chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Nausea, Product storage error
Clinical narrative: A LOT OF NAUSEA; TOOK UNREFRIGERATED VIVOTIF; A spontaneous case report was received from a consumer on 02-Dec-2019.  Based on the information obtained from the consumer two individual case safety report PVX201912-000916 (PVX2019-2938, mother) and PVX201912-000917 (PVX2019-2939, daughter) were created and cross-linked in the database.  This case (PVX2019-2939) described an 18-year-old female consumer who had "a lot of nausea" (PT: Nausea), while receiving Vivotif for typhoid prophylaxis. She also "took unrefrigerated Vivotif" (PT: Product storage error).  Case report: The consumer took Vivotif doses, which were left unrefrigerated. It was reported that she had a lot of nausea.  Action taken with Vivotif with respect to reported event "a lot of nausea" was unknown, while with respect to the event "took unrefrigerated Vivotif" was not applicable.  The clinical outcome of the reported events was unknown.  Company's comment: A consumer took unrefrigerated Vivotif (Incorrect product storage) and had a lot of nausea. Considering the potential of Vivotif to cause nausea, the causality of nausea is assessed as possible with Vivotif. The causality of the event (incorrect product storage) is assessed as not related.; Sender's Comments: A consumer took unrefrigerated Vivotif (Incorrect product storage) and had a lot of nausea. Considering the potential of Vivotif to cause nausea, the causality of nausea is assessed as as possible with Vivotif. The causality of the event (incorrect product storage) is assessed as not related. US-PaxVax Berna GmbH-PVX201912-000916:
Sex: M
Vaccine: TYP
Symptoms: Nausea, Oral administration complication, Vomiting
Clinical narrative: VOMITING; NAUSEA; This spontaneous case report (PVX2019-2940) was received from a pharmacist on 02-Dec-2019. It described a male consumer who had nausea (PT: Nausea) and vomiting (PT: Vomiting), while being on oral Vivotif capsule for typhoid fever prophylaxis.  Case report: The consumer took first and second dose of Vivotif on 29-Nov-2019 and 01-Dec-2019 respectively. It was reported that the consumer had nausea after the first and the second dose of Vivotif and had vomiting after taking the second dose of Vivotif and he thought that he threw up the capsule of the second dose of Vivotif.   Consumer's concomitant medications included Claritin (loratadine) for an unknown indication.  The action taken with Vivotif with respect to event nausea was dosage maintained while, with respect to event vomiting was unknown.  The consumer had recovered from the event vomiting, while the clinical outcome of event nausea was unknown.  Company's Comment: A consumer had nausea after first and second dose of Vivotif and had vomiting after second dose of Vivotif. Vomiting was resolved. Considering the case information and potential of Vivotif to cause nausea and vomiting, the causality of both the events is assessed as possible with Vivotif.; Sender's Comments: A consumer had nausea after first and second dose of Vivotif, and also had vomiting after second dose of Vivotif. Vomiting was resolved. Considering the case information and potential of Vivotif to cause nausea and vomiting, the causlaity of both the events is assessed as possible with Vivotif.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test abnormal, Fallopian tube cancer, Fallopian tube cancer metastatic, Peripheral swelling, Pyrexia
Clinical narrative: Malignant neoplasm of fallopian tube; Shingles vaccine shot site was infected; Received shingles vaccine and arm swelled up and experienced a fever of 101.7; Received shingles vaccine and arm swelled up and experienced a fever of 101.7; Received shingles vaccine and arm swelled up and experienced a fever of 101.7; Taking niraparib 100mg by mouth daily; UTI infection; This case was reported by a consumer via patient support programs and described the occurrence of vaccination site infection in a 70-year-old female patient who received Herpes zoster (Shingles vaccine) for product used for unknown indication.   Co-suspect products included Herpes zoster (Shingles vaccine) for product used for unknown indication.   On 16th December 2019, the patient started niraparib (oral) 100 mg once daily (100 mg daily). On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, an unknown time after receiving niraparib and Shingles vaccine, the patient experienced vaccination site infection, fever, vaccination adverse reaction, swelling arm and underdose. Niraparib was interrupted. The action taken with Shingles vaccine was unknown. On an unknown date, the outcome of the vaccination site infection, fever, vaccination adverse reaction, swelling arm and underdose were unknown.   It was not reported if the reporter considered the vaccination site infection to be related to niraparib and Shingles vaccine. The reporter considered the fever, vaccination adverse reaction and swelling arm to be unrelated to niraparib. The reporter considered the fever, vaccination adverse reaction and swelling arm to be related to Shingles vaccine.  Additional information: Due to patient experiencing swollen arm and fever of 101.7 after receiving Herpes zoster (Shingles vaccine), the patient's doctor instructed the patient do not take niraparib that evening (date was not reported). The patient's doctor also believed that her vaccine shot site was infected and prescribed an antibiotic (medication name, dose and route of administration was not provided).  Follow up information was received from consumer on 9th January 202 On an unknown date, the patient received Shingles vaccine and experienced urinary tract infection. On 12th December 2019 the patient was receive niraparib at 17:39:19 to 17:39:20.   Follow up information was received from the consumer on 31st January 2020: On an unknown date the patient was diagnosed with Malignant neoplasm of fallopian tube. On 16th December 2019  at 17:39:19 the patient Start to received Zejula and had advise that no longer taking the zejula based on the fact that her cancer has started to spread and patient was discontinued on 17 January 2020 at 10:49:13.
Sex: F
Vaccine: VARZOS
Symptoms: Urinary tract infection, Vaccination complication, Vaccination site infection
Clinical narrative: Malignant neoplasm of fallopian tube; Shingles vaccine shot site was infected; Received shingles vaccine and arm swelled up and experienced a fever of 101.7; Received shingles vaccine and arm swelled up and experienced a fever of 101.7; Received shingles vaccine and arm swelled up and experienced a fever of 101.7; Taking niraparib 100mg by mouth daily; UTI infection; This case was reported by a consumer via patient support programs and described the occurrence of vaccination site infection in a 70-year-old female patient who received Herpes zoster (Shingles vaccine) for product used for unknown indication.   Co-suspect products included Herpes zoster (Shingles vaccine) for product used for unknown indication.   On 16th December 2019, the patient started niraparib (oral) 100 mg once daily (100 mg daily). On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, an unknown time after receiving niraparib and Shingles vaccine, the patient experienced vaccination site infection, fever, vaccination adverse reaction, swelling arm and underdose. Niraparib was interrupted. The action taken with Shingles vaccine was unknown. On an unknown date, the outcome of the vaccination site infection, fever, vaccination adverse reaction, swelling arm and underdose were unknown.   It was not reported if the reporter considered the vaccination site infection to be related to niraparib and Shingles vaccine. The reporter considered the fever, vaccination adverse reaction and swelling arm to be unrelated to niraparib. The reporter considered the fever, vaccination adverse reaction and swelling arm to be related to Shingles vaccine.  Additional information: Due to patient experiencing swollen arm and fever of 101.7 after receiving Herpes zoster (Shingles vaccine), the patient's doctor instructed the patient do not take niraparib that evening (date was not reported). The patient's doctor also believed that her vaccine shot site was infected and prescribed an antibiotic (medication name, dose and route of administration was not provided).  Follow up information was received from consumer on 9th January 202 On an unknown date, the patient received Shingles vaccine and experienced urinary tract infection. On 12th December 2019 the patient was receive niraparib at 17:39:19 to 17:39:20.   Follow up information was received from the consumer on 31st January 2020: On an unknown date the patient was diagnosed with Malignant neoplasm of fallopian tube. On 16th December 2019  at 17:39:19 the patient Start to received Zejula and had advise that no longer taking the zejula based on the fact that her cancer has started to spread and patient was discontinued on 17 January 2020 at 10:49:13.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site joint movement impairment, Injection site pain, Neck pain
Clinical narrative: on same day as administered vaccine patient began complaining of excruciating pain at site that prompted a return to office for evaluation.  A second visit on day of report with worsening pain that radiated to L trapezius and L side of neck and distally to end of fingers.  Gripping movement of L hand associated with pain of entire L arm, L posterior shoulder and L neck.  Patient describes circumferential stocking - glove like numbness immediately distal to injection site and extending to fingers lasting a couple of hours.  exam demonstrated limited range of motion of left shoulder due pain and intact though weak strength of left are  compared to right
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: on same day as administered vaccine patient began complaining of excruciating pain at site that prompted a return to office for evaluation.  A second visit on day of report with worsening pain that radiated to L trapezius and L side of neck and distally to end of fingers.  Gripping movement of L hand associated with pain of entire L arm, L posterior shoulder and L neck.  Patient describes circumferential stocking - glove like numbness immediately distal to injection site and extending to fingers lasting a couple of hours.  exam demonstrated limited range of motion of left shoulder due pain and intact though weak strength of left are  compared to right
Age: 18.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Abdominal pain upper, Alopecia, Benign breast lump removal, Blood test, Breast pain
Clinical narrative: Almost immediately She said her arms were very sore for a long time after with a very large red spots on each arm.  Within days after the 1st round of these vaccines she bagan headaches. She described them as headaches worse than she ever had before and she said her muscles were very weak. A Few more days passed and she began to lose hair and have stomach problems. Pain in stomach nausea and diarrhea.  Soon after she was discharged she found a lump in her right breast that was very painful growing rapidly they did surgery to remove it said it was benign.  When She was in the employer reception and when she would go to the clinic they would give her something for headache and do nothing else. She came home 08/2018 and is not well yet the uncontrollable vomiting and diarrhea began 05/2018 and continues to today 03/26/2020 .   They've tried many bouts of antibiotics and medications nothing has helped her they have said they found H pylori (that they can't get rid of with any medicine as of today) and she also has the worst case of IBS any GI has ever seen so far this is where she is at. She was also 128 lbs when she came home an 18 year old and at 20 she is now 94 lbs and cannot eat hardly anything cannot take liquid medication anymore without vomiting, and is now allergic to amoxicillin where her throat closed up and she could not breath.
Age: 18.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Colonoscopy, Computerised tomogram abdomen, Diarrhoea, Drug hypersensitivity, Dyspnoea
Clinical narrative: Almost immediately She said her arms were very sore for a long time after with a very large red spots on each arm.  Within days after the 1st round of these vaccines she bagan headaches. She described them as headaches worse than she ever had before and she said her muscles were very weak. A Few more days passed and she began to lose hair and have stomach problems. Pain in stomach nausea and diarrhea.  Soon after she was discharged she found a lump in her right breast that was very painful growing rapidly they did surgery to remove it said it was benign.  When She was in the employer reception and when she would go to the clinic they would give her something for headache and do nothing else. She came home 08/2018 and is not well yet the uncontrollable vomiting and diarrhea began 05/2018 and continues to today 03/26/2020 .   They've tried many bouts of antibiotics and medications nothing has helped her they have said they found H pylori (that they can't get rid of with any medicine as of today) and she also has the worst case of IBS any GI has ever seen so far this is where she is at. She was also 128 lbs when she came home an 18 year old and at 20 she is now 94 lbs and cannot eat hardly anything cannot take liquid medication anymore without vomiting, and is now allergic to amoxicillin where her throat closed up and she could not breath.
Age: 18.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Eating disorder, Endoscopy, Gastric disorder, Gastric emptying study, Headache
Clinical narrative: Almost immediately She said her arms were very sore for a long time after with a very large red spots on each arm.  Within days after the 1st round of these vaccines she bagan headaches. She described them as headaches worse than she ever had before and she said her muscles were very weak. A Few more days passed and she began to lose hair and have stomach problems. Pain in stomach nausea and diarrhea.  Soon after she was discharged she found a lump in her right breast that was very painful growing rapidly they did surgery to remove it said it was benign.  When She was in the employer reception and when she would go to the clinic they would give her something for headache and do nothing else. She came home 08/2018 and is not well yet the uncontrollable vomiting and diarrhea began 05/2018 and continues to today 03/26/2020 .   They've tried many bouts of antibiotics and medications nothing has helped her they have said they found H pylori (that they can't get rid of with any medicine as of today) and she also has the worst case of IBS any GI has ever seen so far this is where she is at. She was also 128 lbs when she came home an 18 year old and at 20 she is now 94 lbs and cannot eat hardly anything cannot take liquid medication anymore without vomiting, and is now allergic to amoxicillin where her throat closed up and she could not breath.
Age: 18.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Helicobacter infection, Hypophagia, Irritable bowel syndrome, Laboratory test, Muscular weakness
Clinical narrative: Almost immediately She said her arms were very sore for a long time after with a very large red spots on each arm.  Within days after the 1st round of these vaccines she bagan headaches. She described them as headaches worse than she ever had before and she said her muscles were very weak. A Few more days passed and she began to lose hair and have stomach problems. Pain in stomach nausea and diarrhea.  Soon after she was discharged she found a lump in her right breast that was very painful growing rapidly they did surgery to remove it said it was benign.  When She was in the employer reception and when she would go to the clinic they would give her something for headache and do nothing else. She came home 08/2018 and is not well yet the uncontrollable vomiting and diarrhea began 05/2018 and continues to today 03/26/2020 .   They've tried many bouts of antibiotics and medications nothing has helped her they have said they found H pylori (that they can't get rid of with any medicine as of today) and she also has the worst case of IBS any GI has ever seen so far this is where she is at. She was also 128 lbs when she came home an 18 year old and at 20 she is now 94 lbs and cannot eat hardly anything cannot take liquid medication anymore without vomiting, and is now allergic to amoxicillin where her throat closed up and she could not breath.
Age: 18.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Nausea, Pain in extremity, Rash, Rash erythematous, Throat tightness
Clinical narrative: Almost immediately She said her arms were very sore for a long time after with a very large red spots on each arm.  Within days after the 1st round of these vaccines she bagan headaches. She described them as headaches worse than she ever had before and she said her muscles were very weak. A Few more days passed and she began to lose hair and have stomach problems. Pain in stomach nausea and diarrhea.  Soon after she was discharged she found a lump in her right breast that was very painful growing rapidly they did surgery to remove it said it was benign.  When She was in the employer reception and when she would go to the clinic they would give her something for headache and do nothing else. She came home 08/2018 and is not well yet the uncontrollable vomiting and diarrhea began 05/2018 and continues to today 03/26/2020 .   They've tried many bouts of antibiotics and medications nothing has helped her they have said they found H pylori (that they can't get rid of with any medicine as of today) and she also has the worst case of IBS any GI has ever seen so far this is where she is at. She was also 128 lbs when she came home an 18 year old and at 20 she is now 94 lbs and cannot eat hardly anything cannot take liquid medication anymore without vomiting, and is now allergic to amoxicillin where her throat closed up and she could not breath.
Age: 18.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Vomiting, Weight decreased
Clinical narrative: Almost immediately She said her arms were very sore for a long time after with a very large red spots on each arm.  Within days after the 1st round of these vaccines she bagan headaches. She described them as headaches worse than she ever had before and she said her muscles were very weak. A Few more days passed and she began to lose hair and have stomach problems. Pain in stomach nausea and diarrhea.  Soon after she was discharged she found a lump in her right breast that was very painful growing rapidly they did surgery to remove it said it was benign.  When She was in the employer reception and when she would go to the clinic they would give her something for headache and do nothing else. She came home 08/2018 and is not well yet the uncontrollable vomiting and diarrhea began 05/2018 and continues to today 03/26/2020 .   They've tried many bouts of antibiotics and medications nothing has helped her they have said they found H pylori (that they can't get rid of with any medicine as of today) and she also has the worst case of IBS any GI has ever seen so far this is where she is at. She was also 128 lbs when she came home an 18 year old and at 20 she is now 94 lbs and cannot eat hardly anything cannot take liquid medication anymore without vomiting, and is now allergic to amoxicillin where her throat closed up and she could not breath.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Pollakiuria, Polydipsia, Type 1 diabetes mellitus
Clinical narrative: My son received the MMR vaccination on 1/14/2019  on 4/28/2019 he was diagnosed with Type1 Diabetes which clearly states on the MMR insert that type 1 diabetes mellitus is an adverse reaction.   he now has to be monitored hourly and given insulin injections at every meal, carb count for each meal, check ketones through finger prick.   the "handout" the pediatrician gave me did not include the adverse reactions that are on the actual insert we noticed he was   urinating a lot, and drinking a lot - we didnt think anything of it , just thought he was a growing 1.5 yr old.
Age: 18.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Alopecia areata, Benign breast lump removal, Benign breast neoplasm, Breast pain, Cough
Clinical narrative: Arm very sore, muscles weak, horrible terrible headaches,  sore throat, cough upper respiratory infection, hair loss in patches (alopecia areata)  later uncontrollable nausea, diarrhea later a lump was found in her right breast they said it was benign but it was painful and grew rapidly so they had to surgically remove it.  Temporary VAERS E report No. 190325 has more details of everything she experienced And everything she is still going through
Age: 18.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Diarrhoea, Headache, Laboratory test, Muscular weakness, Nausea
Clinical narrative: Arm very sore, muscles weak, horrible terrible headaches,  sore throat, cough upper respiratory infection, hair loss in patches (alopecia areata)  later uncontrollable nausea, diarrhea later a lump was found in her right breast they said it was benign but it was painful and grew rapidly so they had to surgically remove it.  Temporary VAERS E report No. 190325 has more details of everything she experienced And everything she is still going through
Age: 18.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Oropharyngeal pain, Pain in extremity, Upper respiratory tract infection
Clinical narrative: Arm very sore, muscles weak, horrible terrible headaches,  sore throat, cough upper respiratory infection, hair loss in patches (alopecia areata)  later uncontrollable nausea, diarrhea later a lump was found in her right breast they said it was benign but it was painful and grew rapidly so they had to surgically remove it.  Temporary VAERS E report No. 190325 has more details of everything she experienced And everything she is still going through
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: VACCINE WAS GIVEN 9/30/19 AND PATIENT COMPLAINT/REPORT DIDN'T OCCUR AT PHARMACY UNTIL 3/26/20. PATIENT STATES THERE WAS REDNESS AND ITCHING AT SITE OF INJECTION IMMEDIATELY FOLLOWING THE VACCINE AND IS STILL PRESENT. HOWEVER, SITE EXPLAINED BY PATIENT WAS IN AREA NOT TYPICAL OF FLU VACCINE; SITE WAS AT BACK OF ARM HALF-WAY BETWEEN ELBOW AND SHOULDER, MORE TYPICAL OF A SUB-Q LIVE VACCINE. LITTLE INFORMATION WAS GIVEN BY PATIENT. SHE EXPLAINS SHE'S HAD THE AFFECTED AREA SINCE THE VACCINE AND IT HASN'T GONE AWAY, EVEN WITH SELF-APPLICATION OF HYDROCORTISONE CREAM. PATIENT STATED SHE HAD SEEN A DOCTOR WHO ADVISED PATIENT TO COME BACK AFTER ONE MONTH IF THE AREA DID NOT IMPROVE, BUT RELEASED NO OTHER SPECIFIC DETAILS.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Joint range of motion decreased, Pain, Pyrexia
Clinical narrative: Vaccine was given at 1620. 5/10 pain in L shoulder began 2000. Pain progressively got worse to 7/10 with movement. Range of motion began to be limited the next morning. Pain was more significant at 7/10. Red rash began to spread from front of L shoulder around the deltoid to the bicep/tricep and is spreading distally. Fever was reported overnight during the second night around 0400am. No fever reported at 0730am when patient reported to work. Rash continues to spread but pain level has decreased to 1/10. Pt has been taking 600mg Motrin every 12hrs since the first night. Pt also has been icing the rash 2x daily.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Vaccine was given at 1620. 5/10 pain in L shoulder began 2000. Pain progressively got worse to 7/10 with movement. Range of motion began to be limited the next morning. Pain was more significant at 7/10. Red rash began to spread from front of L shoulder around the deltoid to the bicep/tricep and is spreading distally. Fever was reported overnight during the second night around 0400am. No fever reported at 0730am when patient reported to work. Rash continues to spread but pain level has decreased to 1/10. Pt has been taking 600mg Motrin every 12hrs since the first night. Pt also has been icing the rash 2x daily.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Eye swelling, Incomplete course of vaccination, Tremor
Clinical narrative: Patient called our clinic on 3/24/2020 to let us know that he had a "bad reaction" to his first Shingrix shot. He reported having a swollen eye, shakes and chills and he went to the ER.  When he was at the ER he didn't even think to mention that he had gotten the vaccination.  ER providers weren't sure what was going on with him during the visit and suggested that he follow up with his PCP.  He states he started thinking about what could have possibly caused him to feel like that.  He remembered that he had his shot and called one of his friends who is a DO and he suggested that he may have had a reaction to the Shingrix vaccine and he suggested that he start to take Valtrex, his pharmacist also agreed. Patient took Valtrex and said it's better now.  He decided to cancel his apt for the second shot. "I don't want to take any chance that I will feel like that again."
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Alopecia areata, Benign breast lump removal, Breast pain, Drug hypersensitivity, Dyspnoea
Clinical narrative: There are 2 previous VAERS Reports Temporary report No 190325, and 190327  regarding my daughters adverse events after receiving all of these vaccinations from the army. She started to get headaches and sore muscles, the headaches continued to worsen after this round of vaccinations as did the soreness at injection sites and sore muscles. She had hair loss alopecia areata, a benign large painful lump in her right breast requiring it to be surgically removed, she has since been diagnosed with h pylori and the worst case of IBS any GI Dr has ever seen for which no medication has cured her or helped her. she has only been getting worse. She can not eat much of anything she can not keep weight on her she is now 94 lbs and severely allergic to amoxicillin so much as her throat closed she could not breathe.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Headache, Helicobacter infection, Hypophagia, Injection site pain, Irritable bowel syndrome
Clinical narrative: There are 2 previous VAERS Reports Temporary report No 190325, and 190327  regarding my daughters adverse events after receiving all of these vaccinations from the army. She started to get headaches and sore muscles, the headaches continued to worsen after this round of vaccinations as did the soreness at injection sites and sore muscles. She had hair loss alopecia areata, a benign large painful lump in her right breast requiring it to be surgically removed, she has since been diagnosed with h pylori and the worst case of IBS any GI Dr has ever seen for which no medication has cured her or helped her. she has only been getting worse. She can not eat much of anything she can not keep weight on her she is now 94 lbs and severely allergic to amoxicillin so much as her throat closed she could not breathe.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Laboratory test, Myalgia, Throat tightness, Weight decreased
Clinical narrative: There are 2 previous VAERS Reports Temporary report No 190325, and 190327  regarding my daughters adverse events after receiving all of these vaccinations from the army. She started to get headaches and sore muscles, the headaches continued to worsen after this round of vaccinations as did the soreness at injection sites and sore muscles. She had hair loss alopecia areata, a benign large painful lump in her right breast requiring it to be surgically removed, she has since been diagnosed with h pylori and the worst case of IBS any GI Dr has ever seen for which no medication has cured her or helped her. she has only been getting worse. She can not eat much of anything she can not keep weight on her she is now 94 lbs and severely allergic to amoxicillin so much as her throat closed she could not breathe.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: Patient said that had his first ever seizure two days after receiving Shingrix vaccine.  He is questioning if it's related and whether or not he should receive his second dose when due.  I don't know where he was treated (i.e. doctor's office, hospital, etc.) after suffering from a seizure.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Extreme chills, nausea, fatigue
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Skin warm
Clinical narrative: Patient said that the second dose caused redness at the injection site and was warm to the touch.  This did not happen to her with the first dose.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Pain, Pyrexia
Clinical narrative: Elevated fever, chills, aches.  Lasted for 4 days and I was bedridden except to use the bathroom.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia
Clinical narrative: PATIENT'S MOTHER STATES IMMUNIZATION ARM IS NUMB UP TO ARMPIT AND SPREAD GRADUALLY. NO REDNESS, SWELLING OR RASH AT INJECTION SITE.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: INFLAMMATION, WARMTH AND REDNESS NOTICED 3/25/2020 9:05PM. ENCOURAGED TO PUT ICE PACK ON 3/26/2020 WHEN TOLD TO MSA.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pustule, Injection site swelling
Clinical narrative: Area of redness noted around injection site on Friday, 3/20/20. Raised patches appeared in center redness on 3/23/20. This worsened with expanding redness with 3 distinct circular pustules in center of redness on 3/26/20. Photos were taken and examined by Dr. on 3/26/20. Diagnosis of cellulitis made and cephalexin 25mg/kg X10 days prescribed.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash & swollen in area of vaccination, was given allergy medication at ER by mother, doesn't know name,  P return to clinic to f/u and rash was gone
Age: 27.0
Sex: M
Vaccine: FLUR4, HEPA
Symptoms: Dizziness, Malaise, Visual impairment
Clinical narrative: PATIENT RECEIVED VACCINES.  SAT IN LOBBY AFTERWARD.  STARTED FEELING DIZZY, SICK AND WAS LOSING VISION. PATIENT TALKED WITH PHARMACIST AND LAID DOWN.  BY THE TIME RESPONDERS ARRIVED (EMTS) PATIENT WAS FEELING BETTER.  EMT CHECKED PATIENT AND CLEARED HIM.  NOT SURE OF TIME COURSE SINCE I WASN'T RPH INVOLVED AND THAT RPH WORKS AT ANOTHER STORE.  I'D ESTIMATE 30 TO 40 MINUTES FROM START TO FINISH.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Body temperature increased, Febrile convulsion, Generalised tonic-clonic seizure, Influenza virus test negative
Clinical narrative: 2/21/2020 Febrile seizure the same evening Tonic-clonic-lasted 1.5 minutes EMS was called Temp was 102 3/25/2020: Had another Febrile seizure 1 minute.
Age: 65.0
Sex: M
Vaccine: FLUC4
Symptoms: Blindness transient
Clinical narrative: The patient came into Pharmacy and stated he could not see for 30 minutes in the morning. The patient is blind one sided.
Age: 33.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm pain, redness (not at injection site) and general arm swelling x 1 week.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Adverse reaction
Clinical narrative: Vis given to mom. Verify by employee. Pt had a reaction 3/25/2020.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles on his back.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Pain
Clinical narrative: Prolonged Regional Pain Syndrome / Pain to R deltoid since injection; Prolonged Regional Pain Syndrome / Pain to R deltoid since injection; This report was identified from a line listing obtained on request by the Company from the FDA (VAERS# 811984) under the Freedom of Information Act from registered nurse and refers to a 10 year-old female patient. The patient did not take prescription, over-the-counter medications, dietary supplements or herbal medicines at the time of the vaccination. She had no known allergies and no other illness at the time of the vaccination and up to 1 month prior. She had no chronic or long-standing health conditions. She had no other vaccinations within 1 months prior.  On 10-DEC-2018, at 09:25 am, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, dose 2 of 2, lot # R024264, expiry date was not reported but upon internal validation was confirmed to be 29-OCT-2019, intramuscularly in the right deltoid, for prophylaxis; administered at the private doctor's office or hospital.   On 10-DEC-2018, at 09:25 am, the patient experienced prolonged pain syndrome and pain to the right deltoid since injection. The outcome of the events was not recovered. The causality was not reported.  Follow-up information has been received from the registered nurse on 24-MAR-2020. The nurse was unable to identify the patient in the report. Date of vaccination and lot number were provided to assist the nurse in obtaining related information. The nurse stated that she had gone through her records after the call and found that the only patient that was vaccinated with the above vaccine on 10-DEC-2019 was a 17-year-old male, and he did not experience any adverse reaction. She was unable to locate any information on a 10-year-old female experiencing the above adverse reaction after being vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). She was unable to locate any information on a 10-year-old female experiencing the above adverse reaction after being vaccinated with the above product. No further information was available at the time of the call.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Soreness at injection site (left upper arm and shoulder); Shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 19th February 2020, the dose was an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and shoulder pain. On an unknown date, the outcome of the injection site pain and shoulder pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain and shoulder pain to be related to Shingrix.  Additional case details were reported as follows: The patient stated that the first dose was administered in her left upper arm and she experienced soreness at the injection site, her left shoulder was sore, and the soreness lasted for 5 days. The patient consented to follow up. This case has been linked with case US2020AMR032745, reported for same reporter.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Soreness at injection site (left upper arm and shoulder); Shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 19th February 2020, the dose was an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and shoulder pain. On an unknown date, the outcome of the injection site pain and shoulder pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain and shoulder pain to be related to Shingrix.  Additional case details were reported as follows: The patient stated that the first dose was administered in her left upper arm and she experienced soreness at the injection site, her left shoulder was sore, and the soreness lasted for 5 days. The patient consented to follow up. This case has been linked with case US2020AMR032745, reported for same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Balance disorder, Diplopia
Clinical narrative: nephropathy; imbalance issue; atraumatic acute optic nerve palsy; double vision; malaise; headache; fever; sore arm; sore at injection site; cough; sputum; This case was reported by a consumer via call center representative and described the occurrence of optic nerve injury in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2020, the patient received the 2nd dose of Shingrix. On 2nd February 2020, 1 days after receiving Shingrix, the patient experienced malaise, headache, fever, pain in arm and injection site pain. On 14th February 2020, the patient experienced optic nerve injury (serious criteria GSK medically significant) and double vision. On 15th February 2020, the patient experienced nephropathy and balance disorder. In February 2020, the patient experienced cough and sputum. On an unknown date, the outcome of the optic nerve injury, pain in arm, double vision and balance disorder were recovering/resolving and the outcome of the nephropathy was unknown and the outcome of the malaise, headache, fever, cough and sputum were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the optic nerve injury, nephropathy, malaise, headache, fever, pain in arm, double vision, balance disorder, cough, sputum and injection site pain to be related to Shingrix.  Additional details were provide as follows: This case was reported by the patient for herself. The patient received a dose of Shingrix on the left arm. A day after vaccination, the patient experienced general side effects of malaise, headache, fever and sore arm. That day was the worst and the reactions lasted a few days before resolving, but the left arm was still sore at injection site. On 14th February 2020, the patient presented with double vision and on 15th February 2020, the patient had imbalance issues. On 18th February 2020, the patient was seen by an ophthalmologist and diagnosed with atraumatic acute optic nerve palsy on 3 and 6 in the right eye only. On 19th February 2020, the patient was seen by her neurologist and stroke, MS and myasthenia were ruled out. A test revealed that the imbalance was due to a nephropathy. During that same week that she was seen by her ophthalmologist  and neurologist, she developed a cough and sputum and was prescribed prednisone and a z-pack. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Balance disorder, Cough, Diplopia, Headache, Injection site pain
Clinical narrative: nephropathy; imbalance issue; atraumatic acute optic nerve palsy; double vision; malaise; headache; fever; sore arm; sore at injection site; cough; sputum; This case was reported by a consumer via call center representative and described the occurrence of optic nerve injury in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2020, the patient received the 2nd dose of Shingrix. On 2nd February 2020, 1 days after receiving Shingrix, the patient experienced malaise, headache, fever, pain in arm and injection site pain. On 14th February 2020, the patient experienced optic nerve injury (serious criteria GSK medically significant) and double vision. On 15th February 2020, the patient experienced nephropathy and balance disorder. In February 2020, the patient experienced cough and sputum. On an unknown date, the outcome of the optic nerve injury, pain in arm, double vision and balance disorder were recovering/resolving and the outcome of the nephropathy was unknown and the outcome of the malaise, headache, fever, cough and sputum were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the optic nerve injury, nephropathy, malaise, headache, fever, pain in arm, double vision, balance disorder, cough, sputum and injection site pain to be related to Shingrix.  Additional details were provide as follows: This case was reported by the patient for herself. The patient received a dose of Shingrix on the left arm. A day after vaccination, the patient experienced general side effects of malaise, headache, fever and sore arm. That day was the worst and the reactions lasted a few days before resolving, but the left arm was still sore at injection site. On 14th February 2020, the patient presented with double vision and on 15th February 2020, the patient had imbalance issues. On 18th February 2020, the patient was seen by an ophthalmologist and diagnosed with atraumatic acute optic nerve palsy on 3 and 6 in the right eye only. On 19th February 2020, the patient was seen by her neurologist and stroke, MS and myasthenia were ruled out. A test revealed that the imbalance was due to a nephropathy. During that same week that she was seen by her ophthalmologist  and neurologist, she developed a cough and sputum and was prescribed prednisone and a z-pack. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Laboratory test abnormal, Malaise, Nephropathy, Optic nerve injury, Pain in extremity
Clinical narrative: nephropathy; imbalance issue; atraumatic acute optic nerve palsy; double vision; malaise; headache; fever; sore arm; sore at injection site; cough; sputum; This case was reported by a consumer via call center representative and described the occurrence of optic nerve injury in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2020, the patient received the 2nd dose of Shingrix. On 2nd February 2020, 1 days after receiving Shingrix, the patient experienced malaise, headache, fever, pain in arm and injection site pain. On 14th February 2020, the patient experienced optic nerve injury (serious criteria GSK medically significant) and double vision. On 15th February 2020, the patient experienced nephropathy and balance disorder. In February 2020, the patient experienced cough and sputum. On an unknown date, the outcome of the optic nerve injury, pain in arm, double vision and balance disorder were recovering/resolving and the outcome of the nephropathy was unknown and the outcome of the malaise, headache, fever, cough and sputum were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the optic nerve injury, nephropathy, malaise, headache, fever, pain in arm, double vision, balance disorder, cough, sputum and injection site pain to be related to Shingrix.  Additional details were provide as follows: This case was reported by the patient for herself. The patient received a dose of Shingrix on the left arm. A day after vaccination, the patient experienced general side effects of malaise, headache, fever and sore arm. That day was the worst and the reactions lasted a few days before resolving, but the left arm was still sore at injection site. On 14th February 2020, the patient presented with double vision and on 15th February 2020, the patient had imbalance issues. On 18th February 2020, the patient was seen by an ophthalmologist and diagnosed with atraumatic acute optic nerve palsy on 3 and 6 in the right eye only. On 19th February 2020, the patient was seen by her neurologist and stroke, MS and myasthenia were ruled out. A test revealed that the imbalance was due to a nephropathy. During that same week that she was seen by her ophthalmologist  and neurologist, she developed a cough and sputum and was prescribed prednisone and a z-pack. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Productive cough, Pyrexia
Clinical narrative: nephropathy; imbalance issue; atraumatic acute optic nerve palsy; double vision; malaise; headache; fever; sore arm; sore at injection site; cough; sputum; This case was reported by a consumer via call center representative and described the occurrence of optic nerve injury in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2020, the patient received the 2nd dose of Shingrix. On 2nd February 2020, 1 days after receiving Shingrix, the patient experienced malaise, headache, fever, pain in arm and injection site pain. On 14th February 2020, the patient experienced optic nerve injury (serious criteria GSK medically significant) and double vision. On 15th February 2020, the patient experienced nephropathy and balance disorder. In February 2020, the patient experienced cough and sputum. On an unknown date, the outcome of the optic nerve injury, pain in arm, double vision and balance disorder were recovering/resolving and the outcome of the nephropathy was unknown and the outcome of the malaise, headache, fever, cough and sputum were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the optic nerve injury, nephropathy, malaise, headache, fever, pain in arm, double vision, balance disorder, cough, sputum and injection site pain to be related to Shingrix.  Additional details were provide as follows: This case was reported by the patient for herself. The patient received a dose of Shingrix on the left arm. A day after vaccination, the patient experienced general side effects of malaise, headache, fever and sore arm. That day was the worst and the reactions lasted a few days before resolving, but the left arm was still sore at injection site. On 14th February 2020, the patient presented with double vision and on 15th February 2020, the patient had imbalance issues. On 18th February 2020, the patient was seen by an ophthalmologist and diagnosed with atraumatic acute optic nerve palsy on 3 and 6 in the right eye only. On 19th February 2020, the patient was seen by her neurologist and stroke, MS and myasthenia were ruled out. A test revealed that the imbalance was due to a nephropathy. During that same week that she was seen by her ophthalmologist  and neurologist, she developed a cough and sputum and was prescribed prednisone and a z-pack. The reporter consented to follow up.