. The patient was asymptomatic. The reporter assessed this case as serious due to hospitalization. Follow-up received from other health professional on 04-Dec-2018: Added current condition (still's disease) in patient's tab and concomitant medication (methotrexate) in the product's tab. The symptoms prior to hospitalization were fever (greater than 101-degree F) for over 24 hours, chest pain, back pain, trouble in breathing and intense cough (wet). The patient was treated with azithromycin and diagnostic tests were not available as they were performed in the hospital. All symptoms were resolved except cough which could last for one or 2 months. The narrative was amended accordingly. Follow-up received from other health professional on 04-Jan-2019: The outcome of the events cough and pneumonia was changed from not recovered to recovered in the event tab. It was reported that the patient was asymptomatic. The narrative was amended accordingly.; Reporter's Comments: A 45-year-old female patient with concomitant methotrexate therapy experienced fever, cough (wet), chest pain, back pain and trouble in breathing, within 24 hours after receipt of FLUCELVAX QIVc vaccine and was diagnosed with Pneumonia. Upon diagnosis patient was treated with Azithromycin. The event pneumonia can be alternately explained by infection (suspected bacterial) rather than the inactivated suspect vaccine. Hence, the company assessed the causality of the event as not related to suspect vaccine. Concomitant methotrexate therapy is considered as a known risk factor for pneumonia.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Quality of life decreased
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. In 2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Patient is a 61-year-old female who is self-referred for evaluation of right arm injection site reaction. Patient states she received an injection on 10/8/18 in her proximal right upper extremity. States that she first noticed some changes a couple weeks following the injection. Patient states she received a weeks worth of antibiotics in October 2018 following reaction. Patient states she had the lesion lanced in November 2018. Patient reports at that time cultures were obtained, but states they did not show anything per patient. States that there was significant erythema surrounding the injection site at one point, but states this has since improved significantly. Patient reports that the area is tender to palpation. Rates pain 1/10. Denies any recent drainage, but does report drainage prior to and since the lesion was lanced. Reports chills and sweats, but states this is normal for her. Denies any known fevers.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Abscess, Dermal cyst, Erythema, Incisional drainage, Pain
Clinical narrative: Patient is a 42-year-old female who is seen in consultation for Dr. for evaluation of left arm lesion. Patient states she had a hepatitis A vaccination injections on 10/8/18 and her proximal left upper extremity. About 1 week after getting the injection, patient noticed redness, swelling him a and drainage. Patient states the swelling and redness improved, but has since returned multiple times. Patient states she has been on minocycline ×1 week, steroids, and been taking ciprofloxacin since 12/19/18 and has one month left of this. Patient states the area on her left upper extremity is tender to palpation, and rates this pain 3/10. Patient states the area on her left upper extremity has drained 4 times. Reports drainage is dark yellow and malodorous. Patient reports no drainage since November. Patient states she has not had a fever since the second week of November. Patient had ultrasound performed on 1/4/19 which revealed the following per report: nonspecific lesion as detailed above; differential considerations would include abscess and sebaceous cyst. I&D performed, cultures obtained, wet-to-dry dressing BID.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Secretion discharge, Skin lesion, Swelling, Tenderness, Ultrasound scan abnormal
Clinical narrative: Patient is a 42-year-old female who is seen in consultation for Dr. for evaluation of left arm lesion. Patient states she had a hepatitis A vaccination injections on 10/8/18 and her proximal left upper extremity. About 1 week after getting the injection, patient noticed redness, swelling him a and drainage. Patient states the swelling and redness improved, but has since returned multiple times. Patient states she has been on minocycline ×1 week, steroids, and been taking ciprofloxacin since 12/19/18 and has one month left of this. Patient states the area on her left upper extremity is tender to palpation, and rates this pain 3/10. Patient states the area on her left upper extremity has drained 4 times. Reports drainage is dark yellow and malodorous. Patient reports no drainage since November. Patient states she has not had a fever since the second week of November. Patient had ultrasound performed on 1/4/19 which revealed the following per report: nonspecific lesion as detailed above; differential considerations would include abscess and sebaceous cyst. I&D performed, cultures obtained, wet-to-dry dressing BID.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram normal, Eye pain, Headache, Nuclear magnetic resonance imaging normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 85-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in early October 2018). On 3rd December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In December 2018, less than a day after receiving SHINGRIX, the patient experienced headache (serious criteria hospitalization) and eye pain. On an unknown date, the outcome of the headache and eye pain were recovering/resolving. It was unknown if the reporter considered the headache and eye pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left deltoid. On the same day, at night the patient experienced severe headache on the right side of her head. The patient was hospitalized for two days and had a magnetic resonance imaging and a computerised tomogram, but both were negative. Less than month after vaccination, the patient also experienced eye pain. The patient went to her eye physician, but they found nothing wrong with eye. Since the beginning of January 2019, the patient's condition was improved and the overall pain was less. The reporter consented to follow up.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Headache, Nuclear magnetic resonance imaging brain, Ophthalmological examination, Scan with contrast
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 85-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in early October 2018). On 3rd December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In December 2018, less than a day after receiving SHINGRIX, the patient experienced headache (serious criteria hospitalization) and eye pain. On an unknown date, the outcome of the headache and eye pain were recovering/resolving. It was unknown if the reporter considered the headache and eye pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left deltoid. On the same day, at night the patient experienced severe headache on the right side of her head. The patient was hospitalized for two days and had a magnetic resonance imaging and a computerised tomogram, but both were negative. Less than month after vaccination, the patient also experienced eye pain. The patient went to her eye physician, but they found nothing wrong with eye. Since the beginning of January 2019, the patient's condition was improved and the overall pain was less. The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: HIBV, HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a four-months-old female patient who received vaccine ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Jan-2019, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE via unknown route in the left thigh. (Lot powder- UI900AA, expiry date: 10/08/2019, NDC 49281-547-58 Lot liquid U6018AA expiry date: 9/17/2019 NDC 49281-546-58 Package: Lot UI900AAA, expiry date: 9/17/2019 NDC 49281-545-03.) It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that gave the ACTHIB with sterile water instead of the diluent that comes in the box. It was discovered during inventory when a single bottle of diluent was found in the ACTHIB box.  No side effects reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Incorrect product formulation administered, Product preparation error, Product preparation issue
Clinical narrative: Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a four-months-old female patient who received vaccine ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Jan-2019, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE via unknown route in the left thigh. (Lot powder- UI900AA, expiry date: 10/08/2019, NDC 49281-547-58 Lot liquid U6018AA expiry date: 9/17/2019 NDC 49281-546-58 Package: Lot UI900AAA, expiry date: 9/17/2019 NDC 49281-545-03.) It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that gave the ACTHIB with sterile water instead of the diluent that comes in the box. It was discovered during inventory when a single bottle of diluent was found in the ACTHIB box.  No side effects reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Dizziness, Fatigue, Hypersomnia, Oropharyngeal pain
Clinical narrative: Some pain in arm as expected, mild fever (around 99.8), very sore throat, dizziness, no appetite at all, exhaustion, slept most of the time for like 3 days. Initially I thought it was the flu although I had the flu shot. See item 20: feeling better, but not yet 100%.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Some pain in arm as expected, mild fever (around 99.8), very sore throat, dizziness, no appetite at all, exhaustion, slept most of the time for like 3 days. Initially I thought it was the flu although I had the flu shot. See item 20: feeling better, but not yet 100%.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Aphasia, Feeling abnormal, Grunting, Unresponsive to stimuli
Clinical narrative: Patient was given the pneumonia vaccine, then his regular morning medication. About 5-10 minutes later the patient starting making grunting noises and was unable to follow commands or respond to questions. The episode lasted about 5-10 minutes and the patient returned to normal. Patient stated he "felt funny" after getting the vaccine, but was unable to talk or call for help. He stated he could hear us and see us but could not respond.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: I woke up at 2 am with severe body aches, a headache, fever of 101.2 and chills that lasted for 24 hours.
Age: 37.0
Sex: F
Vaccine: MMRV
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Off label use, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 37 year old non-pregnant female patient. The patient's concurrent conditions included gastrooesophageal reflux disease (GERD). Concomitant medications included ranitidine. She had none drug reactions or allergies. On an unspecified date, when the patient was a child, she was vaccinated with an unspecified vaccine for measles, mumps, rubella and varicella. On 21-DEC-2018, the patient was performed the titers count laboratory test for measles, mumps, rubella and varicella all with negative results (values not provided) (measles antibody negative, antibody test negative, rubella antibody negative, and mumps antibody test negative). It was specified that the patient sought medical attention and received treatment for the events. On 03-JAN-2019, the patient was vaccinated with PROQUAD 0.5 mL (lot # R006213, expiration date: 28-AUG-2019), administered subcutaneously in the right arm, once for prophylaxis (product administered to patient of inappropriate age, off label use). The vaccine was diluted with a sterile diluent (lot # and expiration date were not reported). The outcome measles antibody negative, antibody test negative, rubella antibody negative, and mumps antibody test negative was reported as not resolved. The causality between the events and PROQUAD was not reported.
Age: 37.0
Sex: F
Vaccine: MMRV
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 37 year old non-pregnant female patient. The patient's concurrent conditions included gastrooesophageal reflux disease (GERD). Concomitant medications included ranitidine. She had none drug reactions or allergies. On an unspecified date, when the patient was a child, she was vaccinated with an unspecified vaccine for measles, mumps, rubella and varicella. On 21-DEC-2018, the patient was performed the titers count laboratory test for measles, mumps, rubella and varicella all with negative results (values not provided) (measles antibody negative, antibody test negative, rubella antibody negative, and mumps antibody test negative). It was specified that the patient sought medical attention and received treatment for the events. On 03-JAN-2019, the patient was vaccinated with PROQUAD 0.5 mL (lot # R006213, expiration date: 28-AUG-2019), administered subcutaneously in the right arm, once for prophylaxis (product administered to patient of inappropriate age, off label use). The vaccine was diluted with a sterile diluent (lot # and expiration date were not reported). The outcome measles antibody negative, antibody test negative, rubella antibody negative, and mumps antibody test negative was reported as not resolved. The causality between the events and PROQUAD was not reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a physician referring to a 1 year old patient of unknown gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On 10-JAN-2019, the  patient was inadvertently administered a dose of PROQUAD, subcutaneous, lot # R011802 and expiration date 21-OCT-2019 (dosage schedule, and anatomical location were not reported) instead of an intended dose of M-M-R II (wrong vaccine administered), which was administered concomitantly with a dose of VARIVAX subcutaneous, lot # R009411 and expiration date 29-MAR-2019 (dosage schedule, and anatomical location were not reported). Both PROQUAD, and VARIVAX doses were reconstituted with the same lot of sterile diluent lot R001088, expiration date 16-SEP-2020 (dosage schedule, and anatomical location were not reported). The physician reported the error occurred because the nurse mistook PROQUAD for M-M-R II, because the vials are similar in color (product appearance confusion) and she did not notice that the PROQUAD label said "varicella" in addition to "measles/mumps/rubella (product label confusion)." No adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Quality of life decreased
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about  29-FEB-2012, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 23-MAY-2013, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 09-APR-2015, the patient was treated by a physician for post herpetic neuralgia. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Atrial fibrillation
Clinical narrative: This is a spontaneous report obtained from a contactable Health Care Professional. A patient of an unspecified age and gender received, on an unknown date, PREVNAR 13, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient developed atrial fibrillation (Afib) after receiving pneumococcal 13-val conj vac (dipht crm197 protein). Clinical outcome of the event was unknown at time of this report. The information on the lot number has been requested.; Sender's Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of medical history, concomitant medications and concurrent illness.  However, a causal relationship between the serious event atrial fibrillation (Afib) and PREVENAR 13 might not be completely ruled out considering the plausible time association.  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.
Age: 14.0
Sex: F
Vaccine: IPV
Symptoms: Dizziness, Headache, Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: Received call from parent this morning stating child had complained of arm soreness last night which then radiated into the right arm. She also complained of nausea and headache and feeling dizzy and was unable to go to school. Parent will take child to doctor for eval.