chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: X-ray normal
Clinical narrative: Pt received the vaccine on 1/2/18 and then started with pain on 1/21/18. It was described as a burning in the center of her low back and spread anteriorly around her right side. The pain or discomfort progressed to a tingling feeling sparing the buttock but continuing down the back of her right leg and this numbness had worsened over the subsequent 4-5 days. No headaches, fevers, known trauma, walking normally, not feeling good but not feeling weak. No recent trauma. Pt received a lumbosacral xray that was negative and was subsequently referred to Ortho, Physical Therapy and Rheumatology. Sx have continued and are being followed by specialists.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Pediatric dose given instead of adult dosage. Pt. accidently received Pediatric dose of hepatitis B rather than the adult dosage. No adverse outcomes noted. Pt will receive adult dosage one month after pediatric dose given.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: Severe swelling and hot to touch very painful.
Age: 20.0
Sex: M
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Gave wrong MMR.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Incorrect route of drug administration, Influenza like illness, Injection site erythema
Clinical narrative: Redness and swelling greater than baseball size at subcutaneous injection site went large induration at center of injection site on under side of left arm. Developed around 4pm the same date of injection, flu like symptoms (headache, low grade fever, muscle aches, neck ache severe fatigue) had to go to bed at 6pm. Symptoms worsens the next day. Took ADVIL, TYLENOL, BENADRYL and used ice at site. On 24-May-2018, flu like symptoms subsided except headache and site reddness was a little larger on the upper part of the reaction that was till red, warm to touch with induration at center. Seeing Dr. today at 8:30 AM.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Myalgia, Neck pain
Clinical narrative: Redness and swelling greater than baseball size at subcutaneous injection site went large induration at center of injection site on under side of left arm. Developed around 4pm the same date of injection, flu like symptoms (headache, low grade fever, muscle aches, neck ache severe fatigue) had to go to bed at 6pm. Symptoms worsens the next day. Took ADVIL, TYLENOL, BENADRYL and used ice at site. On 24-May-2018, flu like symptoms subsided except headache and site reddness was a little larger on the upper part of the reaction that was till red, warm to touch with induration at center. Seeing Dr. today at 8:30 AM.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness and swelling greater than baseball size at subcutaneous injection site went large induration at center of injection site on under side of left arm. Developed around 4pm the same date of injection, flu like symptoms (headache, low grade fever, muscle aches, neck ache severe fatigue) had to go to bed at 6pm. Symptoms worsens the next day. Took ADVIL, TYLENOL, BENADRYL and used ice at site. On 24-May-2018, flu like symptoms subsided except headache and site reddness was a little larger on the upper part of the reaction that was till red, warm to touch with induration at center. Seeing Dr. today at 8:30 AM.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Fatigue, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Redness and swelling greater than baseball size at subcutaneous injection site went large induration at center of injection site on under side of left arm. Developed around 4pm the same date of injection, flu like symptoms (headache, low grade fever, muscle aches, neck ache severe fatigue) had to go to bed at 6pm. Symptoms worsens the next day. Took ADVIL, TYLENOL, BENADRYL and used ice at site. On 24-May-2018, flu like symptoms subsided except headache and site reddness was a little larger on the upper part of the reaction that was till red, warm to touch with induration at center. Seeing Dr. today at 8:30 AM.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Skin ulcer, Swelling
Clinical narrative: Patient said on 5/23 that she has been having tingling, swelling and soreness since the day she received the immunization. Since then, more recently she has had sores develop on her arm.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Eye swelling, Ocular hyperaemia, Skin warm
Clinical narrative: Red bulls eye, swollen, hot to touch.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Pain in extremity, Paraesthesia, Pyrexia, Stomatitis
Clinical narrative: Patient experienced the expected side effects of the vaccine (arm soreness and fever) initially after vaccine administration. Two weeks later the patient reports a sore developed on the roof of her mouth as well as tingling pain in her back. The mouth sore was treated with oral nystatin 100,000 unit suspension prescribed by MD. Currently the symptoms have resolved.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Heart rate irregular, Palpitations
Clinical narrative: I started with a fast heart rate and palpitations. They lasted all day. That evening, I decided to check my blood pressure and my fancy meter let me know I was having an irregular heart rate. I called Dr.'s after hours doctor (10 pm) and asked if I should go to the emergency room and she said I did not need to go but could call in the morning for an appointment. I went to bed and when I woke this morning, my heart rate seemed to stabilize. I have checked my blood pressure with my monitor and it is not giving me the warning. I am feeling better. I do have occasions when I have palpitations but they have never lasted that long and I have not had them recently. I am going to continue to monitor my heart rate today.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: Skin reaction.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed redness, swelling, and warmth of the right upper arm the day following the vaccination. Patient was given a dose of BENADRYL with no improvement. Followed up in the clinic 48 hours post vaccine with some improvement. No fevers, chills, or URI symptoms present. Right arm without defined area of erythema. Right upper arm and forearm are affected with visible swelling. No pain or itching.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Child was given Varicella and MMRV (PROQUAD) instead of Varicella and MMR.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Fever, Chills, Muscle pain (flu like symptoms) lasting 24 hours (5 am on May 23 to 5 am on May 24).
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Computerised tomogram head, Concussion, Confusional state, Fall, Head injury
Clinical narrative: Patient passed out and hit head while walking out of the doctors office. He was required to have an emergency head cat scan due to the force of the fall and blow to the head. Patient was "out" for several seconds before coming to. He remained very confused for approximately 30-45 minutes post fall.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Loss of consciousness
Clinical narrative: Patient passed out and hit head while walking out of the doctors office. He was required to have an emergency head cat scan due to the force of the fall and blow to the head. Patient was "out" for several seconds before coming to. He remained very confused for approximately 30-45 minutes post fall.
Age: 22.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Seizure like phenomena, Syncope, Tremor
Clinical narrative: PATIENT WITH REACTION AFTER GIVING GARDASIL. PRESENTED FOR VACCINE OF GARDASIL AND MENACTRA. 2-3 MINUTES AFTER GIVING GARDASIL WAS SHAKING (SEIZURE LIKE) AND FAINTED ALMOST FALLING OFF EXAM TABLE. PROVIDER CAUGHT PATIENT NO INJURY WAS SUSTAINED AND PATIENT CAME TO WITHIN 10 SECONDS. LAID PATIENT DOWN FOR 30 MINUTES AND CALLED HER MOTHER FOR A RIDE AND EXPLAINED EVERYTHING TO MOM.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Erythemic area with no tenderness, no decreased range of motion, and patient was in no distress. Area was warm to the touch but painless per patient.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Lethargy, Pain in extremity
Clinical narrative: Following day patient experienced lethargy and had sore arm; following that arm is red, hot and itchy at injection site; redness getting larger every day.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PT GIVEN VACCINE 5/17/18; RETURNED TO CLINIC 5/18/18 WITH C/O LEFT ARM PAIN, REDNESS, DEPENDENT SWELLING. LEFT UPPER ARM APPREARED RED, WARM TO TOUCH, TENDER TO TOUCH. COLD COMPRESSES APPLIED. ON-CALL PHYSICIAN PRESCRIBED KEFLEX FOR SUSPECT CELLULITIS. NOTE: INFECTION PREVENTION NURSE MET WITH PT, THEN DISCUSSED WITH MD, URGED THAT ANTIBIOTICS BE HELD, BUT PHYSICIAN WAS NOT IN AGREEMENT. IP PLACED FOLLOW-UP PHONE CALL TO PT ON 5/24; PT REPORTED THAT REDNESS AND SWELLING EXTENDED PAST ELBOW OVER THE WEEKEND, BUT IS NOW RESOLVING. SHE IS TAKING KEFLEX AS PRESCRIBED.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: PT GIVEN VACCINE 5/17/18; RETURNED TO CLINIC 5/18/18 WITH C/O LEFT ARM PAIN, REDNESS, DEPENDENT SWELLING. LEFT UPPER ARM APPREARED RED, WARM TO TOUCH, TENDER TO TOUCH. COLD COMPRESSES APPLIED. ON-CALL PHYSICIAN PRESCRIBED KEFLEX FOR SUSPECT CELLULITIS. NOTE: INFECTION PREVENTION NURSE MET WITH PT, THEN DISCUSSED WITH MD, URGED THAT ANTIBIOTICS BE HELD, BUT PHYSICIAN WAS NOT IN AGREEMENT. IP PLACED FOLLOW-UP PHONE CALL TO PT ON 5/24; PT REPORTED THAT REDNESS AND SWELLING EXTENDED PAST ELBOW OVER THE WEEKEND, BUT IS NOW RESOLVING. SHE IS TAKING KEFLEX AS PRESCRIBED.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a properly stored but expired dose of Oka-Merck PROQUAD intramuscularly, lot # M042501, expiration date 17-APR-2018, (dose was not reported). No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report as received from a nurse refers to an unknown number of unspecified patients. The patients' concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On unknown dates, the patients were vaccinated with incorrectly stored GARDASIL 9 (strength and route of administration were not provided) lot # N000326, expiration date 14-OCT-2019 for prophylaxis. The vaccines were stored in temperature below 32 degrees Fahrenheit for 24 hours and 54 minutes. Digital data logger was involved. No adverse effects were reported. The outcome of the event was unknown.
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Protein total increased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration on an unspecified date to an unspecified date at single dose for immunization, SHINGRIX via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient experienced a high unspecified active protein count when getting blood work done, after taking SHINGRIX and PREVNAR 13. The outcome of event was unknown.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired product administered
Clinical narrative: On 5/14/18 patient was given an expired vaccine due to the person that is normally responsible for those duties was on the phone. So they got the person that covers her to give shot and wasn't aware they were expired. The shot were still in the refrigerator because they expired over weekend. What's going to be done so it don't occur again. Nurse 1 will be the only one giving shots, If other nurse is needed to cover nurse 1 due to she is not here. Nurse 1 will make sure to have shots that are approaching expiration date labeled. Patient will be given an extra hep B a next visit.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Low grade fever, all over achy feeling, headache lasting about 18 hours.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, Pain in extremity, Rash, Rash erythematous, Skin warm
Clinical narrative: The pt came in and her arm was red with a rash and she said it was extremely hot and real sore. I counseled her and told her to put some ice on it and take some TYLENOL and BENADRYL and asked her to sit and wait til the manager come back from lunch to talk with her, she said she was in a hurry and just wanted us to see it. I told her the manager would call her and advise her further and I gave it to the manager. The pt may be having a reaction also because she had the same shot PREVNAR 13 on 3/21/2018. I will call the pt again to check on her but she told the pharmacy manager she would come back in on Friday or Saturday.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient's right arm has hurt since having the injection. Stated it hurt when she sleeps on it up to her neck.
Age: 62.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Burning sensation, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Patient was running a fever of 100.4 about 26 hours after vaccination and both arms (specifically shoulders)were very sore. Patient described pain as being "on fire." Patient was advised to take TYLENOL for pain and she did take a TYLENOL with a prescription pain reliever that she already had at home.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal eruption, Rash
Clinical narrative: Patient stated that she developed a bad rash on her face, neck and mouth within 24 hours of getting the vaccine. She did not report it until 5/24/18.
Age: 0.42
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, hot to touch, hard spot above injection site. Reddened area is 4cm by 5 cm. Treatment: KEFLEX 125mg/5cc give 3cc po bid for 10 days. Warm compresses and massage area daily.
Age: 53.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Headache, Pain in extremity, Swelling
Clinical narrative: Patient reported severe pain in both arms and legs beginning on Friday, 5/18/18 in the evening. Patient reported taking 1 dose of an unknown new medication for infection/bacteria on Friday, 5/18/18 in the evening around the time the pain started; medication name is unknown and was dispensed by a pharmacy. Patient went to the Emergency Room on Saturday, 5/19/18 around 5am. ER doctors instructed patient to take TYLENOL. Patient reported taking 1 tablet of TYLENOL at 4pm and 1 tablet at 10pm which made him feel better and he went to sleep. Patient reported severe headache on Sunday, 5/20/18 in the morning. Patient visited primary care MD on Monday, 5/21/18 due to continued pain. Per patient, primary MD gave the patient a prescription for ibuprofen 600mg for pain and swelling. Patient reported visiting primary MD on Wednesday, 5/23/18. Patient stated he continues to have some pain in his arms and reported taking ibuprofen 600mg.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Limb mass, Pain, Skin warm
Clinical narrative: Pt. called our office on 5.23.18 stating her arm was hot and had a lump, also had a headache, joint pain and general aches. Pt. states she will not be getting the 2nd dose.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Functional gastrointestinal disorder, Influenza, Injection site rash, Pain
Clinical narrative: Rash to elbow from injection site and on stomach. Flu sx bowel changes aching chills. All 2-10 days.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash to elbow from injection site and on stomach. Flu sx bowel changes aching chills. All 2-10 days.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling cold, Pain in extremity, Peripheral swelling
Clinical narrative: I was very cold for about 6 hours - same day - arm very sore - red - swollen for a week.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Had the new shingles shot 1 of 2 parts. Later on had high temp then chills like a flu reaction also arm was sore where needle went in.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema
Clinical narrative: Patient reported felt fatigued on 5/22/18. On 5/23/18- noticed a red area that enlarged to 3 inches X 3 inches skin redness, inches below the injection site, closer to elbow rather not the deltiod that was the site of injection. A second quarter size red area was developing along side the larger one. Cool compresses 15 minutes on and 15 minutes off was recommended by physician with office follow up if no improvement noted.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: Tingling lips (presumed allergy)
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal behaviour, Balance disorder, Confusional state, Decreased appetite, Electrocardiogram
Clinical narrative: Fatigue, confusion, memory lapse, anorexia, off balance. Unable to recall conversations, activities from the day after vaccine. Was acting unusual all day after vaccine but no weakness of body parts, no slurred speech, no fever or syncope. Red and painful arm which has persisted
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Memory impairment, Pain in extremity
Clinical narrative: Fatigue, confusion, memory lapse, anorexia, off balance. Unable to recall conversations, activities from the day after vaccine. Was acting unusual all day after vaccine but no weakness of body parts, no slurred speech, no fever or syncope. Red and painful arm which has persisted
Age: 16.0
Sex: M
Vaccine: HPV9, MEN, MENB
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Severe pain in arm, headache, extreme nausea, fatigue/exhaustion.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Cheilitis, Eye irritation, Eye swelling, Hyperhidrosis, Lip swelling
Clinical narrative: Swollen, irritated eyes/lips, and sweaty palms.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Gait inability, Pain, Somnolence
Clinical narrative: An hour after receiving the vaccine patient felt very sleepy and went to bed. Woke up in extreme pain (9/10) and could not walk due to pain/disability in her back. Her healthcare aid administered TYLENOL and patient was able to get up about an hour after dose. Has been on TYLENOL ATC since Monday.  Pain today is 6/10 with NSAID.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Pyrexia
Clinical narrative: Low-grade fever, lethargy resolved within 24-36 hours.
Age: 73.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Blister, Dry skin, Rash
Clinical narrative: Patient described a rash that developed on her face, in addition to dry and blistered skin. She reports the events started Sunday 5/20 3 days after receiving the vaccines.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Computerised tomogram normal, Diarrhoea, Insomnia
Clinical narrative: Started with severe swelling between shoulder and elbow along with a deep reddish bluish discoloration that lasted 10 days. Then my joints began to become very painful to the point that I could not climb stairs unless I crawled on my hands and knees. Walking became painful. I had a low grade temperature since May 5th. On May 19th, I could not sleep from the pain and aches in my legs and an increasingly higher temperature. I also had a faint sense of nausea. On May 20th my temp got to 100 (normal is 97.4) and I thought it might be diverticulitis flare so there was a CAT scan done to rule that out. Negative scan. Blood showed elevated WBC. This continued through to May 23rd when I completely had a shutdown and became listless and my temp went up to 101.6, May 24th I now have diarrhea along with a lowered temperature but still severe muscle and joint pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Listless, Mobility decreased, Myalgia, Nausea, Pain
Clinical narrative: Started with severe swelling between shoulder and elbow along with a deep reddish bluish discoloration that lasted 10 days. Then my joints began to become very painful to the point that I could not climb stairs unless I crawled on my hands and knees. Walking became painful. I had a low grade temperature since May 5th. On May 19th, I could not sleep from the pain and aches in my legs and an increasingly higher temperature. I also had a faint sense of nausea. On May 20th my temp got to 100 (normal is 97.4) and I thought it might be diverticulitis flare so there was a CAT scan done to rule that out. Negative scan. Blood showed elevated WBC. This continued through to May 23rd when I completely had a shutdown and became listless and my temp went up to 101.6, May 24th I now have diarrhea along with a lowered temperature but still severe muscle and joint pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin discolouration, White blood cell count increased
Clinical narrative: Started with severe swelling between shoulder and elbow along with a deep reddish bluish discoloration that lasted 10 days. Then my joints began to become very painful to the point that I could not climb stairs unless I crawled on my hands and knees. Walking became painful. I had a low grade temperature since May 5th. On May 19th, I could not sleep from the pain and aches in my legs and an increasingly higher temperature. I also had a faint sense of nausea. On May 20th my temp got to 100 (normal is 97.4) and I thought it might be diverticulitis flare so there was a CAT scan done to rule that out. Negative scan. Blood showed elevated WBC. This continued through to May 23rd when I completely had a shutdown and became listless and my temp went up to 101.6, May 24th I now have diarrhea along with a lowered temperature but still severe muscle and joint pain.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Blister rupture, Injection site reaction, Injection site vesicles, Rash, Skin lesion
Clinical narrative: Got punched at SPV site and blister popped. Multiple lesions around SPV site and down arm. Also with a lesion on outer lower right eyelid and nostril. Saw optometry- treated with Emycin for possible blepharitis. Follow up one week later eye lesion clearing, cont emycin for one more week. No worsening. No other follow up. Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Red, hardened, swollen, sore area around the injection site. The treatment is to just apply warm compresses and take some BENADRYL if needed. PNP believes it is just a localized reaction and that it will go away on its own.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Patient arm around injection site red, swollen, and warm to touch. The arm had also blistered at the injection site. Patient went to physician who stated that vaccine was given to low on the arm and should have been given higher. The physician put the patient on VALTREX prophylactically.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site pain, Nausea, Neck pain
Clinical narrative: Pt reports that within hours of receiving TDAP she has had extreme tiredness, injection site redness, nausea, right should ache, right side neck pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 66 y.o. female patient of Dr. here today for evaluation of pain and swelling in her left upper arm.  She had a wellness visit yesterday and received the PNEUMOVAX 23. Couple hours later she started having some pain and swelling. She took some ibuprofen last night which helped a little bit. It's been moderately achy for her since. She denies any swelling of her lips, tongue. She's not had a scratchy or sore throat or voice change. She denies cough or wheeze. She had some abdominal cramping this morning which was relieved by a bowel movement she should be small to what she ate yesterday. There's been no fever or chills otherwise is feeling okay. Musculoskeletal? left upper arm is moderately swollen, mildly red, warm and mildly tender everything is inferior to where she received the injection. There is no injection site hematoma extremity is otherwise benign looking.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash vesicular
Clinical narrative: Several patches of rash, minor itchiness. No pain. Resembled shingles.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Pruritus, Skin warm
Clinical narrative: Redness at injection site and about 6 inches below site. Warm to the touch. Itchy.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Joint range of motion decreased, Loss of personal independence in daily activities, Musculoskeletal pain, Pain
Clinical narrative: 5/22/2018: Pt received a TDAP at a local pharmacy x 3 weeks ago. Patient is a 51 year old male, dull pain to left upper shoulder, loss of range of motion above shoulder and loss of range reaching back. Pain with motion and weight bearing and also weakness. Pt is left handed. Pt swims, but cannot freestyle right now. Can butterfly swim. Pt feels his TDAP injection was given too high in his left arm at outside pharmacy 3 weeks ago and is concerned he has SIRVA vaccine reaction with damage of his upper arm. The pain started right after his injection though the next day he did travel on a plane and use the overhead. His youngest daughter is about 3 years. He has pain reaching towards her. Pt denies injury from work though he does have hx of right shoulder pain.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered at inappropriate site, Repetitive strain injury, Rotator cuff syndrome, Shoulder injury related to vaccine administration, Ultrasound scan abnormal
Clinical narrative: 5/22/2018: Pt received a TDAP at a local pharmacy x 3 weeks ago. Patient is a 51 year old male, dull pain to left upper shoulder, loss of range of motion above shoulder and loss of range reaching back. Pain with motion and weight bearing and also weakness. Pt is left handed. Pt swims, but cannot freestyle right now. Can butterfly swim. Pt feels his TDAP injection was given too high in his left arm at outside pharmacy 3 weeks ago and is concerned he has SIRVA vaccine reaction with damage of his upper arm. The pain started right after his injection though the next day he did travel on a plane and use the overhead. His youngest daughter is about 3 years. He has pain reaching towards her. Pt denies injury from work though he does have hx of right shoulder pain.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Weight bearing difficulty
Clinical narrative: 5/22/2018: Pt received a TDAP at a local pharmacy x 3 weeks ago. Patient is a 51 year old male, dull pain to left upper shoulder, loss of range of motion above shoulder and loss of range reaching back. Pain with motion and weight bearing and also weakness. Pt is left handed. Pt swims, but cannot freestyle right now. Can butterfly swim. Pt feels his TDAP injection was given too high in his left arm at outside pharmacy 3 weeks ago and is concerned he has SIRVA vaccine reaction with damage of his upper arm. The pain started right after his injection though the next day he did travel on a plane and use the overhead. His youngest daughter is about 3 years. He has pain reaching towards her. Pt denies injury from work though he does have hx of right shoulder pain.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The health care professional mentioned that himself, had gotten 2 doses of SHINGRIX. He was a 60 years old male who got the first dose of SHINGRIX and said he had a lot of arm pain that he could barely lift his arm. This case has been linked with US2018084276 (case for same patient) and US2018084274, reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received SHINGRIX. Concomitant products included amlodipine, cetirizine hydrochloride, lansoprazole, Meclizine, Montelukast, Amlodipine-Benaz. On 7th May 2018 12:00, the patient received the 1st dose of SHINGRIX. On 7th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and injection site itching. On 8th May 2018, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site itching were recovering/resolving and the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. The reporter considered the injection site pain, injection site itching, injection erythema and injection site swelling to be related to SHINGRIX. Additional information was reported as follows: The patient reported that the healthcare professional pulled the needle out, pressed and rubbed on the injection site immediately after injecting. It hurted and later on the same day of vaccination towards the evening it started to itch. One day after vaccination, the patient experienced injection site erythema and injection site swelling. The next day of the vaccination with SHINGRIX, there was swelling and redness. She called the office and was instructed to put ice on it for 2-3 days. On the day of reporting, the redness was bigger than what is was earlier, it was the size of a silver dollar. The pain was better unless the area was bumped. It was still painful when ice was applied. The itching was still present as she felt it either last night to the day of reporting or morning on the day of reporting. The patient couldn't say exactly. The patient provided permission to contact the doctor mentioned in the report.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Musculoskeletal pain, Pain, Rash
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in a 68-year-old female patient who received SHINGRIX. Concurrent medical conditions included core sores (on chronic therapy of FAMVIR, had not taken FAMVIR one week prior to receiving SHINGRIX). On 27th March 2018, the patient received the 1st dose of SHINGRIX. On 28th March 2018, 1 days after receiving SHINGRIX, the patient experienced pain, erythema, rash and scapula pain. The patient was treated with Analgesic. On an unknown date, the outcome of the pain, erythema, rash and scapula pain were unknown. It was unknown if the reporter considered the pain, erythema, rash and scapula pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced increase redness and pain the next day after vaccination, continued to progress and spread to scapula and rash developed over breast area. The patient was under case of physician and taking analgesic for pain at the time of reporting. The reporter agreed to follow up from GlaxoSmithKline. This case has been linked with case US2018GSK085328 and US2018GSK085329, reported by the same reporter.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site streaking, Wrong drug administered
Clinical narrative: Pneumococcal vaccine injected in error to potential new employee instead of TUBERSOL. Developed redness and "streak" at site. Appt at Clinic on 5/24/18 at 1200 noon.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929  Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT) (no more information was provided).   No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009898: US-009507513-1805USA009899: US-009507513-1805USA009900: US-009507513-1805USA009901: US-009507513-1805USA009902: US-009507513-1805USA009903: US-009507513-1805USA009904: US-009507513-1805USA009905: US-009507513-1805USA009906: US-009507513-1805USA009907: US-009507513-1805USA009908: US-009507513-1805USA009909: US-009507513-1805USA009910: US-009507513-1805USA009911: US-009507513-1805USA009912: US-009507513-1805USA009913: US-009507513-1805USA009914: US-009507513-1805USA009915: US-009507513-1805USA009916: US-009507513-1805USA009917: US-009507513-1805USA009918: US-009507513-1805USA009919: US-009507513-1805USA009920: US-009507513-1805USA009921: US-009507513-1805USA009922: US-009507513-1805USA009923: US-009507513-1805USA009924: US-009507513-1805USA009925: US-009507513-1805USA009926: US-009507513-1805USA009927: US-009507513-1805USA009928: US-009507513-1805USA009929: US-009507513-1805USA009930: US-009507513-1805USA009931: US-009507513-1805USA009932: US-009507513-1805USA009933: US-009507513-1805USA009934: US-009507513-1805USA009935.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA006787: US-009507513-1805USA009899: US-009507513-1805USA009900: US-009507513-1805USA009901: US-009507513-1805USA009902: US-009507513-1805USA009903: US-009507513-1805USA009904: US-009507513-1805USA009905: US-009507513-1805USA009906: US-009507513-1805USA009907: US-009507513-1805USA009908: US-009507513-1805USA009909: US-009507513-1805USA009910: US-009507513-1805USA009911: US-009507513-1805USA009912: US-009507513-1805USA009913: US-009507513-1805USA009914: US-009507513-1805USA009915: US-009507513-1805USA009916: US-009507513-1805USA009917: US-009507513-1805USA009918: US-009507513-1805USA009919: US-009507513-1805USA009920: US-009507513-1805USA009921: US-009507513-1805USA009922: US-009507513-1805USA009923: US-009507513-1805USA009924: US-009507513-1805USA009925: US-009507513-1805USA009926: US-009507513-1805USA009927: US-009507513-1805USA009927: US-009507513-1805USA009927: US-009507513-1805USA009930: US-009507513-1805USA009931: US-009507513-1805USA009932: US-009507513-1805USA009933: US-009507513-1805USA009934: US-009507513-1805USA009935.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929 , Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA006787: Original Case: 1805USA006787; US-009507513-1805USA009900: Original Case: 1805USA006787; US-009507513-1805USA009901: Original Case: 1805USA006787; US-009507513-1805USA009902: Original Case: 1805USA006787; US-009507513-1805USA009903: Original Case: 1805USA006787; US-009507513-1805USA009904: Original Case: 1805USA006787; US-009507513-1805USA009905: Original Case: 1805USA006787; US-009507513-1805USA009906: Original Case: 1805USA006787; US-009507513-1805USA009907: Original Case: 1805USA006787; US-009507513-1805USA009908: Original Case: 1805USA006787; US-009507513-1805USA009909: Original Case: 1805USA006787; US-009507513-1805USA009910: Original Case: 1805USA006787; US-009507513-1805USA009911: Original Case: 1805USA006787; US-009507513-1805USA009912: Original Case: 1805USA006787; US-009507513-1805USA009913: Original Case: 1805USA006787; US-009507513-1805USA009914: Original Case: 1805USA006787; US-009507513-1805USA009915: Original Case: 1805USA006787; US-009507513-1805USA009916: Original Case: 1805USA006787; US-009507513-1805USA009917: Original Case:1805USA006787; US-009507513-1805USA009918: Original Case: 1805USA006787; US-009507513-1805USA009919: Original Case: 1805USA006787; US-009507513-1805USA009920: Original Case: 1805USA006787; US-009507513-1805USA009921: Original Case: 1805USA006787; US-009507513-1805USA009922: Original Case: 1805USA006787; US-009507513-1805USA009923: Original Case: 1805USA006787; US-009507513-1805USA009924: Original Case: 1805USA006787; US-009507513-1805USA009925: Original Case: 1805USA006787; US-009507513-1805USA009926: Original Case: 1805USA006787; US-009507513-1805USA009927: Original Case: 1805USA006787; US-009507513-1805USA009928: Original Case: 1805USA006787; US-009507513-1805USA009929: Original Case: 1805USA006787; US-009507513-1805USA009930: Original Case: 1805USA006787; US-009507513-1805USA009931: Original Case: 1805USA006787; US-009507513-1805USA009932: Original Case: 1805USA006787; US-009507513-1805USA009933
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787; US-009507513-1805USA006787:Original Case : 1805USA006787; US-009507513-1805USA009901:Original Case : 1805USA006787; US-009507513-1805USA009902:Original Case : 1805USA006787; US-009507513-1805USA009903:Original Case : 1805USA006787; US-009507513-1805USA009904:Original Case : 1805USA006787; US-009507513-1805USA009905:Original Case : 1805USA006787; US-009507513-1805USA009906:Original Case : 1805USA006787; US-009507513-1805USA009907:Original Case : 1805USA006787; US-009507513-1805USA009908:Original Case : 1805USA006787; US-009507513-1805USA009909:Original Case : 1805USA006787; US-009507513-1805USA009910:Original Case : 1805USA006787; US-009507513-1805USA009911:Original Case : 1805USA006787; US-009507513-1805USA009912:Original Case : 1805USA006787; US-009507513-1805USA009913:Original Case : 1805USA006787; US-009507513-1805USA009914:Original Case : 1805USA006787; US-009507513-1805USA009915:Original Case : 1805USA006787; US-009507513-1805USA009916:Original Case : 1805USA006787; US-009507513-1805USA009917:Original Case : 1805USA006787; US-009507513-1805USA009918:Original Case : 1805USA006787; US-009507513-1805USA009919:Original Case : 1805USA006787; US-009507513-1805USA009920:Original Case : 1805USA006787; US-009507513-1805USA009921:Original Case : 1805USA006787; US-009507513-1805USA009922:Original Case : 1805USA006787; US-009507513-1805USA009923:Original Case : 1805USA006787; US-009507513-1805USA009924:Original Case : 1805USA006787; US-009507513-1805USA009925:Original Case : 1805USA006787; US-009507513-1805USA009926:Original Case : 1805USA006787; US-009507513-1805USA009927:Original Case : 1805USA006787; US-009507513-1805USA009928:Original Case : 1805USA006787; US-009507513-1805USA009929:Original Case : 1805USA006787; US-009507513-1805USA009930:Original Case : 1805USA006787; US-009507513-1805USA009931:Original Case : 1805USA006787; US-009507513-1805USA009932:Original Case : 1805USA006787; US-009507513-1805USA009933.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain in extremity, Skin warm
Clinical narrative: Local reaction to pneumococcal vaccine C/O (L) arm pain, warmth, and redness.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (see case US2018GSK091903). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm and chills. On an unknown date, the outcome of the pan in arm was unknown and the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the pain in arm and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional originally called to report that some of the SHINGRIX liquid leaked out from the needle during administration to a patient. Maladministration was taken prior (see case- US2018084274). After the health care professional was transferred about if that dose that leaked out needed to be repeated for that patient, the health care professional mentioned that himself, had gotten 2 doses of SHINGRIX. He was 60 years old male who got the first dose of SHINGRIX and said he had a lot of arm pain that he could barely lift his arm. (see case-US2018GSK091903). Then he got the 2nd dose of SHINGRIX 2 months later and again experienced arm pain (but not quite as bad as the first dose) and then also said had chills the night he got the 2nd dose of SHINGRIX. He said the chills only lasted that night. No further information was provided. This case has been linked with US2018084274 and US2018GSK091903, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: This case was reported by a physician and described the occurrence of injection site pain in unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, general malaise and fatigue. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, general malaise and fatigue were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, general malaise and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient experienced adverse events. This case was linked with case US2018GSK085312 reported by the same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Lip swelling, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myalgia upper extremities in a 75-year-old female patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia upper extremities and influenza like illness. On an unknown date, the patient experienced lip swelling. On an unknown date, the outcome of the myalgia upper extremities, influenza like illness and lip swelling were recovered/resolved. The reporter considered the myalgia upper extremities, influenza like illness and lip swelling to be related to SHINGRIX. Additional information was reported as follows: The consumer reported that after vaccination with SHINGRIX, her arm hurted at the muscle and she felt fluish for approximately one day. The patient was vaccinated with SHINGRIX on the right arm. The second morning after receiving the vaccination, she woke up with her upper right half of lip swollen, this lasted for half of the day and then the event was resolved. The patient had denied permission to contact their physician. The reporter was unable to provide any additional details at the time of reporting.