chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Autoimmune thyroiditis, Condition aggravated, Feeling abnormal
Clinical narrative: Pt called the following day approximately 21 hours after the immunization was given. States that he is in a "full-on Hashimoto's attack." States he felt fine on the evening the vaccine was given and the following morning, however, around 11:00 he developed whole body muscle and joint pain and weakness. States he has a "brain fog." States he doesn't want anyone to touch him due to the pain. States all he wants to do is lay down. Denies fever/chills. NO localized soreness/swelling/redness. No headache. He wanted to report this so that people with Hashimoto's could be cautioned appropriately. RN discussed that he could be experiencing side effects to the vaccine as written on the VIS. Requested pt call the next day to discuss symptoms. Pt did not do this. RN called and tried to get ahold of pt and messages left to update clinic on status.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Tenderness
Clinical narrative: Pt called the following day approximately 21 hours after the immunization was given. States that he is in a "full-on Hashimoto's attack." States he felt fine on the evening the vaccine was given and the following morning, however, around 11:00 he developed whole body muscle and joint pain and weakness. States he has a "brain fog." States he doesn't want anyone to touch him due to the pain. States all he wants to do is lay down. Denies fever/chills. NO localized soreness/swelling/redness. No headache. He wanted to report this so that people with Hashimoto's could be cautioned appropriately. RN discussed that he could be experiencing side effects to the vaccine as written on the VIS. Requested pt call the next day to discuss symptoms. Pt did not do this. RN called and tried to get ahold of pt and messages left to update clinic on status.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Patient got her shingle shot on Monday on the same arm as her other shot. She reported experiencing fever, malaise, 'blisters' and 'redness' at the injection site, and the injection site is warm to the touch. It has gradually gotten better since then but her arm is still red.
Age: 0.25
Sex: F
Vaccine: HEP
Symptoms: Erythema, Inappropriate schedule of drug administration, Lethargy, Vomiting
Clinical narrative: The injection was not supposed to have been given...she had her first dose at birth, her second dose at 2 months old, and they gave her 3rd dose today...it was too soon for the 3rd dose. She became red in the face, began throwing up, and acting lethargic.
Age: 0.17
Sex: M
Vaccine: HEP, HIBV, IPV, PNC13, RV5
Symptoms: Barium double contrast, Diet refusal, Enema administration, Intussusception, Irritability
Clinical narrative: Increased fussiness, fever, not eating. Seen in local ER. Abd U/S done. Had concerns for intussusception. Was transferred to another Hospital on 02/26/2018.
Age: 0.17
Sex: M
Vaccine: HEP, HIBV, IPV, PNC13, RV5
Symptoms: Pyrexia, Ultrasound abdomen normal
Clinical narrative: Increased fussiness, fever, not eating. Seen in local ER. Abd U/S done. Had concerns for intussusception. Was transferred to another Hospital on 02/26/2018.
Age: 10.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Altered state of consciousness, Fall, Feeling abnormal, Muscle twitching, Unresponsive to stimuli
Clinical narrative: Pt received 2 vaccines at 4:51pm. Pt aware and alert. Upon checkout patient told his mother, "I don't feel good, I think I'm going to pass out." Mother attempted to sit patient down and he fell to the ground. Upon entering the room, RN found patient on floor at 5:06pm on left side. Pt eyes and arms twitching slightly. Patient's eyes were open, but non-responsive to name. Patient came back to consciousness at 5:07pm and was able to identify self, surroundings, and reason for his appt. Pt does not recall moments up to the event. EMT services declined by parent. Patient was sat in a chair, given a juice box and monitored closely. At 5:25 patient was fully alert and speaking to his mother about their plans after leaving.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Reports approx 5 hours after injection noted to have swelling, erythema and tenderness to left anterior arm distal to shoulder. Arm was tender to move and swollen. Took ibuprofen that first night. The next day it was improving. By 48 hours noted the redness had progressed to her lower arm. Denies any other rash, SOB, wheezing, fever or pain. No prior reaction to vaccines.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: Chills and fever starting 9 hours after vaccine. Next morning fever. Very weak. Fever all day that day. Fever stopped middle of that night. I was fine next morning.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Hypoaesthesia, Injection site pain, Nausea
Clinical narrative: Pain at site progressing to numbness & tingling in left arm extending to wrist day 1 & 2- fatigue, nausea, head & neck pain day 1 & 2.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Neck pain, Paraesthesia
Clinical narrative: Pain at site progressing to numbness & tingling in left arm extending to wrist day 1 & 2- fatigue, nausea, head & neck pain day 1 & 2.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient stated that after receiving vaccine, he went home and took a nap. About 2 hours after receiving vaccine he had sharp shoulder pain. He claims that the shoulder pain continues and will not go away. He claimed he has trouble lifting his arm above shoulder height.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Electroencephalogram normal, Febrile convulsion
Clinical narrative: Febrile seizure, seen at Emergency Room.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 01-MAR-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route in 2012, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. During 2015, the patient was treated at a medical center for blistering vesicular outbreaks that were diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Dyspnoea, Injection site rash, Lethargy
Clinical narrative: Patient experienced lethargy, signficant rash on arm around injection site. In addition, patient reported potentially unrelated side effects of slight episodes of anxiety and shortness of breath when walking up and down the stairs. This occurred not immediately after the vaccine, but between 1 and 3 days after administration. Side effects dissipated after this time frame.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: OUTBREAK/RASH FROM SHOULDER TO WRIST.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Pharyngitis, Streptococcus test positive
Clinical narrative: Induration, erythema of the upper left arm, diffuse overlying the entire upper arm laterally.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Lymphadenopathy
Clinical narrative: Injection site reaction  (swollen lymph node, tender/painful arm).  Received a toradol injection for the pain from her prescriber.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Allergic reaction, Hives. Given Benadryl allergy childrens liquid12.5 mg/5mL, 7.5 Ml orraly every 6 hrs. Prednisolone solution 15 MG/5ML, 10 Ml orally daily for 3 days. Triamcinolone Acetonide Cream 0.1% twice a day.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: I received an email this morning regarding a concern from a flu vaccine last October 2017. This is the first complaint received to pharmacy. She stated that she received a flu vaccine Oct 26, 2017 as well as her husband and child. She states that her arm has been hurting over the past several months and has been seeing a physician. She states he does not know what is wrong with her and suggests she see a specialist. She is a traveling individual here from another country and has 6 months of travelers insurance that ends in June and is concerned what to do medically when she needs to be seen from a doctor in the future. She states her arm continues to hurt and that she cannot get further insurance unless she has a preexisting condition from prior injury.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase normal, C-reactive protein normal, Differential white blood cell count normal, Eosinophil percentage increased, Erythema
Clinical narrative: Patient has minimal redness at site (appropriate response) until the morning of encounter (roughly 36 hours after injection) when the patient developed swelling, redness and warmth in the ipsilateral upper arm. It was NOT associated with pain, tenderness, decreased motion, effect on distal circulation, or induration. Even though the affected arm circumference was 5 cm wider than the opposite arm, it didn't bother the patient at all. If anything it was less hard than when they first noticed it in the morning. It was the school who sent the patient here.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count normal, Injection site erythema, Peripheral swelling, Red blood cell sedimentation rate normal, Skin warm
Clinical narrative: Patient has minimal redness at site (appropriate response) until the morning of encounter (roughly 36 hours after injection) when the patient developed swelling, redness and warmth in the ipsilateral upper arm. It was NOT associated with pain, tenderness, decreased motion, effect on distal circulation, or induration. Even though the affected arm circumference was 5 cm wider than the opposite arm, it didn't bother the patient at all. If anything it was less hard than when they first noticed it in the morning. It was the school who sent the patient here.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Rash vesicular, Tenderness
Clinical narrative: Blistery lesions, over left buttocks and left posterior leg, itchy and painful to touch. Put on antiviral by family physician which lessened pain in leg on 12/27/18. Had also previously inoculated with the Zoster Vax at age 60.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia, Rash
Clinical narrative: PATIENT REPORTED SWELLING AT INJECTION SITE AND PAIN AND SWELLING FROM SHOULDER TO ELBOW THAT LASTED ABOUT A WEEK. ALSO HAD CHILLS AND FEVER THAT LASTED ABOUT A WEEK AS WELL AS A RASH FROM SHOULDER TO ELBOW THAT LASTED ABOUT A MONTH.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: Fever, hot red patch on arm.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Rheumatoid arthritis
Clinical narrative: Newly diagnosed rheumatoid arthritis.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Persistent and debilitating pain at he arm.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Nodule, Pain of skin, Skin disorder
Clinical narrative: This case was reported by a consumer and described the occurrence of shingles in a male patient who received SHINGRIX. In February 2018, the patient received SHINGRIX. In February 2018, 3 days after receiving SHINGRIX, the patient experienced shingles, scalp pain, scalp disorder, local swelling and localized erythema. On an unknown date, the outcome of the shingles, scalp pain and scalp disorder were unknown and the outcome of the local swelling and localized erythema were recovered/resolved. It was unknown if the reporter considered the shingles, scalp pain, scalp disorder, local swelling and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient took the new SHINGRIX shot on 2nd of February, as the patient's pharmacist warned to the patient. The patient had experienced large arm knot on it with a red circle around it and it went away 3 to 4 days later. Three to four days later after the patient got the shot he started noticing a soreness in the scalp on the left side of his head, after another two or three days he asked his wife to look at his head and found that his scalp was covered with bumps and it had been quite painful. On the day of reporting the patient finally went to the doctor and said he had shingles. The patient stated that he know the story line was that the shot could not cause shingles but this timing was extremely close. The doctor said to the patient there was no treatment except within the first 2 to 3 days so guess the patient would just have to live with the pain until it goes away. The patient know this was a brand new drug and said that the GlaxoSmithKline might appreciate this feedback.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of shingles in a male patient who received SHINGRIX. In February 2018, the patient received SHINGRIX. In February 2018, 3 days after receiving SHINGRIX, the patient experienced shingles, scalp pain, scalp disorder, local swelling and localized erythema. On an unknown date, the outcome of the shingles, scalp pain and scalp disorder were unknown and the outcome of the local swelling and localized erythema were recovered/resolved. It was unknown if the reporter considered the shingles, scalp pain, scalp disorder, local swelling and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient took the new SHINGRIX shot on 2nd of February, as the patient's pharmacist warned to the patient. The patient had experienced large arm knot on it with a red circle around it and it went away 3 to 4 days later. Three to four days later after the patient got the shot he started noticing a soreness in the scalp on the left side of his head, after another two or three days he asked his wife to look at his head and found that his scalp was covered with bumps and it had been quite painful. On the day of reporting the patient finally went to the doctor and said he had shingles. The patient stated that he know the story line was that the shot could not cause shingles but this timing was extremely close. The doctor said to the patient there was no treatment except within the first 2 to 3 days so guess the patient would just have to live with the pain until it goes away. The patient know this was a brand new drug and said that the GlaxoSmithKline might appreciate this feedback.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of erythema in a 55-year-old female patient who received SHINGRIX. On 22nd February 2018, the patient received the 1st dose of SHINGRIX .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced erythema. On an unknown date, the patient experienced pain. The patient was treated with MOTRIN and medication unknown, Ice Pack (NOS). On an unknown date, the outcome of the erythema and pain were unknown. It was unknown if the reporter considered the erythema and pain to be related to SHINGRIX. Additional details were provided as follows: On 25th February 2018, the healthcare professional reported that the patient had a reaction to the vaccine. The reporter did not know when the reaction started. The healthcare professional told the patient to take MOTRIN and apply ice and let him know if it did not improve. This case is linked with US2018032635, as reported by same reporter.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash macular, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 81-year-old female patient who received SHINGRIX. Concurrent medical conditions included glaucoma and rosacea. Concomitant products included biotin, Vitamin B12, Vitamin C, vitamin d, COSOPT, LUMIGAN, Flax Seed Oil and Glucosamine Chondroitin. On 6th February 2018, the patient received the 1st dose of SHINGRIX  (intramuscular). In February 2018, 1 day 6 hrs after receiving SHINGRIX, the patient experienced localized erythema and skin warm. The patient was treated with KEFLEX. On an unknown date, the outcome of the localized erythema was recovering/resolving and the outcome of the skin warm was recovered/resolved. The reporter considered the localized erythema to be related to SHINGRIX. It was unknown if the reporter considered the skin warm to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm at 14:30. On 7th February 2018, about 30 hours after the vaccination, the patient developed a few red splotches 3 inches below the injection site. The next day it had become one large, oval spot, 3 inches long one direction and 3.5 inches long the other direction. The spot was warm to the touch, but did not hurt or itch. The patient did not experienced fever. It resembled the rosacea she has on her face. The patient saw her primary care physician (PCP) and then a dermatologist about the spot, but did not treat it with anything other than a couple of days of KEFLEX to make sure it was not an infection. The warmth was resolved and the redness was fading, though the spot remained the same size. At the time of report, the spot almost blended in with the rest of the arm.
Sex: M
Vaccine: HEPAB
Symptoms: Hypersensitivity, Rash pruritic, Urticaria
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of allergic reaction in a male patient who received TWINRIX. On 20th February 2018, the patient received the 2nd dose of TWINRIX. On 20th February 2018, 30 min after receiving TWINRIX, the patient experienced allergic reaction, rash urticaria-like and itchy rash. On 20th February 2018, the outcome of the allergic reaction, rash urticaria-like and itchy rash were recovered/resolved. The reporter considered the allergic reaction, rash urticaria-like and itchy rash to be probably related to TWINRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received TWINRIX earlier on the day of reporting and then a little around 30 to 45 minutes later she started to get an outbreak on my other arm right on the inside at the joint inside elbow. It was not hives but a kind of started to resemble hives. The patient stated that he got a weird reaction, which seemed like an allergic reaction, in his left inner elbow which was itchy and hive looking. The outcome was resolved after 45 minutes to one hour. The reporter stated that he was leaving the country soon so a form would not be of any help to him. The patient stated that he was fine now. The patient was not sure what caused it. The reported stated that he did not want to be contacted by mail and preferred to be contacted by phone or email.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Heart rate irregular, Hyperhidrosis, Injected limb mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 76-year-old male patient who received SHINGRIX. Concomitant products included BENICAR, CRESTOR, Vitamin D3, Levothyroxine, Magnesium, COQ10 and fish oil. On 19th February 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular). In February 2018, less than a week after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On 19th February 2018, the patient experienced weakness, sweating, sleeplessness, fever, heartbeats irregular, injection site pain and injection site lump. On 19th February 2018 18:00, the patient experienced shivering. The patient was treated with Acetaminophen and (NOS) BENADRYL. On an unknown date, the outcome of the shivering, weakness, sweating, sleeplessness, fever, heartbeats irregular and injection site lump were recovering/resolving and the outcome of the injection site pain was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. The reporter considered the shivering, weakness, sweating, sleeplessness, fever, heartbeats irregular, injection site pain and injection site lump to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that, on 19th February 2018, he got SHINGRIX at noon on an by 6 PM he started shivering uncontrollably and spent the next day and a half on a heating pad. On the same day, the patient had a low grade fever, around 100 to 100.5 and all other adverse events, the patient stated that, he never had symptoms like this following a vaccination. The patients arm also hurts where he got the injection such that it effects his ability to move his arm, and he had a lump at the injection site. After the symptoms started he began taking acetaminophen and BENADRYL every 4 to 6 hours, but the patient did not think they helped. This case has been linked with case US2018029340, reported by the same reporter.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Insomnia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 76-year-old male patient who received SHINGRIX. Concomitant products included BENICAR, CRESTOR, Vitamin D3, Levothyroxine, Magnesium, COQ10 and fish oil. On 19th February 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular). In February 2018, less than a week after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On 19th February 2018, the patient experienced weakness, sweating, sleeplessness, fever, heartbeats irregular, injection site pain and injection site lump. On 19th February 2018 18:00, the patient experienced shivering. The patient was treated with Acetaminophen and (NOS) BENADRYL. On an unknown date, the outcome of the shivering, weakness, sweating, sleeplessness, fever, heartbeats irregular and injection site lump were recovering/resolving and the outcome of the injection site pain was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. The reporter considered the shivering, weakness, sweating, sleeplessness, fever, heartbeats irregular, injection site pain and injection site lump to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that, on 19th February 2018, he got SHINGRIX at noon on an by 6 PM he started shivering uncontrollably and spent the next day and a half on a heating pad. On the same day, the patient had a low grade fever, around 100 to 100.5 and all other adverse events, the patient stated that, he never had symptoms like this following a vaccination. The patients arm also hurts where he got the injection such that it effects his ability to move his arm, and he had a lump at the injection site. After the symptoms started he began taking acetaminophen and BENADRYL every 4 to 6 hours, but the patient did not think they helped. This case has been linked with case US2018029340, reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old female patient who received SHINGRIX. On 20th February 2018, the patient received SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On 20th February 2018, the patient experienced fever. The patient was treated with BENADRYL. On an unknown date, the outcome of the fever, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the fever, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported via live chat. On 20th February 2018, less than a day after receiving SHINGRIX, the patient was feverish at night. The site of injection was red about 2 inches and swollen.
Age: 0.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received KINRIX (batch number 75F53, expiry date 9th December 2019). In January 2018, the patient received KINRIX. In January 2018, unknown after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: The health care professional reported that the 4 months old patient received KINRIX, which led to inappropriate age at vaccine administration. No side effects was reported. No additional information was provided. Follow up information was received by a other health professional via call center representative on 22nd February 2018: The patient received the 0.5 ml dose of KINRIX intramuscularly. Less than a month after receiving KINRIX, the patient experienced low grade fever. The registered nurse who administered KINRIX did not knew that it was for certain ages and certain dose of DTAP/Polio. Warning labels were put on every boxy of KINRIX in their clinic. It was unknown if the reporter considered the low grade fever to be related to KINRIX. This was an accidental medication error associated with an adverse event. The VAERS details were updated.
Age: 37.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Chest discomfort, Chills, Cough, Dizziness, Dyspnoea
Clinical narrative: 2/28 1 day after receiving INJ. Typhoid (TYPHIM-VI) and Hepatitis A (HAVERIX) dose #1 client developed low grade fever, body aches, chills, lightheadedness, HA. 3/1/18 she felt tight chested and experienced wheezing and cough and difficulty breathing.
Age: 37.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Headache, Pain, Pyrexia, Wheezing
Clinical narrative: 2/28 1 day after receiving INJ. Typhoid (TYPHIM-VI) and Hepatitis A (HAVERIX) dose #1 client developed low grade fever, body aches, chills, lightheadedness, HA. 3/1/18 she felt tight chested and experienced wheezing and cough and difficulty breathing.
Sex: U
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of local reaction in a 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 local reaction. The patient was treated with MOTRIN and Ice pack (NOS). On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that he had a patient who had a local reaction. The reporter did not recall any details other than he told the patient to apply ice and take MOTRIN and call him if it did not improve. This case is linked with US2018032633, as reported by same reporter.
Sex: U
Vaccine: MENB
Symptoms: Blood test, Culture throat negative, Headache, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a child patient who received BEXSERO. On 14th February 2018, the patient received BEXSERO. On 20th February 2018, 6 days after receiving BEXSERO, the patient experienced fever, headache and pain in arm. The patient was treated with NOS Steroids. In February 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the fever and headache were unknown. It was unknown if the reporter considered the fever, headache and pain in arm to be related to BEXSERO. Additional information was received as follows: The age at vaccination was not reported. The patient went to the physician on 20th February 2018, and was treated by oral steroids. On 23rd February 2018, the patient visited the physician again with continuous low grade fever and headache. In February 2018, the patient undergone culture throat test which was resulted negative. In February 2018, the patient undergone blood test but result was not provided till the time or reporting. The parent of the patient stated that she was not allowing child to receive the 2nd dose of BEXSERO. No additional information was provided.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: 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 29-year-old female patient who received ENGERIX B adult (batch number B39CM, expiry date 3rd February 2020). On an unknown date, the patient received ENGERIX B adult. On an unknown date, unknown after receiving ENGERIX B adult, the patient experienced pain in arm and inappropriate age at vaccine administration. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the pain in arm to be related to ENGERIX B adult. Additional details were provided as follows: The age at vaccination was not reported. Health Care Professional reported that the patient inadvertently received an adult dose of ENGERIX-B as 1st dose in series, which led to inappropriate age at vaccine administration. No further information was reported regarding the event.
Age: 10.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Blood magnesium normal, Blood phosphorus increased, Blood thyroid stimulating hormone normal
Clinical narrative: 2 hours after vaccine administered pt experience bilateral arm and leg weakness with difficulty walking, tingling joint pain and shaking lasting about 18 hours, he has experienced weakness and paresthesia symptoms reoccurring 3 additional times over the past 5 months. Pt was seen on 10/13/17 for minor R clavicle injury, immunizations were given during this visit. Mother with hx of Guillain-Barre and is concerned with the recurrent symptoms.
Age: 10.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Gait disturbance, Haematocrit normal, Haemoglobin normal, Metabolic function test normal, Muscular weakness
Clinical narrative: 2 hours after vaccine administered pt experience bilateral arm and leg weakness with difficulty walking, tingling joint pain and shaking lasting about 18 hours, he has experienced weakness and paresthesia symptoms reoccurring 3 additional times over the past 5 months. Pt was seen on 10/13/17 for minor R clavicle injury, immunizations were given during this visit. Mother with hx of Guillain-Barre and is concerned with the recurrent symptoms.
Age: 10.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Paraesthesia, Platelet count normal, Tremor, White blood cell count normal
Clinical narrative: 2 hours after vaccine administered pt experience bilateral arm and leg weakness with difficulty walking, tingling joint pain and shaking lasting about 18 hours, he has experienced weakness and paresthesia symptoms reoccurring 3 additional times over the past 5 months. Pt was seen on 10/13/17 for minor R clavicle injury, immunizations were given during this visit. Mother with hx of Guillain-Barre and is concerned with the recurrent symptoms.
Sex: F
Vaccine: FLU4
Symptoms: Injection site joint pain, Injection site pain
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site joint pain in a adult female patient who received Influenza vaccine Quadrivalent. Concomitant products included Levothyroxine. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent, the patient experienced injection site joint pain. On an unknown date, the outcome of the injection site joint pain was recovered/resolved. The reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The patient had annual flu vaccinations for about thirty five years and had only ever experienced achiness at the injection site following administration of those flu vaccines within hours after the vaccine was given each year into her upper left arm. That achiness usually had resolved within no more than a couple of days. The patient was unable to provide further related details about the previous flu vaccines and did not know who manufactured those vaccines. This case has been linked with case US2018GSK028804, reported by the same reporter for the same patient.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient had severe swelling of the arm at the site of the injection with warmth and pruritus that lasted for several days. The parents were extremely worried that the patient would need to take oral ntibiotics and be hospitalized.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Rash, Rash erythematous, Rash pruritic
Clinical narrative: ITCHY, RED RASH TO BOTH SIDES OF NECK (LEFT AND RIGHT). DRY, IRRITATING COUGH.
Age: 1.25
Sex: F
Vaccine: DTAP, HEP, PNC13, UNK
Symptoms: Gait inability, Injection site erythema, Pain, Screaming, Vaccination site swelling
Clinical narrative: Could not walk for 3 days, screaming in pain lasting hours and even in her sleep, huge red bump at site of vaccination.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Blood test normal, Burning sensation, Erythema, Erythrodermic psoriasis
Clinical narrative: Less than 24 hrs of injection small bumps on arms, swelling heat at injection site. Injection site heat lasted through the week of 2/26. Rash spread down both arms - chest, back to stomach. Swelling of lymph nodes in arm pits felt like baseballs were under my arm pits. Rash slowly moved down legs to feet. Burning itchy extremely hot bottom of upper arms. Skin dark red. Red blotches moved to top and bottom of hands. Nothing on my face. Dr visits - 2/19 walk in care at dr office. Could not get apt and my dr was off. Nurse practitioner unsure of cause and called in another dr. Both felt was from ZOLOFT.   2/26 Dermatologist - Dr saw the rash and advised to get to the emergency room ASAP. Felt rash was erythrodermic psoriasis. ER administered IV drip of prednisone and PEPCID plus saline drip. ER dr said felt that rash was allergic reaction to ZOLOFT even though I started taking the drug January 18th.    Next dr visit February 28th with Dr. She felt that rash was due to flu shot - From preservatives. Previous flu shots had no reactions. Those shots were pre-filled vials, not taken from a bottle. Taking prednisone for 6 days now and on my last pill. Still taking ZOLOFT. Redness is subsiding but skin peeling on body and hands.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site swelling, Injection site warmth, Lymphadenopathy, Pruritus
Clinical narrative: Less than 24 hrs of injection small bumps on arms, swelling heat at injection site. Injection site heat lasted through the week of 2/26. Rash spread down both arms - chest, back to stomach. Swelling of lymph nodes in arm pits felt like baseballs were under my arm pits. Rash slowly moved down legs to feet. Burning itchy extremely hot bottom of upper arms. Skin dark red. Red blotches moved to top and bottom of hands. Nothing on my face. Dr visits - 2/19 walk in care at dr office. Could not get apt and my dr was off. Nurse practitioner unsure of cause and called in another dr. Both felt was from ZOLOFT.   2/26 Dermatologist - Dr saw the rash and advised to get to the emergency room ASAP. Felt rash was erythrodermic psoriasis. ER administered IV drip of prednisone and PEPCID plus saline drip. ER dr said felt that rash was allergic reaction to ZOLOFT even though I started taking the drug January 18th.    Next dr visit February 28th with Dr. She felt that rash was due to flu shot - From preservatives. Previous flu shots had no reactions. Those shots were pre-filled vials, not taken from a bottle. Taking prednisone for 6 days now and on my last pill. Still taking ZOLOFT. Redness is subsiding but skin peeling on body and hands.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash macular, Skin exfoliation, Skin warm
Clinical narrative: Less than 24 hrs of injection small bumps on arms, swelling heat at injection site. Injection site heat lasted through the week of 2/26. Rash spread down both arms - chest, back to stomach. Swelling of lymph nodes in arm pits felt like baseballs were under my arm pits. Rash slowly moved down legs to feet. Burning itchy extremely hot bottom of upper arms. Skin dark red. Red blotches moved to top and bottom of hands. Nothing on my face. Dr visits - 2/19 walk in care at dr office. Could not get apt and my dr was off. Nurse practitioner unsure of cause and called in another dr. Both felt was from ZOLOFT.   2/26 Dermatologist - Dr saw the rash and advised to get to the emergency room ASAP. Felt rash was erythrodermic psoriasis. ER administered IV drip of prednisone and PEPCID plus saline drip. ER dr said felt that rash was allergic reaction to ZOLOFT even though I started taking the drug January 18th.    Next dr visit February 28th with Dr. She felt that rash was due to flu shot - From preservatives. Previous flu shots had no reactions. Those shots were pre-filled vials, not taken from a bottle. Taking prednisone for 6 days now and on my last pill. Still taking ZOLOFT. Redness is subsiding but skin peeling on body and hands.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Rash pruritic
Clinical narrative: Itchy rash started several days after the injection. It is at the injection site and is about 3 by 4 inches in size. I still have the rash nine days after the injection.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe upper arm and shoulder pain after 4 weeks of getting the vaccine.
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: FLU VACCINE GIVEN WAS INTENDED FOR CHILDREN ABOVE 3 YEARS OF AGE. PATIENT HAD NO REACTION TO VACCINE. NOTIFIED FAMILY OF MISHAP. NO NEED TO REVACCINATE.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blepharospasm, Chills, Headache, Injection site swelling, Injection site vesicles
Clinical narrative: Severe headache, chills, fever >101, left eye twitching, tingling along nerve pathway, right arm swelling beyond site of injection from site down to elbow, with 2 small blisters at edge of site.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Severe headache, chills, fever >101, left eye twitching, tingling along nerve pathway, right arm swelling beyond site of injection from site down to elbow, with 2 small blisters at edge of site.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blepharospasm, Chills, Extensive swelling of vaccinated limb, Headache, Injection site induration
Clinical narrative: Severe headache, chills, fever >101, left eye twitching, tingling along nerve pathway, right arm swelling beyond site of injection from site down to elbow, with 2 small blisters at edge of site.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Paraesthesia, Pyrexia, Scab
Clinical narrative: Severe headache, chills, fever >101, left eye twitching, tingling along nerve pathway, right arm swelling beyond site of injection from site down to elbow, with 2 small blisters at edge of site.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: PATIENT WAS VACCINATED WITH DOSE OF FLU INTENDED FOR CHILDREN AGES 3 AND ABOVE. FAMILY WAS NOTIFIED OF MISHAP, NO REACTION TO VACCINE.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: PATIENT WAS GIVEN VACCINE INTENDED FOR CHILDREN ABOVE 3 YEARS OF AGE. FAMILY HAS BEEN NOTIFIED OF MISHAP. NO ILLNESS OR REACTIONS CAUSED BY VACCINE.
Age: 0.92
Sex: M
Vaccine: DTAP, FLU4, HIBV, IPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: PATIENT WAS GIVEN FLU VACCINE INTENDED FOR CHILDREN ABOVE 3 YEARS OF AGE. FAMILY WAS NOTIFIED OF MISHAP. THERE WAS NO REACTION TO VACCINE.
Age: 58.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Anxiety, Depression
Clinical narrative: Patient reports shingles vaccines made in experience depression and anxiety.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PATIENT WAS GIVEN FLU VACCINE INTENDED FOR CHILDREN ABOVE AGE 3. FAMILY WAS NOTIFIED OF MISHAP, ACCORDING TO GUIDELINES THERE IS NO NEED TO REVACCINATE.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Extreme itching, rash and hot to the touch for an entire week after injection.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient came in with redness and swelling from shoulder down past elbow. Significant swelling shown just below elbow but no pain or discomfort reported.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient presented with redness and swelling from shoulder down past elbow. Significant swelling just below elbow.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Pain
Clinical narrative: Patient developed malaise, headache, extreme fatigue and aches/pains, 24 hours post-vaccination.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Redness, inflammation, pain surrounding injection site.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: HIVES, ITCHINESS, SEVERE RASH. INFLAMED ARMS, REDNESS. STARTED FROM INJECTION SITE AND SPREAD TO ARMS, LEGS, AND TRUNK.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site rash, Injection site urticaria, Pruritus, Rash, Urticaria
Clinical narrative: HIVES, ITCHINESS, SEVERE RASH. INFLAMED ARMS, REDNESS. STARTED FROM INJECTION SITE AND SPREAD TO ARMS, LEGS, AND TRUNK.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient started to feel light-headed after shot was administered and lost consciousness for less than a minute while sitting in chair behind pharmacy privacy screen. He came to after verbal and physical stimulation to the arm. He appeared pale and began to sweat. He showed no signs of hives or difficulty breathing. We gave him water, cool damp cloths to wipe his face with, and sat with him for 20-30 minutes. After an hour, patient still looks pale and feels tired/fatigued.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: ON 03/02/2018, PATIENT RECEIVED VACCINE THAT EXPIRED ON 02/23/2018, MERCK WILL BE CONTACTED ON NEXT BUSINESS DAY AND VACCINE STABILITY ALONG WITH PROPER PROTOCOL WILL BE TAKEN.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Left arm pain , above elbow and forearm.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Soreness in upper arm beginning about 2 hours after injection. Fatigue and chills beginning about 15 hours after injection, low grade fever (37.8  measured 20 hours post-injection).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Headache, nausea, mild fever (101.2), fatigue, muscle aches, pain at injection site. Symptoms started over night.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Headache, nausea, mild fever (101.2), fatigue, muscle aches, pain at injection site. Symptoms started over night.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Headache, Induration, Pain, Skin warm
Clinical narrative: 4in diameter swelling and red, hard and hot to the touch, headache, painful. So far it's been just over 2 days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Swelling
Clinical narrative: 4in diameter swelling and red, hard and hot to the touch, headache, painful. So far it's been just over 2 days.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injected limb mobility decreased, Pain, Swelling
Clinical narrative: Redness, swelling, pain, inability to lift left arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Itching at injection site every day since 2/8/18.
Age: 69.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Headache, Hypersomnia
Clinical narrative: Started to have body aches about 9:00 PM on evening of immunizations. This progressed to GI upset, including stomach discomfort and diarrhea, and mild headache. Did not feel able to go to work the next morning so stayed home from work on 3/2 and slept all that day, with no eating. Felt better by morning of 3/3 with one last episode of diarrhea.
Age: 69.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Impaired work ability, Pain
Clinical narrative: Started to have body aches about 9:00 PM on evening of immunizations. This progressed to GI upset, including stomach discomfort and diarrhea, and mild headache. Did not feel able to go to work the next morning so stayed home from work on 3/2 and slept all that day, with no eating. Felt better by morning of 3/3 with one last episode of diarrhea.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Heart rate increased
Clinical narrative: About 10-15 minutes after receiving the injection while grocery shopping next door to the pharmacy where I received the injection I suddenly felt odd and slightly dizzy. I looked at my watch that I was wearing and my heart rate was 194 beats per minute, I confirmed this rate by taking my pulse manually too. Needless to say, that was a very high heart rate especially when not exercising at the time. After observing that my heart rate was staying in the 184-194 range for 10 minutes, I drove myself to the hospital emergency room but they were very busy and I was told to have a seat and wait despite my heart rate at 186. After about 10 minutes of waiting in the emergency room waiting room my heart rate suddenly dropped down to 114 beats per minute. After about 5 more minutes of observing my heart rate on my watch as being normal, I chose to leave the emergency waiting room since the elevated heart rate event was over. I do have the graph of it on the Cardiogram app. Since then, all has been fine.