chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Influenza like illness
Clinical narrative: I experienced the following side effects for both SHINGRIX shots: Tiredness, headache, shivering, fever, no appetite, flu-like symptoms. After the second SHINGRIX shot I also had a pain down the right left from my knee to my toes. The pain started three days after the shot and lasted three days. It was so severe that I went to Urgent Care on the third day and the doctor could not identify what caused the pain. I was referred to a osteopathic specialist on the fourth day (since the shot) but by that morning, all the pain was virtually gone. I went to the appointment anyway and the doctor could not identify the cause of the pain. By the fifth day after the shot, the pain was completely gone. I would also like to note that I had my second SHINGRIX shot in my right arm and the pain was also on my right side (down the outer side of my right leg). I did not injure my leg in any way leading up to this event. The pain came suddenly and left as quickly with no other lingering effects.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, X-ray limb normal
Clinical narrative: I experienced the following side effects for both SHINGRIX shots: Tiredness, headache, shivering, fever, no appetite, flu-like symptoms. After the second SHINGRIX shot I also had a pain down the right left from my knee to my toes. The pain started three days after the shot and lasted three days. It was so severe that I went to Urgent Care on the third day and the doctor could not identify what caused the pain. I was referred to a osteopathic specialist on the fourth day (since the shot) but by that morning, all the pain was virtually gone. I went to the appointment anyway and the doctor could not identify the cause of the pain. By the fifth day after the shot, the pain was completely gone. I would also like to note that I had my second SHINGRIX shot in my right arm and the pain was also on my right side (down the outer side of my right leg). I did not injure my leg in any way leading up to this event. The pain came suddenly and left as quickly with no other lingering effects.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection, Pain
Clinical narrative: I received the SHINGRIX vaccine a few months ago and since then have had 2 herpes outbreaks while suppressive therapy with acyclovir. I typically have about one outbreak a year that is mild. These have both been very painful outbreaks. I found numerous people on an internet thread that have had the same experience.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: I received the PNEUMOVAX 23 vaccine yesterday and had an allergic reaction to it. I experienced extreme itchiness of skin, especially the bottoms of my feet. My arm and armpit are extremely sore. I cannot lift my arm without pain and I cannot sleep on that side. An approximate six inch area surrounding the injection site is red and hot to the touch.
Age: 11.0
Sex: M
Vaccine: HEP, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Developed redness, itching, pain, swelling to (L) upper arm within 24 hrs of vaccine. Treated for cellulitis.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: Pt started complaining of feeling tired, dizzy, headache, lightheaded around lunchtime 9/11 followed by body aches at 3PM for which she took EXTRA STRENGTH TYLENOL. Symptoms included occipital headache, wrist pain and malaise which resolved by 9/14, injection site remained red and marked until 9/16.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: Pt started complaining of feeling tired, dizzy, headache, lightheaded around lunchtime 9/11 followed by body aches at 3PM for which she took EXTRA STRENGTH TYLENOL. Symptoms included occipital headache, wrist pain and malaise which resolved by 9/14, injection site remained red and marked until 9/16.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Right upper arm swelling, pain and erythema started w/in 6 hrs of vaccine, persisted 1-2 wks, improving course.
Age: 47.0
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: 1st syringe leaked, needle, not tight enough. Second flu vaccine given. None from 1st vaccine pt. received. Visually saw vaccine serum on pt. arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Had a fever for 2 days (101.4)-severe body aches and pains-red line on arm (3-4 inches long-11/2-2 inches wide).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt reported to me at our Sept 20 visit that her arm became red, hot, swollen, and painful at the injection site, and remained so for 4-5 months afterward; she also reported low grade subj temp for the first week post-vaccination.
Sex: U
Vaccine: FLU3
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: Pt has flu shot then at midnight, her throat was swollen up, she had difficulty breathing. She went to primary care MD for some allergies med and she is doing ok now.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Contusion, Injection site pain, Sleep disorder
Clinical narrative: Began as a circular bruising pattern. By day 12, a circular outline remains. Pain reported by patient as radiating towards back, but not increasing in intensity throughout course. Pain and bruising has decreased, but still remains causing concern. Pain specifically surrounding left shoulder area causing issues with sleep.
Age: 27.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Pregnancy
Clinical narrative: Patient attended a clinic to receive medical services. Anthrax and typhoid were administered. Upon checking out, it was suggested she get a pregnancy test performed, which resulted in a positive result. RN at event recommended she seek evaluation by an obstetrician. Patient is currently scheduled for an appointment on 10/8/18.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Injection site warmth, Peripheral swelling
Clinical narrative: 9-19-18 approx. 2 pm mother brought patient in for immunization. Dtap was given in the left deltoid muscle using sterile 25GA1" syringe-(mother states nurse did clean arm well with alcohol swab) dried with cotton ball and spot Band-Aid applied. 9-20-18- patient noted arm swelling, redness induration and warmth - worse 9-21-18 around 6 am-mother took patient to health clinic and saw clinician states she thought it was either local reaction or cellulitis. (Mother states no fever).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: 9/20 PM - Arm soreness, lack of energy, felt feverish, tired, headache. 9/14/18 - symptoms started again today.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient standing at check out counter with mother. Alert and oriented x3 no signs of distress. Sudden onset of brief unconsciousness less than 1 min. 1620 VS taken. Resp and HR remained reg. BP (R) arm 113/67 HR69 (L) 96/60 77HR. Resp reg 12. Unlabored. Skin sweaty to touch. (L) BP 109/71 FR 73. Standing BP 117/74 HR 77. Patient states he feels fine and drank water.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Moderate localized swelling and redness to (L) upper arm three days after administration of Tdap.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Administration site erythema, Administration site inflammation, Administration site pain, Injection site pruritus
Clinical narrative: Patient presented to pharmacy on 9/23/2018 with erythema, inflammation, itching and pain in the area of administration. Cold compress administration was recommended and MD office visit also recommended. Prescriber called on 9/24 and said patient was doing better that area has mild erythema and patient will continue with cold compress treatment. No infection. Prescriber Dr. provided diagnostics of visit.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized swelling, erythema, warmth at site of injection. Circular area measuring 2-3 inches in diameter. Picture was visualized by MD.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Around injection site, redness, itching, swelling noted. Patient reports similar to tomato on upper arm. When assessed on 9/24/18 area is improving, redness, swelling decreased per pt, area from injection site improved by 9/20 (distal to shoulder) down arm approx 2" from elbow. Tired, chills, initial started on 9/19/18 followed by arm swelling etc.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Around injection site, redness, itching, swelling noted. Patient reports similar to tomato on upper arm. When assessed on 9/24/18 area is improving, redness, swelling decreased per pt, area from injection site improved by 9/20 (distal to shoulder) down arm approx 2" from elbow. Tired, chills, initial started on 9/19/18 followed by arm swelling etc.
Age: 9.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Patient felt lightheaded after administration w/o fainting.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness and swelling and hot to touch.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Laboratory test
Clinical narrative: Rt upper arm with redness, swelling. IV cefazolin 1 gm. Cephalexin 500mg x 10 days. DX= cellulitis on Sept 22, 2018.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness at the injection site and itchiness for 1 week.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncope. Lost consciousness.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling hot, Injection site joint movement impairment, Injection site pain, Malaise, X-ray limb normal
Clinical narrative: 3 days after vaccine - (R) arm pain at injection site, difficulty moving R shoulder and elbow, malaise, face feeling hot evaluated in clinic 2 wk after vaccine. Also ER eval - discharged home.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Dyspnoea, Erythema, Swelling, Wheezing
Clinical narrative: Swelling area administered with redness - progressed to cough and wheezing and SOB.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site pain
Clinical narrative: Pain to (L) arm where BEXSERO vaccine was given.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Entire arm (shoulder to elbow) was bruised, arm swelled up to almost 2 x 1 size, very stiff. Pt is also on warfarin so some bruising to be expected.
Age: 92.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Feeling cold, Nausea, Pollakiuria, Pyrexia
Clinical narrative: Patient received her second dose of the SHINGRIX vaccine on 9/7/18. Then early in the morning on 9/8/18 the patient went to the hospital. She had a fever, felt weak, felt nauseous, and had two large stools. Also frequent urination. Patient received her second dose of the SHINGRIX vaccine on 9/7/18. Then early in the morning on 9/8/18 the patient went to the hospital. The patient had a fever, felt weak, felt nauseous, had two large stools, was very cold, and had frequent urination. The hospital believed her symptoms were do to the SHINGRIX vaccine. They gave her IV fluids and she stayed for 4-5 hours and then was discharged. Later that day she felt better. The patient also didn't have any injection site reaction.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. On 12th September 2018, 1 hr after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site lump, fever, chills, upset stomach and diarrhea. On an unknown date, the outcome of the injection site pain, injection site swelling, fever, upset stomach and diarrhea were recovered/resolved and the outcome of the injection site erythema and injection site lump were not recovered/not resolved and the outcome of the chills was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site lump, fever, chills, upset stomach and diarrhea to be related to SHINGRIX. Additional details were reported as follows: The patient asked how she would know whether or not her reaction to the SHINGRIX vaccine was a side effect or an allergic reaction. She experienced every side effect listed on the website starting just an hour or so after injection, and it was lasting for several days. She had vaccine on Wednesday morning, and it was Saturday morning and many side effects have subsided but less than week after vaccination, she still had a significant lump with redness on injection site at the time of reporting. The reporter asked to email them to let them know what an allergic reaction would look like. The reporter asked was that trouble breathing, hives etc. She have never had a reaction to a vaccine quite this severe so she was a little concerned that she would need a second dose in 2 months.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. On 12th September 2018, 1 hr after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site lump, fever, chills, upset stomach and diarrhea. On an unknown date, the outcome of the injection site pain, injection site swelling, fever, upset stomach and diarrhea were recovered/resolved and the outcome of the injection site erythema and injection site lump were not recovered/not resolved and the outcome of the chills was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site lump, fever, chills, upset stomach and diarrhea to be related to SHINGRIX. Additional details were reported as follows: The patient asked how she would know whether or not her reaction to the SHINGRIX vaccine was a side effect or an allergic reaction. She experienced every side effect listed on the website starting just an hour or so after injection, and it was lasting for several days. She had vaccine on Wednesday morning, and it was Saturday morning and many side effects have subsided but less than week after vaccination, she still had a significant lump with redness on injection site at the time of reporting. The reporter asked to email them to let them know what an allergic reaction would look like. The reporter asked was that trouble breathing, hives etc. She have never had a reaction to a vaccine quite this severe so she was a little concerned that she would need a second dose in 2 months.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Injection site erythema, Injection site mass
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. On 12th September 2018, 1 hr after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site lump, fever, chills, upset stomach and diarrhea. On an unknown date, the outcome of the injection site pain, injection site swelling, fever, upset stomach and diarrhea were recovered/resolved and the outcome of the injection site erythema and injection site lump were not recovered/not resolved and the outcome of the chills was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site lump, fever, chills, upset stomach and diarrhea to be related to SHINGRIX. Additional details were reported as follows: The patient asked how she would know whether or not her reaction to the SHINGRIX vaccine was a side effect or an allergic reaction. She experienced every side effect listed on the website starting just an hour or so after injection, and it was lasting for several days. She had vaccine on Wednesday morning, and it was Saturday morning and many side effects have subsided but less than week after vaccination, she still had a significant lump with redness on injection site at the time of reporting. The reporter asked to email them to let them know what an allergic reaction would look like. The reporter asked was that trouble breathing, hives etc. She have never had a reaction to a vaccine quite this severe so she was a little concerned that she would need a second dose in 2 months.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. On 12th September 2018, 1 hr after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site lump, fever, chills, upset stomach and diarrhea. On an unknown date, the outcome of the injection site pain, injection site swelling, fever, upset stomach and diarrhea were recovered/resolved and the outcome of the injection site erythema and injection site lump were not recovered/not resolved and the outcome of the chills was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site lump, fever, chills, upset stomach and diarrhea to be related to SHINGRIX. Additional details were reported as follows: The patient asked how she would know whether or not her reaction to the SHINGRIX vaccine was a side effect or an allergic reaction. She experienced every side effect listed on the website starting just an hour or so after injection, and it was lasting for several days. She had vaccine on Wednesday morning, and it was Saturday morning and many side effects have subsided but less than week after vaccination, she still had a significant lump with redness on injection site at the time of reporting. The reporter asked to email them to let them know what an allergic reaction would look like. The reporter asked was that trouble breathing, hives etc. She have never had a reaction to a vaccine quite this severe so she was a little concerned that she would need a second dose in 2 months.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report was received from a nurse practitioner (also reported as nurse prescriber) and refers to a 76 year old female. The patient's drug allergies included allergic reaction after previous administration of penicillin. The patient's concomitant medications included multiple unspecified medications. The patient did not have any relevant medical history. On 17-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 injection, lot # R006466, expiration date 20-OCT-2018, intramuscularly (dose and frequency were not reported) for prophylaxis. On the same date, a few hours after vaccination, the patient experienced pain, discomfort, redness and swelling of her entire upper arm. The patient sought medical attention and saw her nurse practitioner. Then, a treatment with topical ice, difenhidramine  (BENADRYL) and methylprednisolone (MEDROL DOSEPACK) was initiated. No laboratory tests were performed. At the reporting time, the outcome of peripheral swelling, erythema, limb discomfort and pain in extremity was reported as not recovered. The reporter did not provide  a causality assessment between the events and PNEUMOVAX 23.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin discolouration, Skin warm
Clinical narrative: This spontaneous report was received from a nurse practitioner (also reported as nurse prescriber) and refers to a 76 year old female. The patient's drug allergies included allergic reaction after previous administration of penicillin. The patient's concomitant medications included multiple unspecified medications. The patient did not have any relevant medical history. On 17-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 injection, lot # R006466, expiration date 20-OCT-2018, intramuscularly (dose and frequency were not reported) for prophylaxis. On the same date, a few hours after vaccination, the patient experienced pain, discomfort, redness and swelling of her entire upper arm. The patient sought medical attention and saw her nurse practitioner. Then, a treatment with topical ice, difenhidramine  (BENADRYL) and methylprednisolone (MEDROL DOSEPACK) was initiated. No laboratory tests were performed. At the reporting time, the outcome of peripheral swelling, erythema, limb discomfort and pain in extremity was reported as not recovered. The reporter did not provide  a causality assessment between the events and PNEUMOVAX 23.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a nurse practitioner (also reported as nurse prescriber) and refers to a 76 year old female. The patient's drug allergies included allergic reaction after previous administration of penicillin. The patient's concomitant medications included multiple unspecified medications. The patient did not have any relevant medical history. On 17-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 injection, lot # R006466, expiration date 20-OCT-2018, intramuscularly (dose and frequency were not reported) for prophylaxis. On the same date, a few hours after vaccination, the patient experienced pain, discomfort, redness and swelling of her entire upper arm. The patient sought medical attention and saw her nurse practitioner. Then, a treatment with topical ice, difenhidramine  (BENADRYL) and methylprednisolone (MEDROL DOSEPACK) was initiated. No laboratory tests were performed. At the reporting time, the outcome of peripheral swelling, erythema, limb discomfort and pain in extremity was reported as not recovered. The reporter did not provide  a causality assessment between the events and PNEUMOVAX 23.
Sex: U
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: Initial information regarding an unsolicited valid serious case received on 17-Sep-2018 from a pharmacist. This case involves a 90 years old patient who experienced the patient was then thrown into atrial fibrillation, while he/she received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the arm nos and SHINGRIX. On an unknown date, the patient developed a serious the patient was then thrown into atrial fibrillation (atrial fibrillation) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and SHINGRIX. This event was assessed as medically significant. Other relevant tests included no lab data. Final diagnosis was the patient was then thrown into atrial fibrillation. It was not reported if the patient received a corrective treatment. Outcome of the events is recovering as patient was now stable. List of documents held by sender: none.; Sender's Comments: This case concerns an elderly patient who presented with Atrial Fibrillation after vaccination with Fluzone HD and SHINGRIX vaccines. The time to onset is not known. Patient has no reported history of any cardiac pathology but is of an advanced age. There are no lab or radiological tests provided that rule out the presence of a pre-existing cardiac disease in this patient. Moreover, multiple vaccines preceded the event. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dehydration, Insomnia, Migraine, Muscle spasms
Clinical narrative: Two hours after receiving the vaccination, patient reported that she had a fever of 102 degrees. Later, she reported that she also experienced joint pain in her ankles, wrist, elbow, and back. She also reported that she started to have major muscle spasms in her major muscles. She also reported that she had extreme migraines, vertigo, dehydration, and insomnia. She said that she felt like this since receiving the shot (did not go out or do anything from Wednesday through Sunday).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vertigo
Clinical narrative: Two hours after receiving the vaccination, patient reported that she had a fever of 102 degrees. Later, she reported that she also experienced joint pain in her ankles, wrist, elbow, and back. She also reported that she started to have major muscle spasms in her major muscles. She also reported that she had extreme migraines, vertigo, dehydration, and insomnia. She said that she felt like this since receiving the shot (did not go out or do anything from Wednesday through Sunday).
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Had typical/reported headache, pain in arm, some mild nausea, tired feeling. Had not reported diarrhea, very liquid. Started about 24 hrs after injection, lasted at least 20 hrs so far - seems to be easing.
Age: 21.0
Sex: F
Vaccine: ADEN_4_7, HEP, IPV, MMR, MNQ, VARCEL
Symptoms: Blood creatine phosphokinase increased, Demyelination, Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Local site reaction on right arm, and then several days later developed Numbness and tingling in bilateral arms, and big toe. EMG confirmed diagnosis of Guillan Barre Syndrome.
Age: 21.0
Sex: F
Vaccine: ADEN_4_7, HEP, IPV, MMR, MNQ, VARCEL
Symptoms: Injection site reaction, Paraesthesia
Clinical narrative: Local site reaction on right arm, and then several days later developed Numbness and tingling in bilateral arms, and big toe. EMG confirmed diagnosis of Guillan Barre Syndrome.
Age: 58.0
Sex: F
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Cellulitis, Lethargy, Peripheral swelling, Skin warm
Clinical narrative: Patient reported that she had been severely lethargic since the day after her shot and that the arm in which she received her SHINGRIX shot was very swollen and hot. Her husband, an ER nurse, suspected cellulitis and she sought treatment at his facility. The provider on staff at the ER concurred and prescribed Bactrim DS bid  for 7 days.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a physician referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. The M-M-R II was reconstituted with properly stored sterile diluent (MRK). The doses of M-M-R II were exposed to a temperature excursion of 47 degree Fahrenheit (°F) to 77°F (53°F) during a time frame of 5 hours, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. Upon receipt of follow-up information it was determined that this case was now valid because the patient identifier was received. Follow-up information has been received from nurse on 14-SEP-2018. On 14-SEP-2018, the call was placed to the physician. The call was answered by the receptionist and transferred to nurse. The nurse provided information regarding the patient's vaccinated with the above product. This report refers to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug allergies/reactions or concomitant medications. On 09-APR-2018, the patient was vaccinated with improperly stored doses of M-M-R II intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. Sender's Comments: 1809USA010671: Original Case: 1805USA001303.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions and allergies were not reported. On 28-AUG-2018, the patient was vaccinated with M-M-R II subcutaneously, lot# N023145, expiration date 24-AUG-2019 (dose of the vaccine was unspecified). It was reported that a dose of M-M-R II was reconstituted with 0.5 ml of Sterile Saline for injection, manufactured by Excelsior Medical, 0.9%, 5 ml, lot# 3129219, expiration date 01-DEC-2018 instead of sterile diluent. No adverse effect has been reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a advanced practice registered nurse, via medical assistant, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was reported. On 29-JUN-2018, the patient was vaccinated with ROTATEQ one dose, orally (strength, dose number, lot # and expiration date were not reported) for prophylaxis. On 24-AUG-2018, the patient was vaccinated with expired and improperly stored dose of ROTATEQ one dose, orally, lot # M035828 and expiration date 28-MAY-2018 (strength and dose number were not reported) for prophylaxis. Administered doses of vaccine were exposed to the temperature excursion prior to expiration (temperature excursion and duration were not reported). It was unknown by reporter if data logger was involved and if there was previous temperature excursions. There was no adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product preparation issue
Clinical narrative: This spontaneous report was received from a female pharmacy student of unknown age referring to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, dose number, site and route of administration, lot # and expiration date were not reported) which was not agitated thoroughly prior to administration. No adverse effect was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 27-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot# reported as N032958 and expiration date 13-JUL-2020, or lot# N022583 and expiration date 20-JUN-2020 (strength, dose, dose number, site and route of administration were unspecified). Administered doses of vaccine were exposed to the temperature excursion below 32 degrees Fahrenheit (29.1 degrees Fahrenheit) for 16 days and the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit (57.9 degrees Fahrenheit) for 15 hours. Data logger was involved. There was no previous temperature excursions. There was no adverse effects reported. This is one of two reports received from the same reporter. Lot number N032958 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Sender's Comments: US-009507513-1808USA013371.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age. Information about drug reactions/allergies, concomitant medication and medical history was unknown. On 04-SEP-2018 the patient was vaccinated with VARIVAX (dose, and frequency unknown; lot # M037642 and expiration date 01-SEP-2018) for prophylaxis. Other suspect therapy included sterile diluent (dose, and frequency unknown; lot # reported as M040413 and expiration date 25-SEP-2018). The sterile diluent used to reconstitute the VARIVAX was not expired. No adverse events reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided. On 12-SEP-2018, the patient was vaccinated with one dose of PNEUMOVAX 23 (intramuscular, lot # M032635, expiration date 05-MAY-2018; strength was not reported) for prophylaxis. No adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report was received from a pediatrician via company representative, regarding a girl patient of unknown age. The patient concurrent, historical conditions and concomitants medications were not reported. On unknown date, the pediatrician expressed that he had a patient who received a dose of GARDASIL 9 (strength, dosage, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. On unspecified date, the patient experienced strong edema of the arm. During the company representative conversation with the pediatrician, the pediatrician was called by another physician, so the company representative was not able to obtain more information about the adverse event. The action taken with GARDASIL 9 was not applicable. The outcome of the event was unknown. The causality assessment between GARDASIL 9 and the events was not provided.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Blood culture, Chills, Computerised tomogram, Injection site erythema
Clinical narrative: This spontaneous report was received from a licensed practical nurse, via a company representative, referring to a 79 year old male patient. The patient had none pertinent medical history, concurrent conditions or concomitant medications. On 05-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N024717 (expiration date: 06-APR-2019) intramuscular in the right deltoid for vaccination (strength, dose and frequency were not reported). Subsequently the patient experienced; increased pain around the injection site, redness around injection site (injection site erythema), felt generally weak with malaise, fever (pyrexia) and chills at home before bedtime. Also reported the patient woke up with lacked strength to get back into the bed (asthenia) and went to the emergency room, were in consequence, he was hospitalized due to events. On unspecified date, the patient had a computed tomography scan (CT) and blood culture (results not provided), he also received treatment with vancomycin, piperacillin sodium, tazobactam sodium (ZOSYN) and cyclophosphamide (CTX) 2 grams daily. On 09-SEP-2018, the patient was discharged from the hospitalized. The outcome of asthenia, chills, pyrexia, malaise, injection site erythema and injection site pain was reported as resolved on unspecified date in September 2018. At the time of the report, the casual relationship between the aforementioned events and PNEUMOVAX 23 was not reported.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Malaise, Pyrexia
Clinical narrative: This spontaneous report was received from a licensed practical nurse, via a company representative, referring to a 79 year old male patient. The patient had none pertinent medical history, concurrent conditions or concomitant medications. On 05-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N024717 (expiration date: 06-APR-2019) intramuscular in the right deltoid for vaccination (strength, dose and frequency were not reported). Subsequently the patient experienced; increased pain around the injection site, redness around injection site (injection site erythema), felt generally weak with malaise, fever (pyrexia) and chills at home before bedtime. Also reported the patient woke up with lacked strength to get back into the bed (asthenia) and went to the emergency room, were in consequence, he was hospitalized due to events. On unspecified date, the patient had a computed tomography scan (CT) and blood culture (results not provided), he also received treatment with vancomycin, piperacillin sodium, tazobactam sodium (ZOSYN) and cyclophosphamide (CTX) 2 grams daily. On 09-SEP-2018, the patient was discharged from the hospitalized. The outcome of asthenia, chills, pyrexia, malaise, injection site erythema and injection site pain was reported as resolved on unspecified date in September 2018. At the time of the report, the casual relationship between the aforementioned events and PNEUMOVAX 23 was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Varicella zoster pneumonia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, the patient was inoculated at a health care facility with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 27-JUL-2016, the patient was treated by a certified physician assistant (PA-C) at a health care facility for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX.  The outcome of the events was unknown. Upon internal review, Severe varicella pneumonia was determined to be a medically significant event. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 6 months old patient of unknown gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-FEB-2018, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # N013393 and expiration date: 11-DEC-2018), (strength and dose were not reported) orally for prophylaxis. It was reported that the vaccine was stored between 0 degrees Celsius to 1 degrees Celsius (0.4 C) for 30 minutes. Previous cold temperature excursion (09-FEB-2018) was from 0 degrees Celsius to 1 degrees Celsius (0.9 C) for 40 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1809USA008677: US-009507513-1809USA008678: US-009507513-1809USA008679: US-009507513-1803USA009994.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 68 year old patient of unknown gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 06-MAR-2018, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 lot # N030111, expiration date 21-APR-2019 (dose, route of administration were not reported), (strength and dose were not reported) orally for prophylaxis. It was reported that the vaccine was stored between 0 degrees Celsius to 1 degrees Celsius (0.4 C) for 30 minutes. Previous cold temperature excursion (09-FEB-2018) was from 0 degrees Celsius to 1 degrees Celsius (0.9 C) for 40 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the multiple reports received from the same Reporter. Sender's Comments: US-009507513-1809USA008676: US-009507513-1803USA009994: US-009507513-1809USA008678: US-009507513-1809USA008679: US-009507513-1809USA008678.
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 12 month old patient of unknown gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 13-MAR-2018, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # N013393 and expiration date: 11-DEC-2018), (strength and dose were not reported) orally for prophylaxis (product storage error). It was reported that the vaccine was stored between 0 degrees Celsius to 1 degrees Celsius (0.4 C) for 30 minutes. Previous cold temperature excursion (09-FEB-2018) was from 0 degrees Celsius to 1 degrees Celsius (0.9 C) for 40 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1809USA008676: US-009507513-1803USA009994: US-009507513-1809USA008677: US-009507513-1809USA008679: US-009507513-1809USA008677:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 8 week old patient of unknown gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 19-MAR-2018, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # N021308 and expiration date: 05-MAR-2019), (strength and dose were not reported) orally for prophylaxis (product storage error). It was reported that the vaccine was stored between 0 degrees Celsius to 1 degrees Celsius (0.4 C) for 30 minutes. Previous cold temperature excursion (09-FEB-2018) was from 0 degrees Celsius to 1 degrees Celsius (0.9 C) for 40 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1809USA008678: US-009507513-1803USA009994: US-009507513-1809USA008676: US-009507513-1809USA008677:
Sex: M
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a physician, via company representative, referring to a male child of unknown age. Information regarding the patient's medical history, concurrent conditions or concomitant medications was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscularly as prevention of human papillomavirus (HPV) (dose, anatomical location, lot number and expiration date were not reported). On an unknown date, after receiving GARDASIL 9 the patient experienced seizures. Furthermore, the patient visited the neurologist and received treatment to the aforementioned event. It was unknown if any laboratory diagnostic was performed. At the time of the report, the outcome of seizure was unknown. The reporter did not provide causality assessment between the event and vaccination with GARDASIL 9.  Upon internal review, the event seizures was determined to be medically significant. This is one of two cases from the same source.; Sender's Comments: US-009507513-1809USA008294:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 18-AUG-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. Upon information and belief, on or about 18-AUG-2016, a physician, recommended and/or administered the ZOSTAVAX vaccine to the patient for its intended purpose of long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles or zoster-related injuries as intended. On or about 31-AUG-2016, the patient was treated by a physician for herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.