chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Crying, Pain
Clinical narrative: Patient received vaccination 4/24/18 and called 4/25/18 to report reaction. Patient stated he was in so much pain that he was in tears. He was also having chills. He tried a hot bath which helped while he was in the hot bath. He is feeling better now since about 6 am on 4/25/18.
Sex: M
Vaccine: MMR, TYP
Symptoms: Rash, Rash pruritic
Clinical narrative: 3/10/18. Presents with rash over anterior/posterior thorax. Also involving axilla and neck. Rash is itching.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Oedema
Clinical narrative: Pt with erythematous injection site with 2 lines of tracking redness down upper arm. (L) neck -> clavicular area with slight edema. BENADRYL taken without relief. Tx'd with IV ceftriaxone, SOLU-MEDROL and course of oral BACTRIM.
Age: 24.0
Sex: F
Vaccine: HPV9, FLU4, HEPA, HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient was given HPV, patient stated her last period was on 2/20/2018 but stated she was on birth control. Doctor ordered a pregnancy test after the HPV was given and it was positive.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Impaired work ability
Clinical narrative: I was expecting a sore arm and rash which happened with the first dose but by the late afternoon and evening, I was very tired. In the middle of the night, I got chills, nausea, headache and generally felt like I had been hit by a bus! General muscle pain and weakness. If I had to go to work, I would have been unable to work. It felt like the flu which I have only had two times in my past.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Muscular weakness, Myalgia, Nausea
Clinical narrative: I was expecting a sore arm and rash which happened with the first dose but by the late afternoon and evening, I was very tired. In the middle of the night, I got chills, nausea, headache and generally felt like I had been hit by a bus! General muscle pain and weakness. If I had to go to work, I would have been unable to work. It felt like the flu which I have only had two times in my past.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Notified on April 6, 2018 that the shipment of MMR II was not viable because it was improperly stored, prior to delivery to our facility, because of inclement weather. This meant the vaccines were not viable according to standards and the patients needed to receive another vaccine. The shipment was received on March 23, 2018 and 7 patients received the vaccine prior to notification.
Sex: F
Vaccine: MMR, MMR
Symptoms: Mumps, Swelling face
Clinical narrative: This spontaneous report was received from a nurse prescriber via a company representative and refers to a non-pregnant 10 years old female patient. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with M-M-R II for routine vaccination (dose, route of administration, lot number and expiration date were not reported). Other suspect therapies included sterile diluent (dose, route of administration, lot number and expiration date were not reported). On an unknown date, after completing the M-M-R II vaccination schedule (as indicated in the Prescribing Information), the patient presented to a clinic with cheeks "really swollen" (not further clarified). Later on the same day, the patient was diagnosed with mumps. Treatment given was unknown at the reporting time. The outcome of mumps was reported as not recovered/not resolved. The relatedness between the event and the suspect therapies was not reported. This is one of two reports received from the same reporter (cross-referenced with MARRS number 1805USA004102). Sender's Comments: US-009507513-1805USA004102.
Sex: F
Vaccine: MMR, MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report was received from a nurse prescriber via a company representative and refers to a non-pregnant 10 years old female patient. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with M-M-R II for routine vaccination (dose, route of administration, lot number and expiration date were not reported). Other suspect therapies included sterile diluent (dose, route of administration, lot number and expiration date were not reported). On an unknown date, after completing the M-M-R II vaccination schedule (as indicated in the Prescribing Information), the patient presented to a clinic with cheeks "really swollen" (not further clarified). Later on the same day, the patient was diagnosed with mumps. Treatment given was unknown at the reporting time. The outcome of mumps was reported as not recovered/not resolved. The relatedness between the event and the suspect therapies was not reported. This is one of two reports received from the same reporter (cross-referenced with MARRS number 1805USA004102). Sender's Comments: US-009507513-1805USA004102.
Sex: U
Vaccine: MMR, MMR
Symptoms: Mumps, Swelling face
Clinical narrative: This spontaneous report was received from a nurse prescriber via a company representative and refers to a child patient (exact age and gender were not reported). The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with M-M-R II (dose, route of administration, lot number and expiration date were not reported). Other suspect therapies included sterile diluent (dose, route of administration, lot number and expiration date were not reported). On an unknown date, after completing the M-M-R II vaccination series, the patient might had been diagnosed with mumps. At the reporting time, it was not further clarified if there was a confirmed mumps diagnosis. The outcome of mumps was not reported. The relatedness between the event and the suspect therapies was not reported. This is one of two reports received from the same reporter (cross-referenced with MARRS number 1805USA000317). Sender's Comments: US-009507513-1805USA000317.
Sex: U
Vaccine: MMR, MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report was received from a nurse prescriber via a company representative and refers to a child patient (exact age and gender were not reported). The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with M-M-R II (dose, route of administration, lot number and expiration date were not reported). Other suspect therapies included sterile diluent (dose, route of administration, lot number and expiration date were not reported). On an unknown date, after completing the M-M-R II vaccination series, the patient might had been diagnosed with mumps. At the reporting time, it was not further clarified if there was a confirmed mumps diagnosis. The outcome of mumps was not reported. The relatedness between the event and the suspect therapies was not reported. This is one of two reports received from the same reporter (cross-referenced with MARRS number 1805USA000317). Sender's Comments: US-009507513-1805USA000317.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Malaise, Nausea, Pain
Clinical narrative: The patient felt very ill about 4 hours after receiving the vaccination. He felt nauseous, had flu-like symptoms, fever, diarrhea, body, aches. The patient took Aspirin on that night to relief his fever. He called us the next day, and the pharmacist talked with him and counseled him. He is doing better but does not intent to take the second dose that is due in 2-6 months.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: The patient felt very ill about 4 hours after receiving the vaccination. He felt nauseous, had flu-like symptoms, fever, diarrhea, body, aches. The patient took Aspirin on that night to relief his fever. He called us the next day, and the pharmacist talked with him and counseled him. He is doing better but does not intent to take the second dose that is due in 2-6 months.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Erythema, Full blood count normal, Headache
Clinical narrative: Swollen red warm arm, Headaches, Myalgia, Arthralgia. Nausea and then a rash of blisters on the left buttock very painful upper arm then radiated to the shoulder and neck associated with general weakness.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex test positive, Metabolic function test normal, Musculoskeletal pain, Myalgia, Nausea
Clinical narrative: Swollen red warm arm, Headaches, Myalgia, Arthralgia. Nausea and then a rash of blisters on the left buttock very painful upper arm then radiated to the shoulder and neck associated with general weakness.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Peripheral swelling, Rash vesicular, Skin warm
Clinical narrative: Swollen red warm arm, Headaches, Myalgia, Arthralgia. Nausea and then a rash of blisters on the left buttock very painful upper arm then radiated to the shoulder and neck associated with general weakness.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Arm pain, sick to stomach, ache all over.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Disorientation, Fatigue, Headache
Clinical narrative: Shot administered at 12PM on 5/8/2018. By 4PM right arm was very tender and hot, and fatigue was setting in. 6PM I was feeling lethargic and took a hot bath to try to make the arm stop hurting. Went to bed at 9PM. Woke at 11PM with a fever, body aches, upset stomach, headache and disorientation. Took nothing for the fever. The disorientation subsided by 1PM 5/9/2018. Headache, diarrhea, fatigue subsided during the night 5/10/2018. Fever broke at 9AM on 5/10/2018. The whole experience reminded me of having the flu.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Shot administered at 12PM on 5/8/2018. By 4PM right arm was very tender and hot, and fatigue was setting in. 6PM I was feeling lethargic and took a hot bath to try to make the arm stop hurting. Went to bed at 9PM. Woke at 11PM with a fever, body aches, upset stomach, headache and disorientation. Took nothing for the fever. The disorientation subsided by 1PM 5/9/2018. Headache, diarrhea, fatigue subsided during the night 5/10/2018. Fever broke at 9AM on 5/10/2018. The whole experience reminded me of having the flu.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Shot administered at 12PM on 5/8/2018. By 4PM right arm was very tender and hot, and fatigue was setting in. 6PM I was feeling lethargic and took a hot bath to try to make the arm stop hurting. Went to bed at 9PM. Woke at 11PM with a fever, body aches, upset stomach, headache and disorientation. Took nothing for the fever. The disorientation subsided by 1PM 5/9/2018. Headache, diarrhea, fatigue subsided during the night 5/10/2018. Fever broke at 9AM on 5/10/2018. The whole experience reminded me of having the flu.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Rash
Clinical narrative: Tiredness. Rash - 2 days, so far diarrhea, headache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection sites visible both upper biceps with surrounding erythema and swelling without induration. Recommend icing both upper arms every few hours, NSAIDS or tylenol prn, monitor temp follow up for  fever or change is status for recheck. Left upper biceps - site of vaccine administration noted with surrounding erythema, heat covering medial to lateral & 6-7cm wide area. ** right upper arm vacine administration site noted with 6cm well demarcated area of erythema, swelling and heat.  All area have demarcated borders and no exudate or crusting. No open lesions. Remainder of body is free of lesions or rash.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: On R arm, at the site of DTaP vaccine, arm became red, warm, ruddy and swollen ( about 1.5 times the size of his other arm, this was measured) from elbow to top of shoulder. Patient also developed a fever of 102.4 the night of receiving the vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient became pale and diaphoretic and passed out. Patient was placed on the exam table and vital signs were obtained. Cool compresses were placed on the child. VS were P-104, RR-38, 02 sat-99% B/P-80/60. The event started within a minute of the administration of the vaccines at 10:00am and Patient was fully responsive to verbal commands by 10:05am. )2 sat was 100%, RR-28, P-84 and B/P was 96/58. Patient was observed for over 20 minutes and released to Mother. Mother stated the child has this reaction every time he has an immunization.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Middle insomnia, Pain in extremity
Clinical narrative: PATIENT DESCRIBES SEVERE PAIN IN RIGHT ARM, AWAKENED IN THE MIDDLE OF THE NIGHT, SO SEVERE ALMOST WENT TO THE ER, ALMOST PASSED OUT.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Discomfort, Musculoskeletal pain, Pain, Paraesthesia
Clinical narrative: Severe shoulder pain, aching, tenderness, weakness, discomfort. Tingling paint that moved down into the hand, all mentioned symptoms within 12 hours of vaccination.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Severe shoulder pain, aching, tenderness, weakness, discomfort. Tingling paint that moved down into the hand, all mentioned symptoms within 12 hours of vaccination.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: L upper arm with 10 cm By 8 cm erythematous macule with also induration and swelling. It is mild to moderately tender. Warm to the touch.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Rash macular
Clinical narrative: L upper arm with 10 cm By 8 cm erythematous macule with also induration and swelling. It is mild to moderately tender. Warm to the touch.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Temporomandibular joint syndrome
Clinical narrative: Bilateral TMJ pain starting 3 days after injection. No tooth pain. Pt does have hx of grinding teeth at night prior to vaccine administration but did not complain of the TMJ pain until afterward.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: On the day after the vaccine I developed muscle aches, mostly in arms and hands as well as extreme fatigue. The muscle aches went away after two days and the fatigue lasted 4 days. I was told by the very goo pharmacist about the possible side effects. Having such fatigue is most likely an exception. I will make plans to be home and resting for the 4 days after my 2nd round of the Recombinant Zoster vaccine.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, nausea, aches.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Product preparation error
Clinical narrative: Pt was administered the adjuvant portion of the vaccine only 0.5 ml IM. Pt arm sore x 5 days after administration, no other side effects.
Age: 87.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: SHINGRIX was administered in left deltoid muscle around 11am on 5/9/18 patient reported around 6pm on 5/9/18 fever chills and muscle pain/aches throughout the night for about 12 to 15 hours and then eventually subsided the next morning 5/10/18 around 8am.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None known.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives on arms and neck on May 3 in the afternoon. About 48 hours after vaccination. Started warm compresses and BENADRYL, which stopped progression of hives. No airway, lip, tongue involvement. No respiratory distress.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: PEDIARIX combination given today. Patient tolerated well. Should have been given single dose DTAP (INFANRIX).
Age: 70.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Rash
Clinical narrative: Skin Rash.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an adult patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was inadvertently vaccinated with a 0.5 ml dose of PROQUAD injection via subcutaneous route, lot number M044719 with expiration date on 07-MAY-2018 instead of M-M-R II injection (dose, lot number and expiration date were not reported). The vaccine was reconstituted with Merck sterile diluent injection via subcutaneous route, lot number M037769 with expiration date on 16-MAR-2019. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Splenectomy
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On an unknown date in 2006, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (route of administration, anatomical location and expiration date were not reported). On an unknown date in 2006, the patient experienced a local site reaction. On an unspecified date, the patient had her spleen removed for unspecified reason. The patient sought medical attention (details were not provided). The outcome of the events was unknown. Causality assessment was not provided. Upon internal review, the event of spleen removal was determined to be medically significant.
Age: 0.33
Sex: U
Vaccine: HIBV, PNC13, RV5
Symptoms: Body temperature increased, Crying, Cyanosis, Dyspnoea, Flushing
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative concerning a 4 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date approximately in March 2018 (reported as 2 months ago), the patient received a dose of the following vaccines: ROTATEQ, orally (frequency, strength, lot number and expiration date were not reported) for prophylaxis, PEDVAXHIB (frequency, strength, indication, lot number and expiration date were not reported) and PREVNAR (frequency, strength, indication, lot number and expiration date were not reported). On 02-MAY-2018, the patient received another dose of the vaccines listed above. On the same date, in the evening, the patient became flushed, and started crying, and had difficulty breathing. Furthermore, at night, the patient was taken to the Emergency Room. The patient was found to have a rectal temperature of 100 degrees Fahrenheit (°F), and it was sent home with TYLENOL. On the morning of 03-MAY-2018, the patient had episodes were breathing stopped, also had seizure like activity, and began to turn purple. Additionally, the patient vomited after breastfeeding. Then the patient was taken back to the emergency room. At the time of reporting, it was unknown the patient's outcome regarding the aforementioned events. The causality assessment of the events was unknown. Upon internal review, the event apnoea was determined to be medically significant.
Age: 0.33
Sex: U
Vaccine: HIBV, PNC13, RV5
Symptoms: Respiratory arrest, Seizure like phenomena, Skin discolouration, Vomiting
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative concerning a 4 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date approximately in March 2018 (reported as 2 months ago), the patient received a dose of the following vaccines: ROTATEQ, orally (frequency, strength, lot number and expiration date were not reported) for prophylaxis, PEDVAXHIB (frequency, strength, indication, lot number and expiration date were not reported) and PREVNAR (frequency, strength, indication, lot number and expiration date were not reported). On 02-MAY-2018, the patient received another dose of the vaccines listed above. On the same date, in the evening, the patient became flushed, and started crying, and had difficulty breathing. Furthermore, at night, the patient was taken to the Emergency Room. The patient was found to have a rectal temperature of 100 degrees Fahrenheit (°F), and it was sent home with TYLENOL. On the morning of 03-MAY-2018, the patient had episodes were breathing stopped, also had seizure like activity, and began to turn purple. Additionally, the patient vomited after breastfeeding. Then the patient was taken back to the emergency room. At the time of reporting, it was unknown the patient's outcome regarding the aforementioned events. The causality assessment of the events was unknown. Upon internal review, the event apnoea was determined to be medically significant.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 13-year-old patient of an unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 04-MAY-2018, the patient was was inadvertently given an adult dose of VAQTA 50/1.0 U/ml injection, lot number N028743 with an expiration date 23-NOV-2018 for prophylaxis (route of administration and anatomical location were not reported). There was no adverse effects reported.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure inadequately controlled, Cerebrovascular accident, Condition aggravated, Haemorrhagic stroke, Intensive care
Clinical narrative: This initial spontaneous report was received from the wife of a 75 year old male patient. The daughter (who is a naturopath) also participated in the call. Medical history/concurrent conditions included "no major health problems, just high blood pressure". The wife declined to provide concomitant medications. On 22-OCT-2012, the patient was vaccinated with ZOSTAVAX at a pharmacy for the indication of "by recommendation of a physician" (dose, route, and lot # were unknown by the reporter). He also received diluent for the vaccine (lot # of this was also unknown by the reporter). On an unknown date after receiving ZOSTAVAX, the patient began having problems controlling his blood pressure that he never had before. On 11-JUN-2015, he experienced a "massive brain bleed stroke and almost died." The patient was hospitalized for months and was in intensive care "for months and months and months" and then he was in rehabilitation. It was almost a year before he came home. The wife did not know if there was any relevant laboratory data. The wife reported that the patient was now paralyzed (considered result of the stroke) and used a motorized wheelchair. Since the stroke, he had difficulty seeing on his left side (considered result of the stroke). Also, he had not learned to control the motorized wheelchair well and he crashed it into walls, eventually leading them to move to a home with wider hallways. Since moving to the new home, the patient still crashed the wheelchair into walls, but not as much as he did before. The wife further reported that the patient had to be dressed, could not go to the bathroom by himself and had to be kept in diapers, and that someone had to bathe him (these were all considered result of the stroke and were ongoing). The wife was currently paying for a caretaker to assist with these tasks. The patient was closely followed by a team of physicians. As of 08-MAY-2018, it was unknown if the patient would receive more ZOSTAVAX. The outcomes of the events were not recovered/not resolved. Causality assessment was not provided. Upon internal review, hemorrhagic stroke was considered medically significant. Hemorrhagic stroke was considered disabling and life threatening. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Paralysis, Rehabilitation therapy, Visual impairment, Wheelchair user
Clinical narrative: This initial spontaneous report was received from the wife of a 75 year old male patient. The daughter (who is a naturopath) also participated in the call. Medical history/concurrent conditions included "no major health problems, just high blood pressure". The wife declined to provide concomitant medications. On 22-OCT-2012, the patient was vaccinated with ZOSTAVAX at a pharmacy for the indication of "by recommendation of a physician" (dose, route, and lot # were unknown by the reporter). He also received diluent for the vaccine (lot # of this was also unknown by the reporter). On an unknown date after receiving ZOSTAVAX, the patient began having problems controlling his blood pressure that he never had before. On 11-JUN-2015, he experienced a "massive brain bleed stroke and almost died." The patient was hospitalized for months and was in intensive care "for months and months and months" and then he was in rehabilitation. It was almost a year before he came home. The wife did not know if there was any relevant laboratory data. The wife reported that the patient was now paralyzed (considered result of the stroke) and used a motorized wheelchair. Since the stroke, he had difficulty seeing on his left side (considered result of the stroke). Also, he had not learned to control the motorized wheelchair well and he crashed it into walls, eventually leading them to move to a home with wider hallways. Since moving to the new home, the patient still crashed the wheelchair into walls, but not as much as he did before. The wife further reported that the patient had to be dressed, could not go to the bathroom by himself and had to be kept in diapers, and that someone had to bathe him (these were all considered result of the stroke and were ongoing). The wife was currently paying for a caretaker to assist with these tasks. The patient was closely followed by a team of physicians. As of 08-MAY-2018, it was unknown if the patient would receive more ZOSTAVAX. The outcomes of the events were not recovered/not resolved. Causality assessment was not provided. Upon internal review, hemorrhagic stroke was considered medically significant. Hemorrhagic stroke was considered disabling and life threatening. Additional information has been requested.
Age: 117.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Skin Rash.
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. This female patient of an unspecified age 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. On an unspecified date, the patient experienced headache, muscle ache, fatigue and some joint pain with outcome of unknown. The information on the lot number has been requested.
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable medical assistant communicated to a Pfizer sales representative for 3 patients. This is the 2nd of 3 reports. A patient in his/her 70's patient of unknown race and gender received PREVNAR 13 for immunization at single dose on unknown date.  Relevant medical history and concomitant medications were unknown. On unknown date the patient experienced redness, swelling, and itchiness at the injection site three to four days after the injection. The outcome of the events was reported as recovered. Sender's Comments: Linked Report(s): US-PFIZER INC-2018191051 same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable medical assistant via a Pfizer sales representative. This medical assistant reported 3 cases for different patients. This is the 1st of 3 reports. A patient of unspecified ethnicity and gender in his/her early 70's received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced redness, swelling, and itchiness at the injection site three to four days after the injection. The events recovered about three days after they began. The information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018190998 Same reporter/drug, different patient; US-PFIZER INC-2018191055 Same reporter/drug, different patient.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Pain, Urticaria
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck and Co., Inc. (Case Number: 00811688). A contactable Nurse reported for a female patient that: Description: The primary reporter is Nurse (Nurse name). Nurse reports that on "07Feb2018" a patient was administered PREVNAR 13 (Company name) and experienced "Injection site erythema, pain and hives around her trunk". Patient was treated with "Prednisone" (Unknown manufacturer) for an unspecified amount of time. No further clarifying information provided. No additional information. Product: Product: PREVNAR; Product circular number: Unknown by reporter; Lot number: Unknown by reporter; Expiration date: Unknown by reporter; Dose/frequency: Unknown by reporter; Manufacturer (if available): (Company name). The information listed above is all data we have received. Please do not contact Merck and Co., Inc. for additional information. Any follow-up information received by Merck and Co., Inc. regarding this case will be forwarded to you upon receipt. No follow-up attempts possible. No further information expected.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Throat tightness
Clinical narrative: Patient received vaccine on 5/4/18 and started itching the night of 5/5/18. On Sunday morning 5/6/18, patient woke up and throat was closing. The patient went to the ER and contacted us 5/7/18 about the incident.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site urticaria
Clinical narrative: Urticaria at injection site spreading to whole extremity. Occurred 2/8/18 and 4/25/18 1-2d after MCV B injection. Patient give BENADRYL with relief.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: 1 day after administration-arm pain, swelling, redness. Chills and fatigue. Duration for 2-3 days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus, Rash generalised, Urticaria
Clinical narrative: 4/30/18 received SHINGRIX vaccine and later that evening reports urticaria and rash all over body. 5/8/18 Pt. calls into medical office stating she is having an allergic reaction to the Shingles vaccine she received a week ago. Pt. states she has been using BENADRYL and taking oatmeal baths without relief of her symptoms. Pt. states a friend of hers who is a MD prescribed her lidocaine cream for itching and it seems to be helping. 5/9/18 Pt. called into medical office stating her itching and rash are getting worse and was advised to do go to UC for evaluation and treatment. Pt. seen in UC and prescribed Cetirizine HCL 10 mg for her symptoms.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Application site pain, Cough, Decreased appetite, Dizziness, Dry throat
Clinical narrative: Dry throat, deep cough, headache, dizziness, swelling above left eye lid, pain at application site, loss of appetite, hot and cold flashes.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Eyelid oedema, Feeling of body temperature change, Headache
Clinical narrative: Dry throat, deep cough, headache, dizziness, swelling above left eye lid, pain at application site, loss of appetite, hot and cold flashes.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: Patient reported swollen hands and joint pain, severe at first, decreasing by the next day. Swollen hands decreased also by next day.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: After receiving the SHINGRIX vaccine, I developed a rash which covered approx 30% of my body.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Biopsy, Erythema, Facial pain, Herpes zoster, Pruritus
Clinical narrative: On May 4th, the day following the vaccination, I noticed an enlarged itchy spot on right of center forehead above the right eye. At first I suspected poison ivy but by the third day the site was, reddening, swelling and sore. There was increasing sensitivity on right side of face alongside my eye. By May 7th, I was very suspicious that I was experiencing shingles symptoms. On May 8th, I returned to the pharmacist who administered the vaccination. He said that symptoms of shingles was not in the literature and that I'd received a killed virus. On May 9th at 8:30 AM, I consulted with my dermatologist who confirmed that I have shingles and prescribed a 9 day course of the antibiotic Valacyclovir HCL. I've taken facial photos to document the occurrence.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: On May 4th, the day following the vaccination, I noticed an enlarged itchy spot on right of center forehead above the right eye. At first I suspected poison ivy but by the third day the site was, reddening, swelling and sore. There was increasing sensitivity on right side of face alongside my eye. By May 7th, I was very suspicious that I was experiencing shingles symptoms. On May 8th, I returned to the pharmacist who administered the vaccination. He said that symptoms of shingles was not in the literature and that I'd received a killed virus. On May 9th at 8:30 AM, I consulted with my dermatologist who confirmed that I have shingles and prescribed a 9 day course of the antibiotic Valacyclovir HCL. I've taken facial photos to document the occurrence.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: On May 4th, the day following the vaccination, I noticed an enlarged itchy spot on right of center forehead above the right eye. At first I suspected poison ivy but by the third day the site was, reddening, swelling and sore. There was increasing sensitivity on right side of face alongside my eye. By May 7th, I was very suspicious that I was experiencing shingles symptoms. On May 8th, I returned to the pharmacist who administered the vaccination. He said that symptoms of shingles was not in the literature and that I'd received a killed virus. On May 9th at 8:30 AM, I consulted with my dermatologist who confirmed that I have shingles and prescribed a 9 day course of the antibiotic Valacyclovir HCL. I've taken facial photos to document the occurrence.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: On May 4th, the day following the vaccination, I noticed an enlarged itchy spot on right of center forehead above the right eye. At first I suspected poison ivy but by the third day the site was, reddening, swelling and sore. There was increasing sensitivity on right side of face alongside my eye. By May 7th, I was very suspicious that I was experiencing shingles symptoms. On May 8th, I returned to the pharmacist who administered the vaccination. He said that symptoms of shingles was not in the literature and that I'd received a killed virus. On May 9th at 8:30 AM, I consulted with my dermatologist who confirmed that I have shingles and prescribed a 9 day course of the antibiotic Valacyclovir HCL. I've taken facial photos to document the occurrence.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Facial pain, Herpes zoster, Hyperaesthesia, Irritability, Pruritus
Clinical narrative: On May 4th, the day following the vaccination, I noticed an enlarged itchy spot on right of center forehead above the right eye. At first I suspected poison ivy but by the third day the site was, reddening, swelling and sore. There was increasing sensitivity on right side of face alongside my eye. By May 7th, I was very suspicious that I was experiencing shingles symptoms. On May 8th, I returned to the pharmacist who administered the vaccination. He said that symptoms of shingles was not in the literature and that I'd received a killed virus. On May 9th at 8:30 AM, I consulted with my dermatologist who confirmed that I have shingles and prescribed a 9 day course of the antibiotic Valacyclovir HCL. I've taken facial photos to document the occurrence.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Injection site reaction, Injection site vesicles, Pruritus, Urticaria
Clinical narrative: About 5 days after the immunization was given the patient developed welts and blisters on her upper arms and upper back. She also experienced itching.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pruritus, Urticaria
Clinical narrative: About 5 days after the immunization was given the patient developed welts and blisters on her upper arms and upper back. She also experienced itching.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Headache, Myalgia
Clinical narrative: Weakness, aches (head, muscles, joints), fever/chills, nausea - treated with 440 mg naproxen plus 1000 mg acetaminophen which took the edge off but still symptomatic.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Weakness, aches (head, muscles, joints), fever/chills, nausea - treated with 440 mg naproxen plus 1000 mg acetaminophen which took the edge off but still symptomatic.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms beginning about 12 hours following the vaccine.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Patient received the vaccination and was speaking about bed sores for a few minutes after vaccine injection. I asked her to come back to waiting room to wait 15 minutes after vaccination. As we were walking back to waiting room, she stated she felt dizzy and light-headed. I asked if she had eaten anything today and she stated she had not. She asked me for a Sprite and I offered her some crackers. She sat in the waiting room until 3:16 PM. At that time she stated she felt much better and well enough to go home. I called her later that day in the 6 o'clock hour and she stated she had felt fine since.
Age: 27.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Abdominal pain upper, Hyperhidrosis, Impaired work ability, Pyrexia
Clinical narrative: 3 hours after taking the 3rd dose of VIVOTIF, I began having stomach cramps in waves that were painful enough that I had to leave work. I also was sweating and shaking (I had a 100 degree fever later that night). 2 hours later I vomited, following by another instance of vomiting an hour later. Taking anti-nausea medication helped with the vomiting, but extremely painful stomach cramps continued over the next roughly 30 hours.
Age: 27.0
Sex: M
Vaccine: TYP
Symptoms: Tremor, Vomiting
Clinical narrative: 3 hours after taking the 3rd dose of VIVOTIF, I began having stomach cramps in waves that were painful enough that I had to leave work. I also was sweating and shaking (I had a 100 degree fever later that night). 2 hours later I vomited, following by another instance of vomiting an hour later. Taking anti-nausea medication helped with the vomiting, but extremely painful stomach cramps continued over the next roughly 30 hours.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Injection site pain
Clinical narrative: Patient reports feeling exhausted and very cold. She does not have a fever. Injection site is also very tender and sore.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: 2"x 2" red, tender induration.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Pt has a raised, circumscribed red area on the deltoid approx 2.5 inches diameter that is warm and itchy, possibly allergic reaction.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid pain , swelling, tenderness severe enough to interfere with use of left arm for a week at time of report.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Crying, Culture urine negative, Insomnia, Irritability, Pyrexia
Clinical narrative: Excessive crying and irritability with fever starting 24 hrs after vaccine administration and continuing for 36 hrs total. Patient unable to sleep for close to 36 hrs due to excessive fussiness. Patient seen at about 30 hours into reaction. No source on exam. Urine negative- see below. By 48 hrs the reaction had subsided - patient was eating and sleeping normally again. No treatment except TYLENOL for fever over 101.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Urine analysis normal
Clinical narrative: Excessive crying and irritability with fever starting 24 hrs after vaccine administration and continuing for 36 hrs total. Patient unable to sleep for close to 36 hrs due to excessive fussiness. Patient seen at about 30 hours into reaction. No source on exam. Urine negative- see below. By 48 hrs the reaction had subsided - patient was eating and sleeping normally again. No treatment except TYLENOL for fever over 101.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Exposure during pregnancy, Eye pain, Eye swelling, Hypersensitivity
Clinical narrative: This spontaneous prospective pregnancy report was received from a consumer (patient's mother) via nurse practitioner refers to a 16 year old female patient. The patient's current condition included Allergy to dogs, dust-mites, roaches, and some grass. The patient takes allergy shots. Concomitant therapies included ALLEGRA, ZYRTEC and daily vitamins and allergy shots. On an unknown date in July 2017 (reported as last year), the patient was vaccinated with the first dose of GARDASIL 9 (route, expiration date and lot number not specified) in the right arm for human papilloma virus prophylaxis. On an unknown date in July 2017, the patient developed swollen, painful, puffy eyes and a red face after receiving her first shot of GARDASIL 9. The patient became pregnant. The last menstrual period (LMP) and estimate date of delivery (EDD) were not known. The pregnancy outcome was pending. On 18-APR-2018 at 9 AM (reported as this morning), the patient was vaccinated with second dose of GARDASIL 9 one injection (1DF) (expiration date and lot number not specified) in the right deltoid by intramuscular route for human papilloma virus prophylaxis (vaccine exposure during pregnancy) and a few hours later noticed her eyes were hurting and swollen and her face was turning red. It was reported that the patient was having an allergic reaction to GARDASIL 9. The patient's one of the eyes appears more swollen than the other and was almost swollen shut. The event did not cause hospitalization to the patient. The patient called a doctor who recommended the patient take 25mg of BENADRYL, and PEPCID AC. The patient already had taken ALLEGRA for seasonal allergies. The patient didn't seek medical attention and the swelling seemed less severe last year than this day. Lab diagnostics/studies were not performed. The reporter wants to know whether the patient's need to get third shot. The outcome of the events eye pain, erythema, eye swelling and allergy to vaccine was unknown. Causality assessment was not provided. Product quality complaint was not involved.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) (lot number M037669, expiry date: 09-MAY-2018) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot number M042599) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown demographics. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot number M042599) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.