chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Serious chills; Had a 101 degree fever; Shaking; Yawning constantly (very weird); Creeping body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 10:30 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no 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 not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 29Mar2021 at 20:30, four days after getting first vaccine shot, the patient had sudden and severe reaction of side effects. At 8:30 PM, the patient was fine and then within minutes, the patient was having serious chills (the patient had a 101-degree fever), shaking, yawning constantly (very weird) and having creeping body aches. The patient struggled to bed and thankfully, the worst of it had receded within a couple of hours and patient had recovered in about 36 hours. While the patient cannot be 100 percent sure this was vaccine related. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatments for the events of general body pain, yawning, shaking, fever and chills. The clinical outcomes of the events general body pain, yawning, shaking, fever and chills were resolved in 31Mar2021 at 08:30.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 07-JUL-2015, the patient was vaccinated with an improperly stored dose of VAQTA 25U/0.5 ml injection (lot# K005323, expiry date 10-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified), lasting for 48 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
dizzy, lightheaded, blurry vision, diaphoretic. Evaluated by EMS-Cleared
FEELS LIKE SOMETHING CRAWLING IN RIGHT EAR; This spontaneous report received from a physician concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced feels like something crawling in right ear. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from feels like something crawling in right ear. This report was non-serious. The suspected product quality complaint has been confirmed to be confirmed no : PQC was identified within the reporter complaint reported. complaint is approved for void. based on the PQC investigation performed. This report was associated with product quality complaint:90000179264
Rigors; Feverish (yet afebrile); Myalgias; Fatigue; This is a spontaneous report from a non-contactable consumer (patient herself).  This 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date at single dose; and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 at single dose, for COVID-19 immunisation. Vaccine location was right arm. The patient did not have a relevant medical history. No known allergies. No relevant concomitant medications were provided.  No other vaccine was received in four weeks. On unknown date, the patient developed rigors, feverish (yet afebrile), myalgias, and fatigue. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was not treated for the events. She recovered from the events on unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Return of covid long haul Heart palpitations, chest pain, shortness of breath, fatigue, brain fog
Patient is 62 years old.  Fluzone high dose was administered at her visit, which is indicated for individuals 65+ y.o.
mom phoned on 31JAN97 states pt was running fever of 102-wondered if it was caused by 28JAN97 vax of MMR/varicella;5FEB97 pt seems to be cutting teeth-has not seen MD;
Aching arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aching arms) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Aching arms). At the time of the report, PAIN IN EXTREMITY (Aching arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter. Treatment details was not reported by the reporter.
Symptoms: Extreme fever, body aches, chills, sweats, fatigue, dark urine/blood in urine Duration: Saturday night - Sunday night (ongoing fatigue, aches, and dark urine/blood in urine)
About a month after getting the second dose of the vaccine I got a severe rash all over my body. The rash was in big welts all over my body, arms, chest, neck, back and legs. It was very itchy and raised and arm to the touch. I went to the Dermatologist, and I took Benadryl. It would calm down after a few hours and then return the next day. It lasted over two weeks but I had another incidence about five months after the vaccine but it only lasted for one day. I took Benadryl and then it went away and did not return.  I have also been diagnosed with drug allergies to Penicillin five months after the vaccine. I am not sure if I was allergic before the vaccine.
Information has been received from a pharmacist concerning a 67 year old female patient with sulfonamide and codeine allergies who on 22-MAY-2008 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# unknown). The pharmacist reported that the patient developed shingles after receiving ZOSTAVAX (Merck) over 2 years ago. At the time of the report, the patient's outcome was unknown. The patient sought medical attention by an office visit. Additional information has been requested.
Client started having hives, wheals all over body on 8/16/05 and vaccine was given on 8/12/05. Saw pediatrician on 8/17/05.
Son reports that the case was not reacting the same after taking his usual blood pressure medications-disoriented, fatigue, complaints of not feeling well and blood pressure was not responding as normal to the medications. THus son took this case to the hospital for his hypertension around 700pm on 05/21/21. He was never in the mechanically ventilated nor in the intensive care unit.
Information has been received from a nurse and a medical assistant concerning a female patient who was vaccinated IM with a dose of Gardasil.  Concomitant therapy included antimicrobial (unspecified).  The reporter reported that the patient did not have her period for 2 months.  Her pregnancy test was negative.  The patient's grand mother mentioned that it was unknown whether the patient has a history of irregular menstrual periods.  The outcome was unknown.  Additional information has been requested.
8:00 am on 3/11 - Fever of 100 degrees and extreme fatigue, body aches, chills   10:00 am - Started to become nauseous and threw up  Until midnight  - could not keep any food or liquids down, fever fluctuated between 100 degrees and 104 degrees, extreme body aches and chills   12:30 am - no fever, body temp returned to normal, still could not keep food or water down   4 am on 3/12 - able to drink some water and felt almost normal other than some lingering body aches
Injection at approximately 9:15 am (Saturday, March 6th).  Nausea, vomiting, and diarrhea began at 6:30 pm.  High fever  (103+) began at approximately 7:45pm, and lasted until 4:00 am (Sunday, March 7th).  SEVERE ringing in both ears lasted until 1:00 pm the following day (Monday, March 8th).  Woke up to 2 fever blisters on Monday, March 8th (Note:  I have never had these in my life).
Hives of face, cough, conjunctivitis, edema throat (Prednisone).
23 hours after vaccination with DTaP and Hib (of note her first in the series were Sanofi vaccines ACTHIB and DAPTACEL. These were GSK as above). She had a BRUE (previously known as ALTE) she had just fallen asleep in the rock n play and the nanny was still rocking it, she stopped breathing (no choking, spitting up or coughing) and turned blue. Nanny tried to swim w/o response, then finger sweep, 3 back blows and 3 rescue breaths. She was seemingly postictal for about 30 minutes. No jerking or rigidity. Was seen at ER, bx BRUE and has neurology follow up. No fever before, during or after the event.
Rash on entire torso increasing daily. Now on chin & cheeks. Slight alteration in sleep, slightly irritable and slight decrease appetite. Afebrile.
12 hours after shot had chills, body aches, fatigue lasted for 16 hours.  9 days after vaccine hives outbreak. All over my upper body-waist up to head with some hives on the back of knees. Hives can go from achy pain to burning warm to itchy. When break out, the skin is raised white with red surroundings the raised spot. My eyes, throat and even tongue felt swollen. My knees and forearms ached. Took Benadryl & Zyrtec with little relief. Dr gave 5 day of steroid helped but didn?t stop hives.  12/26 my eyes, throat and tongue no longer felt swollen, seemed like internal inflammation had broken through the night. The hives still persist as of today 12/29.
redness of at injection site; tenderness at injection; swelling of 5x7; A Spontaneous report was received from a nurse concerning a male patient who was participating in the mRNA-1273 Emergency Use Program and developed redness, swelling, and tenderness at the injection site   The patient's medical history not provided. No relevant concomitant medications were reported.   On 28 Dec 2020 the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced redness, swelling of 5x7, and tenderness at the injection site. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events redness, swelling, and tenderness at the injection site were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Lightheaded and dizzy Period came very early. It started on day 13 of my 56 day cycle.
Vaccinations given. After vaccinations patient stated she felt fine in the room. She left the room and walked out to the waiting room and told her she did not feel good. I immediately laid her down flat on the chairs with knees up and she started to feel better. She laid there for 5 minutes. She sat up and felt  fine. I informed mom if she felt that way again to have her lay down and if condition worsens take her to the ER. Mom stated she understood and I walk patient to the vehicle.
Patient felt tingling in both legs immediately after vaccination. After 30 minutes of observation, patient did not feel tingling in the legs.
Onset of fever 6/1/07 and blisters in mouth started 6/3/07. Treated for bilateral ear infection diagnosed 6/3/07 and treated with Amoxicillin and Motrin.
Left Deltoid was hot to touch, swollen upper arm at site of injection. Has 3-4 raised area with small blisters at area. On 4/19/00 called pt's house, talked with uncle, the uncle didn't have time to take the child to the MD, but the swelling is going and redness and itching remains. Gave Benadryl. Mom says he is allergic to Benadryl, (rash).
mom states 4 days p/flu shot pt more fussy than usual- fever; severe asthma attack which required mom to give treatment of Intal & ventolin; not seen by MD or in ER; 27OCT92 t102 oral, nasal d/c green, diff breathing thru nose, lethargic;
Breakthrough case after Covid vaccination. Dose # 1 3/5/2021 Dose #2 4/2/2021. C/O chills, muscle aches, loss of taste/smell, headache, fatigue, cough, and nausea/vomiting. Onset 8/25/2021
Varivax following temperature excursion; no adverse event; This spontaneous report was received from a nurse and refers to unknown number of patients of  unknown age and gender. The patient's medical history, historical drugs and concurrent conditions were not reported.   On unknown dates, the patients were vaccinated with incorrect storage doses of varicella virus vaccine live (oka/merck) (VARIVAX) dose and route were not reported, (lot # S020965, expiration date 07-JUL-2021) for prophylaxis. Concomitant therapies included sterile diluent. The temperature was in the range of 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) (-2.5 C) for 4 hours. A data logger was involved.
Temperature excursion at maximum 11.5  Celsius for total excursion of 6 hours and 16 minutes, 11.4 Celsius for total excursion of 8 hours, and 12.3 Celsius for total excursion of 17 hours and 8 minutes/ NOAE; This case was considered as non-case as temperature excursion reported without stability data.
End of February , I began to have racing heart rate  and palpitations and after a week went to primary. she prescribed Xanax . I didn't take the meds and within 10 days I went to cardiologist. I was put on heart monitor for a week.. results were some irregular heartbeats.   I was put on beta blockers and after three days had to discontinue due to exhaustion. I have a follow up appt at cardiologist on June 15, 2021.
Severe aching of almost every muscle in my body. Initial fever which faded after 3-4 hours. Some nausea,no vomiting. Intense headache off and on for 4 days. Some tiredness,sleepiness,but not like others have had. Aching of muscles continued for 4 days, finally relenting by the middle of 4th day. Foggiest of mind for several days after all that. Back to normal self and function after about 1 week.
Pt received moderna vaccine that is for 6-11 year olds.  Advised to return in 2 months to receive appropriate age dose.
A non-serious spontaneous report of administration to pregnant female was received from a registered nurse/health professional concerning a 18-year-old female. No relevant medical history have been reported for this patient. The obstetrical history includes gravida two and para one. In Jan-2010, after the vaccination, pregnancy test was conducted and it came out to be positive. Her gestation age was six to eight weeks at the time of vaccination. Her EDD was approximately 03-Aug-2010 and LMP was at the end of Oct-2009. No concomitant medications have been reported for this patient. On 05-Jan-2010, the patient received H1N1, Intranasal. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments were not applicable. The outcome of this vaccine exposure during pregnancy was considered resolved. Additional information was received on 19-Jan-2010 and incorporated into the narrative: obstetrical history, gestation age, EDD, LMP and lab information. Other information obtained were reporter's address and title of the reporter.
Within 24 hours of receiving vaccine, patient had the onset of a fever of 101-102, sore throat, arm swelling and local erythema.
Generalized seizure,  with tonic clonic movements and no memory for event witnessed by spouse, lasted 10 seconds
Chills followed by fever 101. Took Advil, fever releived.  Felt chilled and as if having fever at 6AM 4/20/15 and took more Advil - fever relieved. Feels tired, slight nausea, no appetite.
doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medications were reported.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer. The excursion was found out in an audit. The agent guided the reporter to the online temperature excursion tool and found that vaccines were viable. Patient did not report any adverse reactions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-675735 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675735:Master case Same reporter
Employee states that she "I broke out in a rash one day after getting the flu shot" she also states that the rash was "itchy and painful when it first popped up on my chest". On 11/21/2018 employee states that it is no longer painful but it is still very itchy. Rash is on upper chest. Employee also states that she did have palpitations a couple of days after flu shot, she does state that she has a history of palpitations but they have never been as bad as that night.
Patient  states one day after receiving second dose of the Moderna Vaccine he has been having moderate fatigue and c/o increase sob with running
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 35 years, in left 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG, start date: 13Jun2007; LEVOTHYROXINE, start date: 17Jun2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Nov2022) Negative, notes: tested negative; (11Nov2022) Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Information has been received from a health professional concerning a 5.5 yr old female with no allergies or medical conditions who on 23Feb01 was vaccinated in the left anterior thigh with a second dose of varicella virus vaccine live (lot636360/1334K). Concomitant vaccination on the same day included a second dose in the right anterior thigh of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot633822/1168K). There was no illness at the time of vaccination. On 30Oct05, the pt was seen in the office for scattered lesions for five days (starting approx 25Oct05) involving the scalp, abdomen, and extremities. One lesion on the abdomen was infected. The pt was treated with mupirocin (Bactroban). It was noted that the pt's mother had shingles two weeks prior and the pt's sibling and had lesions and was examined by a physician. Additional information is not expected.
5/9/06 at 19:30 PM Temp 101.2, swelling, nausea, nasal congestion, soreness on R side of the neck and lethargy. No fever at present but other symptoms persist.
Fever, chills, body aches, fatigue deceased, appetite started day after injection.  moderately severe for 2 days slowly improving 3-4 days.
80 minutes following flu shot administration, pt. c/o lightheadedness & said felt heart pounding & felt like B/P was elevated. B/P = 154/100 HR = 128. Cont'd B/P check is = 162/100 - 150/98. HX of tachycardia & HTN.
Monday night - throwing up and very week Tuesday - week and started uncontrollable diarrhea which is only (seemingly) beginning to ease on Thursday. It has not stopped but does seem better.