chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Shortly after 12 month vaccines, the patient developed bilateral lower extremity swelling below the knee along with redness, swelling and heat. He was given BENADRYL and cold packs and after a few minutes the swelling appeared to be going away. There was no shortness of breath or other symptoms.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Skin warm
Clinical narrative: Shortly after 12 month vaccines, the patient developed bilateral lower extremity swelling below the knee along with redness, swelling and heat. He was given BENADRYL and cold packs and after a few minutes the swelling appeared to be going away. There was no shortness of breath or other symptoms.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pain in extremity, Somnolence
Clinical narrative: Arm pain, nausea and excessive drowsiness for 3 days thereafter.
Age: 17.0
Sex: F
Vaccine: UNK, UNK, FLU4, MENB
Symptoms: Back pain, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: On day of vaccines the left arm hurt significantly through the evening. Treated with ice, tylenol and motrin. Approximately, 7 am the next day patient experiencing headache, backache, and malaise.  Patient felt chills with mild rigors treated with tylenol. Patient went to school. Around 750 headache as well as pins and needles sensation throughout bidy except head. Between 0900 and 1000 chills returned. 1110 to 1210 patient felt more chilled and noticed numbness in both feet. At the same time the pins and needles sensation increased significantly in the legs up to the waist. Patient also felt very tired. Hands and feet were cold. Patient described anything touching her skin increased the discomfort from the tingling sensation. Around 1215 took motrin. Around 1400 patient felt warmer. At about 1630 temperature noted to be 100.4 F. Tylenol and motrin given. Myalgia, headache and mile tingling continues.
Age: 17.0
Sex: F
Vaccine: UNK, UNK, FLU4, MENB
Symptoms: Hypoaesthesia, Malaise, Myalgia, Paraesthesia, Peripheral coldness
Clinical narrative: On day of vaccines the left arm hurt significantly through the evening. Treated with ice, tylenol and motrin. Approximately, 7 am the next day patient experiencing headache, backache, and malaise.  Patient felt chills with mild rigors treated with tylenol. Patient went to school. Around 750 headache as well as pins and needles sensation throughout bidy except head. Between 0900 and 1000 chills returned. 1110 to 1210 patient felt more chilled and noticed numbness in both feet. At the same time the pins and needles sensation increased significantly in the legs up to the waist. Patient also felt very tired. Hands and feet were cold. Patient described anything touching her skin increased the discomfort from the tingling sensation. Around 1215 took motrin. Around 1400 patient felt warmer. At about 1630 temperature noted to be 100.4 F. Tylenol and motrin given. Myalgia, headache and mile tingling continues.
Age: 17.0
Sex: F
Vaccine: UNK, UNK, FLU4, MENB
Symptoms: Skin warm
Clinical narrative: On day of vaccines the left arm hurt significantly through the evening. Treated with ice, tylenol and motrin. Approximately, 7 am the next day patient experiencing headache, backache, and malaise.  Patient felt chills with mild rigors treated with tylenol. Patient went to school. Around 750 headache as well as pins and needles sensation throughout bidy except head. Between 0900 and 1000 chills returned. 1110 to 1210 patient felt more chilled and noticed numbness in both feet. At the same time the pins and needles sensation increased significantly in the legs up to the waist. Patient also felt very tired. Hands and feet were cold. Patient described anything touching her skin increased the discomfort from the tingling sensation. Around 1215 took motrin. Around 1400 patient felt warmer. At about 1630 temperature noted to be 100.4 F. Tylenol and motrin given. Myalgia, headache and mile tingling continues.
Age: 17.0
Sex: F
Vaccine: UNK, UNK, FLU4, MENB
Symptoms: Asthenia, Grip strength decreased, Headache, Hypoaesthesia, Loss of personal independence in daily activities
Clinical narrative: On day of vaccines the left arm hurt significantly through the evening. Treated with ice, tylenol and motrin. Approximately, 7 am the next day patient experiencing headache, backache, and malaise.  Patient felt chills with mild rigors treated with tylenol. Patient went to school. Around 750 headache as well as pins and needles sensation throughout bidy except head. Between 0900 and 1000 chills returned. 1110 to 1210 patient felt more chilled and noticed numbness in both feet. At the same time the pins and needles sensation increased significantly in the legs up to the waist. Patient also felt very tired. Hands and feet were cold. Patient described anything touching her skin increased the discomfort from the tingling sensation. Around 1215 took motrin. Around 1400 patient felt warmer. At about 1630 temperature noted to be 100.4 F. Tylenol and motrin given. Myalgia, headache and mile tingling continues.
Age: 17.0
Sex: F
Vaccine: UNK, UNK, FLU4, MENB
Symptoms: Muscular weakness, Myalgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: On day of vaccines the left arm hurt significantly through the evening. Treated with ice, tylenol and motrin. Approximately, 7 am the next day patient experiencing headache, backache, and malaise.  Patient felt chills with mild rigors treated with tylenol. Patient went to school. Around 750 headache as well as pins and needles sensation throughout bidy except head. Between 0900 and 1000 chills returned. 1110 to 1210 patient felt more chilled and noticed numbness in both feet. At the same time the pins and needles sensation increased significantly in the legs up to the waist. Patient also felt very tired. Hands and feet were cold. Patient described anything touching her skin increased the discomfort from the tingling sensation. Around 1215 took motrin. Around 1400 patient felt warmer. At about 1630 temperature noted to be 100.4 F. Tylenol and motrin given. Myalgia, headache and mile tingling continues.
Age: 17.0
Sex: F
Vaccine: UNK, UNK, FLU4, MENB
Symptoms: Pyrexia
Clinical narrative: On day of vaccines the left arm hurt significantly through the evening. Treated with ice, tylenol and motrin. Approximately, 7 am the next day patient experiencing headache, backache, and malaise.  Patient felt chills with mild rigors treated with tylenol. Patient went to school. Around 750 headache as well as pins and needles sensation throughout bidy except head. Between 0900 and 1000 chills returned. 1110 to 1210 patient felt more chilled and noticed numbness in both feet. At the same time the pins and needles sensation increased significantly in the legs up to the waist. Patient also felt very tired. Hands and feet were cold. Patient described anything touching her skin increased the discomfort from the tingling sensation. Around 1215 took motrin. Around 1400 patient felt warmer. At about 1630 temperature noted to be 100.4 F. Tylenol and motrin given. Myalgia, headache and mile tingling continues.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Type III immune complex mediated reaction
Clinical narrative: ARTHUS REACTION TO LEFT ARM.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site rash
Clinical narrative: Patient reported a rash about 2 inches around the injection site.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: Pt reported abdominal pain after taking the vaccine by oral route- which subsided after several hours. Did consult with CDC Info whom reported that this has been a reported adverse reaction in the past. Discussed with patient to discontinue vaccine and continue probiotic/hydration. Pt states that the symptoms have subsided by phone call this afternoon. Pt is aware if symptoms return to seek care from ER. Did follow up with patient by phone.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Patient received shot on 8/16/17. No problems were noted at that time or within the 15 minutes after the shots were received. Patient returned to pharmacy 8 days after shots were received complaining that 1) left arm had hurt since having shot, so much that he had to sleep in a chair, 2) left arm began to swell 3 days after receiving shots and that there was a rash, 3) patient had seen the physician assistant on 8/22/17 and received a shot "for the pain" but it didn't help. Since patient didn't know what the shot was, I called and found out that he had received a dexamethasone injection and a referral to the chiropractor. He wasn't given anything for the pain and was still complaining his arm was swollen. Office asked if he had seen the chiropractor which patient said he had but was told the chiropractor could not help. I indicated that I could not help the patient at this point beyond recommending something like Ibuprofen or BENADRYL for his reaction and pain and seeing the doctor. Office stated to please let the patient know he needed to come back to the office.
Age: 1.42
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Parent states the patient developed red bumps all over her body. No fever.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral swelling
Clinical narrative: Patient reported to pharmacy today 08/24/17 that she has been feeling tingling and numbness and swelling in the last 3 fingers of her arm that she received the vaccine in. The symptoms started same day after vaccination and last until 08/23/17.
Age: 57.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Computerised tomogram, Grip strength decreased, Paraesthesia
Clinical narrative: Patient said he felt fine following administration of the vaccine. He said that when he went home and slept and then woke up, he said he was having trouble gripping with his left hand, and that when he massaged it, it felt tingly. He said he was going to the ER to have it checked out. I asked him to call me to update so I could submit to VAERS. I followed up several times, finally reaching him on 7/27/17. He had an appointment with the doctor the next day who said it could take a couple weeks for the symptoms to go away. But he did say the severity of his symptoms was getting better. On 8/8/17, per a conversation with the doctor's office, patient had received a TDaP vaccine already on 7/16/17 (although patient reported on his consent form that he had not had any vaccinations or skin tests in the past 4 weeks). When I asked for a diagnosis, they did not have a specific diagnosis and their information about which arm was affected was conflicting. I called the patient several days without being able to reach him, but on 8/24/17 he came into the pharmacy and confirmed it was his left arm. He said his symptoms were much better.
Age: 77.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient came to pharmacy to inform that the shot that was provided on 9/13/2016 on the Right Arm is still sore after almost a year from the PNEUMOVAX Vaccination. When rotating arm, or arm movement there is still soreness that occurred and still lingering from that vaccination date of 9/13/2016.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Swelling
Clinical narrative: Extreme muscle pain, swelling.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Hyperhidrosis, Palpitations
Clinical narrative: Patient said she felt real weak. She broke out in a profuse sweat and had heart palpitations. These symptoms lasted about 10-15 minutes. She said she sat real still until they subsided. She stated that she felt real weak for the rest of the day but felt normal the next day and since that time.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Eye swelling, Pyrexia
Clinical narrative: Low grade fever for almost 20 hours, swollen eyes for 8 hours.
Age: 23.0
Sex: M
Vaccine: HPV9
Symptoms: Chest discomfort, Electrocardiogram ST segment elevation, Pericarditis, Troponin normal
Clinical narrative: Received vaccination at 1400 on 15 Aug 2017 without complications. Around 1800 that day he started experiencing mild chest discomfort. Symptoms worsened and went to the ER on 16 Aug at 0519 and was diagnosed with pericarditis. Treated with NSAIDs/Tylenol.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injection site bruising, Pain
Clinical narrative: Patient has been in pain and has had increasing soreness since the injection. There is now a bruise in the area around the injection site. The injection site also appears to be higher up on the patient's arm, approx 2 inches from the top of the shoulder, indicating it possibly reached into the bursa area.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Nausea, Pain, Swelling
Clinical narrative: Patient came in 8/20/17 for a Pnemococcal 23 shot at 11 AM. On Monday she went to ER and was complaining about Swelling, vomiting, redness, pain, nausea and Joint pain. ER MD stated that this was possibly an allergic reaction gave her BENADRYL. No other issues reported
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Patient came in 8/20/17 for a Pnemococcal 23 shot at 11 AM. On Monday she went to ER and was complaining about Swelling, vomiting, redness, pain, nausea and Joint pain. ER MD stated that this was possibly an allergic reaction gave her BENADRYL. No other issues reported
Age: 65.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Nausea
Clinical narrative: Today was my second injection; the first injection was on 6/28/2017. The first injection (upper left arm) my arm was sore for several days and a noticeable lump was present for nearly a month.   Today I have experienced nausea and a headache from late afternoon into the evening.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Laparoscopic surgery, Nausea
Clinical narrative: My son awoke at 2:00 am on 8/22/17, approximately 10 hours after receiving vaccine, with abdominal pain, nausea and vomiting. This lasted with same intensity pain with nausea and repeated episodes of vomiting (pain scale 7 out of 10) throughout the course. He was seen at pediatrician's office due to concern of adverse reaction at 2:00 pm on 8/22/17 and exam was concerning for appendicitis. He was then brought to hospital emergency room. Ultrasound was performed around 3:30 pm and confirmed he had appendicitis. Surgery was scheduled the same day and done around 8:00 pm on 8/22/17. He had laparoscopic appendectomy with an overnight stay in the hospital, discharged home on 8/23/17 around 11:00 am. Pain from appendicitis resolved and recovering from surgical pain.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Procedural pain, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: My son awoke at 2:00 am on 8/22/17, approximately 10 hours after receiving vaccine, with abdominal pain, nausea and vomiting. This lasted with same intensity pain with nausea and repeated episodes of vomiting (pain scale 7 out of 10) throughout the course. He was seen at pediatrician's office due to concern of adverse reaction at 2:00 pm on 8/22/17 and exam was concerning for appendicitis. He was then brought to hospital emergency room. Ultrasound was performed around 3:30 pm and confirmed he had appendicitis. Surgery was scheduled the same day and done around 8:00 pm on 8/22/17. He had laparoscopic appendectomy with an overnight stay in the hospital, discharged home on 8/23/17 around 11:00 am. Pain from appendicitis resolved and recovering from surgical pain.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Nausea, Pain, Vomiting
Clinical narrative: Patient had the following symptoms - Chills, soreness, nausea, vomiting. Joint Pain. Called him MD and was informed of a possible allergy reaction. Symptoms went away in 2 days.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Hypotonia, Pallor, Somnolence, Syncope, Unresponsive to stimuli
Clinical narrative: Child was in lobby playing, while sibling was being seen. Seemed to have fainted to floor. Mom was behind child. Tried to assist child up, child was limp and not responding. Mom ran to water fountain (nurses right behind) splashed him with water, child came to. Alert and oriented x 3. Child seemed pale, slightly sleepy. Mom wanted us to call clinic for child to be seen. Nurse practitioner stated child needed to be seen in an Emergency room facility and then seen by a pediatrician to follow up. This was advised for Mom to do. Mom stated she wanted to go home and discuss situation with husband. I stressed the importance of child needing to go to ER and be checked out.
Age: 36.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Erythema, Pain, Pain in extremity
Clinical narrative: Right arm - red - sore - body aches - chills.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth, Local reaction
Clinical narrative: Local injection site reaction approximately 11.5 cm x 10 cm oval shaped, erythematous urticarial lesion that is warm to touch. Required PO and topical steroids.
Age: 79.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Came in 8/24/17 at 12:50 pm to report to administering RPh site where vaccine administered clear however front very red - saw MD today who gave RX for antibiotic.
Age: 79.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema
Clinical narrative: Came in 8/24/17 at 12:50 pm to report to administering RPh site where vaccine administered clear however front very red - saw MD today who gave RX for antibiotic.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Body temperature increased, Dizziness, Dysphemia, Limb discomfort, Pain in extremity
Clinical narrative: Pain in (R) arm, pt was stuttering and ditzy. Pt. seen at a chiropractor's office, because of all the pain. 8/23 Pt. Mom states arm feels heavy, ditzy, stuttering, running a temp. 100.4.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Arthralgia, Head banging, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: P.C. from Mom on 8/16/17 to report pt. has temp. of 101 and redness and tenderness R deltoid. Mom states fever started upon awakening 8/16. Pt. reported headache evening of 8/15/17. Mom gave 600 mg ibuprofen Q6 hrs. Pt. has Hx of Danlos syndrome and often gets local reaction with immunizations. Nurse instructed Mom to take child to ER if temp does up and she made an appt. with pediatrician Dr. for 8/17/17. See attached OV from Dr. 8/17/17. 13 year old in with Mom. He had vaccines at clinic on 8/15/17 and has been having joint pain, headache and a fever. Injection sites look a little better today per Mom arms had warmth and minimal swelling over both shoulders. No drainage from sites. He has reacted to vaccines in the past. Fever high 101. Appetite is down. He went to bed without eating.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: P.C. from Mom on 8/16/17 to report pt. has temp. of 101 and redness and tenderness R deltoid. Mom states fever started upon awakening 8/16. Pt. reported headache evening of 8/15/17. Mom gave 600 mg ibuprofen Q6 hrs. Pt. has Hx of Danlos syndrome and often gets local reaction with immunizations. Nurse instructed Mom to take child to ER if temp does up and she made an appt. with pediatrician Dr. for 8/17/17. See attached OV from Dr. 8/17/17. 13 year old in with Mom. He had vaccines at clinic on 8/15/17 and has been having joint pain, headache and a fever. Injection sites look a little better today per Mom arms had warmth and minimal swelling over both shoulders. No drainage from sites. He has reacted to vaccines in the past. Fever high 101. Appetite is down. He went to bed without eating.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Testis discomfort
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of testis discomfort in a 18-year-old male patient who received BEXSERO (batch number 169701A, expiry date January 2019). Co-suspect products included BEXSERO (batch number 169701A, expiry date 5th July 2017). On 5th July 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 7th August 2017, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 6th July 2017, 1 days after receiving BEXSERO and BEXSERO and not applicable after receiving BEXSERO, the patient experienced testis discomfort. On an unknown date, the patient experienced pain and testis discomfort. On an unknown date, the outcome of the testis discomfort and pain were recovered/resolved and the outcome of the testis discomfort was not recovered/not resolved. The reporter considered the testis discomfort to be possibly related to BEXSERO. It was unknown if the reporter considered the pain to be related to BEXSERO and BEXSERO. The reporter considered the testis discomfort to be possibly related to BEXSERO. Additional details were provided as follows: The patient reported testicular discomfort following both doses of BEXSERO. The patient did not report this after the second dose. Vague discomfort began approximately 24 hours after the first dose of BEXSERO and lasted about 7 days. The patient did not report this or seek treatment. After the second dose, the patient reported pain which might have begun prior to the second dose. The reporter stated that this was unclear whether pain started after 1st (less than a week) or 2nd (less than a month) doses of BEXSERO. Pain has persisted for 9 days and the patient was seen by his physician. The reporter stated that the patient did not had any medications and not received any other vaccines in the last month, from the date of reporting. The reporter would report the case of VAERS, but it was not done till the time of reporting.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Neck pain, Swelling
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain, neck pain and neck swelling. On an unknown date, the outcome of the injection site pain, neck pain and neck swelling were recovered/resolved. It was unknown if the reporter considered the injection site pain, neck pain and neck swelling to be related to BEXSERO. Additional details were provided as follows: The nurse told that her daughter (the patient) had arm pain at the injection site which travelled to her neck at some unknown time soon after receiving her first dose of BEXSERO. The patient's neck then became swollen and the pain and swelling lasted for two to three. The reporter said that her daughter was a freshman about to start college and that the BEXSERO dose had been administered at the patient's doctor's office. No further related details were provided by the reporter. The nurse gave permission to be contacted if necessary for related questions.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a adult female patient who received HAVRIX adult (batch number M252Y, expiry date 17th August 2018). On 17th August 2016, the patient received HAVRIX adult. On an unknown date, less than a year after receiving HAVRIX adult, the patient experienced nausea, fever, diarrhea and vomiting. On an unknown date, the outcome of the nausea, fever, diarrhea and vomiting were recovered/resolved. It was unknown if the reporter considered the nausea, fever, diarrhea and vomiting to be related to HAVRIX adult. Additional details were reported as follows: The patient received HAVRIX adult on left arm. It was reported that, the exact onset date of the events was unknown.
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Condition aggravated, Diarrhoea, Eye pain, Interchange of vaccine products
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a female patient who received RABAVERT. Co-suspect products IMOVAX RABBIA. Concurrent medical conditions included knee pain (due to old injuries) and pain in elbow. On 3rd August 2017, the patient received the 1st dose of RABAVERT. On 7th August 2017, the patient received the 2nd dose of IMOVAX RABBIA. In August 2017, less than a week after receiving RABAVERT, the patient experienced diarrhea, general body pain, pain in arm, arthralgia, eye pain and interchange of vaccine products. In August 2017, the outcome of the diarrhea, general body pain, pain in arm, arthralgia and eye pain were recovered/resolved. On an unknown date, the outcome of the interchange of vaccine products was unknown. It was unknown if the reporter considered the diarrhea, general body pain, pain in arm, arthralgia and eye pain to be related to RABAVERT. Additional details were provided as follows: The patient noted that she was a small frame and stature. She declined any other personal demographics. The age at vaccination was not reported. The patient declined any other personal demographics. After vaccination, the patient experienced diarrhea, body ache, pain with old injuries exacerbated (knee and elbow pain) and eye pain. These issues were resolved after the second day. On 7th August 2017, at an urgent care, the patient received IMOVAX as her second dose of rabies vaccine, which led to interchange of vaccine products. Less than a month after IMOVAX, the patient experienced fever, tiredness, eye pain, arm pain and leg weakness. She stated, the issues appeared to be worse than with the first dose (RABAVERT). The patient did not receive any other doses and was not sure how to proceed. The patient was referred to her physician or the initial Emergency room physician where she received the RABAVERT. The patient noted that she had pain in her left arm, but that was opposite the side of the potential bite and immunizations. The patient was also referred to the Centers for Disease Control and Prevention (CDC) for direction. The patient reported that she had eye pain with both vaccines. The patient had denied permission to contact their physician.
Sex: F
Vaccine: RAB
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a female patient who received RABAVERT. Co-suspect products IMOVAX RABBIA. Concurrent medical conditions included knee pain (due to old injuries) and pain in elbow. On 3rd August 2017, the patient received the 1st dose of RABAVERT. On 7th August 2017, the patient received the 2nd dose of IMOVAX RABBIA. In August 2017, less than a week after receiving RABAVERT, the patient experienced diarrhea, general body pain, pain in arm, arthralgia, eye pain and interchange of vaccine products. In August 2017, the outcome of the diarrhea, general body pain, pain in arm, arthralgia and eye pain were recovered/resolved. On an unknown date, the outcome of the interchange of vaccine products was unknown. It was unknown if the reporter considered the diarrhea, general body pain, pain in arm, arthralgia and eye pain to be related to RABAVERT. Additional details were provided as follows: The patient noted that she was a small frame and stature. She declined any other personal demographics. The age at vaccination was not reported. The patient declined any other personal demographics. After vaccination, the patient experienced diarrhea, body ache, pain with old injuries exacerbated (knee and elbow pain) and eye pain. These issues were resolved after the second day. On 7th August 2017, at an urgent care, the patient received IMOVAX as her second dose of rabies vaccine, which led to interchange of vaccine products. Less than a month after IMOVAX, the patient experienced fever, tiredness, eye pain, arm pain and leg weakness. She stated, the issues appeared to be worse than with the first dose (RABAVERT). The patient did not receive any other doses and was not sure how to proceed. The patient was referred to her physician or the initial Emergency room physician where she received the RABAVERT. The patient noted that she had pain in her left arm, but that was opposite the side of the potential bite and immunizations. The patient was also referred to the Centers for Disease Control and Prevention (CDC) for direction. The patient reported that she had eye pain with both vaccines. The patient had denied permission to contact their physician.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Paraesthesia
Clinical narrative: Round red area where shot was given, slightly swollen, warm, and sore. Some tingling in arm and hand.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Cyanosis, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 16-year-old female patient who received MENVEO (batch number M16109, expiry date March 2018). On 15th August 2017, the patient received MENVEO. On 16th August 2017, 1 days after receiving MENVEO, the patient experienced injection site pain. On 17th August 2017, the patient experienced cyanosis peripheral. On 16th August 2017, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the cyanosis peripheral was unknown.  The reporter considered the injection site pain and cyanosis peripheral to be probably related to MENVEO. Additional details were provided as follows: The patient received MENVEO left arm. Then the patient left for school. The pain went away by the end of the day. On 17th August 2017, the patient woke up to Blue Fingers on left hand. The reporter felt, may the nerve was hit. The patient's mother was taking the patient to the emergency room. No additional information was provided.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Feeling hot
Clinical narrative: Chest tightness, SOB, feeling hot. Advised technician to call 911 and gave EPIPEN 0.3mg and patient symptoms began to improve w/in 5 mins. She then received treatment at Hospital.
Age: 10.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Altered state of consciousness, Immediate post-injection reaction, Pallor, Posture abnormal, Presyncope
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pallor in a 10-year-old male patient who received MENVEO (batch number M16164, expiry date 31st October 2018). Concomitant products included DTaP vaccine. On 16th August 2017, the patient received MENVEO .5 ml. On 16th August 2017, immediately after receiving MENVEO, the patient experienced pallor and vasovagal symptoms. On 16th August 2017, the outcome of the pallor and vasovagal symptoms were recovered/resolved. It was unknown if the reporter considered the pallor and vasovagal symptoms to be related to MENVEO. Additional details were provided as follows: The reporter administered the Dtap to the patient prior to MENVEO without an incident. On 16th August 2017 at 11:25 am, while being injected with the MENVEO the patient partially fainted. He did not lose completely consciousness but his eyes closed and his head fell to the side. It lasted for one second. He was also pale. The reporter said it happened when the needle was half inserted. The dose was administered. The reporter believed it might be a vasovagal because she vaccinated 3 others that day with the same lot without incidence. The patient was sent to the emergency room for monitoring and when the reporter checked on the patient last night, he was fine.
Age: 10.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Syncope
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pallor in a 10-year-old male patient who received MENVEO (batch number M16164, expiry date 31st October 2018). Concomitant products included DTaP vaccine. On 16th August 2017, the patient received MENVEO .5 ml. On 16th August 2017, immediately after receiving MENVEO, the patient experienced pallor and vasovagal symptoms. On 16th August 2017, the outcome of the pallor and vasovagal symptoms were recovered/resolved. It was unknown if the reporter considered the pallor and vasovagal symptoms to be related to MENVEO. Additional details were provided as follows: The reporter administered the Dtap to the patient prior to MENVEO without an incident. On 16th August 2017 at 11:25 am, while being injected with the MENVEO the patient partially fainted. He did not lose completely consciousness but his eyes closed and his head fell to the side. It lasted for one second. He was also pale. The reporter said it happened when the needle was half inserted. The dose was administered. The reporter believed it might be a vasovagal because she vaccinated 3 others that day with the same lot without incidence. The patient was sent to the emergency room for monitoring and when the reporter checked on the patient last night, he was fine.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Skin warm
Clinical narrative: Patient had red arm hot to the touch. Redness started at injection site went around deltoid/bicep and down to mid forearm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, pain, warm to touch on right deltoid after injection - (Parent) Patient instructed to use ice pack 4x/day for 1-2 days, OTC CHILDREN'S BENADRYL in the evening and to go to the ER if worsening allergic reaction symptoms develop per PA-C.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt developed nausea, vomiting, fever and weakness few hours after receiving shot. Was admitted to ER where it was determined that FLUZONE caused this.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Pt broke out into severe hives and rash.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Abasia, Abdominal pain upper, Decreased appetite, Feeling cold, Mobility decreased
Clinical narrative: Stiff/unable to walk/move, freezing, stabbing feeling in stomach, loss of appetite.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff/unable to walk/move, freezing, stabbing feeling in stomach, loss of appetite.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Pt. mother noticed a red lump on (L) arm the day after receiving vaccines. On third day there was swelling and a red knot on injection site.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Right arm pain, redness, couldn't lift arm on 8-19-17, hot, sore to the touch, inflammation, puffy.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: Right arm pain, redness, couldn't lift arm on 8-19-17, hot, sore to the touch, inflammation, puffy.
Age: 93.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Erythema, Injection site erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Severe redness on the left arm (where FLUAD and PNEUMOCOCCAL 23 injected), on chest and back. Pain, warm to touch and swollen arm since Monday 8/21/17 PM but didn't fully notice till 8/22/17 PM. The patient was requested to be seen by Dr on 8/23/17.
Age: 74.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Cough, Influenza, Pneumonia, Productive cough
Clinical narrative: 8-17 pt got flu and pneumonia. 8/18 pt "had phlegm". 8-19 pt had cough. 8-24 went to PCP, put on OTC med and antibiotic, poss bronchitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling at site of vaccines. No fever.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous report has been received from a consumer concerning a female patient of unknown age. Information about concomitant medication and medical history was unknown. On 13-JUL-2017, the patient was given VARIVAX 0.5 ml, once, injection (lot # and expiration date unknown) and sterile diluent (STERILE DILUENT) 0.5 ml, once (route, lot # and expiration date unknown) to prevent Varicella. The patient became pregnant "later" on an unknown date. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The patient did not seek medical attention and no treatment was given for the event.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous report has been received from a consumer concerning a female patient of unknown age. Information about concomitant medication and medical history was unknown. On 13-JUL-2017, the patient was given VARIVAX 0.5 ml, once, injection (lot # and expiration date unknown) and sterile diluent (STERILE DILUENT) 0.5 ml, once (route, lot # and expiration date unknown) to prevent Varicella. The patient became pregnant "later" on an unknown date. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The patient did not seek medical attention and no treatment was given for the event.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 73 year old female patient. Past medical history and concomitant medication was not reported. The patient's concurrent conditions include hepatic cirrhosis, diabetes mellitus and allergic to Codeine. On 15-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # M039060, expiry date: 22-MAY-2018, dosing details unspecified) in the arm for prophylaxis. Other suspect therapies included FLUZONE (dosing details unspecified) vaccinated on the same day (15-AUG-2017) and in the same arm as PNEUMOVAX 23. On the same day (15-AUG-2017), 2 hours after the vaccination the patient noticed redness at the injection site, but she did not seek treatment until the redness spread all the way down to her unspecified arm to her wrist. On 17-AUG-2017, the patient sought treatment at the emergency room where she was diagnosed with cellulitis and was prescribed with BACTRIM DS as treatment. The outcome of cellulitis was reported as not recovered. Causality was not reported. No product quality complaint was reported. Upon internal review, the event cellulitis was determined to be medically significant.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 73 year old female patient. Past medical history and concomitant medication was not reported. The patient's concurrent conditions include hepatic cirrhosis, diabetes mellitus and allergic to Codeine. On 15-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # M039060, expiry date: 22-MAY-2018, dosing details unspecified) in the arm for prophylaxis. Other suspect therapies included FLUZONE (dosing details unspecified) vaccinated on the same day (15-AUG-2017) and in the same arm as PNEUMOVAX 23. On the same day (15-AUG-2017), 2 hours after the vaccination the patient noticed redness at the injection site, but she did not seek treatment until the redness spread all the way down to her unspecified arm to her wrist. On 17-AUG-2017, the patient sought treatment at the emergency room where she was diagnosed with cellulitis and was prescribed with BACTRIM DS as treatment. The outcome of cellulitis was reported as not recovered. Causality was not reported. No product quality complaint was reported. Upon internal review, the event cellulitis was determined to be medically significant.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV, FLU3, PPV
Symptoms: Erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 73 year old female patient. Past medical history and concomitant medication was not reported. The patient's concurrent conditions include hepatic cirrhosis, diabetes mellitus and allergic to Codeine. On 15-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # M039060, expiry date: 22-MAY-2018, dosing details unspecified) in the arm for prophylaxis. Other suspect therapies included FLUZONE (dosing details unspecified) vaccinated on the same day (15-AUG-2017) and in the same arm as PNEUMOVAX 23. On the same day (15-AUG-2017), 2 hours after the vaccination the patient noticed redness at the injection site, but she did not seek treatment until the redness spread all the way down to her unspecified arm to her wrist. On 17-AUG-2017, the patient sought treatment at the emergency room where she was diagnosed with cellulitis and was prescribed with BACTRIM DS as treatment. The outcome of cellulitis was reported as not recovered. Causality was not reported. No product quality complaint was reported. Upon internal review, the event cellulitis was determined to be medically significant.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Syncope with tonic-clonic activity.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: Syncope with tonic-clonic activity.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist, who was also a company employee concerning his/her a friend, a 21 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The patient was uncertain if the first dose she received in the GARDASIL series was GARDASIL or GARDASIL 9 (interchange of vaccine products) (product name confusion). On an unknown date the patient was vaccinated with her second dose of GARDASIL 9 (dose, route, lot# and expiry date were unknown) for prophylaxis. On an unknown date, later that night after being administered GARDASIL 9, the patient began to experience body aches and pains over her entire body and had a fever of "104 degrees." The patient went to an unspecified emergency room around 2:00 the morning after receiving GARDASIL 9. The patient was treated with an unknown dose of TORADOL intravenously (IV), an unknown dose of COMPAZINE IV and a third unknown IV medication. The patient was released from the emergency room about 5 hours later. The outcome of the events was not reported. The patient stated she was scheduled to receive her third dose in the GARDASIL series on an unknown date in September of 2017. The reporter considered the events to be related to GARDASIL 9. Causality between the events and GARDASIL (unidentified Merck HPV vaccine) was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. On an unknown date the patients administered doses of GARDASIL 9 (dose, frequency and route unknown, lot # N012093, expiration date: 13-JAN-2020) for prophylaxis following a temperature excursion of 28F for 6 hours. There was no previous temperature excursion. Data logger involved. No adverse effects were reported in any patients.
Age: 3.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 3 year old patient. On 03-AUG-2017 the patient was vaccinated with GARDASIL 9 for prophylaxis. On 03-AUG-2017, 1 day after onset of therapy the patient experienced drug administered to patient of inappropriate age. On an unknown date the patient experienced no adverse event. The outcome of drug administered to patient of inappropriate age and no adverse event is unknown. The reporter considered drug administered to patient of inappropriate age and no adverse event to be not related to GARDASIL 9. {Additional information has been requested. / Additional information is not expected.}
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received a currently 70 year old male pharmacist (was also the patient) concerning himself via a company representative. Information about concomitant medication and medical history was unknown. On unspecified date in November 2011, when the patient was 64 years old, he received ZOSTAVAX (dose, route, lot # and expiration date were unknown) which was reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, route, lot # and expiration date were unknown) for prophylaxis. On an unspecified date, the patient developed ''shingles band in torso area". On an unknown date, the patient went to his primary care physician who prescribed antiviral Acyclovir, topical ointment capsaicin (ZOSTRIX), and at night time diphenhydramine hydrochloride (BENADRYL) for itching. The outcome of the events was recovered. The causality between the events and ZOSTAVAX was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients. There was no information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 for prophylaxis. The vaccines were stored in temperature from 9°C to 25°C for 4 hours and 30 minutes. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. There was no product quality complaint involved in this case. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with M-M-R II (albumin status RHA) lot # M029919, M048368 and M040558 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown.; Sender's Comments: US-009507513-1708USA002090: US-009507513-1708USA002734: US-009507513-1708USA002735: US-009507513-1708USA002736:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, medical history and drug allergy were not reported. On an unspecified date, the patient was vaccinated with one dose of improperly stored GARDASIL 9 (lot # N000326 and expiration date 14-OCT-2019, route and indication not reported). The vaccine was exposed to temperature excursion of 1 degree Celsius or colder for 3.5 hours. There was no previous temperature excursion. No adverse effects were reported.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 year old patient. The patient's concurrent condition, and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD (dose, frequency, lot #, expiration date and indication unknown) reconstituted with sterile diluent (manufacturer unknown) (drug administered to patient of inappropriate age). No adverse effects were reported.