chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ONE HALF HOUR AFTER VACCINE felt warmth at injection site and had a low grade temp. Upon 12 hours following body aches, malaise, sore throat, cough and asthma symptoms such as wheezing and now going into third day post vaccine.
Moderna Covid19- Vaccine EUA Swollen lymph nodes (left side of mouth)-- color bright red  After eating avocado-- the inside of my mouth started to swell at gums (where wisdom teeth sit) along with the inside of my cheek). The swelling remained even after taking 10 ml of Benadryll.
Fever of 102, nausea, fatigue, chills, body aches, severe headache.  Treatment was rest, maintain hydration, and BRAT diet.  Signs and symptoms resolved within 24 hours.
I thought I had a head cold but then I got a sore throat. I took a home test and it was negative. It became progressively worse so I went to see the doctor on April 20th and tested positive. When I went to see the doctor, he suggested OTC medicine-Vitamin D3 and zinc both once daily. Tylenol as needed. He also recommended Chloraseptic spray for the sore throat. I had a lot of cough but no phlegm. I am still suffering from fatigue. My throat pain did subside. I do have a follow up visit to see the doctor. I'm am out of quarantine currently. I am better but not yet a 100%.
OBGYN provider ordered Gardasil injection to be given during clinic visit. injection given to pt as ordered by provider. no adverse event noted.
Narrative: 92 y/o male patient with a past medical history significant for A-fib, COPD, seizure disorder, GERD, pacemaker placement went to ER on 9/13/21 when feeling ill & found to be hypoxic due to pulm. edema. Pt wa at non-agency ER so little notes after this event until pt deceased on 9/17/2021 (4 days later) at hospital PROGRESSIVE CARE UNIT. Pt had received covid vaccines on 2/3/21 & 3/4/21. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
Significant cellulitis of upper right arm starting evening of Menveo administration, worsening over following 48 hours. Seen in ER and given po clindamycin. Seen back in provider's office 2 days later for follow-up- lesion spreading further so sent back to ER.
Strong pain on the left arm, between back and scapula, and axillary pain. I only had taken acetaminophen. Having a slow recovery. Today, 4th day after the vaccination with second dose still have pain but is lower.
There is something not right since I had the COVID shot; it did not help as far as I kept getting COVID but it did not helped COVID / I did get the vaccination and I did get COVID; There is something not right since I had the COVID shot; it did not help as far as I kept getting COVID but it did not helped COVID / I did get the vaccination and I did get COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6201), on 17Mar2021 as dose 2, single (Lot number: ER2613), on 08Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 25Aug2022 as dose 4 (booster), single (Lot number: FT7140) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "There is something not right since I had the COVID shot; it did not help as far as I kept getting COVID but it did not helped COVID / I did get the vaccination and I did get COVID". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Breakthrough case admission after 2 vaccines Pfizer 3/6/21 Lot# EL3248;  Pfizer 3/27/21 Lot# EL9265
Soreness in both arms and redness and bump forming at injection site. Severe Fatigue lasted 24 hours.
COVID 19 infection diagnosed with positive PCR test on 10/25/2022. A RAT was negative that morning but positive later that day. RAT tests were positive that week. Initial symptoms were hoarseness, fever, chills, and fatigue. Cough, hoarseness, and fatigue are still present on 11/14/2022, but RAT is negative.
GMOM REPORTS THAT CHILD WAS "FEVERISH" ON 27DEC; ON MORNING OF 28DEC90, HAD CONVULS (HEAD BACK, EYES ROLLED BACK STOPPED BREATHING), WAS TAKEN TO ER- TEMP 104.6(R), WAS GIVEN 02.
Left deltoid erythema, warmth, tenderness. Treated for non-purulent cellulitis with KEFLEX and BACTRIM.
Continued pain in shoulder joint, not muscle. Weakness in left arm and no longer have full range of motion. Possible SIRVA.
fainted; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75-year-old female patient (not pregnant) received PF-06928316 (ABRYSVO), on 03Sep2023 at 15:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years, in arm for immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 03Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; LISINOPRIL; ALENDRONATE. No known allergy. The following information was reported: DIZZINESS (non-serious) with onset 04Sep2023 at 10:30, outcome "recovered" (04Sep2023); SYNCOPE (medically significant) with onset 04Sep2023 at 10:30, outcome "recovered" (04Sep2023), described as "fainted". Therapeutic measures were not taken as a result of syncope, dizziness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling at arm pit; lump swollen at collar bone, hurts to touch; lump swollen at collar bone, hurts to touch; lump swollen at collar bone, hurts to touch; lump swollen at collar bone, hurts to touch; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Fj8757), administered in arm left, administration date 14Dec2021 08:00 at the age of 51 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol; "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfzer, Prev dose brand unknown=False, Prev dose lot number=Ew0161, Prev dose lot unknown=False, Prev dose administrationdate=14Apr2021, Prev dose administration_time=01:00 PM , Prev dose dose number=2, Prev dose vaccine location=Left arm), administration date: 14Apr2021, for Covid-19 immunization; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfzer, Prev dose brand unknown=False, Prev dose lot number=Er8730, Prev dose lot unknown=False, Prev dose administration date=25Mar2021, Prev dose administration time=01:00 , Prev dose dose number=1, Prev dose vaccine location=Left arm), administration date: 25Mar2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 08:00, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (non-serious) with onset 15Dec2021 12:00, outcome "not recovered", described as "Swelling at arm pit"; MASS (non-serious), LYMPHADENOPATHY (non-serious), HYPERAESTHESIA (non-serious), PAIN (non-serious) all with onset 15Dec2021 12:00, outcome "not recovered" and all described as "lump swollen at collar bone, hurts to touch". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of peripheral swelling, mass, lymphadenopathy, hyperaesthesia, pain. The patient was not diagnosed with covid-19 prior and after vaccination.  Follow-Up (30DEC2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Pt received PREVNAR-13 vaccination. Later that day pt had severe headache with nausea. We must stress that the vaccine may have been the cause. The MD's could not determine a probable cause; they could only infer the possibility.
2DEC95 830AM pt awoke, not moving, lips blue, face white;taken to local ER-pt did not respond to any pain stimuli assoc w/IV;did not cry or move;CAT scan neg;transferred to another hosp;mom states there was some convuls activity;
local inflammation: reddened, warm, sl swollen area approx 3" x 1 1/2" rt arm-deltoid area; has taken Ibuprofin;TD given 7NOV95;
About 12 hours after injection extreme joint pain and headache. Every joint in body with more pain in areas that have historically bothered me such as neck arms and knees. Took 800mg of Ibuprofen twice a day for 3 days to reduce pain. Headache subsided after day 4. Since pain has subsided unable to sleep well due to constant dreaming that feels more like daydreaming as I?m partially awake. Actually recall some of dream up to 24 hours later. I have not recalled a dream the moment I have awaken in decades. Having issues focusing and memory loss. Extremely short term memory loss. Having to do task multiple times as I forget what I was attempting to do. Symptoms have not gotten better but appear to be stabilized now at week 3 of the second vaccination.
Admitted to hospital 1/13/2022 with acute encephalopathy and generalized weakness with odd presentation. Initially blamed on a possible urinary tract infection, but subsequently the neurologic condition continued to worsen to a severe state not consistent with UTI. Symptoms of severe encephalopathy, generalized weakness, tremor and confusion. He required intubation and mechanical ventilation on 1/18/2022 due to such severe neurologic condition that he could not maintain an airway. He has been seen by multiple specialists (to include two neurologists, an infectious disease specialist, critical care physicians) without a clear diagnosis other than possibly aseptic meningitis based on minimal findings on a lumbar puncture (see below) possibly due to "autoimmune encephalitis" (per neurology assessment of all these findings). Patient continues in critical care in ICU and continues to worsen neurologically. No improvement after trial of IVIG. No obvious improvement with steroids (continuing to treat, most recent neurology assessment indicates they think patient may be plateau of symptoms).  No obvious improvement after broad spectrum antibiotics. Remains on mechanical ventilation in ICU.  Note: onset of symptoms (one week after vaccination) is based on a very lengthy conversation I had with wife the night of 1/18/2022.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 31-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the local Health Authority at this time. It was reported that no adverse reactions were reported by any patients. No treatment medication was provided.
Patient felt dizzy the day after her immunizations, and had 1 episode of syncope, no injuries.
12 hrs after taking injection I started being cold to the point that I was shivering and shaking. Lasted around 12 hrs.
Fever and swollen arm that I could not move. Took 480 mg of Tylenol, but fever persisted until Wednesday p.m. I could not move my arm and had to miss work. Fever made me nauseous, and I could not eat. Became very weak.
Information has been received from a licensed practical nurse concerning a 10 year old male patient with seizure disorder and "mental delay" who on 31-MAY-2009 was vaccinated SQ with a 0.5 mL second dose of VARIVAX (Merck) (lot # 664021/0502Y).  Concomitant therapy included DILANTIN, TEGRETOL and clonidine (unspecified).  On 26-AUG-2009 the patient experienced redness and swelling at the injection site of the left upper arm.  The patient's parent called the office and was recommended to give the patient TYLENOL and to apply cool compresses.  No laboratory or diagnostic tests were performed.  The patient's symptoms resolved on 28-AUG-2009.  Additional information has been requested.
1 day after receiving Menactra, developed increasing pain and swelling at vaccine site. (+) dizziness 3 days later x 1 day. No fever. Seen in office 4 days after immunization with 20cm induration, tender and no erythema. Treated with Keflex.
9MAY96 w/in 10min of inj, c/o tingling in lt hand & fingers;no pain @ lt deltoid site, then itching @ elbow & upper arm but not @ inj site;tx epi & APAP;10MAY96 returned w/pain, itching, swelling @ lt deltoid inj site;DPH & APAP
Itchy rash on trunk and upper arms. Started February 24, 2021 during early morning hours.
I had the Zoster/Shingles shot in 2012 and currently have an active case of shingles. I have had this episode for almost a month. I had to go to the doctor twice and am on 3 medications to help with pain and skin lesions.
rash over body; itching over body; body swelling; itchy throat; arm pain(site where vaccine was placed); big red circle (where vaccine was placed)
Pt reports day after vaccine 01/22/2021 she had approx. a quarter size, red, harden, elevated area to LUA . She states it was extremely painful and days following injection pain worsened to radiate down her arm which started to cause numbness and tingling. She presented today for 2nd covid injection which was not recommended by her PCP due to current ongoing problem since her last vaccine. She was wearing splint to left wrist upon arrival per pt report due to pain and some numbness that she has been having. Pt states per PCP looked at area and she was referred to neurologist for nerve conduction study due to ongoing serve pain.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9, via the subcutaneous route (dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. No known adverse effects were reported.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient concerned a 61 year old male with unspecified race and ethnicity. Initial information was processed along with the additional information received on 06-SEP-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-AUG-2021, it was reported that the patient was tested positive for covid (suspected clinical vaccination failure and suspected covid-19 infection). The patient had sore throat, fever, body aches and chills for nearly a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000192658.; Sender's Comments: V0: -20210915647 - covid-19 vaccine ad26.cov2 - Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. Since an unspecified date in November 2014, doses of GARDASIL, which were improperly stored (incorrect product stored), were administered to unspecified number of patients (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were noted. No concomitant therapies were reported. This is one of several reports received from the same reporter. Additional information is not expected, because the reporter not consent further follows up.
This spontaneous report was received from a pharmacist and refers to a 70 year old male patient with no drug reactions or allergies. The patient's medical history included port placement possibly for pneumonia. On 20-MAY-2016, the patient received a dose of ZOSTAVAX (lot # L048452, expiration date: 01-MAR-2017) 0.65 ml, subcutaneously as vaccination. There was no concomitant medication. On approximately 27-MAY-2016 (reported as "about a week later"), an abscess was on patient's left chest, where his daughter stated he had a port placed in the past. The patient sought medical attention and wen to healthcare professional, who sent him to the emergency room (ER), where the infection was cut out. No lab diagnostic studies were performed. The outcome of the events was reported as recovering. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Mom took pictures of rash to L and R thighs. Rash appears to be a solid red circle slightly lower than the injection sight. Injection sight appears bruised with a small red dot over puncture site. Mom states injection site was raised and was hot to touch.
BP 169/101; HR 109; tongue and throat itching; tongue and throat itching; chest pain; discomfort; This is a spontaneous report from a non-contactable pharmacist.   A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2), at the age of 60 years-old, dose 2 intramuscular, administered in Arm Left on 14Apr2021 (Batch/Lot Number: ER8733) as a single dose for covid-19 immunisation. And dose 1 Lot number: ER8727Administration route: Intramuscular, Administration Date: 24Mar2021, Vaccine location: Left arm. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination was given in a hospital. on 14Apr2021, at 1557: Pt went up to nursing staff 15minutes after vaccine administration to report tongue and throat itching. VS assessed: BP 169/101, HR 109, O2 99%. Pt then c/o chest pain and discomfort, was seen gripping chest for relief. Code MET called 1602: Code MET team transported pt to ER for higher level of care. Pt received diphenhydramine 50 mg PO and methylprednisolone 125 mg IV in the ED as well as cardioversion (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19, nor was tested after vaccination. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
The morning of 12/20/2021  I woke up with swollen right knee and sharp pains shooting down to my foot. I took ibuprofen put a heating pad on it and would switch to ice.  In about 5 days that pain switched to my left knee with pain worsened I did the same as I did for my right knee but me left knee is still swollen and in a lot of pain
No additional AE information; Vaccine was going through temperature excursion/was administered to patients; Information has been received from a Nurse concerning to a patient (age and gender not reported). No medical history, concurrent condition nor concomitant medications were reported.  The nurse informed that since 01-NOV-2020 doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No.  S027465, exp. date 02-MAR-2021) went through temperature excursions and was administered to patients.  On 04-DEC-2020, the patient was vaccinated with a temperature excursion dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (product storage error). No adverse event was experienced.   Call because of data logger: Yes   Temperature excursion: -14°C for 0.25 hours
feeling sick; small fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), PYREXIA (small fever) and CHILLS (chills) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Birth control pill.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MALAISE (feeling sick), PYREXIA (small fever) and CHILLS (chills). At the time of the report, MALAISE (feeling sick), PYREXIA (small fever) and CHILLS (chills) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2022-461233 (Patient Link).
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female (age: 87; units unknown) patient of unknown ethnicity received PREVNAR 13 at single dose on an unspecified date. After vaccination, her arm turned red and was swollen and hot. She went to the emergency room and was diagnosed with cellulitis and was given an antibiotic. Her arm was very red all the way to her elbow 10 days after the shot on an unknown date. Outcome was unknown.