chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received Menveo reconstituted with sterile water; received Menveo reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA585A, expiry date 31st March 2022) for prophylaxis.   On 31st March 2022, the patient received Menveo. On 31st March 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comment: No reactions were reported. The reporter consented to follow up via email. Additional Supportive Information: The patient received Menveo after being reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
This report was identified from a line listing obtained on request by the Company from the FDA. A 21 year old female patient, on 07-AUG-2007, was vaccinated with the third dose of Gardasil (lot# 658282/0929U). On 07-AUG-2007, two hours after the injection, she fainted, and had "shaking" seizure activity. The patient was taken to the emergency room. At the time of this report, the outcome of the events was unknown. The original reporting source was not provided. No further information is available. Follow up information had been received, via a company representative, in the form of a newspaper article containing a statement made by the patient's mother, who had been present when her daughter had the seizure. The mother noted that the seizure occurred approximately 3 hours after vaccination. She reported that her daughter was followed up by a neurologist, had a computed tomography (CT) scan, magnetic resonance imaging (MRI), blood work, electroencephalogram (EEG), and X-rays, all of which were negative. She added that "none of the physicians would say it was from the vaccine," though she reported her "daughter is perfectly healthy, no medical problems, so I know it was from the vaccine." The outcome of seizures was not specified. Upon internal review, "seizure activity 2 hours after injection" was considered to be serious, as an other important medical event. This report was filed with the FDA. The ISR number is 1-2273704943.
Pt had a muscular seizure, approx. 5-10 minutes. EMS came and took her to the ER.
Patient stated she had "normal" side effects from the booster vaccine (aches, pain, fever) about 24 hours after her dose on 10/30. On 10/31 at 3am she awoke with a racing heart. This went away. On Monday, 11/1 the symptoms came back and her rate was racing and she had a blood pressure of 238/118, She went to the ER for full evaluation where she was told they could not find what was wrong and why her blood pressure as so high. The patient is still experiencing high blood pressure (184/78) but is being monitored at home by Dr. . Dr. is working with patient to adjust her dose and suggested that these blood pressure issues "may" be associated from her vaccine dose.
This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 10-NOV-2016)( dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the requested made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M. A. via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 10-JUN-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
Per witness, patient "fainted", falling out of chair shortly after arriving to recovery area. Upon writer arrival patient was diaphoretic, A&Ox4 , V/S WNL (121/80, HR 99, O2 100%, Resp. 18), patient reports hx of anxiety and untreated syncopal episodes. EMS activated. Upon EMS arrival, VS 117/62, HR 116, Resp. 18, O2 100%, finger stick blood sugar 96. Patient transported to ED by EMS at own request.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. It was reported that since 24-JUL-2014 the patients were vaccinated with the doses of improperly stored RECOMBIVAX HB (dose, route and lot number were not reported). No adverse effects were noted. No additional information was reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Initially pt felt malaise and fatigue 2 hours post vaccine. At 4 hours the injection site was red, swollen and hot. Pt called in sick to work the next day. By Wednesday her upper arm was bright red in area measuring 100 x 50 mm. On Friday she sought medical treatment from her PCP for pain, swelling, redness and burning of upper arm and distally to her elbow.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site rash (whelp around the injection site looked like a rash), vaccination site pruritus (itchy) and vaccination site swelling (itchy and swollen) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 036B21A) for COVID-19 immunization. No medical history reported. On Apr 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 22, 2021, patient experienced vaccination site rash (whelp around the injection site looked like a rash), vaccination site pruritus (itchy) and vaccination site swelling (itchy and swollen). At the time of the report, vaccination site rash (whelp around the injection site looked like a rash), vaccination site pruritus (itchy) and vaccination site swelling  (itchy and swollen) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported/provided.
This spontaneous report as received from a vaccine coordinator refers to a patient of unknown age and gender. No medical history and concurrent condition were reported. On 11-JAN-2019, the patient was vaccinated with an improperly stored second dose of PROQUAD (lot # R020677, expiry date 15-JAN-2020) for prophylaxis. The suspect vaccine was reconstituted with an properly stored sterile diluent. The vaccine was exposed to the temperature of -14.6 degree Celsius (C) for 30 minutes. Previous excursion included exposure to 0.1 C for 2 hours and -13.7 C for 45 minutes. A data logger was involved. No adverse effects were reported. No product quality complaint was present. This is one of the several reports received from same reporter source. Sender's Comments: US-009507513-1901USA006695: US-009507513-1901USA006696: US-009507513-1901USA006698: US-009507513-1901USA006697.
(7:06pm) Within one minute of receiving vaccine, patient started having difficulty breathing and started to turn red. (7:07pm) I asked the tech to grab the epi pen and call 911. Within 30 seconds of first event, patient was almost not breathing. (7:08pm) I placed the patient on her back and delivered the contents of one epi pen into her left upper thigh. (7:09pm) Patient started to regain her breathing. (7:10pm) Patient  was breathing better and able to talk. (about 7:13) 911 arrived, accessed the patient, eventually taking the patient to the hospital. Patient was fully aware and breathing at that time.
I woke up on 3/27/22 with a headache and some dizziness; I have previously received 2 doses of Pfizer
Achy joints, sore, very fatigued as soon as I woke up by lunch time had a low fever/chills, felt like flu.
On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness on injection arm) and VACCINATION SITE SWELLING (swelling on injection arm). At the time of the report, VACCINATION SITE ERYTHEMA (redness on injection arm) and VACCINATION SITE SWELLING (swelling on injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided.  No treatment details were reported.  Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Additional information added: Reporter Email id added This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2021 and was forwarded to Moderna on 30-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness on injection arm) and VACCINATION SITE SWELLING (swelling on injection arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness on injection arm) and VACCINATION SITE SWELLING (swelling on injection arm). At the time of the report, VACCINATION SITE ERYTHEMA (redness on injection arm) and VACCINATION SITE SWELLING (swelling on injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided.  No treatment details were reported.  Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Additional information added: Reporter Email id added
Redness and swelling surrounding the injection site (about 3.5 inches across and 2.5 inches in height) that is hot to the touch.   Drew a border around the site with a marker and instructed her to watch for any signs of it spreading or signs of infection.  In that case, she would need to have it further examined by a physician.  She reports that the same thing happened with the first dose; however, this time it seems to be worse.  She does not seem to have similar reactions with the flu shot.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown gender and unknown age. It was reported that on an unspecified date in 2014, unspecified number of patients received unspecified doses of M-M-R II, 0.5ml once, subcutaneously (lot/batch number not available) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively (also reported as 15C for more than 50  hours) through 07-MAY-2014. It was reported that also GARDASIL, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS#1406USA000955, 1406USA000956, 1406USA000957, and 1406USA000958 respectively). No adverse effects were reported.   Follow up information was received from the registered nurse. I was reported that the nurse was inquiring about temperature excursions that occurred from October 2013-March 2014 (previously reported as from 20-MAR-2014 to 07-MAY-2014). The reporter stated they were replacing the refrigerator, freezer, and the data logger and were sending the data logger for calibration to the health department.   Follow up information has been received from the registered nurse. She called back to specify that 7 patients were vaccinated with doses of M-M-R II, lot J002934 expiry date: 14-MAR-2015, which was stored improperly for a period from 28-AUG-2013 until June 2014 (previously reported as October 2013-March 2014). One patient received dose that was stored at highest temperature 9.5C for 269 hours. Four patients were given doses that were stored at highest temperature 10C for 274 hours. Two patients were vaccinated with doses that were stored at highest temperature 10C for 278 hours. This is one of several reports from the same reporter. Additional information is not expected as the correspondence was returned by the post office.
Flu-like symptoms next morning, which subsided gradually over the next week:  Felt very cold, sore muscles & joints, headache, weak and very tired. Also had diarrhea a day or so later. I felt "unwell" for a week or more.
Prolonged malaise, F/C, myalgia, Headache, ? localized adenopathy. x 9-7 days after vaccination.
8/16/07 Made by mother who stated child's left arm was redden swollen (in deltoid) area stated she did not see the child on 8/15/07 but the a.m. of 8/16/07 she noticed the swelling and redness.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received bnt162b2 (BNT162B2), on 03Nov2021 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: Rebound 4 days after 1st negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient was treated with Paxlovid and had rebound 4 days after 1st negative test.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Approximately 6 hours later, fever, chills (teeth chattering), mental blurriness, had to go to bed, tossed and turned all night, sweating, next day the same, and symptoms lasted from severe to moderate until the next night, and today, two days later, still feeling not quite "here." Put off working out for yesterday and today, because I was kind of pummeled from this. No one else had these issues, among the people I know. I would like to get me back and hope tomorrow is better.
Information has been received from an office manager concerning 8 patients who were vaccinated with PNEUMOVAX (lot # 662599/1076X). It was unspecified if this was the first or second dose for the patients. Subsequently the patients developed "very severe" injection site reactions. The patients sought medical attention in the office. In follow-up, the office manager indicated that 1 of the patients was a male who had a mild reaction to the PNEUMOVAX vaccination. The patient had redness around the injection site. This is one of several reports form the same source. Additional information has been requested.
Arm soreness, joint pain and weakness throughout body ( including arms, wrists, fingers, knees, ankles, feet). Not being able to move body parts, lift limps, finger swelling, finger numbness and tingling.
The adverse event that I am reporting is a swollen lymph node along the left side of my collar bone.  It is swollen, tender, and moderately painful to touch.
C/O dizziness and headache  Vital Signs: BP 119/79 HR 66 Resp 15 O2Sat 98%  Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Initial Treatment: Patient sitting on floor and continues to C/O dizziness. No increase in S/S  Notes:  Parents instructed to follow up with PCP and to seek medical care if symptoms increase. Parents verbalized understanding. Home with parents.
This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Intestinal pain), DIARRHOEA (I have had diarrhea), VACCINATION SITE PAIN (shot hurt alot, pain when the needle went in also while the serum was going in it burned), MYALGIA (aches and pains all over my body) and PYREXIA (fever lasted 2 to 3 days) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Mar-2021, the patient experienced ABDOMINAL PAIN (Intestinal pain), DIARRHOEA (I have had diarrhea), VACCINATION SITE PAIN (shot hurt alot, pain when the needle went in also while the serum was going in it burned), MYALGIA (aches and pains all over my body) and PYREXIA (fever lasted 2 to 3 days). On 11-Mar-2021, VACCINATION SITE PAIN (shot hurt alot, pain when the needle went in also while the serum was going in it burned) had resolved. On 14-Mar-2021, PYREXIA (fever lasted 2 to 3 days) had resolved. On 16-Mar-2021, ABDOMINAL PAIN (Intestinal pain), DIARRHOEA (I have had diarrhea) and MYALGIA (aches and pains all over my body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-258749 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: NNI Case
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    No concomitant medications were provided. It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was repored that administered 113 Bivalent doses administered after the BUD to patients 12 and up. 60 doses from Lot AS7148B.  No treatment medication was provided.
after recieving the vaccine, patient turned very pale and appeared to lose conciousness as well as have convulsions. 911 was called. nurse had patient lie on the floor. o2 was measured to be 96 and bp was 103/74
Information has been received from a pharmacist concerning an "adult" female patient with no know drug allergies who within the past 3 weeks on approximately 01-OCT-2009 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (lot# 663889/0632Y). It was not known if she had received PNEUMOVAX 23 in the past. On approximately 01-OCT-2009 "within 12 hours of vaccination" the patient experienced pain, swelling, heat, redness and possible bruising at the injection site. The patient did not have fever. The patient was instructed to take diphenhydramine and ibuprofen. At the time of the  report, the patient was recovering. The patient came to the pharmacy to seek medical attention. No lab diagnostic study was performed. This is one of several reports  received from the same source Additional information has been requested.
1115 patient complains of dizziness bp 165/110 hr 85. patient states she did not take her blood pressure medicine prior to shot. states she took Benadryl in the parking lot due to seasonal allergies 02 sat 97%. 1155 patient states she feels better. patient refused for her blood pressure to be rechecked, states  " I'm going home to take may blood pressure meds, I  think i am ok now". patient advised to visit emergency department or call 911 if blood pressure or dizziness persist. patient verbalized understanding
Delayed reaction five days after vaccine. Headache, mild fever and extreme fatigue. The first two responded to Motrin which I took twice. The fatique was intense and lasted three full days.
His eyes rolled in the back of his head , became stiff , and was shaking. It lasted approximately 1 minute. EMS was called to check out.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Severe, Additional Details: swallowing golf ball size under arm
4/15/2021 10:55 AM B/P 140/80, Pulse 68, 11:15 AM B/P 120/80 Pulse 48, 12:05 PM B/P 110/80 Pulse 78 Per EMT Chief Complaint Syncope, patient fainted for about 10 seconds, was seated in chair and assisted to lie down without falling, water and ice pack to neck and head, taken to First Aid Station via wheelchair, monitored for additional 30 minutes and felt better when discharged home to rest.
Vaccines given 10/19/16 Week of 11/1/16 Lacy eruption on back and trunk.
This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-MAR-2015, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). In July 2017, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 22-NOV-2017, the patient received the third dose of GARDASIL 9 lot number N020139 and expiration date of 14-FEB-2020 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. There was not product quality complaint involved. This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA010323:
Tinnitus in both ears, started 11 hours after the date of vaccination and continues to present time.  I have NO past history of this disorder. My nurse practitioner will refer me to ENT if this does not resolve in another few weeks. I have ringing and hissing in both ears.