chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stiff arm a few hours after injection. 11 hours after injection, fever (100.9), chills, body aches. Next day, fever was gone. Residual body aches were less (mostly lower back pain). Slight headache upon waking.
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in March 2017 (reported as "starting on or after 06-MAR-2017"), the patients were vaccinated with doses of PNEUMOVAX 23, lot # M037669, expiry date: 09-MAY-2018, for prophylaxis (dose number and route of administration were unknown), which were improperly stored at 11.4 degrees Celsius (C) for 1 hour 10 minutes. A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012133: US-009507513-1703USA011911.
1JUL96 t103, vomiting, rash;8JUL96 sz activity;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Medium
High fever, screaming initially. Personality change. Stopped talking, stopped looking at us...was no longer there.
Administration of the powder component of Menveo with a Non-GSK supplied diluent; only the A vial was administered and did not receive the C,W,Y portion; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 15-MAY-2023, the patient received Menveo. On 15-MAY-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Administration of the powder component of Menveo with a Non-GSK supplied diluent) and inappropriate dose of vaccine administered (Verbatim: only the A vial was administered and did not receive the C,W,Y portion). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-MAY-2023 The sales representative reported that a 11 year and 3 months old patient received a vial of Menveo reconstituted with other diluent. The office informed that a non Glaxo smith Klein (GSK) diluent was used to mix only the A vial and was administered that as a dose.  The patient did not receive the C,W,Y portion. The reporter was wondering what the procedure was now, as the full MCV-4 was not correctly administered. No data about lot number or expiration date. The medical information department had never spoken with the healthcare professional involved on this case. The reporter consented to follow up. The patient received Menveo reconstituted with other diluent which was used to mix only the A vial and did not receive the C,W,Y portion, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Breakthrough covid case; Breakthrough covid case; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 18:00 (Lot number: FC3180) at the age of 36 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies:no, reaction(s): "Drug Allergy", notes: Known allergies:No. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Right, Vaccine Administration Time: 01:30 PM), administration date: 28Mar2021, when the patient was 35 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Right, Vaccine Administration Time: 01:30 PM), administration date: 07Mar2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Sep2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "Breakthrough covid case". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of immunisation. Therapeutic measures were not taken as a result of vaccination failure, covid-19. On 29Sep2021 6:00 PM the patient administered COVID-19 vaccine at Pharmacy or Drug Store. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Birth control medication within 2 weeks of vaccination. The event reported as Breakthrough covid case. Prior to the vaccination the patient does not diagnosed with COVID-19. Since the vaccination the patient has been tested for COVID-19. Device Date was 28Dec2021.  No follow-up attempts are possible. No further information is expected.
3/9/17 Pt. received PREVNAR 13 and TDaP. Pt. is resident at facility, pt. never C/O any S/S then on the 15th (L) arm slightly swollen, painful, warm to touch and redden - measured 16 x 12 inches (Tx ice and TYLENOL). By day 18th S/S completely resolved.
Flu shot 9/30/13. Thurs. AM facial swelling, in PM tongue "funny". BENADRYL given and went to MD. MD ? related to flu shot vs. allergic reaction to something else.
Patient stated she was experiencing blurry vision, nausea and dizziness approximately 10minutes post vaccination. Vitals were stable BP 137/87 P. 72 Sp02 99% Patient was provided cold compress and monitored for an additional 20minutes. Patient's s/s resolved. Patient stable.
-severe menorrhagia following vaccination (a report was filed last spring) -diagnosed with iron deficient anemia in July -menorrhagia persisting 5 months after initial shot
Itchy, hive-like rash on both arms; mild headache; chest tightness.
Day 1. Had numbness in left hands. Nausea as well that day.  Day 3 had a headache and couldn?t sleep from it. Day 4 stiff neck started early morning but night couldn?t sleep from pain and not able to find a comfortable spot.  Day 5. Neck pain significantly increased. Couldn?t turn my head right or left. Any movement caused agonizing pain even the slightest touch on my face caused stabbing pain down my left side of my neck. Neck was tender to touch. Had minimal to no range of motion  of left or right side of neck. To move. Needed to support my neck with something like a board which kept my neck straight in order to get up from a sitting to standing position. Had no relief. Dr prescribed a strong pain relief medication with a muscle relaxant that did nothing. Ended up in the ER that night because I couldn?t get relief from pain. Upon moving my neck I?d have a level 15 stabbing pains. When my neck was resting i had an intense squeezing/ throbbing and burning sensation at level 8 pain. Could not move from sitting position to reclining position let alone laying down without excruciating pain:
15 minutes after vaccine - had generalized "itching" feeling every where. She rubbed, hives bright red presented. Took liquid 50 mg Benadryl 1 hr later, no hives, no itchiness but a bad headache.
Patient had the first dose from Moderna and the second dose from Pfizer; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient had the first dose from Moderna and the second dose from Pfizer) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient had the first dose from Moderna and the second dose from Pfizer). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient had the first dose from Moderna and the second dose from Pfizer) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
pt recieved vaccine at 1135 on 4/9,  pt reported tongue swelling around 1130 the next day (4/10, 24 hrs after), presented to ED via EMS 1518,  was diagnosed with angioedema likley due to ramipril, was intubated by 1624. pt had difficult intubation, was transferred to ICU, in critical condition on a ventilator, days later,  after multiple cardiac arrests and multiple rounds of  ACLS were performed, the pt was pronounced dead at 0127 on 4/12
Information has been received from an office manager concerning an eight week old patient who on an unknown date was vaccinated with an oral dose of ROTATEQ (lot # not reported) (reporter believed it was the first dose). Subsequently the patient developed blood in the stools and petechiae. It was also reported that the patient had a platelet count of six (normal range not reported). The patient sought medical attention by an office visit. At the time of the report, the outcome of the patient was unknown. Follow up information has been received from the physician who indicated that the child had received all other "2-month vaccines" (not further specified) on the same visit when the child received the first dose of ROTATEQ. Upon internal review, blood in the stools was considered to be an other important medical event. Additional information has been requested.
A 4 year old female developed a rash following RabAvert administration. The pt received her 2nd dose of RabAvert 1ml, IM, in her leg on 8/28/01 (Day 3) for post-exposure vaccination. On 8/31/01, the pt developed a rash on her arms.
2 swollen lymph nodes in left arm pit on day 6; Headache within one hour of shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 28Jul2021 15:00 (Lot number: EW0196) at the age of 13 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing), notes: Autism; "DMDD" (unspecified if ongoing), notes: DMDD; "ADHD" (unspecified if ongoing), notes: ADHD; "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: GUANFACINE; BUSPAR; LEXAPRO; METFORMIN; ABILIFY. The following information was reported: HEADACHE (non-serious) with onset 28Jul2021 16:00, outcome "unknown", described as "Headache within one hour of shot"; LYMPHADENOPATHY (non-serious) with onset 03Aug2021 02:00, outcome "not recovered", described as "2 swollen lymph nodes in left arm pit on day 6". The events "headache within one hour of shot" and "2 swollen lymph nodes in left arm pit on day 6" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy. No follow-up attempts are possible. No further information is expected.
Patient called pharmacy on Friday morning . He stated that his whole arm is red , swollen and hurts him. It started Tuesday and continued till Friday morning. Patient states he is stable and concerned about his arm.
Starting 08/01/2022, I woke up with a very sore throat. The next day, I had a stuffy nose and thought it was the hotel air. On 08/02/2022, I got home and felt sickly, and took an at home test which was negative and then I went to urgent care and they did a COVID/strep test but they were both negative. On 08/05/2022, I went to another urgent care and got a COVID-19 test, Strep test and Flu test which all came back negative. The doctor put me on a Z-PAK because he didn't like the way my throat looked. I started feeling better by 08/06/2022. I feel fine today but still have some runny nose/nasal congestion and my voice hasn't returned to normal yet (I lost my voice on Saturday).
soreness at the injection site; low fever of 99 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) and PYREXIA (low fever of 99 degrees Fahrenheit) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site) and PYREXIA (low fever of 99 degrees Fahrenheit). On 05-Mar-2021, VACCINATION SITE PAIN (soreness at the injection site) and PYREXIA (low fever of 99 degrees Fahrenheit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 99°f (Low) low fever of 99°F.         Concomitant medications was not provided.  Treatment information was not provided.
Once the patient received the vaccine, after 2-3 minutes, he felt dizzy and I asked him to sit down. He went on to say that his head feels heavy and he could no longer see. He drank water and wanted to laid down. Right after he vomited and was escorted by paramedics to the hospital as his blood pressure was very low.
PARALYSIS; UNABLE TO WALK/ WALKING DIFFICULTY; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1total, for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient was paralyzed after receiving vaccine, the patient was hospitalized for 7 days. The patient did not had blood clot, but had difficulty walking, fever, chills, headache and was unable to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralysis, fever, chills, headache, and unable to walk/ walking difficulty. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210430056-Covid-19 vaccine ad26.cov2.s-Paralysis. This events is considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Shaky  Narrative:  Patient is a 75 yo MALE with PMHx significant for T2DM (c/b neuropathy), HLD, HTN, gout, and partial first ray and second toe amputation. Patient received COVID-19 vaccine (Moderna dose #1) on 2/13/21. Noted to be shaky and upon sitting down he felt dizzy & worried he would not be able to stand up. Patient transferred to a wheelchair and moved to observation area. Patient assessed by vaccine clinic provider; noted to be alert and oriented, no headache, no chest pain, no nystagmus, BP 149/96 and HR 105 (repeat 10 min later: BP 153/89 and HR 105), O2sat 99%, and RRR. Patient stated he took his insulin and breakfast this morning. Per provider assessment, sx consistent with hypoglycemia; treated with 2 boxes of orange juice (24gm glucose) and finger stick glucose noted to be 226. Patient responded to glucose tx, sx resolved, and patient monitored for 40 mints total. Clinic provider does not feel hypoglycemia/dizziness presentation is related to COVID-19 vaccine.
Severe headache 8/10 unrelieved by OTC acetaminophen, nausea, dry mouth, chills without fever
Above mentioned patient was given ZASTOVOX (shingles vaccine) on 12/26/2008 in left deltoid area.  Subq. Large reddened area with small amt. of warmth noted.  Stated temp increased 101.3 for 2 days post injection.  T 98.3 today on 12/29/2008.
Left arm became red, hot, hard, swollen and patient developed fever, headache. Patient developed cellulitis and/or hypersensitivity. Nurse follow up on 06/09/04 states: Add: dehydration, lethargy.
Patient reports fever of 102 F and cold chills by 5pm the evening of 10/15/18, over the next two days the patient reports chest congestion, ear congestion on the left side, soreness in the left arm and left side of neck, headache, and general lack of energy and strength. She began taking Tylenol when the fever started, and maintained a fever of 100 F or below for the next two days. Patient came to the pharmacy the morning of 10/18/18 to report her signs and symptoms.
I am reaching out as I have a relative who recently mentioned that she got a MMR titer that showed no immunity for measles or mumps; I am reaching out as I have a relative who recently mentioned that she got a MMR titer that showed no immunity for measles or mumps; This spontaneous report was received from a company representative and refers to a 47-year-old female patient. 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 Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) (dose, route of administration, anatomical location, lot # and expiration date were not provided). On an unknown date, the patient got Measles, Mumps and Rubella (MMR) titer test that showed no immunity for measles or mumps (measles antibody negative; mumps antibody test negative). Outcome of the events was unknown.  Causality assessment was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA000897:
Has shoulder pain afterward and couldn't lift arm the next day, able to lift arm now but still has pain in the shoulder area.
Swollen left arm, rash, swollen joints, pain in upper arms (bilateral). Cortisone injection gave 60 day relief before pain, swelling returned.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown dates, unspecified number of patients were vaccinated with a dose of improperly stored oral, ROTATEQ, (lot number, Expiry date and dose were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I received the shingles vaccine in lthe left shoulder  and flu in the right shoulder.  I immediately felt nauseous and started sweating.  I had to sit there for a few minutes, drank some water.  I bought some cookies on my way out the door and ate 4 in the car, and started to feel better.  The rest of this afternoon I've felt exhausted.
Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival; Total duration of the excursion refrigerated temps for max of 4 hrs; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Total duration of the excursion refrigerated temperature for maximum of 4 hour. On 06 Oct 2021, vial was moved to fridge. The facility thought that the vials are received frozen from  Moderna so they had unpacked them and put them back into the facility freezer.They just recently found out that the vials are received in refrigerated temperatures and not frozen. They have been accidentally administering refrozen vials to their patients. Vaccine administered post 30 days from the initial storage at 2 degree Celsius to 8 degree Celsius.  Treatment information was not provided.   This case was linked to MOD-2022-496015 (Patient Link).