chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Fall, Fatigue, Nausea
Clinical narrative: Pt was given the Tdap in left arm.  Turned to expose his right side and was given the menveo and gardasil 9.  Pt stated that he felt fine and was ready to return to the waiting room.  Upon returning to the waiting room he fainted and fell forward.  A pt in the waiting room was able to catch him and help him to the floor.  This nurse then joined him in the waiting room and found him to be lying prone on the floor.  He was observed to be pale in color and felt clammy and hot to the touch.  Cool compresses were applied.  He stated that he hadn't felt well before having the shot.   He also stated to feel light headed, nauseous, and tired.  He laid on the floor for several minutes before he was moved to a near by chair.  he remained on his knees on the floor with body bent over chair.  Water and sucker were offered but patient stated he was nauseous.  After several minutes, the pt stated that he would like to lay down.  He was moved to an exam room and laid supine on the exam table.  He then was able to drink some water and have a sucker.  At this time his BP was 108-60 and pulse was 66 bpm.  Pt stated that he was beginning to feel better, color was returning to normal.  Pt stated that he felt fine and was moved to a sitting position.  He then ate an granola bar and drank more water stating that he felt fine.  Vitals at this time were 114/70 and 68 bpm.  Mom felt she was able to take him home and stated that she felt comfortable with his care.  Pt was released and walked out on his own.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor, Skin warm, Syncope
Clinical narrative: Pt was given the Tdap in left arm.  Turned to expose his right side and was given the menveo and gardasil 9.  Pt stated that he felt fine and was ready to return to the waiting room.  Upon returning to the waiting room he fainted and fell forward.  A pt in the waiting room was able to catch him and help him to the floor.  This nurse then joined him in the waiting room and found him to be lying prone on the floor.  He was observed to be pale in color and felt clammy and hot to the touch.  Cool compresses were applied.  He stated that he hadn't felt well before having the shot.   He also stated to feel light headed, nauseous, and tired.  He laid on the floor for several minutes before he was moved to a near by chair.  he remained on his knees on the floor with body bent over chair.  Water and sucker were offered but patient stated he was nauseous.  After several minutes, the pt stated that he would like to lay down.  He was moved to an exam room and laid supine on the exam table.  He then was able to drink some water and have a sucker.  At this time his BP was 108-60 and pulse was 66 bpm.  Pt stated that he was beginning to feel better, color was returning to normal.  Pt stated that he felt fine and was moved to a sitting position.  He then ate an granola bar and drank more water stating that he felt fine.  Vitals at this time were 114/70 and 68 bpm.  Mom felt she was able to take him home and stated that she felt comfortable with his care.  Pt was released and walked out on his own.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain, Rash
Clinical narrative: L shoulder-  shoulder sore, aches, pains, rash R arm- joint pain
Age: 50.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Feeling hot, Pruritus, Rash generalised
Clinical narrative: PATIENT CLAIMS SHE WAS FEELING ITCHY AND HOT WITH RASH ALL OVER HER BODY.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: The patient developed a round rash that is warm to the touch about 3 inches from the injection site  (lower and to the front of the arm) . The rash is getting a bit larger during the day and he will see his doctor tomorrow if still not improving.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Pain, Pain in extremity
Clinical narrative: Arm pain, chills, body aches, stomach upset, diarrhea
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: vaccine expired on 7-17-2019. Merck was contacted to see if they had and extended expiration date. they did not and recommended revaccination
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Pain, Pyrexia
Clinical narrative: 101+ fever, body  aches,  fatigue, joint pain,
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness, Posture abnormal
Clinical narrative: Injections were given intramuscularly in the left arm.  RN was still in the room speaking with mother when patient lost consciousness and slumped over on the table.  This occurred approximately 2-3 minutes after vaccines were administered.  Patient regained consciousness in 10-15 seconds.  HR was initially 60 beats per minute following the incident, but recovered to 90s within 30 seconds.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Swelling
Clinical narrative: Swollen. Painful at injection site. Very red and hot. 2 days later still red, painful and hot. Also now itching.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram normal, Fatigue, Headache
Clinical narrative: At noon today, patient came in for the second dose of pneumonia. After giving the patient the shot, a few minutes later she told me, "I think I am having a reaction to the shot." I quickly went other there and started talking to her. She described her reaction as a pressure on her chest making breathing a bit difficult and then the pain started moving to different areas of her body such as lower back, behind, back of neck, behind the ears, and head.  She then told me she was nauseous but not enough to vomit. A couple minutes of sitting with her she asked me if I could call the paramedics. I asked her again to confirm that she would like me to call 911. Within 10 minutes the paramedics arrived and all her symptoms were gone. When the paramedics left, she came to the counter and said she is feeling better but feels tired and wants to go home and rest.  I later called her a few hours later to check on her (around 3pm I think it was) and she said she is doing better after resting but has a headache.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain
Clinical narrative: At noon today, patient came in for the second dose of pneumonia. After giving the patient the shot, a few minutes later she told me, "I think I am having a reaction to the shot." I quickly went other there and started talking to her. She described her reaction as a pressure on her chest making breathing a bit difficult and then the pain started moving to different areas of her body such as lower back, behind, back of neck, behind the ears, and head.  She then told me she was nauseous but not enough to vomit. A couple minutes of sitting with her she asked me if I could call the paramedics. I asked her again to confirm that she would like me to call 911. Within 10 minutes the paramedics arrived and all her symptoms were gone. When the paramedics left, she came to the counter and said she is feeling better but feels tired and wants to go home and rest.  I later called her a few hours later to check on her (around 3pm I think it was) and she said she is doing better after resting but has a headache.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Condition aggravated, Injection site discolouration, Injection site erythema, Injection site reaction
Clinical narrative: patient received vaccination 7/24/2019 and noticed in the morning on 7/25/2019 that the injection site was welted up, red, and warm to the touch; she did not experience fever or any flu-like symptoms; her arthritis also flared up and continues to be; the redness and warmth subsided by 7/28/2019 but still has traces of discoloration
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Urticaria
Clinical narrative: patient received vaccination 7/24/2019 and noticed in the morning on 7/25/2019 that the injection site was welted up, red, and warm to the touch; she did not experience fever or any flu-like symptoms; her arthritis also flared up and continues to be; the redness and warmth subsided by 7/28/2019 but still has traces of discoloration
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Impaired driving ability, Loss of consciousness, Nausea, Tremor
Clinical narrative: Nausea, Vomiting, Unconsciousness (Reported by husband as fainting and potential seizure). Pt was disoriented and shaking. Pt was brought to the ED by her husband immediately. ED mentioned concussion and potential seizure activity.  Pt is not allowed to drive for 3 months and will follow up with a Neurologist.  Pt is not allowed to drive for 3 months and will follow up with a Neurologist.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Nausea, Vomiting, Unconsciousness (Reported by husband as fainting and potential seizure). Pt was disoriented and shaking. Pt was brought to the ED by her husband immediately. ED mentioned concussion and potential seizure activity.  Pt is not allowed to drive for 3 months and will follow up with a Neurologist.  Pt is not allowed to drive for 3 months and will follow up with a Neurologist.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pruritus, Injection site swelling
Clinical narrative: Local allergic reaction with redness, swelling and intermittent itching around injection site approximately 8cmX8cm-treated w/ Benadryl, cool compress
Age: 67.0
Sex: M
Vaccine: MMR
Symptoms: Muscular weakness, Posture abnormal
Clinical narrative: Patient is reporting neck weakness, cannot lift head up, using hand to lift head and hold head upright.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: patient started having redness and swelling on right arm in deltoid area 2 days after vaccination
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dry mouth, Middle insomnia, Pain, Paraesthesia
Clinical narrative: After 7 days of vaccination (shingrix) , pt stated the tingling pain woke her up, she experienced swelling arms and pinch pain, dry mouth, diziness and shaking. She went to the emergency room because could not reach her Dr. Dr checked her blood pressure ok and gave her ibuprofen.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Tremor
Clinical narrative: After 7 days of vaccination (shingrix) , pt stated the tingling pain woke her up, she experienced swelling arms and pinch pain, dry mouth, diziness and shaking. She went to the emergency room because could not reach her Dr. Dr checked her blood pressure ok and gave her ibuprofen.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm, red, raised area at site of injection
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt. experienced chills later that night on 7/26/19 (L) arm painful, red and swollen. pt seen in office for reaction given Dexamethasone IM
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Inappropriate schedule of product administration
Clinical narrative: I called patient to inform that overdue for 2nd dose in series. I was informed that family believes that the Shingrix shot caused patient to have a Stroke on 11-28-19 (21 days after vaccination). Patient had been in previous good health (no blood pressure issues or high cholesterol).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Injection site reaction, Limb discomfort, Peripheral swelling, Rash macular
Clinical narrative: 4 hrs after receiving shot, heaviness spread from hips to knees to feet. Felt like extremities were swelling. Had feeling of heaviness in chest. Though would have to go to ER. I elevated my legs and used ice packs for swelling and just lay in bed waiting to see if it was going to get worse. Waited for approx. 1 hr. Symptoms did not get any worse, so I went on to sleep and decided to see Dr. the next day. The next day I felt much better. Also had red splotches around inj. site which lasted for 3 days. I work in health care & spoke with a Dr. informally. Did not require office visit. Dr. did suggest that I report this reaction to vaccine.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Approximately 48 hours after administration, patient noticed a red bump at the injection site. She drew dots around the red area, and the next day, it had expanded about 11/2 inches up to the size of a hockey puck. It was red, burning, and painful. She consulted on online prescriber who prescribed Cetirizine 10mg. Bump is still sore today but has decreased in size by half.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Borrelia test, Facial paralysis
Clinical narrative: facial paralysis / developed left sided bells palsy with in hours of HPV vaccine; borrelia test; This report was identified from a line listing obtained on request by the Company from the FDA (HA# 743103) under the Freedom of Information Act.  This spontaneous report referred to a 15-year-old female patient with cervical lymphadenopathy. The patient does not have any medical history and does not use concomitant medications. On 02-APR-2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # N020139; dose, route and expiration date were not reported) for prophylaxis. The patient developed left sided bell's palsy (facial paralysis) within hours of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On the same day, the patient had borrelia test. It was also reported that Lyme disease test was pending. The outcome of the events was unknown. The causality was not provided.  Follow-up was obtained on request by the Company from the FDA (HA# 743103) under the Freedom of Information Act on 15-APR-2019. At the time of vaccination, the patient was not taking prescription drugs, over-the -counter medications, dietary supplements, or herbal remedies. The patient had no chronic or long-standing health conditions and no allergies to medications, food or other products.  Follow-up information was received on 26-JUL-2019. Telephone calls were placed to the physician on 14-MAY-2019 and 26-JUL-2019. The telephone calls were answered by receptionist. During both the calls the physician was not available. First call was transferred to nurse triage, but it was answered by voice mail. The second call was answered by medical assistant (MA), but MA was unable to assist. It was stated that there was no way to accurately identify the patient. Additionally, a request was made for patient's use of product, co-morbid medical issues and concomitant medications (if patient was identified).  This case has been downgraded. The event 'facial paralysis' was considered non-serious by the health authority.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, HPV9, RV5, DTAPHEPBIP, HIBV, HPV9, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Product administered to patient of inappropriate age; This report was identified from a line listing obtained on request by the Company from the FDA. This spontaneous report as received from a regulatory authority (HA# 795459) refers to a 3-month-old female patient. The patient's current conditions included cold. The patient's concomitant medication included albuterol solution. The patient had no historical conditions. On 10-JAN-2019, the patient was vaccinated with the second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot no. R017251has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 04-MAY-2021, intramuscularly in the left leg; rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot no. R003114 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date not reported, but upon internal validation established as 27-SEP-2019, orally; hib conj vaccine (tet toxoid) (ACTHIB) lot # UI895AA, intramuscularly in the right leg; and diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX) lot # 2F977, intramuscularly in the left leg. It was reported that the vaccines were administered to the patient of inappropriate age.  Follow up information has been received on 03-JUL-2019 from healthcare professional. The patient demographics were updated. The patient was not pregnant at the time of vaccination. Information about the facility were the vaccinations were provided was updated. The onset of reaction as well as the time of vaccinations were updated to 10-JAN-2019, at 11:30.  Follow-up information has been received from a healthcare professional on 31-JUL-2019. The patient's current condition and illness at time of vaccination included acute bronchiolitis. The number of previous vaccines doses were reported as zero (initially reported as 1). There was no temperature excursion occurred as a result of reading from a digital data logger.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Musculoskeletal pain, Rash, Rash macular, Skin warm
Clinical narrative: Patient reported rash for over 2 weeks today. She also reported botches/spots on her face (resembling shingles) for over 2 weeks. She also reported itching for over 2 weeks. She went to urgent care and received an anti-viral, prednisone and an anti-biotic.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Patient reported rash for over 2 weeks today. She also reported botches/spots on her face (resembling shingles) for over 2 weeks. She also reported itching for over 2 weeks. She went to urgent care and received an anti-viral, prednisone and an anti-biotic.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash, Rash macular, Rash vesicular
Clinical narrative: Patient reported rash for over 2 weeks today. She also reported botches/spots on her face (resembling shingles) for over 2 weeks. She also reported itching for over 2 weeks. She went to urgent care and received an anti-viral, prednisone and an anti-biotic.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Feeling abnormal, Feeling cold, Night sweats
Clinical narrative: soreness (at injection site); swelling (at injection site); redness (at injection site); sweating; groggy; cold; fever; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 17th May 2019, refer case US2019AMR133459). Concurrent medical conditions included herpes virus infection (type was not known located on buttocks). Concomitant products included valaciclovir hydrochloride (Valacyclovir).   On 16th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th July 2019, less than a day after receiving Shingrix, the patient experienced cold, fever and shivering. On 17th July 2019, the patient experienced sweating and groggy. On 18th July 2019, the patient experienced injection site pain, injection site swelling and injection site erythema. Rechallenge with Shingrix was positive. On 17th July 2019, the outcome of the cold, fever and shivering were recovered/resolved. On 18th July 2019, the outcome of the sweating and groggy were recovered/resolved. On 21st July 2019, the outcome of the injection site swelling and injection site erythema were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, cold, fever, shivering, sweating and groggy to be related to Shingrix.  Additional details were provided as follows: The patient planned to follow up with her physician on an unknown date. On 17th July 2019, 1 days after the patient experienced sweating and groggy. On 18th July 2019, 2 days after the patient experienced injection site pain, injection site swelling and injection site erythema.  The reporter consented to follow up. There is an discrepancy regarding outcome of events keep.  There is a discrepancy between the outcome reported in the structured field "resolved" and the outcome reported in the sender's comment "resolved with sequelae".
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: soreness (at injection site); swelling (at injection site); redness (at injection site); sweating; groggy; cold; fever; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 17th May 2019, refer case US2019AMR133459). Concurrent medical conditions included herpes virus infection (type was not known located on buttocks). Concomitant products included valaciclovir hydrochloride (Valacyclovir).   On 16th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th July 2019, less than a day after receiving Shingrix, the patient experienced cold, fever and shivering. On 17th July 2019, the patient experienced sweating and groggy. On 18th July 2019, the patient experienced injection site pain, injection site swelling and injection site erythema. Rechallenge with Shingrix was positive. On 17th July 2019, the outcome of the cold, fever and shivering were recovered/resolved. On 18th July 2019, the outcome of the sweating and groggy were recovered/resolved. On 21st July 2019, the outcome of the injection site swelling and injection site erythema were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, cold, fever, shivering, sweating and groggy to be related to Shingrix.  Additional details were provided as follows: The patient planned to follow up with her physician on an unknown date. On 17th July 2019, 1 days after the patient experienced sweating and groggy. On 18th July 2019, 2 days after the patient experienced injection site pain, injection site swelling and injection site erythema.  The reporter consented to follow up. There is an discrepancy regarding outcome of events keep.  There is a discrepancy between the outcome reported in the structured field "resolved" and the outcome reported in the sender's comment "resolved with sequelae".
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: soreness (at injection site); swelling (at injection site); redness (at injection site); sweating; groggy; cold; fever; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 17th May 2019, refer case US2019AMR133459). Concurrent medical conditions included herpes virus infection (type was not known located on buttocks). Concomitant products included valaciclovir hydrochloride (Valacyclovir).   On 16th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th July 2019, less than a day after receiving Shingrix, the patient experienced cold, fever and shivering. On 17th July 2019, the patient experienced sweating and groggy. On 18th July 2019, the patient experienced injection site pain, injection site swelling and injection site erythema. Rechallenge with Shingrix was positive. On 17th July 2019, the outcome of the cold, fever and shivering were recovered/resolved. On 18th July 2019, the outcome of the sweating and groggy were recovered/resolved. On 21st July 2019, the outcome of the injection site swelling and injection site erythema were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, cold, fever, shivering, sweating and groggy to be related to Shingrix.  Additional details were provided as follows: The patient planned to follow up with her physician on an unknown date. On 17th July 2019, 1 days after the patient experienced sweating and groggy. On 18th July 2019, 2 days after the patient experienced injection site pain, injection site swelling and injection site erythema.  The reporter consented to follow up. There is an discrepancy regarding outcome of events keep.  There is a discrepancy between the outcome reported in the structured field "resolved" and the outcome reported in the sender's comment "resolved with sequelae".
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nasopharyngitis, Pyrexia, Somnolence, Vaccine positive rechallenge
Clinical narrative: soreness (at injection site); swelling (at injection site); redness (at injection site); sweating; groggy; cold; fever; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 17th May 2019, refer case US2019AMR133459). Concurrent medical conditions included herpes virus infection (type was not known located on buttocks). Concomitant products included valaciclovir hydrochloride (Valacyclovir).   On 16th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th July 2019, less than a day after receiving Shingrix, the patient experienced cold, fever and shivering. On 17th July 2019, the patient experienced sweating and groggy. On 18th July 2019, the patient experienced injection site pain, injection site swelling and injection site erythema. Rechallenge with Shingrix was positive. On 17th July 2019, the outcome of the cold, fever and shivering were recovered/resolved. On 18th July 2019, the outcome of the sweating and groggy were recovered/resolved. On 21st July 2019, the outcome of the injection site swelling and injection site erythema were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, cold, fever, shivering, sweating and groggy to be related to Shingrix.  Additional details were provided as follows: The patient planned to follow up with her physician on an unknown date. On 17th July 2019, 1 days after the patient experienced sweating and groggy. On 18th July 2019, 2 days after the patient experienced injection site pain, injection site swelling and injection site erythema.  The reporter consented to follow up. There is an discrepancy regarding outcome of events keep.  There is a discrepancy between the outcome reported in the structured field "resolved" and the outcome reported in the sender's comment "resolved with sequelae".
Age: 54.0
Sex: F
Vaccine: MNQ, TDAP, TDAP, MNQ, TDAP
Symptoms: Altered state of consciousness, Dizziness, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: dizzy with having to lay down and feeling like passing out; swelling, pain, tenderness, warm heat; swelling; pain,tenderness; warm heat; 8 cm in diameter red area of redness to the injection site of the left deltoid; fever; 8 cm in diameter red area of redness to the injection site of the left deltoid; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 54 years old female patient who experienced dizzy with having to lay down and feeling like passing out, swelling, pain, tenderness, warm heat, 8 cm in diameter red area of redness to the injection site of the left deltoid and fever while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) in right deltoid muscle.  On 26-Jul-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6272AA, expiry date : 30-Apr-2021 via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious dizzy with having to lay down and feeling like passing out (dizziness), swelling, pain, tenderness, warm heat (inflammation), 8 cm in diameter red area of redness to the injection site of the left deltoid (localized erythema) (vaccination site erythema) and fever same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was fever, 8 cm in diameter red area of redness to the injection site of the left deltoid, swelling, pain, tenderness, warm heat and dizzy with having to lay down and feeling like passing out.   The patient was treated with (ADVIL).  The patient was not recovered from all the events.  List of documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: MNQ, TDAP, TDAP, MNQ, TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: dizzy with having to lay down and feeling like passing out; swelling, pain, tenderness, warm heat; swelling; pain,tenderness; warm heat; 8 cm in diameter red area of redness to the injection site of the left deltoid; fever; 8 cm in diameter red area of redness to the injection site of the left deltoid; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 54 years old female patient who experienced dizzy with having to lay down and feeling like passing out, swelling, pain, tenderness, warm heat, 8 cm in diameter red area of redness to the injection site of the left deltoid and fever while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) in right deltoid muscle.  On 26-Jul-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6272AA, expiry date : 30-Apr-2021 via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious dizzy with having to lay down and feeling like passing out (dizziness), swelling, pain, tenderness, warm heat (inflammation), 8 cm in diameter red area of redness to the injection site of the left deltoid (localized erythema) (vaccination site erythema) and fever same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was fever, 8 cm in diameter red area of redness to the injection site of the left deltoid, swelling, pain, tenderness, warm heat and dizzy with having to lay down and feeling like passing out.   The patient was treated with (ADVIL).  The patient was not recovered from all the events.  List of documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: MNQ, TDAP, TDAP, MNQ, TDAP
Symptoms: Depressed level of consciousness, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: dizzy with having to lay down and feeling like passing out; swelling, pain, tenderness, warm heat; swelling; pain,tenderness; warm heat; 8 cm in diameter red area of redness to the injection site of the left deltoid; fever; 8 cm in diameter red area of redness to the injection site of the left deltoid; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 54 years old female patient who experienced dizzy with having to lay down and feeling like passing out, swelling, pain, tenderness, warm heat, 8 cm in diameter red area of redness to the injection site of the left deltoid and fever while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) in right deltoid muscle.  On 26-Jul-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6272AA, expiry date : 30-Apr-2021 via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious dizzy with having to lay down and feeling like passing out (dizziness), swelling, pain, tenderness, warm heat (inflammation), 8 cm in diameter red area of redness to the injection site of the left deltoid (localized erythema) (vaccination site erythema) and fever same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was fever, 8 cm in diameter red area of redness to the injection site of the left deltoid, swelling, pain, tenderness, warm heat and dizzy with having to lay down and feeling like passing out.   The patient was treated with (ADVIL).  The patient was not recovered from all the events.  List of documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: MNQ, TDAP, TDAP, MNQ, TDAP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: dizzy with having to lay down and feeling like passing out; swelling, pain, tenderness, warm heat; swelling; pain,tenderness; warm heat; 8 cm in diameter red area of redness to the injection site of the left deltoid; fever; 8 cm in diameter red area of redness to the injection site of the left deltoid; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 54 years old female patient who experienced dizzy with having to lay down and feeling like passing out, swelling, pain, tenderness, warm heat, 8 cm in diameter red area of redness to the injection site of the left deltoid and fever while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) in right deltoid muscle.  On 26-Jul-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6272AA, expiry date : 30-Apr-2021 via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious dizzy with having to lay down and feeling like passing out (dizziness), swelling, pain, tenderness, warm heat (inflammation), 8 cm in diameter red area of redness to the injection site of the left deltoid (localized erythema) (vaccination site erythema) and fever same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was fever, 8 cm in diameter red area of redness to the injection site of the left deltoid, swelling, pain, tenderness, warm heat and dizzy with having to lay down and feeling like passing out.   The patient was treated with (ADVIL).  The patient was not recovered from all the events.  List of documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: arm felt limp, left arm and fingers weakness; fingers were tingling; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 13 years old female patient who experienced arm felt limp, left arm and fingers weakness and fingers were tingling, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications received.  On 29-Jul-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6104AA and Exp. Date 02-Nov-2020) via intramuscular route in the left deltoid.  On 29-Jul-2019, the patient developed arm felt limp, left arm and fingers weakness (asthenia) and fingers were tingling (paraesthesia) few minutes following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of lab data not reported.  Final diagnosis was fingers tingling and arm felt limp, left arm and fingers weakness.   No corrective treatment was received.  On an unknown date, the patient had recovered from event.  List of documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypotonia, Muscular weakness, Paraesthesia
Clinical narrative: arm felt limp, left arm and fingers weakness; fingers were tingling; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 13 years old female patient who experienced arm felt limp, left arm and fingers weakness and fingers were tingling, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications received.  On 29-Jul-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6104AA and Exp. Date 02-Nov-2020) via intramuscular route in the left deltoid.  On 29-Jul-2019, the patient developed arm felt limp, left arm and fingers weakness (asthenia) and fingers were tingling (paraesthesia) few minutes following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of lab data not reported.  Final diagnosis was fingers tingling and arm felt limp, left arm and fingers weakness.   No corrective treatment was received.  On an unknown date, the patient had recovered from event.  List of documents held by sender: none.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Visual impairment
Clinical narrative: My vision degraded. There was a twinkle or sparkle in my vision. I went back to pharmacy and checked my blood pressure. It was high. I have never had a high blood pressure reading. I spoke with the Pharmacist. She said this was a normal reaction and not to be worried. When I checked the manufacturer website it did not mention anything about high blood pressure as a possible side effect. After about an hour my vision was okay. I checked my blood pressure 4 hours later and it was normal.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Patient said she had soreness at injection site which started about 6 hours after administration. On pain scale 1-10 the highest score she rated the pain was a 3. She also experienced a low grade fever which started about 18 - 20 hours after administration and lasted about 8 - 10 hours.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Joint and muscle pain, headache, nausea, fatigue, shivering, sensitive skin
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Sensitive skin
Clinical narrative: Joint and muscle pain, headache, nausea, fatigue, shivering, sensitive skin
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain
Clinical narrative: severe body aches, nausea, chills.  The symptoms began 7/31/2019  between 1400 and 1500 and are still ongoing as of 8/1/2019 0731.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient received improperly stored PROQUAD; Information has been received from a nurse concerning a 4 years old patient of unknown gender. The patient's concomitant medications, pertinent medical history and and drug reactions/allergies was not provided.   On 01-JUL-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number S002924 and expiration date 28-JUL-2020; dose, dose number, frequency and route of administration were not provided) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent. No adverse effect was reported. No product quality complaint (PQC) was involved.  The time frame: 6 Fahrenheit scale to 14 Fahrenheit scale (10.4 F) for 1 hour and 30 minutes. There was previous temperature excursion, total time in the range 6 Fahrenheit scale to 14 Fahrenheit scale (14 F) for 1 hour 56 minutes and total time in the range 15 Fahrenheit scale to 46 Fahrenheit scale (29 F) for 5 hours. Data logger was involved.  This is one of three linked cases received from the same reporter. ; Sender's Comments:  US-009507513-1907USA002200: US-009507513-1908USA000040:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: No adverse effects reported; The patient recieved VARIVAX which was reconstituted with DILUENT MRK INJ and adminstered via intramuscular; This spontaneous report was received from an healthcare business professional, regarding a patient of unknown age and gender. The patient's concurrent conditions, drug reactions, allergies, pertinent medical history and concomitant therapies were not reported.   On 21-JUL-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), intramuscular (incorrect route of product administration ) for prophylaxis, lot number R00604, and expiration date 23-OCT-2020 (strength, dosage and frequency were not reported), which was reconstituted with sterile diluent(DILUENT MRK INJ) (strength, dosage, frequency, lot number, and expiration date were not reported).  Lot number R00604 is an invalid lot number for varicella virus vaccine live (oka/merck)(VARIVAX).
Sex: U
Vaccine: MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; Patient received PROQUAD which was administered eith expired diluent MRK; Product preparation issue; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On 07-JUN-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R015742, expiration date 02-DEC-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis, which was administered with an expired dose of sterile diluent(MERCK STERILE DILUENT), lot#L028663, expiration date 29-MAR-2018. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; patient inadvertently received an expired dose of PROQUAD; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. Concomitant therapies included sterile diluent.  On 19-JUL-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R001540 (verified to be a valid lot number), expiration date reported and established as 15-JUL-2019, for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pallor, Posture abnormal
Clinical narrative: pale and slumped over; pale and slumped over; Information has been received from a physician via a field representative referring to a 15 years old male patient. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported. The patient had not eaten breakfast on the vaccination date.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R020949 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 04-MAY-2021; route, strength and dose were not reported) for prophylaxis. Other suspect therapy included meningococcal conj vaccine (unspecified) (reported as "MCV4 vaccine") (route, strength, dose, batch/lot # and expiration date were not reported) for an unknown indication on the same date.      On an unknown date, the patient experienced pale and slumped over. The patient was given orange juice.   The outcome of both events was reported as recovered. The causality was not reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; the patient was "inadvertently adminisered an expired dose of GARDASIL 9; This spontaneous report was received from a pharmacy intern referring to a 12 year old patient of an unknown gender. No information was provide regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 24-JUL-2019, the patient was inadvertently administered an expired dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot number M042853 and expiration date on 17-JUL-2019, for prophylaxis (dose, dose number, anatomical injection site and route of administration were not reported) (expired product administered). No adverse effects were reported.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; The patient received an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not reported.    On 26-JUL-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R030485 and expiration date 22-OCT-2020 (strength, anatomical location, dose and route were not provided) for prophylaxis (product storage error). The vaccine was reconstituted with sterile diluent (DILUENT MRK) lot # R000561 and expiration date 30-AUG-2020 (strength, dose and route were not provided). No adverse effects reported. The vaccine and the diluent was stored at the following temperatures: from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 9 hours and  from 15 degrees Fahrenheit to 46 degrees Fahrenheit (mainly at 24.3 degrees Fahrenheit) for 21 hours and 30 minutes. There was a digital data logger involved, but there was no previous temperature excursion.