chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Impaired work ability, Inappropriate schedule of product administration, Induration
Clinical narrative: Redness; Induration; Swelling; Papules on neck and forehead and arm; Headache; Achy all over; Sore throat; Missed a day at work; Inappropriate Schedule of Vaccine; This case was reported by a physician via sales rep and described the occurrence of erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythema, induration, swelling, papular rash, headache, general body pain, sore throat, activities of daily living impaired and drug dose administration interval too short. On an unknown date, the outcome of the erythema, induration, swelling, papular rash, headache, general body pain, sore throat, activities of daily living impaired and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the erythema, induration, swelling, papular rash, headache, general body pain, sore throat and activities of daily living impaired to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced redness, induration, swelling, papules on neck and forehead and arm, headache, achy all over, sore throat.  The patient missed a day at work. The patient received 2nd dose of Shingrix 1 month apart earlier than the recommended interval, which led to shortening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Oropharyngeal pain, Pain, Rash papular, Swelling
Clinical narrative: Redness; Induration; Swelling; Papules on neck and forehead and arm; Headache; Achy all over; Sore throat; Missed a day at work; Inappropriate Schedule of Vaccine; This case was reported by a physician via sales rep and described the occurrence of erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythema, induration, swelling, papular rash, headache, general body pain, sore throat, activities of daily living impaired and drug dose administration interval too short. On an unknown date, the outcome of the erythema, induration, swelling, papular rash, headache, general body pain, sore throat, activities of daily living impaired and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the erythema, induration, swelling, papular rash, headache, general body pain, sore throat and activities of daily living impaired to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced redness, induration, swelling, papules on neck and forehead and arm, headache, achy all over, sore throat.  The patient missed a day at work. The patient received 2nd dose of Shingrix 1 month apart earlier than the recommended interval, which led to shortening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: pain; swelling; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were unknown.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patients husband reported that she had pain and swelling similar to the 2nd shingrix shot. This case has been linked with US2019141361, reported by the same reporter and US2019141362 same patient and same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Heart sounds abnormal, Lymph node pain
Clinical narrative: lymph node pain; lymph node swelling; heart was beating loud; heart was beating strongly; low fever; body aches; headaches; weak; tired; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date, refer case US2019AMR176800).   On 18th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced fever, general body pain, headache, weakness, tiredness, heart sounds abnormal and heart pounding. On 19th September 2019, the patient experienced lymph node pain and enlargement of lymph nodes. On an unknown date, the outcome of the fever, general body pain and headache were recovered/resolved and the outcome of the weakness, tiredness, lymph node pain and enlargement of lymph nodes were not recovered/not resolved and the outcome of the heart sounds abnormal and heart pounding were unknown.   It was unknown if the reporter considered the fever, general body pain, headache, weakness, tiredness, lymph node pain, enlargement of lymph nodes, heart sounds abnormal and heart pounding to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient had the second dose of Shingrix on Wednesday.  She experienced low fever, general body aches, headache. She was pretty much recovered from those symptoms but she was still feeling weak and tired.  The first night, less than a day after she had the shot, she also noticed that her heart was beating strongly or loud. On day before reporting, 1 days after receiving Shingrix she started having pain in the lymph node under the arm, which she also experienced with the first shot of Shingrix.  However, she was also having swelling in the area under the arms. It was under one arm which was exactly the arm where she received the injection. The reporter consented to follow up. This case had been linked to the case US2019AMR176800, reported for same patient. In the XML document outcome of events weakness, tiredness, lymph node pain and enlargement of lymph was reported as recovering, but in system it's mentioned as not recovered, so kept as reported in system.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pain, Palpitations, Pyrexia
Clinical narrative: lymph node pain; lymph node swelling; heart was beating loud; heart was beating strongly; low fever; body aches; headaches; weak; tired; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date, refer case US2019AMR176800).   On 18th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced fever, general body pain, headache, weakness, tiredness, heart sounds abnormal and heart pounding. On 19th September 2019, the patient experienced lymph node pain and enlargement of lymph nodes. On an unknown date, the outcome of the fever, general body pain and headache were recovered/resolved and the outcome of the weakness, tiredness, lymph node pain and enlargement of lymph nodes were not recovered/not resolved and the outcome of the heart sounds abnormal and heart pounding were unknown.   It was unknown if the reporter considered the fever, general body pain, headache, weakness, tiredness, lymph node pain, enlargement of lymph nodes, heart sounds abnormal and heart pounding to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient had the second dose of Shingrix on Wednesday.  She experienced low fever, general body aches, headache. She was pretty much recovered from those symptoms but she was still feeling weak and tired.  The first night, less than a day after she had the shot, she also noticed that her heart was beating strongly or loud. On day before reporting, 1 days after receiving Shingrix she started having pain in the lymph node under the arm, which she also experienced with the first shot of Shingrix.  However, she was also having swelling in the area under the arms. It was under one arm which was exactly the arm where she received the injection. The reporter consented to follow up. This case had been linked to the case US2019AMR176800, reported for same patient. In the XML document outcome of events weakness, tiredness, lymph node pain and enlargement of lymph was reported as recovering, but in system it's mentioned as not recovered, so kept as reported in system.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Inappropriate schedule of vaccine; Pain in upper left arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 27th February 2019, 218 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the incomplete course of vaccination was not recovered/not resolved.   The reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received the 2nd dose of Shingrix on left deltoid. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. She wants to know if she had to restart the vaccine series.  Referred caller to CDC guidelines, referred her to her healthcare provider.  Caller also reported that she experienced pain in her upper left arm for a week after receiving the first shingrix shot. No PQC reported. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: FLUA3
Symptoms: Abdominal pain, Diarrhoea, Myalgia, Wrong product administered
Clinical narrative: Myalgia began Saturday evening, later on  the day that I received the vaccine. The following day, it was worse, and I took Aleve 200 mg ii po bid for relief of symptoms, which I have taken occasionally in the past for minor aches with no problem. Monday evening, I developed abdominal pain. During the night, the pain kept me awake and progressed to watery diarrhea which continued through Tuesday midday. I took clear liquids and apple sauce Tuesday afternoon. Bland solid gluten free food brought a worsening of the pain Tuesday evening. The gastrointestinal symptoms feel much like a celiac flare up due to gluten exposure, much like how I felt when I was first diagnosed with  that disorder in 2001. I have only been eating at home where I keep an entirely gluten free kitchen, so have had no dietary exposure to cause these symptoms. I am hoping it will resolve soon. My belief is that adjuvant containing vaccines should not be given to persons with underlying autoimmune disease. My physician, Dr., had ordered the Fluzone because I have IgA deficiency and impaired immunity. The pharmacist substituted Fluad without asking or telling me until after she had already administered it. .
Age: 1.17
Sex: F
Vaccine: FLUA3, PNC13, VARCEL
Symptoms: Chills, Myalgia, Pain
Clinical narrative: Chills, body aches/muscle pain
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Constipation, Insomnia, Pain, Rash
Clinical narrative: At day 5-6 after the Shingrix vaccine I developed burning arthralgia in my hip and knees and rash on my leg.  These symptoms were not present before the vaccine.  I had shingles in my 20's, I am familiar with post infection pain.  This was not the ordinary dull ache or pain of and stiffness of arthritis that does away during the day.  It is burning pain that prevents sleep and is excruciating.  Tylenol did not dull the pain.  In addition, bowel activity (once regular) came to a slow down.  4-5 days no BM.  Using senna tablets for assistance.  Seems to be tied to vaccine event and not coincidental.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Allergy to vaccine, Erythema, Injected limb mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Patients dad came in with a picture of patients arm on his cell phone. right arm was all red and swollen. warm to touch per dad. told patients dad to put ice on area, give benadryl and call us back in the morning.  Patients mom called the next morning arm was still red and swollen and patient was having a hard time moving it. Patient came in that morning and Dr. did see patient.  patient is allergic to tetnus.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Palpitations, Rash
Clinical narrative: PT CALLED ON 10/8/2019 AND ADVISED THAT SHE BEGAN EXPERIENCING HEART PALPITATIONS AT BEDTIME AND THEN HAD SORENESS IN ARM AT INJECTION SITE. THEN UPON AWAKENING NEXT AM, PT HAD RASH ON CHEST THAT EXPANDED TO ARM. PT TOOK "ALLERGY" MEDICINE TO ALLEVIATE SOME SYMPTOMS. WHEN SHE CALLED PHARMACY, HEAR PALPITATIONS HAD STOPPED BUT RASH PERSISTED. PHARMACIST WHO TOOK CALL ADVISED PT TO CONTINUE ALLERGY MEDICINE AND THEN USE HYDROCORTISONE CREAM. PT CONTACTED 10/9/19 IN AM AND SHE ADVISED RASH BETTER AND NO MORE HEART PALPITATIONS. PT ADVISED TO CALL BACK AND/OR SEEK MD HELP IF ANY FURTHER SYMPTOMS.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within 5-10 minutes she developed a large swelling to the injection site and it became red, hot, and painful.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: He has a confluent area of erythema measuring 11 x 12 centimeters.  Skin is intact and warm to touch.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pain, Eye pruritus, Fatigue, Rash
Clinical narrative: Developed itchy stingy eyes, rashes down both arms which continued to spread, and excessive fatigue.
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Impaired work ability, Musculoskeletal pain, Nausea, Pain, Pyrexia
Clinical narrative: Got the vaccine in the evening.  The following morning I had a fever of 102, hurt all over, had to leave work due to extreme nausea (did not vomit).  Continued having pain across my shoulders for weeks afterwards.
Age: 47.0
Sex: F
Vaccine: FLUR4
Symptoms: Dysphagia, Pruritus, Urticaria
Clinical narrative: Severe itching and hives started to both arms and spread to waist and trunk. Hives worsened significantly over 24 hours spreading to face and she developed difficulty swallowing.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pain, edema and erythema to LT upper arm.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site induration
Clinical narrative: Patient came to me on 10-2-19 about 1645 reporting redness/Firmness to vaccination site. No pain or itching. Redness around site appx 1.5" in diameter. Call placed to employee health however it was end of day. FU on 10-3 shows resolution to site. No redness. Slight firmness still noted, no pain/itching. No treatment needed Resolved on its own.
Age: 11.0
Sex: F
Vaccine: HPV9, UNK, UNK
Symptoms: Altered state of consciousness, Bacterial test negative, Balance disorder, Dizziness, Gait disturbance
Clinical narrative: Dizzyness, lightheaded, feeling of passing out. Headache. Low blood pressure. High heart rate. Unstable. Unable to walk without help. Diagnosed with POTS
Age: 11.0
Sex: F
Vaccine: HPV9, UNK, UNK
Symptoms: Headache, Heart rate increased, Hypotension, Postural orthostatic tachycardia syndrome, Viral test negative
Clinical narrative: Dizzyness, lightheaded, feeling of passing out. Headache. Low blood pressure. High heart rate. Unstable. Unable to walk without help. Diagnosed with POTS
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder
Clinical narrative: Felt out of equilibrium day following 2nd shingrix, worsened the next 2 days to the point he had to hold onto something to be safe, resolved over the next 48 hours.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: body ache, chills
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Patient experience overall body aches the day following the vaccination. She had adverse effects all the way up until the 2nd dose of the vaccination. She did not seek medical attention or let us know of any issues until after getting her 2nd shot. She described the issue as arm soreness/stiffness in both arms to the point it affected everyday life. She had trouble lifting arms and putting on clothing.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Patient experience overall body aches the day following the vaccination. She had adverse effects all the way up until the 2nd dose of the vaccination. She did not seek medical attention or let us know of any issues until after getting her 2nd shot. She described the issue as arm soreness/stiffness in both arms to the point it affected everyday life. She had trouble lifting arms and putting on clothing.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: 10/08/19 Employee noted redness, warmth and swelling to injection site (left deltoid). After she arrived home she noted hives to her lower abdomen and left thigh which itched and burned. 10/09/2019 hives improved, injection site red, swollen and warm to touch. Employee denied difficulty breathing or swallowing on 10/08/19 and 10/09/19.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: 10/08/19 Employee noted redness, warmth and swelling to injection site (left deltoid). After she arrived home she noted hives to her lower abdomen and left thigh which itched and burned. 10/09/2019 hives improved, injection site red, swollen and warm to touch. Employee denied difficulty breathing or swallowing on 10/08/19 and 10/09/19.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Pallor
Clinical narrative: pt passed out after 3rd shot (HPV) awoke quick very pale, lying down on exam table. Dr was called immediately to check patient     ****Computer shuts down before full report is completed/typed ****
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: fever, chills, muscle aches
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Vaccination site erythema, Vaccination site pain
Clinical narrative: She had a redness and soreness at the site of vaccine.  Also,  about 2 inches below the vaccine site, she started having   about 2- inch diameter rash on 10/7/19. It is very red and itchy.  I told her to use Cortaid cream and take Benadryl.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Pain, Pyrexia, Somnolence
Clinical narrative: Aches; Low fever; Slept most of 3 days; No appetite; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, low grade fever, sleepiness and appetite absent. On an unknown date, the outcome of the pain, low grade fever, sleepiness and appetite absent were recovered/resolved.   It was unknown if the reporter considered the pain, low grade fever, sleepiness and appetite absent to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient experienced aches, low fever, slept most of 3 days and no appetite after that patient was fine. This case has been linked with cases US2018239609 and US2018AMR240000 reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Grew a swollen lymph node in groin; This case was reported by a consumer and described the occurrence of lymphadenopathy inguinal in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced lymphadenopathy inguinal. On an unknown date, the outcome of the lymphadenopathy inguinal was unknown.   It was unknown if the reporter considered the lymphadenopathy inguinal to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced a swollen lymph node in groin. The patient asked did the vaccine cause that the patient never had before. The patient asked whether if the patient was alone or whether they had other complaints. The pharmacist replied that one patient reported lymphadenitis and 1 subject and another patient reported fever greater than 39 degree C. There was a basis for a causal relationship with Shingrix. The patient's doctor thought that the event was caused from the shot. The node popped up in 2 days. The patient told if was in 4 weeks still there then a biopsy was scheduled.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Pain, Swelling, Vaccine positive rechallenge
Clinical narrative: Extra Dose administered; pain; swelling; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date 17th October 2021) for prophylaxis.   Previously administered products included Shingrix (received 2 doses at an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional information received were as follows: The pharmacist on the line who administered the vaccine thought that it was the patient's second vaccine, but the patient called back letting her know that it was their third vaccine, which led to extra dose administered. The reporter consented to follow up. This case has been linked with US2019141361, reported by the same reporter.   Follow up information received by a pharmacist on 19th September 2019: The patient's demographics were updated. On 1st August 2019, the patient received the 3rd dose of 0.5 ml of Shingrix intramuscularly. The patient went into the pharmacy with her husband. They asked for the 2nd Shingles vaccine. The pharmacist gave it to them. Thus, patient's husband called later and stated this was actually their 3rd Shingrix shot. The patient's husband reported that less than a week after vaccination, the patient had pain and swelling similar to 2nd dose of Shingrix shot. The VAERS details were updated. It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  For tolerance to 2nd dose, refer linked case US2019AMR179723.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Glossodynia, Swollen tongue, Tongue erythema
Clinical narrative: ToNguE on Left SIDE Became tender an swollen INcreAsed pAIN some RedNess.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: 10/1 had a fever then on 10/3 developed a rash. Went to the ER on 10/7 in which she was given 60mg of Prednisone on 10/8 her MD wrote for a 7 day rx of prednisone 20mg tab qd
Age: 16.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Headache, Pyrexia, Sinusitis
Clinical narrative: fever, headache, lasted for 2 days. Exam findings indicative of sinusitis.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Noticed redness, warmness left arm from injection site to elbow. No swelling.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site reaction, Muscular weakness
Clinical narrative: Patient doesn't recall when symptoms started; just over time. States her arm where shot was given and shoulder is weak now with decreased ROM. She says she has to help lift her arm up if it is any higher then her nose. She kept thinking it would get better but it hasn't. It also hasn't gotten worse since gradual onset
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt recieved  Tdap instead of Pediarix. Error was noticed at clinic immediately after and correct imm was given to pt after tdap was given in error
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Injection site pain and ecchymosis, pain, swelling , redness.  Symptomatically treated with anthistamine and ibuprofen.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Cough, Fatigue, Headache
Clinical narrative: Approximately 5 hours after injection began having chills which turned into tremors.  Within the hour had a fever of 100.  Nausea and trembling with severe chills continued into the night.  Headache began around 1 am.  Heavy sweats at 5 am and diminished chills.  Weak and fatigued next day with no fever. In bed for 2 days.  Headache, intermittent cough, and sore throat for the 3 days.  Two episodes of fast heart rate.  (I have AFIB that I neglected to list in the chronic illnesses.)  I did not see the doctor because by Monday, I was feeling okay.  Have taken flu shot for past 30+ years with no reaction.  First year of 65+ dose.  Scary.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Hyperhidrosis, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Approximately 5 hours after injection began having chills which turned into tremors.  Within the hour had a fever of 100.  Nausea and trembling with severe chills continued into the night.  Headache began around 1 am.  Heavy sweats at 5 am and diminished chills.  Weak and fatigued next day with no fever. In bed for 2 days.  Headache, intermittent cough, and sore throat for the 3 days.  Two episodes of fast heart rate.  (I have AFIB that I neglected to list in the chronic illnesses.)  I did not see the doctor because by Monday, I was feeling okay.  Have taken flu shot for past 30+ years with no reaction.  First year of 65+ dose.  Scary.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Approximately 5 hours after injection began having chills which turned into tremors.  Within the hour had a fever of 100.  Nausea and trembling with severe chills continued into the night.  Headache began around 1 am.  Heavy sweats at 5 am and diminished chills.  Weak and fatigued next day with no fever. In bed for 2 days.  Headache, intermittent cough, and sore throat for the 3 days.  Two episodes of fast heart rate.  (I have AFIB that I neglected to list in the chronic illnesses.)  I did not see the doctor because by Monday, I was feeling okay.  Have taken flu shot for past 30+ years with no reaction.  First year of 65+ dose.  Scary.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Impaired driving ability, Insomnia, Loss of personal independence in daily activities, Pain, Quality of life decreased
Clinical narrative: abnormal pain began within 30 minutes of injection and by that night I had to prop myself up to sleep due to the pain.  I went to my orthopedist the next day whose specialty is shoulders and elbows and he said to give it six weeks and if it is not better to come back.  I not only is no better, it is much worse.  It has affected by quality of life.  I am a very active senior who plays tennis/pickleball three days a week, teaches a water aerobics class two days a week, bikes, kayaks, and have many other activities.  I can no longer even attempt these activities and, in fact, even have difficulty doing household chores like cooking and driving is difficult.  I am making another appointment with the orthopedist soon and I have not had a good night's sleep since August 17th.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Flu vaccine was administered on 10/07/19 in clinic. Mother of patient presented through clinic triage on 10/9/19 with concern of child's right arm, site of where the flu vaccine was given, being red, itching, and swollen. Mother was given clinical advise on how to care for child's arm and was educated on signs to look out for that indicate need to go to emergency department vs. primary care clinic. Mother of patient verbalized understanding of plan.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient received Shingrix  at local pharmacy on 10/6/19 and on 10/7/19 developed painful rash.  Seen in the office in 10/9/19 and diagnosed with shingles. This was based on clinical presentation which was classic for shingles. Decided to report as odd with timing of this nonlive vaccine.  He denied any recent illnesses.  He is not immunosuppressed.
Age: 70.0
Sex: F
Vaccine: FLUN4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered Flumist to a 70 year old, who is above the recommended age range.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: nearly immediate swelling, erythema, pruritis at injection site. Remained localized, no oral/airway involvement. Improved with oral anti-histamines and oral steroids
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Viral rash
Clinical narrative: I developed a viral exanthum rash the following day and as that was fading (about 2 days after that) I developed 3 clear fluid-filled medium-sized blisters in a line on my left side front midsection at the base of my sternum.   The fluid turned cloudy over the next few days and eventually the blisters dried up and went away.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Myalgia, Pruritus, Skin irritation
Clinical narrative: Myalgia over entire body, but more severe in arm that was injected.  Developed itching on upper back and scalp.  Areas were visually inspected by me on 10/8/19.  No rash observed, other than one small colorless bump on back of skull.  Areas on back appeared pink and irritated, but pattern suggested that it was due to her scratching the area, rather than rash.  Patient reported taking Tylenol for the pain. Patient was advised to do a 24 hour trial of oral Benadryl & topical hydrocortisone, and to seek medical attention if no significant relief.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Patient came to pharmacy for flu shot with his father. After receiving the vaccine, patient complained of dizziness and difficulty breathing. Patient remained conscious and as a precaution paramedics were contancted. Paramedics stated child was doing fine, but as a precaution was taken to ER. Symptoms occurred within 3 minutes of vaccination.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Severe pain and stiffness in ankles, knees, hips, wrists, elbows, shoulders, and wrists, lasting 3 days.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: left arm swelled, turned red and progressively spread around arm from just below shoulder all the way down to just above elbow and underarm to side of breast
Age: 39.0
Sex: F
Vaccine: FLUA3
Symptoms: Anxiety, Chills, Feeding disorder, Frequent bowel movements, Injection site erythema
Clinical narrative: Raised red mark at sight of injection, chills, fever, anxiety, lots of bowel movements and urination, muscle aches, can?t sleep,  can?t eat
Age: 39.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site swelling, Insomnia, Myalgia, Pollakiuria, Pyrexia
Clinical narrative: Raised red mark at sight of injection, chills, fever, anxiety, lots of bowel movements and urination, muscle aches, can?t sleep,  can?t eat
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: red swollen left deltoid, painful at touch
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose increased, Hyperhidrosis
Clinical narrative: Complaints of profuse sweating and elevated glucose levels. Reported a fasting blood sugar level of 250 this morning, but denies being a diabetic.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Pallor, Syncope
Clinical narrative: Child given flu vaccine, fainted after vaccine administered. Child placed down on cool floor and feet raised on his back, his skin was pale, but he came to quickly, responsive, school nurse sent him home. I called the parents this morning, left message for call back, as they did not answer, then called school nurse, child is back in school and doing well today as reported by school nurse.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Varicella virus test positive
Clinical narrative: Patient developed shingles on left temple/scalp 6 days following administration of Shingrix #1. Subsequently developed vesicular lesions on torso. Swab of vesicular lesions by dermatologist positive for VARICELLA.  Patient had known history of childhood varicella at age 10 yrs.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Infection, Product complaint, Rash
Clinical narrative: Patient developed shingles on left temple/scalp 6 days following administration of Shingrix #1. Subsequently developed vesicular lesions on torso. Swab of vesicular lesions by dermatologist positive for VARICELLA.  Patient had known history of childhood varicella at age 10 yrs.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Crying, Disorientation, Fear, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately after administration patient fainted, she was caught and laid on her side. Patient LOC for 10 seconds, when she woke up she was disoriented, crying and scared. The doctor was immediately called to the room and the patient began to calm down. Vitals and exam were done, orange juice provided and the patient left the office after 15 minutes of monitoring.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Immediately after administration patient fainted, she was caught and laid on her side. Patient LOC for 10 seconds, when she woke up she was disoriented, crying and scared. The doctor was immediately called to the room and the patient began to calm down. Vitals and exam were done, orange juice provided and the patient left the office after 15 minutes of monitoring.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Patient was given the vaccine in the afternoon of 9/25/19, the next morning she woke up and had hives.  She was given Benadryl and the child was improving.  On 9/28/19 The child was feeling better but still had a rash on her trunk.  On 9/29/19 the rash was worsening and the child was seen by her physician who said "the vaccine could have provoked some kind of virus" and the child was given Prednisolone x3 days.  She had never had any previous reactions to the flu vaccine.  The incident was reported to Nursing Services by the school nurse.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Dizziness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: The day I had the  shot at pharmacy I was getting the 1st of 2 shots for shingles (Shingrix version).  I recently changed GYNs and she wanted me to get all sorts of shots so they're up to date.  That day I only  had the 1st shingles shot but recently before that I had various other shots including: flu, 2nd pneumonia shot, tetanus shot, B12 shots,.  The only reactions I got from any of those was pain in the arm like someone punched me.  However, the reaction I got after the shingles (shringrix) shot was much worse and something I've not had before.  I had a painful arm, I had a rash/bruise-like marks on my arm (bluish red patches), extreme dizziness so couldn't stand up or even lie down comfortably and also had a low grade fever of about 100.2 or so as well as nausea.  I reported it to pharmacy and will now also report it to my primary care physician and also notified the surgeon's office who will be performing my 2nd upcoming surgery, as they need me to have a complete physical prior to the surgery, as well as various pre op radiology tests so needed them to be aware.  I was told by pharmacy to take Tylenol which I did and this helped to bring down the fever.  The next day (Monday) I had no fever but my arm rash marks were still there and I was still quite dizzy.  The dizziness slowly started going away as the day progressed.  I understand I will need to have the 2nd shingles (shingrix) shot in a few months and am concerned I will have the same reaction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin discolouration
Clinical narrative: The day I had the  shot at pharmacy I was getting the 1st of 2 shots for shingles (Shingrix version).  I recently changed GYNs and she wanted me to get all sorts of shots so they're up to date.  That day I only  had the 1st shingles shot but recently before that I had various other shots including: flu, 2nd pneumonia shot, tetanus shot, B12 shots,.  The only reactions I got from any of those was pain in the arm like someone punched me.  However, the reaction I got after the shingles (shringrix) shot was much worse and something I've not had before.  I had a painful arm, I had a rash/bruise-like marks on my arm (bluish red patches), extreme dizziness so couldn't stand up or even lie down comfortably and also had a low grade fever of about 100.2 or so as well as nausea.  I reported it to pharmacy and will now also report it to my primary care physician and also notified the surgeon's office who will be performing my 2nd upcoming surgery, as they need me to have a complete physical prior to the surgery, as well as various pre op radiology tests so needed them to be aware.  I was told by pharmacy to take Tylenol which I did and this helped to bring down the fever.  The next day (Monday) I had no fever but my arm rash marks were still there and I was still quite dizzy.  The dizziness slowly started going away as the day progressed.  I understand I will need to have the 2nd shingles (shingrix) shot in a few months and am concerned I will have the same reaction.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain
Clinical narrative: pain in the back and wrist area
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Swelling, Tenderness
Clinical narrative: localized redness, swelling, induration and tenderness noted by pt 10/8/19. she presented to clinic for evaluation 10/9/19 at 11:00am. bandaid with cortisone cream applied. pt advised to cont this at home and to try cold packs as well.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Contusion, Swelling
Clinical narrative: Large bruise with swelling for at least 15 days following vaccination
Age: 0.5
Sex: M
Vaccine: FLUX, HEP, IPV, PPV, RV5, UNK
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous report was received from a consumer referring to 6 months old male patient. The patient's medical history included gastrooesophageal reflux disease. Concomitant therapies included ranitidine hydrochloride (ZANTAC) and vitamin d (unspecified). The patient had no drug reactions/allergies.  On 09-SEP-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (third dose, dose, unit, lot number and expiration date were not reported), orally for prophylaxis. On the same day, he also received pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), hepatitis b vaccine (recombinant) (manufacturer unknown), poliovirus vaccine inactivated (unspecified) (reported as POLIO), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (reported as DTPA), and influenza virus vaccine (unspecified) for prophylaxis (all dose, unit, route, lot number and expiration date were not reported).  On the same night, the patient had a fever of 101.8 (unit not reported). He was treated with acetaminophen (TYLENOL) 2.5ml. No lab diagnostic/study was performed. The patient didn't seek medical attention. On 10-SEP-2019, the patient recovered from the event. The causality between the event and the therapies was not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: incorrect product storage; No adverse affects reported; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications and drug reaction or allergies was provided.      On an unknown date, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009562 has been verified to be a valid lot number, expiration date reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019 (dose and route of administration were not provided) for prophylaxis. The vaccine underwent temperature excursion of 35.1 Fahrenheit degrees for 5 hours. There was no previous excursion. Data logger was involved. No adverse affects were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse effects reported; inadvertently received a dose of expired PNEUMOV AX 23; PNEUMOV AX 23 was also improperly stored prior to administration; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications and drug reaction or allergies was provided.  On 25-SEP-2019, the patient was inadvertently vaccinated with a dose of improperly stored and expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # N024385, expiration date 18-MAY-2019) 0.5 milliliter (route of administration was not provided) for prophylaxis. The vaccine underwent a temperature excursion of 9 to 25 Celsius degrees for 2 hours and 30 minutes. There was no previous temperature excursion. It was unknown if data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: patient received improperly stored vaccine; This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's concurrent condition, concomitant medication and medical history were unknown. On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), one dose of lot # S007075 with expiry date 06-SEP-2020 (frequency, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccine was exposed to 32.5 Fahrenheit temperature for 8 hours. No previous temperature excursion was reported. Data logger was involved. The outcome of the event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient received improperly stored vaccine at an unspecified date; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (lot # S007075 and expiry date 06-SEP-2020; albumin status was unknown; injection site, route of administration and exact dose were not reported) for prophylaxis. The vaccine was exposed to temperature of 32.5 degrees Fahrenheit (F) for 8 hours. There was no previous temperature excursion. Digital data logger was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Pain, Pyrexia, Somnolence, Vaccine positive rechallenge
Clinical narrative: Aches; Low fever; Slept most of 3 days; No appetite; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (on an unknown date patient received the 1st dose and experienced aches, low fever, slept most of 3 days and no appetite.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, low grade fever, sleepiness and appetite absent. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, low grade fever, sleepiness and appetite absent were recovered/resolved.   It was unknown if the reporter considered the pain, low grade fever, sleepiness and appetite absent to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient experienced aches, low fever, slept most of 3 days and no appetite after that patient was fine. This case has been linked with cases US2018239609 and US2018AMR239999 reported by the same reporter.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection site redness; injection site swelling; injection site heat; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) (batch number AMVA151A, expiry date 31st July 2020) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. Another patient expereinced redness, swelling and heat at the injection site and this patient reacted in similar fashion to the same lot number. The reporter did not agree to follow up. This case is one of 3 cases, reported by same reporter.