chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Smear cervix abnormal, Systemic lupus erythematosus
Clinical narrative: This spontaneous report was received from a registered nurse via field representative, and refers to approximately a 24 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On unspecified dates in 2008, the patient received three doses of Quadrivalent GARDASIL, intramuscularly for prophylaxis (strength, anatomical location, lot number and expiration date were not reported). On an unspecified date in 2010, the patient developed systemic lupus erythematosus and on an unknown date in 2015, she had an papanicolaou smear abnormal. The patient sought medical attention but it was unknown by the reporter if the patient received treatments for the events or if additional laboratory diagnostic or test were performed. The outcome of the events systemic lupus erythematosus and papanicolaou smear abnormal and the causal relationship between the aforementioned events and vaccination with Quadrivalent GARDASIL were not reported. Upon internal review the event systemic lupus erythematosus was considered to be medically significant.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever after 4 y imms to 101.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 7-5 cm area of erythema, warm to touch left upper arm.
Age: 1.08
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Patient was given varicella 4-16-18 and MMR and pneumococcal 13 during well child visit. Mother called this morning 4/19/18 stating patient started with fever and rash this AM 4/19/18.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Chest pain, Fatigue, Herpes zoster, Immediate post-injection reaction
Clinical narrative: Immediatenot adverse symptomswere soreness, redness, swelling at injection site; the following day, had fatigue, flu-like aches all over. These adverse symptoms appeared in the morning of April 9, 2018. There were two blisters on the left side of my chest just below the nipple, and one on my back over the left shoulder blade. There was soreness along the left pectorals. Following day, there was more soreness and extreme sensitivity and pain on the blisters when in contact with clothing. The following day, April 11, the pain increased. That night the pain was 8 out of 10 in bursts for 4 hours. Today, April 12, started acyclovir, 800mg 5/day and Ibuprofen, 2/6 hours. The pain is reduced, the three blisters remain.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Immediatenot adverse symptomswere soreness, redness, swelling at injection site; the following day, had fatigue, flu-like aches all over. These adverse symptoms appeared in the morning of April 9, 2018. There were two blisters on the left side of my chest just below the nipple, and one on my back over the left shoulder blade. There was soreness along the left pectorals. Following day, there was more soreness and extreme sensitivity and pain on the blisters when in contact with clothing. The following day, April 11, the pain increased. That night the pain was 8 out of 10 in bursts for 4 hours. Today, April 12, started acyclovir, 800mg 5/day and Ibuprofen, 2/6 hours. The pain is reduced, the three blisters remain.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Immediatenot adverse symptomswere soreness, redness, swelling at injection site; the following day, had fatigue, flu-like aches all over. These adverse symptoms appeared in the morning of April 9, 2018. There were two blisters on the left side of my chest just below the nipple, and one on my back over the left shoulder blade. There was soreness along the left pectorals. Following day, there was more soreness and extreme sensitivity and pain on the blisters when in contact with clothing. The following day, April 11, the pain increased. That night the pain was 8 out of 10 in bursts for 4 hours. Today, April 12, started acyclovir, 800mg 5/day and Ibuprofen, 2/6 hours. The pain is reduced, the three blisters remain.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No reaction on previous exposure to drug
Clinical narrative: Seasonal Influenza Vaccine given 2/28/18. Already had seasonal Flu vaccine 11/22/2017.  No adverse reaction noted.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: Sore arm with moderate pain, redness and swelling; in addition, I also felt tired, had muscle pain, a headache, and shivering.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Swelling
Clinical narrative: Sore arm with moderate pain, redness and swelling; in addition, I also felt tired, had muscle pain, a headache, and shivering.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, tiredness (lasting 3 days).
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia
Clinical narrative: Major hair loss over proceding 3 months after vaccination. (Over 70% of hair loss). Alopecia.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Pruritus, Skin exfoliation, Urticaria
Clinical narrative: Possible reaction to medication ongoing since January, peeling, swelling of lips and itching, stopped fenofibrate about 2 nights ago, symptoms seem to get worse when taking. Allergic urticaria. Inject/Meds/Vaccines: DEPO-MEDROL 40mg, Prednisone 10 MG (21) pack, Once a day as directed by Taper Pack, 6 days, 0 refills, VISTARIL 25 MG capsule, as needed 1 BID for itching, 30 days, 0 refills. Personal history of anaphylaxis. Epinephrine 0.3 MG/0.3ML kit, as needed IM injection x1 for anaphylaxis may repeat in 5-10 min if needed, 30 days, 0 refills.
Age: 3.0
Sex: F
Vaccine: HEPA, HPV9, PNC13, HPV9
Symptoms: Vaccination error
Clinical narrative: No adverse event at this time. Patient was given GARDASIL 9 in error.
Age: 3.0
Sex: F
Vaccine: HEPA, HPV9, PNC13, HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event at this time. Patient was given GARDASIL 9 in error.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Enlarged uvula, Stomatitis
Clinical narrative: Swollen uvula 4 AM, had to sit up to breathe. Treated with BENADRYL and prednisone. Able to swallow and breathe sitting up. Improving, now has a white sore on uvula.
Age: 1.92
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site warmth, Swelling
Clinical narrative: Started w/redness and swelling on Tues 4-17-18. Left leg outer thigh has an area of erythema approx slightly warm to touch. 4 cm x 2 1/2 cm: slightly swollen, no induration.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Pain and swelling at injection site; headache, chills, fever (100 degrees F). Still continues at time of reporting. Muscle and joint aches all over body, headache, dizzy, tired; symptoms lasted 36 hours from time of injection; unable to perform normal tasks or go to work. Stayed in bed for close to 36 hours.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Injection site pain, Injection site swelling, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Pain and swelling at injection site; headache, chills, fever (100 degrees F). Still continues at time of reporting. Muscle and joint aches all over body, headache, dizzy, tired; symptoms lasted 36 hours from time of injection; unable to perform normal tasks or go to work. Stayed in bed for close to 36 hours.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain and swelling at injection site; headache, chills, fever (100 degrees F). Still continues at time of reporting. Muscle and joint aches all over body, headache, dizzy, tired; symptoms lasted 36 hours from time of injection; unable to perform normal tasks or go to work. Stayed in bed for close to 36 hours.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Urticaria
Clinical narrative: Widespread hives.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram head, Dizziness, Electrocardiogram, Tonic clonic movements
Clinical narrative: The patient began feeling light headed and dizzy, became unresponsive with tonic/clonic activities, unknowingly voided subsequently. EMS was contacted and patient was brought to Emergency Room, where he was later discharged home.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: The patient began feeling light headed and dizzy, became unresponsive with tonic/clonic activities, unknowingly voided subsequently. EMS was contacted and patient was brought to Emergency Room, where he was later discharged home.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain, Herpes zoster, Pruritus, Rash
Clinical narrative: After 1 day or two, began to develop pain and itching near the skin surface on my right abdomen.  After another week a rash developed; my GP believe that it is consistent with shingles.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain, Herpes zoster, Rash
Clinical narrative: After 1 day or two, began to develop pain and itching near the skin surface on my right abdomen.  After another week a rash developed; my GP believe that it is consistent with shingles.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: After 1 day or two, began to develop pain and itching near the skin surface on my right abdomen.  After another week a rash developed; my GP believe that it is consistent with shingles.
Age: 19.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse via company representative refers to a 19 year old patient. On an unknown date, the patient received one dose of GARDASIL when patient was 14 years old. On an unknown date, same unspecified patient received one dose of GARDASIL 9 when patient was 19 years old. No adverse effects reported. No product quality complaint was involved.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Systemic lupus erythematosus
Clinical narrative: This spontaneous report was received from a registered nurse via company representative refers to a 13 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On an unknown date, the patient was vaccinated with (total three doses) GARDASIL, (dose, unit, expiration date and lot number not specified) intramuscularly as prophylaxis at an unknown age. On an unknown date, the patient developed lupus (systemic lupus erythematosus) at age 13, (exact date of diagnosis not provided), and had an abnormal pap smear on an unknown date in 2015. It was unknown, if lab diagnostics/studies were performed. It was unknown if patient received treatment for the adverse event. The patient sought medical attention. The outcome of the events was unknown. Causality assessment was not reported. Product quality complaint was not involved. Upon internal review, the event systemic lupus erythematosus was determined to be medically significant.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 16-APR-2018, the patient was vaccinated with adult dose of VAQTA 50/1.0 U/ml (dosing details were not reported) (lot # N016805 expiry date: 04-SEP-2018) for prophylaxis. No adverse effects reported. No product quality complaint involved.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain, Sleep disorder
Clinical narrative: I had the first of 2 SHINGRIX shots (the new shingles shot). The shot was in my left arm. The location of the shot hurt for more than 3 days. Very painful. I was unable to sleep on my left side for 3 nights in a row. In addition, on the second day I felt like I was coming down with the flu. I hurt all over. Took an aspirin and went to bed at 6pm. Felt bad for about 2 or 3 days. As a result of the pain and other side effects, I am not planning to take the second shot.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: Received new shingles shot. Arm sore for over a week and shot area is still sore to the touch. Also knees hurt for several days.
Age: 38.0
Sex: U
Vaccine: TDAP
Symptoms: Induration, Nodule
Clinical narrative: 2 x 2 cm firm, indurated subq nodule on Lt upper arm at previous injection site per pt was given in Lt (injection is documented as Rt deltoid). BACTRIM BID x 7 days f/u in 3 days.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness and swelling on upper arm, warm/cold compresses, some pain, no changes at time of reporting. Has no deficit in range of motion. Pain not as bad when distracted (swim team).  Will monitor site and add TYLENOL/MOTRIN as needed for pain. Parent will phone back after weekend to report on progress, or phone as needed.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Patient reported fever and chills starting the evening of the vaccine, patient reported that she took TYLENOL for the fever and her symptoms were resolved by 4/14/2018.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Raised, angry red around the site of injection. Painful if touched. Dimensions of redness: 6 in. length x 3 in. wide lasting approximately 48 hours but improving each day.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Patient received vaccine on 4/13/18. On 4/16/18, she noticed redness about 3-4 inches in diameter at the injection site. On 4/17/18, she noticed the area was hot to the touch. On 4/18/18, she noted tiny white blisters had formed on the area. She states that it does not hurt so she has not taken anything to try to remedy the reaction.
Age: 63.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Patient is reporting that they have felt an overall fatigue, and tiredness throughout the day today.  Patient also report experiencing diarrhea this morning, but they indicated that that has subsided throughout the afternoon. The patient informed me that they felt perfectly fine after receiving the shot as well as the following day.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Malaise, Nausea
Clinical narrative: Call from mom, stating that pt has not felt well since vaccine received 4/12/18. C/o nausea and headache that started "a few days after the shot."
Age: 54.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: On left hand patient experienced rash on palm and between thumb and first finger. These are the only areas where the rash developed. Rash is itchy not red or infected and improving. Patient claims we gave SHINGRIX in left arm and BOOSTRIX in right. Patient is a welder and wears gloves.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Feeling cold, Pruritus generalised, Rash macular
Clinical narrative: Patient received the vaccine around 2:30 pm on Sunday, April 15. He said around bedtime about 10 pm that evening he felt very cold and couldn't get warm. The next morning, April 16, he woke up and felt light headed after rising. His wife helped in back to bed and laid for about 10-15 minutes and felt better. He then said around 9 pm he started with some redness and blotches and by the following morning he was covered with redness/blotches/itchy on all over both legs, both arms, and on side of abdomen. He went to see his primary care MD, on Tuesday am. He saw the nurse practitioner that day who gave him a steroid shot. The nurse practitioner recommended BENADRYL, PEPCID, and a MEDROL dose pack. His wife came into the pharmacy on Thursday, April 19 to report what had happened and I got further details from him. He said he was doing better today and still needed to complete the MEDROL dose pack and it would be the last day of the BENADRYL and PEPCID.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea, Injection site rash
Clinical narrative: Diarrhea and developed rash on shoulder at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pain, Vertigo
Clinical narrative: Vertigo, body aches, injection site redness, tender, and firm.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Cold sweat, Unresponsive to stimuli
Clinical narrative: Gave vaccines at 1:20 had him sit in waiting room where he slumped in chair and was not responding at 1:26. Assist of 3 to have him lie on floor with feet up and head cushioned. Got fan and wet cloth for forehead. Hands clammy. After 2 minutes, he was spontaneously opening and closing eyes but not talking. After another 3-4 minutes was able to talk some. Gave him water and had him sit up at 1:40. Dad wanted to take him to Dr. so left agency at 1:45 to go to Dr. Was awake, talking and walking without problems. Blood pressures 120's/90's 3 different times took it.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Erythema, Rash macular, Swelling, Urticaria
Clinical narrative: Mother said that evening around 7:30 the child's nose became red and swollen and he had red splotches all over his body. Later that night the splotches turned to hives. By morning he had blister like areas with the hives. Mom called and reported to the nurse at 9:00 AM 4/17/18, I spoke to her again at 4:00 and the child still had the hives with the blisters. Called mom just now and she says he is better still has the hives and blisters. Mom works in a doctor's office, she had one of the nurse practitioners look at him as a friend but was not as a patient. The nurse practitioner recommend that she call us. This child's brother had a similar reaction but only splotches . The mom gave them both liquid BENADRYL.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient came in stating her arm was sore. APAP had helped a little but was still sore. Pt showed arm and it was swollen and warm to the touch. Pt had not tried BENADRYL or any other medications besides APAP.
Sex: U
Vaccine: HEP, HPV9, MMRV, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions or concomitant medication were not informed. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, sterile diluent (MERCK), VARIVAX, GARDASIL 9, RECOMBIVAX HB and ROTATEQ all for prophylaxis (dosage information, lot numbers, expiration dates and route of administration were not informed). No adverse effects reported. Temperature and Time frame: 15°F to 46°F for 5 hours and 30 minutes. Previous temperature excursion: 15°F to 46°F for 2 hours and 59 minutes, 6°F to 14°F for 18 hours and 56 minutes. Call was because of a "data logger". For GARDASIL 9, RECOMBIVAX HB and ROTATEQ: Temperature: 32°F up to 35°F multiple excursions. Time frame: 19 days and 12 hours. No previous temperature excursion. Call was call because of a "data logger."
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 16-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 21-MAR-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles. In 2016, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Rash macular
Clinical narrative: Around 10-11 PM child had red splotches, no fever. Mom gave BENADRYL. I talked to the mom 4/18/18 9:00 AM she says the splotches are fading, and again at 4:00 says he is better still can see the splotches. I just spoke to her she says he is much better.  This child's brother had shots at the same time but not the same shots and he had a more severe effects after his shots. The mom works at a doctors office and one of her friends is a nurse practitioner that looked at the child but did not see him as a patient. She advised mom to report his reaction to the place that gave him the shots.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Lymph node pain
Clinical narrative: Red, swollen bumps 1 cm square x 4 around injection site, not on injection site, swollen painful axillary node.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy
Clinical narrative: Red, swollen bumps 1 cm square x 4 around injection site, not on injection site, swollen painful axillary node.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: Within an hour patient experienced migraine level headache that lasted for 3 days.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pt complained of severe pain at injection site down to elbow area. 10/10.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Muscle spasms, Tremor
Clinical narrative: Next morning PT had pain in middle upper back with spasms. Experienced chills and shaking (not seizure more like feverish). PT had to take prescription muscle relaxers and pain med to relieve symptoms. Patient slept for 4 hours during the day and after 9 PM symptoms were gone.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Face and mouth X-ray, Face injury, Fall, Fatigue, Influenza like illness
Clinical narrative: Patient reported feeling ill starting at around 11 PM, very tired. On 4/15 began severe flu like symptoms, nausea, vomiting and ended up blacking out and falling and injuring her face/arm. She has a regularly scheduled MD appointment on 4/16, still had flu like symptoms. By 4/17 she was starting to feel better. Her MD recommended that we record this as an adverse reaction.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb injury, Loss of consciousness, Malaise, Nausea, Vomiting
Clinical narrative: Patient reported feeling ill starting at around 11 PM, very tired. On 4/15 began severe flu like symptoms, nausea, vomiting and ended up blacking out and falling and injuring her face/arm. She has a regularly scheduled MD appointment on 4/16, still had flu like symptoms. By 4/17 she was starting to feel better. Her MD recommended that we record this as an adverse reaction.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Hypertension, Laboratory test normal, Migraine, Nausea
Clinical narrative: Migraine for 2 days. High blood pressure - 164/98. Nausea. Blurry vision.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Vision blurred
Clinical narrative: Migraine for 2 days. High blood pressure - 164/98. Nausea. Blurry vision.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Swelling
Clinical narrative: Severe arm pain, swelling.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Tenderness and swelling at thigh day 2 plus - pt playful and no distress.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: RED and SWOLLEN AT INJECTION SITE. MILD RASH AT INJECTION SITE.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Peripheral swelling
Clinical narrative: Arm swelling, nausea.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Eczema
Clinical narrative: Patient states he developed severe eczema after having vaccine.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: Arm pain, difficulty breathing.
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: Crying, Influenza virus test, Injection site rash, Irritability, Pyrexia
Clinical narrative: Fever over 104 degrees, runny nose, cranky, throwing up, rash at injection site, wouldn't stop crying. Went on for over a week.
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: Rhinorrhoea, Streptococcus test, Vomiting
Clinical narrative: Fever over 104 degrees, runny nose, cranky, throwing up, rash at injection site, wouldn't stop crying. Went on for over a week.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Rash, Skin irritation, Swelling
Clinical narrative: Side effects started the next day. Redness, irritation, pain, swelling, rash.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Hypoaesthesia, Pain in extremity, Weight bearing difficulty
Clinical narrative: Patient came in around 01:50pm on 04.19.18. Chief complaint was experienced pain radiate down the left arm and numbness, and it started 2 days after the shot was given. No pain for first 2 days. The pain continuous when trying to lift something.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMRV, PNC13
Symptoms: Injection site erythema, Injection site warmth, Vaccination complication
Clinical narrative: MA was giving patient her vaccination and notified patient mother that she would be given six vaccines which were PENTACEL, Flu, Hep B, Hep A, PCV13 and PROQUAD however patient mom declined flu. As MA was administering the first vaccine (PROQUAD) the site became very red and hot. After all vaccines were administered I notified RN, she came and evaluated the site, applied a cold compress and said it was a reaction. Parents were concerned so RN called Dr. to evaluate the child and Dr. indicated it was a reaction but to stay for about 20 minutes at site for observation with a cold compress applied. MA checked in with patient parents in about 15 minutes to see any progress and the child thigh looked much better with no redness. MA notified Dr. and she came to do the last evaluation at 4:00 PM and Dr. stated it looked good and instructed patient mom to give child a warm bath for soreness and to give child TYLENOL or MOTRIN if needed and if it got worse to come back in to the clinic.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Pain, Pain in extremity
Clinical narrative: Left arm is still very sore, almost 6 months later. Feels bruised, and when I lift arm while picking up kids, during exercise or while driving, it always has a dull ach/soreness. Some times are worse than others, massage or heat is not making it feel better. I have called and reported it to the facility who gave me the shot and my primary doctor as well.
Age: 60.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Epistaxis, Full blood count, Headache
Clinical narrative: On 4/09/18, at about 8:30 AM, I experienced a nose bleed, headache, and light-headedness. The headache and light-headedness continued throughout the day. On 4/12/18, at about 9:30 AM, I again experienced a nose bleed, headache, and light-headedness. The headache and light-headedness continued throughout the day. On 4/16/18, at about 7:30 AM, I experienced a headache and light-headedness which continued throughout the day. From 4/17/18-4/19/18, I experienced a headache and light-headedness which continued throughout the day. On 4/18/18, at about 2:30 PM, I experienced a minor nose bleed. It rained on 4/09/18 and 4/12/18.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Rash
Clinical narrative: The day after the injection, 4-14-18, a rash and swelling started to develop on the arm, about 1 inch BELOW the injection site. The patient's husband reported the reaction at the pharmacy on 4-17-18. He said she does not get out much. The rash and swelling spread around the arm, but did not travel up or down. On 4-19-18 the patient described to pharmacist the current rash/reaction in phone call. She stated the reaction on her arm as "hot, raised, and red". She said it is "itchy and hurts."  She also said she suspects it's "systemic."
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: The day after the injection, 4-14-18, a rash and swelling started to develop on the arm, about 1 inch BELOW the injection site. The patient's husband reported the reaction at the pharmacy on 4-17-18. He said she does not get out much. The rash and swelling spread around the arm, but did not travel up or down. On 4-19-18 the patient described to pharmacist the current rash/reaction in phone call. She stated the reaction on her arm as "hot, raised, and red". She said it is "itchy and hurts."  She also said she suspects it's "systemic."
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: The patient waited in the store after receiving the vaccine as was instructed. After shopping she became lightheaded and dizzy/weak while checking out. She needed assistance to sit down and reported nausea. Paramedics were called, she was evaluated and taken to the hospital in an ambulance as a precaution.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient inadvertently received a 0.5 mL flu vaccine rather than a 0.25 mL flu vaccine. No adverse effects were noted afterwards.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Pt. said they had bruising, redness, and the area was warm to the touch, a couple of inches down on her arm from the injection site was.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Injection site pain
Clinical narrative: Pain/swelling at injection site; extreme fatigue; chills/fever; muscle pain (back, wrist); loss of appetite; diarrhea.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Pain/swelling at injection site; extreme fatigue; chills/fever; muscle pain (back, wrist); loss of appetite; diarrhea.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling
Clinical narrative: What appears to be a localized allergic response: right thigh 5 cm diameter area with erythema and swelling. No induration, warmth, fever, pain or itching. Started on 4/6/18 and was present at time of rechecking the pt on 4/12/18. Of note, pt did have more insect bites on this leg prior to the vaccination.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Headache, Peripheral swelling, Skin warm
Clinical narrative: 4/13: dose administered. 4/14: severe headache, dizziness. 4/18: severe diffuse swelling, redness, heat across entire deltoid, bicep, and upper arm. Primary care physician visit; treated with diphenhydramine and topical hydrocortisone.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Malaise
Clinical narrative: Sick.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Pain, Pain in extremity
Clinical narrative: Arm pain, severe body ache, intermittent headache, rosy skin 5 inch circle where shot applied; all conditions begin peaking 7 hours after shot; fading after 48 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Erythema, Influenza, Influenza like illness
Clinical narrative: Very sore arm, cannot lift arm, swelling, redness. Feel like I have the flu, weakness, no appetite.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Swelling
Clinical narrative: Very sore arm, cannot lift arm, swelling, redness. Feel like I have the flu, weakness, no appetite.
Age: 75.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Rash papular
Clinical narrative: Patient is a 75 y/o M who received herpes zoster vaccine during prime-new patient consult on 4/2/18 reported rash (vesiculopapular lesions like zoster on all limbs per PCP) on 4/16/18. This was attributed to the use of herpes zoster vaccine (ZOSTAVAX Lot # visit and Expiration Date: N026815/2018Dec25) 0.65 mL which was administered subcutaneously once on 4/2/18, ADR was entered 4/16/18.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: Received new shingles shot. Arm sore for over a week and shot area is still sore to the touch. Also knees hurt for several days.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). On 5th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On 9th April 2018, the patient experienced injection site itching. The patient was treated with BENADRYL. In April 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the injection site itching and injection site erythema were unknown. The reporter considered the injection site pain, injection site itching and injection site erythema to be almost certainly related to SHINGRIX. Additional details were reported as follows: At 15:30 hours, the patient received SHINGRIX in left deltoid. The next day after receiving SHINGRIX, the patient noted some pain and redness at the injection site. The patient was resolved, but the redness persisted and spread. Four days post vaccination it was described as an area approximately 6 inches long and 2 inches wide. The patient began to experience itching around the injection site. At the time of reporting, the patient called the pharmacy where SHINGRIX was administered and reported that he had self medicated with BENADRYL. The reporting healthcare professional (HCP) stated that, the patient was told that, he might continue with BENADRYL and also take TYLENOL if required.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Axillary pain, Injection site erythema, Pruritus, Rash
Clinical narrative: 5 days after injection pt complained of redness at injection site, pain underneath armpit, rash and itchiness. Referred to MD for possible cellulitis but patient saw MD who said it has not an infection and recommended BENADRYL.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Mental impairment, Tachyphrenia, Thinking abnormal
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of difficulty thinking in a 73-year-old male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). On 9th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced difficulty thinking (serious criteria GSK medically significant), racing thoughts and thought process disorder. On an unknown date, the outcome of the difficulty thinking, racing thoughts and thought process disorder were unknown. It was unknown if the reporter considered the difficulty thinking, racing thoughts and thought process disorder to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that after receiving SHINGRIX, the patient experienced that his thoughts were racing, could not think straight, and could not get thoughts together. The HCP was not sure when the side effects occurred or if they subsided. No additional information provided.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain lower, Abdominal pain upper, Decreased appetite, Gastrointestinal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX. On 17th March 2018, the patient received the 1st dose of SHINGRIX. On 19th March 2018, 2 days after receiving SHINGRIX, the patient experienced fever. On 22nd March 2018, the patient experienced nausea, sweating, upper abdominal pain and lower abdominal pain. On an unknown date, the patient experienced pain in arm, pain, flu symptoms, gastrointestinal pain, tremor and appetite absent. The patient was treated with PRILOSEC, PEPTO-BISMOL and Probiotics. On an unknown date, the outcome of the pain in arm, flu symptoms and appetite absent were unknown and the outcome of the fever, pain and tremor were recovered/resolved and the outcome of the gastrointestinal pain, nausea, sweating, upper abdominal pain and lower abdominal pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, fever, pain, flu symptoms, gastrointestinal pain, tremor, nausea, sweating, upper abdominal pain, lower abdominal pain and appetite absent to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine on left arm. The consumer stated that she was still experiencing upper and lower gastrointestinal pain, and did not eat much because of this. She had a fever Monday to Wednesday. On an unknown date, less than a month after vaccination, the patient experienced pain in arm, pain, flu symptoms, gastrointestinal pain, tremor and appetite absent. She stated that she was going to see an internist in two days for lab tests to be done. She stated that she received no other vaccines within four weeks of SHINGRIX dose. She stated that she did not want to second dose of SHINGRIX. Consumer did not have address of her provider's office at time of call. She did not have lot number or expiration, and was not willing to provide other information. She stated ache, fever and shakes lasted 1 week then stopped. The nausea, abdominal pain upper and lower, sweats began on the Thursday, 22nd March 2018, 5 days after the vaccination. They had continued and progressively gotten worse. She stated she could not eat without it bothering her gastrointestinal. When she asked the pharmacist if there were any side effects she was told no, just a little arm pain was there. It was asked if she had allergy to eggs and then given the vaccine. The consumer stated she didn't go in asking for the vaccine, she stated the pharmacist approached her about getting it. She didn't ask lot number from pharmacist but did call back and request the name of the product she received and was told SHINGRIX. She was experiencing upper and lower gastrointestinal distress and hadn't eaten much with gastrointestinal pain. She had been taking PRILOSEC and took PEPTO-BISMOL but she threw it up. She was also taking Probiotics. She felt like her stomach is blown up and she woke up nauseous every morning.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Influenza, Nausea, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX. On 17th March 2018, the patient received the 1st dose of SHINGRIX. On 19th March 2018, 2 days after receiving SHINGRIX, the patient experienced fever. On 22nd March 2018, the patient experienced nausea, sweating, upper abdominal pain and lower abdominal pain. On an unknown date, the patient experienced pain in arm, pain, flu symptoms, gastrointestinal pain, tremor and appetite absent. The patient was treated with PRILOSEC, PEPTO-BISMOL and Probiotics. On an unknown date, the outcome of the pain in arm, flu symptoms and appetite absent were unknown and the outcome of the fever, pain and tremor were recovered/resolved and the outcome of the gastrointestinal pain, nausea, sweating, upper abdominal pain and lower abdominal pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, fever, pain, flu symptoms, gastrointestinal pain, tremor, nausea, sweating, upper abdominal pain, lower abdominal pain and appetite absent to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine on left arm. The consumer stated that she was still experiencing upper and lower gastrointestinal pain, and did not eat much because of this. She had a fever Monday to Wednesday. On an unknown date, less than a month after vaccination, the patient experienced pain in arm, pain, flu symptoms, gastrointestinal pain, tremor and appetite absent. She stated that she was going to see an internist in two days for lab tests to be done. She stated that she received no other vaccines within four weeks of SHINGRIX dose. She stated that she did not want to second dose of SHINGRIX. Consumer did not have address of her provider's office at time of call. She did not have lot number or expiration, and was not willing to provide other information. She stated ache, fever and shakes lasted 1 week then stopped. The nausea, abdominal pain upper and lower, sweats began on the Thursday, 22nd March 2018, 5 days after the vaccination. They had continued and progressively gotten worse. She stated she could not eat without it bothering her gastrointestinal. When she asked the pharmacist if there were any side effects she was told no, just a little arm pain was there. It was asked if she had allergy to eggs and then given the vaccine. The consumer stated she didn't go in asking for the vaccine, she stated the pharmacist approached her about getting it. She didn't ask lot number from pharmacist but did call back and request the name of the product she received and was told SHINGRIX. She was experiencing upper and lower gastrointestinal distress and hadn't eaten much with gastrointestinal pain. She had been taking PRILOSEC and took PEPTO-BISMOL but she threw it up. She was also taking Probiotics. She felt like her stomach is blown up and she woke up nauseous every morning.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX. On 17th March 2018, the patient received the 1st dose of SHINGRIX. On 19th March 2018, 2 days after receiving SHINGRIX, the patient experienced fever. On 22nd March 2018, the patient experienced nausea, sweating, upper abdominal pain and lower abdominal pain. On an unknown date, the patient experienced pain in arm, pain, flu symptoms, gastrointestinal pain, tremor and appetite absent. The patient was treated with PRILOSEC, PEPTO-BISMOL and Probiotics. On an unknown date, the outcome of the pain in arm, flu symptoms and appetite absent were unknown and the outcome of the fever, pain and tremor were recovered/resolved and the outcome of the gastrointestinal pain, nausea, sweating, upper abdominal pain and lower abdominal pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, fever, pain, flu symptoms, gastrointestinal pain, tremor, nausea, sweating, upper abdominal pain, lower abdominal pain and appetite absent to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine on left arm. The consumer stated that she was still experiencing upper and lower gastrointestinal pain, and did not eat much because of this. She had a fever Monday to Wednesday. On an unknown date, less than a month after vaccination, the patient experienced pain in arm, pain, flu symptoms, gastrointestinal pain, tremor and appetite absent. She stated that she was going to see an internist in two days for lab tests to be done. She stated that she received no other vaccines within four weeks of SHINGRIX dose. She stated that she did not want to second dose of SHINGRIX. Consumer did not have address of her provider's office at time of call. She did not have lot number or expiration, and was not willing to provide other information. She stated ache, fever and shakes lasted 1 week then stopped. The nausea, abdominal pain upper and lower, sweats began on the Thursday, 22nd March 2018, 5 days after the vaccination. They had continued and progressively gotten worse. She stated she could not eat without it bothering her gastrointestinal. When she asked the pharmacist if there were any side effects she was told no, just a little arm pain was there. It was asked if she had allergy to eggs and then given the vaccine. The consumer stated she didn't go in asking for the vaccine, she stated the pharmacist approached her about getting it. She didn't ask lot number from pharmacist but did call back and request the name of the product she received and was told SHINGRIX. She was experiencing upper and lower gastrointestinal distress and hadn't eaten much with gastrointestinal pain. She had been taking PRILOSEC and took PEPTO-BISMOL but she threw it up. She was also taking Probiotics. She felt like her stomach is blown up and she woke up nauseous every morning.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concomitant products included methotrexate. On 22nd March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 24th March 2018, 2 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. Shingles appeared on the patient's face, neck and back.
Sex: F
Vaccine: VARZOS
Symptoms: Gastrooesophageal reflux disease, Hyperchlorhydria, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via other and described the occurrence of injection site pain in a adult female patient 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 and hyperacidity. On an unknown date, the outcome of the injection site pain and hyperacidity were unknown. It was unknown if the reporter considered the injection site pain and hyperacidity to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The journalist experienced side effects after receiving SHINGRIX. Did not appear to be anything unexpected, but thought they should had it logged anyway. The patient experienced local soreness and an acid stomach for a day or two.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of L upper extremity.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of right upper extremity.
Age: 57.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Full blood count normal, Influenza like illness, Influenza virus test negative, Injection site erythema, Injection site swelling
Clinical narrative: Pt. felt flu like symptoms, (R) arm red and swollen at site of inj.