chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse refers to unspecified patients of unknown demographics. No medical history was reported. On an unknown date, unspecified number of patients were vaccinated with RECOMBIVAX HB (dose, route and frequency unspecified) which was improperly stored since 01-FEB-2014. No concomitant medications were reported. Nurse did not have any patient specific information. No adverse effects were reported. No further information was reported. This is one of several reports received from the same reporter. Additional information has been requested.
rash, swelling especially in nodes, heat, and pain at and around the injection site. Swelling is getting worse as day has progressed.
got diabetes 2 weeks after taking the vaccine; dizziness/lightheadedness; This is stopping him from doing things; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (got diabetes 2 weeks after taking the vaccine), DIZZINESS (dizziness/lightheadedness) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (This is stopping him from doing things) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (dizziness/lightheadedness) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (This is stopping him from doing things). On 13-Apr-2021, the patient experienced DIABETES MELLITUS (got diabetes 2 weeks after taking the vaccine). At the time of the report, DIABETES MELLITUS (got diabetes 2 weeks after taking the vaccine), DIZZINESS (dizziness/lightheadedness) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (This is stopping him from doing things) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatments or concomitant medications were reported.  The patient reported they got diabetes 2 weeks after taking the vaccine, the patient stated symptoms were better but still ongoing.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: No specific follow-up information recorded. On 13-May-2021: Case upgraded to serious, new serious event was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The patient had received a Pfizer vaccine at the above mentioned clinic. She went  back to work. Approximately two hours later, the patient reportedly passed out. She was taken by ambulance to a local hospital.
w/in 2 hrs of vax fever elevated to 105 w/pt shaking; ? sz activity pt taken to ER & provided w/inject to counteract vax; pt not kept overnoc since episode has had problems w/balance; MD ordered Ct Scans & neurological testing;
STROKE.  Hospitalized 03/01/21  Affected left hand.  Was told at the hospital that there was EVIDENCE OF A PRIOR STROKE (date undetermined) at the edge of the visual center in the brain.  Note:First injection of Moderna Covid (Moderna Lot #028L20A) was given on 01/16/2021.    Another STROKE was verified with an MRI on 10/27/2021.  This time the right had was affected.  Received booster (Moderna Lot#032F21A) on 10/31/2021.
Felt like hit by a truck; Extremely bad flu; Trouble getting out of bed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like hit by a truck), INFLUENZA (Extremely bad flu) and BEDRIDDEN (Trouble getting out of bed) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer since 2009 and Lung cancer (Patient reported hardly having any lungs. Never had chemo/radiation) since 2012. Concomitant products included DENOSUMAB (PROLIA) and OMEPRAZOLE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced FEELING ABNORMAL (Felt like hit by a truck), INFLUENZA (Extremely bad flu) and BEDRIDDEN (Trouble getting out of bed). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Felt like hit by a truck), INFLUENZA (Extremely bad flu) and BEDRIDDEN (Trouble getting out of bed) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-359508 (Patient Link).
Pt received shot on 2-21-07. Woke up at 0500 on 2-23-07 with itching in armpits. Rash of little red spots started spreading up and out spots all over arms, legs, trunk, neck and itch. Advised pt to take 50 mg Benadryl and see MD if did not improve or got worse.
Flu like symptoms; Sweating; Chills; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (Sweating), CHILLS (Chills) and FATIGUE (Tiredness) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (Sweating), CHILLS (Chills) and FATIGUE (Tiredness). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (Sweating), CHILLS (Chills) and FATIGUE (Tiredness) outcome was unknown.        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 medications were provided No Treatment information provided   This case was linked to MOD-2021-045543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: No specific follow-up information recorded.
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown ages and genders. Medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (manufacturer unknown) (lot # reported as L237TJ, expiration date unknown) (dose and route were not provided). Concomitant medication was not reported. It was also mentioned that no adverse effects were reported, temperature was low 32 degrees F, the time frame was 28 days, there was not previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Lot number L237TJ is an invalid lot number for RECOMBIVAX HB. Additional information has been requested.
Approximately 1 hour after having had Menactra Meningococcal Conjugate Vaccine administered in her left deltoid muscle, the patient informed her mom that her throat felt tight and funny, and that she felt slightly weak in general, and felt weak in the legs in particular. She also noted some localized redness where her band-aid had been applied over the injection site. The patient, upon her mother calling us, was advised to take Benadryl, 25 mg PO, x one. She did so, and was evaluated within approximately an hour of calling. I diagnosed her with a seeming mild allergic reaction to the Menactra, and confirmed that this seemed to be a reportable adverse event. Upon objective assessment, the patient was in no acute distress. She was noted to NOT be having anaphylaxis. She was without any angioedema or swelling of her eyes. She had some mild nasal congestion and mild anterior cervical adenopathy, consistent with a possible early viral URI. Her breath sounds were clear with excellent aeration, and NO wheezing noted. She was noted to have localized erythema, predominantly underlying where her adhesive bandage has been, at the injection site. I prescribed Zyrtec 10mg tabs, to be taken 1 tab PO, daily for the next 7 to 10 days, to try and suppress any further allergic symptoms. To date, she has done fine since.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient passed out completely and fell out of vaccine chair. I called EMS and rushed to her side. A doctor was in line to get a vaccine as well and helped me walk the patient to another chair. I gave her water and food, which she refused the food. She also refused medical attention and a walk home. She called back, thanked us, and said she made it home ok. She said afterwards she didn't eat and has a history of fainting after giving blood.
woke up with red, swollen, warm to touch, painful (4 on 10 scale) (making neck tighten)
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified date, the patient was vaccinated with an improperly stored dose of VARIVAX injection (dose, frequency and route were not reported) lot # M046004 with expiration date of 18-NOV-2018 or lot # M028547 with expiration date of 07-JUN-2018, for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion of the VARIVAX was between -9 °C and 8 °C for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005163: US-009507513-1706USA005174: US-009507513-1706USA005175: US-009507513-1706USA005176: US-009507513-1706USA005177: US-009507513-1706USA005179:
Back pain, blood in urine, fatigue, felt feverish (no fever). Urgent care indicated UTI and kidney infection and provided 7days of antibiotics. 4 weeks pregnant, estimated delivery date 8/30/2022
When I woke I had severe pain in my feet and the bottoms were red. Nerve pain continues in my left foot today.
Tightness/tingling throat, administered 10ml liquid benadryl, Call placed to EMS, arrived. Symptoms subsiding at this time. Client refused to go to hospital.
Every time my mother blows her nose or coughs up phlegm there is a lot of blood; Every time my mother blows her nose or coughs up phlegm there is a lot of blood; This is a spontaneous report from a contactable consumer (patient's daughter). A 97-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 as a single dose for COVID-19 immunization, lot number: EL0142. Medical history and concomitant medications were reported as none. Patient's daughter reported severe problems with the vaccine. Every time patient blows her nose or coughs up phlegm there is a lot of blood, onset date unknown. No treatment received for the events. Outcome of the events was unknown.
My wife had attended an event may unmasked  individuals were present she tested positive for COVID-19 Test Positive  21JAN2023.   She did an at home test due to loss of smell we isolated as much as possible on 21JAN2023 I was negative for COVID-19.  22JAN20023 COVID-19 Test-Positive,  the next night I had fever and chills and at three AM in the morning I take two Advil's I get up to urinate and I could not stand and slid down to the floor and no strength to went get to my knees. EMS came to my home and transported me to Hospital.. I was treated for dehydration an EKG was done and although telling them I had tested positive for COVID-19 nothing in my medical records indicated it except an the end of the report it states the patient asserted that he tested positive for COVID.  23JAN2023 I was told I was free to go and left the hospital.  The next morning I contacted my Doctor DR. he prescribed Paxlovid, I took for five days and felt good I did end up testing positive for Bronchitis.
Patient spiked a temperature of 100.3 and had a large emesis and large loose BM about 5 hours after receiving the booster shot.
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. On 16-AUG-2017, the patient was vaccinated with RECOMBIVAX HB, dose 4, lot number M045653, expiration date 03-JUL-2018 (also reported as 03-JUL-2019), for prophylaxis. No adverse effects were reported.
Onset rash, itching and swelling at posterior oropharynx, lips swollen and perioral paresthesias.
Low grade fever (<101). NIght sweats. Muscle aches. Headache. Loose stools and some nausea. Decrease in appetite. Runny nose with no congestion. Vaccine site slightly warm and tender but not pink or raised.  Mouth pain with blisters and ulcers especially on tongue and in cheek pockets along gum line.  All symptoms started within 24 hours after vaccination and resolved over 7 days.   Mouth ulcers/blisters very painful. Tongue had burning sensation which lasted full 7 days. No change in taste or smell.  No cough.
Administered vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 49-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 49 year old, female patient.  The patient's medical history is not provided.  The event occurred on 28 Dec 2020, when the patient was given the first dose of the mRNA-1273 (Lot: 025J20-2A) . This report refers to a case of storage error where refrozen mRNA-1273  had been administered to the patient.
On going pain which began the days after injection and continuing until now. Arm of injection sore and weak around shoulder joint. There has been no numbness, tingling, or loss of function of arm. Patient treating pain and soreness with over the counter Aleve and mild exercise/physical therapy. Has not be troubling enough for patient to contact a Dr. or clinic for symptoms.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 51-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 13-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804099 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Breakthrough case admission after 5 vaccines Pfizer 2/2/21 Lot# FW2328;  Pfizer 2/23/21 Lot# EN6202;  Pfizer 8/17/21 Lot# FC3180;  Pfizer 6/16/22 Lot# FK9893;  Pfizer 10/22/22 Lot# GH9703
Kaleidoscope vision; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 15:00 (Lot number: EN6203) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Egg allergy" (unspecified if ongoing), notes: eggs; "Medical iodine allergy" (unspecified if ongoing), notes: Medical iodine. Concomitant medication(s) included: VITAMIN A; VITAMIN C; VITAMIN D3; AIRBORNE; PROBIOTICS. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 15Mar2021 11:00, outcome "recovered" (2021), described as "Kaleidoscope vision"; HEADACHE (non-serious) with onset 15Mar2021 11:00, outcome "recovered" (2021), described as "Headache". The events "kaleidoscope vision" and "headache" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of visual impairment, headache.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 11:00, the patient experienced kaleidoscope vision in right eye lasting about an hour and then a mild headache for 24 hours.  No follow-up attempts are possible. No further information is expected.
First noted conjunctivitis then the following day it became severe. Then fever, anorexia, runny nose, cough developed. After 4-5 days I took her to pediatrician who recommended treating the conjunctivitis. I sought advice of a colleague who is a naturopath and with her help, my daughter fully recovered within about 3 days.
Severe throat and body ache; Severe throat and body ache; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 02Apr2021(at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included loratadine (CLARITIN), ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE-A-DAY) and ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, four days after the vaccination, the patient experienced severe throat ache and body ache and lasting longer than one week. On 09Apr2021, the patient underwent COVID-19 test (Nasal Swab) and the result was Negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the events severe throat ache and body ache were not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On 12/22/2020 we had 1 patient who had a severe allergic reaction to covid 19.  after she was administered covid 19 vaccine at about 11 am she went in to the observation area for 15 minutes.  while there under the observation of the facility staff members she reported to them that she was having some difficulty breathing and her lower throat was closing up.  the staff member came over to the administration area to ask me to bring the epi-pen because they have someone with anaphylactic allergy reaction. I ran over there with a box of epi-pen and patient stated she is having difficulty breathing and her throat is swelling up and I noticed her lips were turning blue. at that time I administered the epi-pen and asked the facility members to call 911. which the facility members did promptly. I kept her under observation with the 2nd pen ready just in case it was needed.  the EMS showed up within 15 minutes and took over from there and transported her to the hospital.  The staff members at the facility also called the patients doctor to inform him of the allergic reaction. I followed up with patient on 12/23/2020 at 4.37 pm. and at that time she was doing fine. she informed me that all of her symptoms of the allergic reaction have gone away and all she has is some cough and some shortness of breath. she had been discharged by the hospital and is on some steroids and under her physicians care.  I talked to employee at store as he is the one charged with recording this incident and he has informed me that he talked to the facility administrator and facility administrator informed him that both patients have recovered completely and were back to work today on 12/23/2020
Localized redness, warmth & swelling to dorsal side of the right arm arm.  Cool Compress applied to the area.
Approximately a 3-inch wide circle surrounding the injection site became red, splotchy, bumpy, hard, raised, hot and very itchy.  Child was taken to urgent care where the doctor stated that it was in fact a reaction to the injection.  A steroid cream was prescribed and is being used twice daily.  After three days of using the cream the spot is beginning to dissipate.  It is still hot, red, raised and itchy, but not as badly as it was a few days ago.
Fainted within 10 min of receiving vaccines and fell backward and hit head on carpeted floor was unresponsive for 20-30 seconds. Complained of headache and neck pain. Transported to ER - CT showed traumatic subarachnoid hemorrhage. Transferred to PICU.  5/11/07 Received medical records from hospital which reveal patient experienced syncopal episode & fell backward w/o bracing herself, striking posterior head & becoming dazed & minimally responsive for several minutes.  Seen at outlying hospital & had CT scan which revealed SAH & skull fx.  Exam revealed alert & oriented, hematomas over skull.  Tx w/dilantin.  Neurosurg & neurology consults done.  Seizure was ruled out & dilantin d/c.  Strong suspicion for vascular abnormality due to amount of intracranial bleeding after fall. FINAL DX: traumatic subarachnoid hematoma.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (gave expired vaccine) in a 38-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 067H21A) for COVID-19 immunization. No medical history reported. On May 11, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 11, 2022, patient administered expired product (gave expired vaccine). At the time of the report, administered expired product (gave expired vaccine) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
The morning of the 28th awoke with chest pain, Felt like an elephant sitting on her chest. She sat on her bed for 45 min and then awoke her son to take her to the hospital.