chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chest X-ray, Chest pain, Chills, Dyspnoea, Exposure during pregnancy
Clinical narrative: On 5-11-19 states hurt a lot, sore immediately then started w/chills, hurts to move arm, this am pain on right side up to neck and hard to breathe, started sweating, pain persisting can't lift left arm, 2 naproxen 8:30 AM no help, no redness. On PE decreased aeration right base, no wheeze, no rales, points to right side of rib cage, pain worsens w/taking deep breaths, softball size left upper arm tender to touch, hurts to lift, no adenopathy, no redness, right arm mild tender no redness. Sent to ER to  r/o PE and OB U/S showed >14 weeks.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Hyperhidrosis, Hypoventilation, Injected limb mobility decreased, Injection site pain, Laboratory test
Clinical narrative: On 5-11-19 states hurt a lot, sore immediately then started w/chills, hurts to move arm, this am pain on right side up to neck and hard to breathe, started sweating, pain persisting can't lift left arm, 2 naproxen 8:30 AM no help, no redness. On PE decreased aeration right base, no wheeze, no rales, points to right side of rib cage, pain worsens w/taking deep breaths, softball size left upper arm tender to touch, hurts to lift, no adenopathy, no redness, right arm mild tender no redness. Sent to ER to  r/o PE and OB U/S showed >14 weeks.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Neck pain, Pain, Pain in extremity, Painful respiration, Peripheral swelling
Clinical narrative: On 5-11-19 states hurt a lot, sore immediately then started w/chills, hurts to move arm, this am pain on right side up to neck and hard to breathe, started sweating, pain persisting can't lift left arm, 2 naproxen 8:30 AM no help, no redness. On PE decreased aeration right base, no wheeze, no rales, points to right side of rib cage, pain worsens w/taking deep breaths, softball size left upper arm tender to touch, hurts to lift, no adenopathy, no redness, right arm mild tender no redness. Sent to ER to  r/o PE and OB U/S showed >14 weeks.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Radioisotope scan, Ultrasound antenatal screen
Clinical narrative: On 5-11-19 states hurt a lot, sore immediately then started w/chills, hurts to move arm, this am pain on right side up to neck and hard to breathe, started sweating, pain persisting can't lift left arm, 2 naproxen 8:30 AM no help, no redness. On PE decreased aeration right base, no wheeze, no rales, points to right side of rib cage, pain worsens w/taking deep breaths, softball size left upper arm tender to touch, hurts to lift, no adenopathy, no redness, right arm mild tender no redness. Sent to ER to  r/o PE and OB U/S showed >14 weeks.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Decreased eye contact, Lethargy, Rash morbilliform
Clinical narrative: Had mmr, chicken pox,pcv13 and Hib vaccines on same day. He was very lethargic later that same day. Not making eye contact. Next day he broke out in a measles like rash that lasted two weeks. I feel li3me it lasted longer but its been 8 years.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Hives and fever presented 6 days following the vaccine. Hives started on trunk and spread to arms, legs, face and feet throughout the day/night. Low grade fever was treated with cool cloth (no medication. Hives were treated by pediatrician with 2.25 ml hydroxyzine, ever six hours as needed. Medication was used as needed for four days, until rash/hives had cleared.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site exfoliation, Injection site scab, Injection site swelling
Clinical narrative: adverse event began 2 hours post vaccination swollen left arm around injection site, redness and bruising that lasted 2-3 days and then left a scab after and started peeling, patient describes it as a skin burn. She self treated with hydrocortisone cream and vitamin E. Patient states not experiencing pain.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site pain, Injection site swelling, Oxygen saturation decreased
Clinical narrative: On saturday 5/25/19 patient contacted the pharmacy that her arm was swollen where she received the shot and was very painful. She had a temp of 102. Pharmacist recommended she go to the ER. Patient upon going to hospital her oxygen levels were low. They admitted her and she stayed in the hospital for 4 days on iv antibiotics.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; the patient was administred a dose of improperly stored VARIVAX; This spontaneous report has been received from a nurse, concerning one patient of unknown age, gender and ethnicity.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 09-MAY-2019 (also reported as "today"), the patient was vaccinated with a improperly stored of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R034396 and expiration date 27-NOV-2020) (dose and anatomical location not reported) (product storage error) as prophylaxis. The vaccine varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored sterile diluent (Lot # S008564 and expiration date 05-AUG-2021). No adverse effects reported.   Additionally, temperature for vaccine was -9C to 8C (7.5C); time frame: 4 hours 55 minutes; with no previous temperature of excursion. The error was identified via a data logger.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Cerebrovascular accident
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 64-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2017, at approximately age 63, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dosage and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated at an eye institute for the treatment of stroke and blindness resulting from her use of ZOSTAVAX. At the time of the report, the outcome of cerebrovascular accident and blindness was unknown. The reporter considered that cerebrovascular accident and blindness were related to ZOSTAVAX. Upon internal review, cerebrovascular accident and blindness were considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Headache, Influenza like illness
Clinical narrative: had severe headache; flu-like symptoms; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age and gender received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had severe headache and flu-like symptoms following first dose of meningococcal group b rlp2086. There was also a notable reaction after receiving the vaccine that lasted 24-48 hours. Outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Bed rest, Blood test abnormal, Chest X-ray abnormal, Cough, Decreased appetite
Clinical narrative: I was injected with the Pneumonia and Shingrex vaccine on 4-22-19. By 4/23/19 I began to experience headache, body aches, fatigue, soreness at the injection site. By 4-27, 2019 I wasened with a deep dry cough, fever, extreme fatigue and body aches. I had begun then to stop eating. On 4-29-19 I visited the ER and was diagnosed with pneumonia and hybotremia. After the first round of antibiotics, my pneumonia had worsened. I began a second round of Levitrin, and confined myself to bed rest and trying to eat/drink. This is the sickest I have been in my 67 years! I continue to believe I had an adverse severe reaction to the vaccine, as was completely healthy (exception of ulcer) before. Thank you!
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Fatigue, Headache, Hyponatraemia, Injection site pain, Malaise
Clinical narrative: I was injected with the Pneumonia and Shingrex vaccine on 4-22-19. By 4/23/19 I began to experience headache, body aches, fatigue, soreness at the injection site. By 4-27, 2019 I wasened with a deep dry cough, fever, extreme fatigue and body aches. I had begun then to stop eating. On 4-29-19 I visited the ER and was diagnosed with pneumonia and hybotremia. After the first round of antibiotics, my pneumonia had worsened. I began a second round of Levitrin, and confined myself to bed rest and trying to eat/drink. This is the sickest I have been in my 67 years! I continue to believe I had an adverse severe reaction to the vaccine, as was completely healthy (exception of ulcer) before. Thank you!
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pain, Pneumonia, Pyrexia, Vaccination complication
Clinical narrative: I was injected with the Pneumonia and Shingrex vaccine on 4-22-19. By 4/23/19 I began to experience headache, body aches, fatigue, soreness at the injection site. By 4-27, 2019 I wasened with a deep dry cough, fever, extreme fatigue and body aches. I had begun then to stop eating. On 4-29-19 I visited the ER and was diagnosed with pneumonia and hybotremia. After the first round of antibiotics, my pneumonia had worsened. I began a second round of Levitrin, and confined myself to bed rest and trying to eat/drink. This is the sickest I have been in my 67 years! I continue to believe I had an adverse severe reaction to the vaccine, as was completely healthy (exception of ulcer) before. Thank you!
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received an accidental third dose of Shingrix.  Patient reports no symptoms or side effects.  Patient had thought she had only received one Shingrix shot but had forgotten about a previous shot on 4/2/20018.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, red in shape of rectangle. Hot to touch.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Swelling
Clinical narrative: Pain and swelling that has continued for 5 days.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Fatigue, Injection site pain
Clinical narrative: Diarrhea, fatigue, sore arm at injection site
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced redness and minor swelling beginning 2 to 3 days post injection at injection site. Presented to pharmacy on 5/28/19 with more generalized redness on his left arm
Age: 19.0
Sex: F
Vaccine: HEP, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reaction occured. MMRV only licensed for patients age 12 mos-12 years. Patient was 19 years at time of admin.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: redness and swelling at vaccine site
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Ear discomfort, Insomnia, Tinnitus, Vestibular disorder
Clinical narrative: 5 min. after injection - noticed pressure both ears. Increased to point uncomfortable. Within 30 min buzzing and roaring both ears - Rt worse (roaring at times). Told by PCP and ENT MD - permanent - times mild buzzing - other loud roar. Most of the time. Taking lipo-flavonoid for ear ringing. I am unable to sleep at night - find spicy food make worse. I'm also using TRP ear drops - does give some relief. This is an over the counter product. I am not pleased with my outcome of this vaccine. Have a vestibular problem from car accident 10 years prior. This adverse reaction has at times made this worse.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 5/23/19 patient contacted pharmacy to report injection site as being hot to touch, red, swollen and painful, RPh suggested that pt seek professional medical care. Pt later called to report that she was seen at a walk-in clinic or ER or by a DR (unclear) and was given an antibiotic to treat possible cellulitis at the site of Injection. RPh tried to follow up with the patient on 5/28/19, left message for the patient.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Incomplete course of vaccination, Pain in extremity
Clinical narrative: Sore Arm  Throwing up 3 times Fever Chills  Tired  Weak   It has been 3 days and I'm slowly recovering. I've never got this sick from any shot before. I will not take the booster as sick as I've been the last 3 days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Sore Arm  Throwing up 3 times Fever Chills  Tired  Weak   It has been 3 days and I'm slowly recovering. I've never got this sick from any shot before. I will not take the booster as sick as I've been the last 3 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Neck pain, Pain in extremity
Clinical narrative: Headache, nausea, pain in neck  pain in left arm
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2007, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (strength, dose number, lot#, expiration date and route were not specified) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles.  On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Abdominal discomfort, Cough, Dyspnoea, Erythema, Feeling hot
Clinical narrative: allergic reaction; He vomited; his face turns hot; coughing; trouble breathing; Face turned bright red; he was irritable/ Extremely irritable; upset stomach; stomach hard; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 9-month-old male patient who received HBV (Engerix B) for prophylaxis.   Concurrent medical conditions included vegetable allergy.   In April 2019, the patient received Engerix B. In April 2019, less than a day after receiving Engerix B, the patient experienced allergic reaction, vomiting, feeling of warmth facial, cough, difficulty breathing, upset stomach, gastric disorder, red face and irritability. On an unknown date, the outcome of the allergic reaction, vomiting, feeling of warmth facial, cough, difficulty breathing and red face were unknown and the outcome of the upset stomach, gastric disorder and irritability were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, vomiting, feeling of warmth facial, cough, difficulty breathing, upset stomach, gastric disorder, red face and irritability to be related to Engerix B.  Additional details were provided as follows: The reporter's son had the shot last week visit and had an allergic reaction. The patient had a corn allergy so the reporter trying to narrow down what the ingredient was and believe it was called Engerix. The patient vomited 2 times in the office after his shot and his face turns hot and bright red like a sunburn. The reporter stated that at night he woke up with coughing, trouble breathing and then vomited again. In April 2019, less than a week after receiving Engerix B the patient was extremely irritable and upset stomach, Stomach hard for the next 3 days. This same reaction he had when he was exposed to corn. He was diagnosed with a corn allergy in Jan 2019. The patient pediatrician also did not believe that the patient was having a reaction, he just thought he was upset that had to have a shot.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Gastric disorder, Hypersensitivity, Irritability, Vomiting
Clinical narrative: allergic reaction; He vomited; his face turns hot; coughing; trouble breathing; Face turned bright red; he was irritable/ Extremely irritable; upset stomach; stomach hard; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 9-month-old male patient who received HBV (Engerix B) for prophylaxis.   Concurrent medical conditions included vegetable allergy.   In April 2019, the patient received Engerix B. In April 2019, less than a day after receiving Engerix B, the patient experienced allergic reaction, vomiting, feeling of warmth facial, cough, difficulty breathing, upset stomach, gastric disorder, red face and irritability. On an unknown date, the outcome of the allergic reaction, vomiting, feeling of warmth facial, cough, difficulty breathing and red face were unknown and the outcome of the upset stomach, gastric disorder and irritability were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, vomiting, feeling of warmth facial, cough, difficulty breathing, upset stomach, gastric disorder, red face and irritability to be related to Engerix B.  Additional details were provided as follows: The reporter's son had the shot last week visit and had an allergic reaction. The patient had a corn allergy so the reporter trying to narrow down what the ingredient was and believe it was called Engerix. The patient vomited 2 times in the office after his shot and his face turns hot and bright red like a sunburn. The reporter stated that at night he woke up with coughing, trouble breathing and then vomited again. In April 2019, less than a week after receiving Engerix B the patient was extremely irritable and upset stomach, Stomach hard for the next 3 days. This same reaction he had when he was exposed to corn. He was diagnosed with a corn allergy in Jan 2019. The patient pediatrician also did not believe that the patient was having a reaction, he just thought he was upset that had to have a shot.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: arm aches hurts to use; fever; body aches; Chills; headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd April 2019, the patient received the 2nd dose of Shingrix. In April 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, general body pain, chills and headache. On an unknown date, the outcome of the pain in arm, fever, general body pain, chills and headache were unknown.   It was unknown if the reporter considered the pain in arm, fever, general body pain, chills and headache to be related to Shingrix.  Additional details were provided as follows: The patient experienced arm aches which hurts to use , fever, body aches , chills and headache. The patient has been given permission for follow up.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: Chills; Tiredness; Feverish; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th April 2019, the patient received the 1st dose of Shingrix. On 29th April 2019, less than a day after receiving Shingrix, the patient experienced chills, tiredness, fever and influenza-like symptoms. On an unknown date, the outcome of the chills, tiredness, fever and influenza-like symptoms were unknown.   It was unknown if the reporter considered the chills, tiredness, fever and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient experienced chills and tiredness as well as feverish. The patient asked how long the side effects last. It was reported that the individual responses may vary, but the majority of solicited local adverse reactions and general adverse events seen with Shingrix in the two pivotal clinical trials had a median duration of 2 to 3 days. Solicited adverse reactions were collected for 7 days after each dose. Some patients may continue to experience reactions beyond 3 days. Unsolicited adverse events were collected for 30 days after each dose.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 05-NOV-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose number, route and lot# were not specified) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 24-FEB-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (strength, dose number, route and lot# were not specified) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Fatigue, Malaise
Clinical narrative: Fatigue; Feel ill; This case was reported by a physician via sales rep and described the occurrence of fatigue in an unspecified number of child patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose and Bexsero at an unknown dose. On an unknown date, unknown after receiving Menveo and Bexsero, the patient experienced fatigue and feeling unwell. On an unknown date, the outcome of the fatigue and feeling unwell were unknown.   It was unknown if the reporter considered the fatigue and feeling unwell to be related to Menveo and Bexsero.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The physician stated that it has come to her attention that the patients seem to have more fatigue or feel ill when both Menveo and Bexsero are given at the same time. The reporter did not agree to follow up from GlaxoSmithKline
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Rash pruritic, Urticaria
Clinical narrative: 3-4 hours after vaccination, patient developed urticarial pruritic rash on palms of hands and on dorsum of feet and around ankles.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient states the injection site became red and swollen around where the vaccine was given. The swelling began the evening the vaccine was administered. It continued to get larger for two days after the date of vaccination. The area was hard to the touch and red. After two days, it began to reduce in size. Patient reports diarrhea within two days of receiving the vaccine.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Feeling hot, Haemorrhage subcutaneous, Injection site pain, Injection site swelling
Clinical narrative: Patient returned for follow-up visit on 5/24/19 complaining of right shoulder pain since her immunization on 5/3/19.  Has pain over the proximal bicep that occurs constantly that feels sore when keeping it still, then has a burning sensation when she moves it especially across to left side of body and moving arm behind her back to put on bra.  Movement and pain has improved on 5/24 since 5/3, and ranges from 6-8/10.  No history of reaction to vaccines.  Patient is right handed.  Admits to having warmth initially after the immunization, but no redness or swelling.  No past injury to right arm/shoulder.  Admits to feeling a bump initially over the bicep that has since resolved.  Is on Plavix for history of Stroke.  Has some bruising on her right arm, which is normal for her as she bruises easily.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Tenderness
Clinical narrative: Patient returned for follow-up visit on 5/24/19 complaining of right shoulder pain since her immunization on 5/3/19.  Has pain over the proximal bicep that occurs constantly that feels sore when keeping it still, then has a burning sensation when she moves it especially across to left side of body and moving arm behind her back to put on bra.  Movement and pain has improved on 5/24 since 5/3, and ranges from 6-8/10.  No history of reaction to vaccines.  Patient is right handed.  Admits to having warmth initially after the immunization, but no redness or swelling.  No past injury to right arm/shoulder.  Admits to feeling a bump initially over the bicep that has since resolved.  Is on Plavix for history of Stroke.  Has some bruising on her right arm, which is normal for her as she bruises easily.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Parent phoned Health Dept to report child has a diffuse light pink rash all over body and asked  if her child's rash could be caused by vaccines he received on 5/16/19.  She currently does not have a  pediatrician until the first of the month.  Parent reports that rash is not raised or itchy.  Child is not accompanied by a fever or any type of illness.  Instructed parent if she did not feel comfortable about the situation and went to the ER to let doctor know that vaccines were given.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Dysphonia, Hyperhidrosis, Swelling face
Clinical narrative: Voice got hoarsed, sweating, coughing and swelling to face. Was seen in ED, IV fluid given with IV steroid. Discharged home with a prescription for Medrol Dose pak and benadryl.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness lasting 5 days Fever peaking 101.4 degrees F that started day 2 and lasted 3 days with general aches throughout the body with a little unsteadiness in the feet headache started after giving the shot and lasted 4 days
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Left upper arm swelling noted the day after receiving the vaccine, pt was seen in the ER
Sex: F
Vaccine: UNK
Symptoms: Abdominal wall neoplasm malignant, Chemotherapy, Endometrial cancer, Radiotherapy, Surgery
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with M-M-R II or M-M-VAX for prophylaxis (dose, route of administration, injection site, lot # and expiration date were not reported). It was unknown which vaccine the patient received. On an unknown date in 2015, also reported as 4 years ago, the patient was diagnosed with endometrial cancer (also reported as unspecified cancer diagnosis). It was reported, that the patient was not diagnosed with microsatellite instability-high. On an unknown date, the patient underwent an unspecified surgery for endometrial cancer. On an unknown date, the patient had an unspecified chemotherapy and unspecified radiation therapy for endometrial cancer. It was reported, that the patient could no longer have either in those areas. On an unspecified date in March 2018, reported as last spring, 3 tumor popped up, one in the vaginal area and two in the abdomen, at the port site of the original surgery. On an unspecified date in May 2018, reported as "the patient had been on therapy for a year", the patient started therapy with KEYTRUDA for endometrial cancer, one tumor in the vaginal area and two in the abdomen (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported). Additionally, the patient received cannabis sativa oil. It was reported, that the therapy with KEYTRUDA was working well for the patient. It was noted reported that the patient was not eligible for the Support program. The outcome of the events was not provided. The relatedness between the events and the suspect products was not provided. Upon internal review, the events of endometrial cancer, vaginal cancer and abdominal wall neoplasm malignant were considered to be medically significant. Sender's Comments: US-009507513-1905USA012646.
Sex: F
Vaccine: UNK
Symptoms: Vaginal cancer
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with M-M-R II or M-M-VAX for prophylaxis (dose, route of administration, injection site, lot # and expiration date were not reported). It was unknown which vaccine the patient received. On an unknown date in 2015, also reported as 4 years ago, the patient was diagnosed with endometrial cancer (also reported as unspecified cancer diagnosis). It was reported, that the patient was not diagnosed with microsatellite instability-high. On an unknown date, the patient underwent an unspecified surgery for endometrial cancer. On an unknown date, the patient had an unspecified chemotherapy and unspecified radiation therapy for endometrial cancer. It was reported, that the patient could no longer have either in those areas. On an unspecified date in March 2018, reported as last spring, 3 tumor popped up, one in the vaginal area and two in the abdomen, at the port site of the original surgery. On an unspecified date in May 2018, reported as "the patient had been on therapy for a year", the patient started therapy with KEYTRUDA for endometrial cancer, one tumor in the vaginal area and two in the abdomen (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported). Additionally, the patient received cannabis sativa oil. It was reported, that the therapy with KEYTRUDA was working well for the patient. It was noted reported that the patient was not eligible for the Support program. The outcome of the events was not provided. The relatedness between the events and the suspect products was not provided. Upon internal review, the events of endometrial cancer, vaginal cancer and abdominal wall neoplasm malignant were considered to be medically significant. Sender's Comments: US-009507513-1905USA012646.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Low fever; fatigue; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, fatigue and muscle pain. On an unknown date, the outcome of the fever, fatigue and muscle pain were unknown.   It was unknown if the reporter considered the fever, fatigue and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient had fatigue, muscle aches and low fever with 1st shot of Shingrix. The patient assumed the events could be expected and no need to stop the series. On 30th April 2019, the patient received Hepatitis A and B six month final booster dose. The patient wanted to know if needed to wait any particular amount of time before getting Shingrix booster. The booster dose was planned in the current month.
Sex: M
Vaccine: MENB, UNK
Symptoms: Heart rate decreased, Presyncope, Syncope
Clinical narrative: fainted; heart rate low; vasovagal response; This case was reported by a nurse via sales rep and described the occurrence of fainting in a male patient who received HAV (Havrix 1440 adult) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included oral allergy syndrome. Concurrent medical conditions included allergy to plants.   On an unknown date, the patient received Havrix 1440 adult at an unknown dose and Bexsero at an unknown dose. In May 2019, unknown after receiving Havrix 1440 adult and Bexsero, the patient experienced fainting (serious criteria GSK medically significant), heart rate low and vasovagal reaction. On an unknown date, the outcome of the fainting, heart rate low and vasovagal reaction were unknown.   It was unknown if the reporter considered the fainting, heart rate low and vasovagal reaction to be related to Havrix 1440 adult and Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient had history of oral allergy syndrome and asked if GSK had any additional information reporter could request regarding. The patient who was freshman living in dorm, visited student health services prior to travel. Nurse administered Havrix adult and Bexsero. After vaccinations (approximately 2 weeks ago before from the day of reporting) the patient fainted, heart rate low, ambulance called and stated patient having vasovagal response. The parent of the patient stated she was not sure if related to vaccines as patient had Birch tree allergy and wondered if lot of birch trees on campus. When patient taken to Primary Care Physician, he stated patient was up to date on vaccinations so was not sure why was given Hepatitis A and Meningitidis B. The patient's parent had now reached out to her seeking additional information. Parent requested prescribing information and documentation on why patient given the two vaccines. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site discomfort
Clinical narrative: injection site discomfort; fingers and arm  numbness; This case was reported by a pharmacist and described the occurrence of injection site discomfort in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site discomfort and numbness of upper extremities. On an unknown date, the outcome of the injection site discomfort and numbness of upper extremities were unknown.   It was unknown if the reporter considered the injection site discomfort and numbness of upper extremities to be related to Shingrix.  Additional details were provided as follows: The reporter was a community pharmacist. The age at vaccination was not reported. The patient received the Shingrix in January this year and had been experiencing injection site discomfort, which was a common adverse reaction. The patient also experienced the numbness on her hands and fingers. The pharmacist wanted to know if these could also be a part of adverse reactions.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphocyte count increased, Paralysis
Clinical narrative: Paralysis for 12 hrs
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pruritus, Rash
Clinical narrative: Bruising, rash (approx. 3 inches), itching - all has lasted for at least 5 days.
Age: 0.58
Sex: M
Vaccine: FLU3
Symptoms: Death, Respiratory distress
Clinical narrative: Severe respiratory distress throughout the night prior to his death, requiring increased nebulizer treatments.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Depressed mood, Injection site erythema, Injection site induration, Injection site swelling, Insomnia
Clinical narrative: Per MOC report, child developed a red "bump" on his left thigh on 5/16/19. Child was described as "sad," "irritated," and "not sleeping" when the bump was noticed. MOC reports she gave child Tylenol, which seemed to help. She continued giving Tylenol "several times a day" for three days. Child seen by PCP today, 5/28/19, who prescribed Desonide ointment to treat apparent itching. Itching is only apparent when child's pants are off. "Bump" is approx 1.5cm in diameter, and is red and hard on palpation.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Irritability, Pruritus
Clinical narrative: Per MOC report, child developed a red "bump" on his left thigh on 5/16/19. Child was described as "sad," "irritated," and "not sleeping" when the bump was noticed. MOC reports she gave child Tylenol, which seemed to help. She continued giving Tylenol "several times a day" for three days. Child seen by PCP today, 5/28/19, who prescribed Desonide ointment to treat apparent itching. Itching is only apparent when child's pants are off. "Bump" is approx 1.5cm in diameter, and is red and hard on palpation.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Hypoaesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: PATIENT ADMINISTERED IMMUNIZATION IN LEFT ARM (INTRAMUSCULAR), NO SIGNIFICANT BLEEDING, PATIENT RETURNED TO PHARMACY ABOUT 1.5 HOURS LATER COMPLAINING OF NUMBNESS OF THROAT AND TONGUE ON LEFT SIDE. SHE ALSO COMPLAINED OF HER EAR FEELING "STRANGE". SHE WAS ABLE TO SWALLOW AND DRINK WATER WITHOUT PROBLEM OR ANY FEELING OF SWELLING OR TIGHTNESS. TONGUE WAS NOT SWOLLEN, HOWEVER, PHARMACIST RECOMMENDED PATIENT GO TO URGENT CARE
Age: 78.0
Sex: M
Vaccine: UNK
Symptoms: Blister, Neuralgia, Rash
Clinical narrative: The vaccine was Shingrix, and this was the 2nd shot on 4/25/2019.  The first was on 2/20/2019 at 3:30 pm.  Dose was .5, concentration 50 mcg.  Injection in upper left arm.  Rash appeared 3 days later behind left ear and spread over the next few days to the left side of head, neck, upper back and left shoulder.  Diagnosis by 3 doctors.  Blisters have faded, but nerve pain remains.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Discomfort, Injection site pain, Injection site reaction, Pain
Clinical narrative: PAIN AND WEAKNESS AT INJECTION SITE. HAND TINGLING . GENERAL PAIN AND DISCOMFORT
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: PAIN AND WEAKNESS AT INJECTION SITE. HAND TINGLING . GENERAL PAIN AND DISCOMFORT
Age: 9.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: High fever ten days after vaccine.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity
Clinical narrative: left arm pain with palpation and movement  lasting until present time. use ice and ibuprofen with only temporary relief.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Paraesthesia, Rash
Clinical narrative: It began with the prickly, somewhat painful spot on my left side above and at the waistline.  On May 12, 2019 a small rash appeared but no blisters. By the next day blisters had appeared, the rash had spread and became very painful.  After the rash appeared I saw Dr, he confirmed that it was  shingles and called it a "trigger response" to the vaccination.  He gave me the antiviral pills, 4 a day for one week and also prescribed Gabapentin.  The rash is fading and the pain is becoming less but still flairs up in the late afternoon and evening.  I get fatigued very easlily.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal discomfort, Chills, Feeling cold, Myalgia, Pain
Clinical narrative: Extreme muscle aches, cold and shivering, upset stomach and pain on right side. Could be related to muscle aches.
Age: 22.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, ANTH
Symptoms: Depression, Fatigue, Weight increased
Clinical narrative: Fatigue, weight gain,  depression after years of complaining I was found to have a thyroid disorder.
Age: 55.0
Sex: M
Vaccine: MMR
Symptoms: Blood test, Eye injury, Fall, Haemorrhage, Head injury
Clinical narrative: patient was in the shower at a warm temperature and patient passed out and went down. He hit his tooth, his eyes, and head, and bleeding profusely. Tried to get up but fell back down and hit knee and right shoulder and went back down. After being found by housekeeper, patient was led to his bed and slept most of the day. Decided not to go to seek urgent care. Next day, went to emergency room, running blood test and MRI. Pending doctor appointments coming up, such as dental, cosmetic plastic surgeon for eyes and head, waiting on MRI for rotator cuff, may need to run an MRI on knee.
Age: 55.0
Sex: M
Vaccine: MMR
Symptoms: Joint injury, Limb injury, Loss of consciousness, Nuclear magnetic resonance imaging, Somnolence
Clinical narrative: patient was in the shower at a warm temperature and patient passed out and went down. He hit his tooth, his eyes, and head, and bleeding profusely. Tried to get up but fell back down and hit knee and right shoulder and went back down. After being found by housekeeper, patient was led to his bed and slept most of the day. Decided not to go to seek urgent care. Next day, went to emergency room, running blood test and MRI. Pending doctor appointments coming up, such as dental, cosmetic plastic surgeon for eyes and head, waiting on MRI for rotator cuff, may need to run an MRI on knee.
Age: 55.0
Sex: M
Vaccine: MMR
Symptoms: Tooth injury
Clinical narrative: patient was in the shower at a warm temperature and patient passed out and went down. He hit his tooth, his eyes, and head, and bleeding profusely. Tried to get up but fell back down and hit knee and right shoulder and went back down. After being found by housekeeper, patient was led to his bed and slept most of the day. Decided not to go to seek urgent care. Next day, went to emergency room, running blood test and MRI. Pending doctor appointments coming up, such as dental, cosmetic plastic surgeon for eyes and head, waiting on MRI for rotator cuff, may need to run an MRI on knee.
Sex: M
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Immune system disorder, Loss of consciousness, Malaise, Nausea
Clinical narrative: My son Passed out 30 seconds after shot, seizure like shaking, high fever and vomiting, took him an hour just to sit up in the dr. Office. then he was nausea all day after shot. He was sick on and off for a year after vaccination his immune system didn't seem to be working.
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia, Seizure like phenomena, Tremor, Vomiting
Clinical narrative: My son Passed out 30 seconds after shot, seizure like shaking, high fever and vomiting, took him an hour just to sit up in the dr. Office. then he was nausea all day after shot. He was sick on and off for a year after vaccination his immune system didn't seem to be working.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Laboratory test abnormal, Memory impairment
Clinical narrative: Shortly after taking shingles shot (SHINGRIX) became very lightheaded and forgetful. Forgetfulness continues even today. Have continued episodes of inability to remember.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Patient received shingrix dose on 4/20/18 and 6/21/18 and on 4/12/19 states that her face was going numb, she saw a neurosurgeon for numbness after hearing that Shingrix could cause numbness. The numbness comes and goes and is on the R side of her face, denies vision or speech problems.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Influenza like illness, Injection site pain, Lethargy, Nausea
Clinical narrative: Shingrix shot - second dose. Severe muscle pain at site of injection. Flu-like symptoms the following day. Lethargy, queasy stomach, slept 12 hrs. night of injection then napped 1-1/2 hrs., slept 12 hrs. following night. After 1 day of symptoms, felt great the next day. First injection I had no side effects whatsoever.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 24 hrs. after 2nd injection, I had a very severe headache, body aches, skin sensativity, chills, + fever of 100 degrees. This lasted 16 hrs with fatigue for 3 days.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensitive skin
Clinical narrative: 24 hrs. after 2nd injection, I had a very severe headache, body aches, skin sensativity, chills, + fever of 100 degrees. This lasted 16 hrs with fatigue for 3 days.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Rash around injection site on Left thigh a day or two after injection. Rash on trunk, face and back starting 5/27/19.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash maculo-papular
Clinical narrative: Red maculopapular rash at injection site on (L) arm
Sex: F
Vaccine: PPV
Symptoms: Axillary mass, Cellulitis, Erythema, Fatigue, Mobility decreased
Clinical narrative: I had the pneumovax 23 PFS INJ at Pharmacy. On Tuesday May 7th, Wednesday my arm was sore as usual when I have had vacinations in the past, by that evening my arm became very sore , a felt very tired and ached all over. I took tylenol and slept ok the next morning I could hardly move my arm, it was swollen and hot and red, my arm pit had a very swollen lump . I contacted my doctor went in at 10 AM she said I had a skin infection, cellulitis, she prescribed an antibiotic, Cephalexin. I spent the next 2 days not able to do much, very painful and frightening experience. I am finishing the antibiotic today hoping it will take care of the infection. I am very alarmed to have such a severe reaction to a "safe" preventative medicine. The Pharmacist was very careful cleaned my arm very thourouly before the injection. I hope this does not happen to everyone.
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling, Skin infection, Skin warm
Clinical narrative: I had the pneumovax 23 PFS INJ at Pharmacy. On Tuesday May 7th, Wednesday my arm was sore as usual when I have had vacinations in the past, by that evening my arm became very sore , a felt very tired and ached all over. I took tylenol and slept ok the next morning I could hardly move my arm, it was swollen and hot and red, my arm pit had a very swollen lump . I contacted my doctor went in at 10 AM she said I had a skin infection, cellulitis, she prescribed an antibiotic, Cephalexin. I spent the next 2 days not able to do much, very painful and frightening experience. I am finishing the antibiotic today hoping it will take care of the infection. I am very alarmed to have such a severe reaction to a "safe" preventative medicine. The Pharmacist was very careful cleaned my arm very thourouly before the injection. I hope this does not happen to everyone.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site cellulitis, Injection site induration, Injection site pain
Clinical narrative: I had my first Shingrix 0.5ML shot on 02/19/2019. 24 hours later I experienced a fever of 102.8, chills, headache,and body aches. 4 days later I was seen in the emergency room for a severe headache and moderate to severe vertigo. I had my 2nd Shingrix 0.5ML shot on 05/11/2019.Within 12 hrs, I had a fever of 102.5 and the chills. My arm hurt at the sight of the injection. There was a 9cm diameter hot, hard, raised, painful circle. Went to the nearest urgent care 48hrs later and was told I had Cellulitis. I don't know if I was administered the shot with a dirty needle.