chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated before getting vaccine he was very nervous and has fainted getting shots/blood draws.After administering Janssen Covid Vaccine, patient states he was feeling light headed and then fainted for about 5 seconds. Patient was sluggish for about 5 minutes. Had him drink some juice and he perked up. Had patient relax in chair for 20 minutes before leaving pharmacy. He did have a parent there to drive him home.
Hives within 3 hrs, swollen stiff arm, fatigue next day took Allegra allergy med extra dose
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 12/28/2020, 01/25/2021, and 11/03/2021. They tested positive for COVID-19 on 05/20/2022 at the nursing home at which they were a resident. They experienced complications of a secondary bacterial infection and possible aspiration pneumonia. They were treated with Paxolvid. They continued to decline and died on 06/04/2022.
Extremely sore shoulder arm and neck stiffness difficulty to turn head with pain coming from shot area up thru arm to neck.
Redness and swelling around vaccination site with warmth.  Pt took BENADRYL 11/7/08 and  IBUPROFEN X several days.  Saw family practitioner.  Pt had already received a dose of PNEUMOVAX 2 years ago.  MD attributed severe rxn to short time frame between doses.  Pt recovered by 11/10/08.
Information has been received from a certified medical assistant referring to a 7 month old patient. On 22-JAN-2016, the patient was inadvertently administered the first dose of VAQTA (lot # L036300, expiration date 04-NOV-2016, route and indication not provided) series (Inappropriate schedule of vaccine administered). No adverse effects were reported. There was no product quality issue (PQC) involved. Additional information has been requested.
Patient presented to the ED with tachycardia within 6 weeks of receiving COVID vaccination. Per notes: "He says that he increased his pills from 3 to 4. Unclear which pill this was. He arranges his own meds." patient has consistently tested positive for covid in the past, as well as this visit.
received vaccine on 2/24/21 at 530pm. this was her second dose and had no issues with first dose. on 2/25/21 around 12pm she became woozy and then around 5:15pm began seeing black spots. She didn't eat dinner and went to get in shower. At injection site she was red and warm to touch. She took Benadryl 50mg and then later began having difficulty swallowing. She went to local ED at 9pm.  At the ED they gave her a normal saline bolus zofran, solumedrol, and rocephin. She fell asleep at the ED and after 1 hour her swallowing improved.  On 2/26 her arm was still sore with redness and swelling at injection site. no hives or weakness noted. She went home on prednisone and antibiotic.
Client reports a red, itchy rash on face, 2 days post vaccination.  Client took Bendaryl  and the rash resolved that same day.  Client denies any shortness of breath, no throat tightening or trouble swallowing.  Client did not follow up with primary doctor.
This child had severe parotitis ,along with facial pain, low grade temp; exactly 1 week post vaccination. The mother consulted the pediatrician by phone. The parotitis resolved completely after 3 days without treatment.
8/10 pain in all shoulder area, rotator cuff, bursa, upper and lower arm muscles in the form of throbbing constantly, sharp pain when arm/shoulder moved, unable to lift arm, unable to sleep very much at one time- continued 24/7 for 9 days straight. Then pain down to 6/7 out of 10 for another week in symptoms as stated above. Then pain down to 5/10 for this following week. Pain is at peak upon waking.
Adverse symptoms started with unusual belching, severe, paralyzing constipation, then bloodshot right eye, went in for medical treatment and questioned blood lab results. Physician was giving excellent report for A1c reading and took no note of malfunctgions in kidneys and liver, dark urine, nitrates found in urine, kidney function dropped 7.8 points from .66 in October 2020 to .59 after Ozempic and Pfizer Covid 19 shot.  Also had an allergy shot one day prior to 2nd Covid shot.
left eye twitching; increased heart rate; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 17:30 (Lot number: FF2587) at the age of 46 years as dose 1,single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BLEPHAROSPASM (non-serious) with onset 19Oct2021, outcome "not recovered", described as "left eye twitching"; HEART RATE INCREASED (non-serious) with onset 19Oct2021, outcome "not recovered", described as "increased heart rate". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blepharospasm, heart rate increased.  Additional information: It was reported that the patient did not taken any other vaccine in four weeks. The patient did not have COVID-19 prior vaccination. The patient did not had COVID-19 tested post vaccination. The patient did not had any known allergies.  No follow-up attempts are possible. No further information is expected.
pt recvd vax & 4 days later devel recurrence of rash, peeling fingers; MD was notified on 2JUL93;
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Facility consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare Facility is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
I had only a sore arm for the first two days after the first dose, but one week later, my entire upper arm was itching. The next morning, I woke up to a red rash about two inches long and one inch wide right below where the injection was put in. It got worse throughout the day. It started as red spots and later in the day became one big red blotch. It?s swollen and warm to the touch, and still itches as well.
Administration error: Patient received booster dose approximately 1 week before 6 month period from second dose (second dose given 4/16/2021).  Patient reported no adverse event.
Patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-369020, MOD-2021-369053, MOD-2021-368935, MOD-2021-369022 (Patient Link).
Pt recvd vax & approx 5 mins p/vax exp arms hurting, pain when arm is lifted in any direction; seen by MD treated over the counter pain med; pt inidcated pain wakes up @ noc; small red spot @ inject site;
Initial information received on 08-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 months old male patient who only received the diluent instead of the ACT-HIB portion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation; and DAPTACEL for Immunisation received on 21-Jan-2019. On 21-Jan-2019, the patient received a 0.5 ml dose of suspect ACT-HIB lot U6054BA via unknown route in unknown administration site. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown whether adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
HEART ATTACK; SEVERE PAIN; SEVERE HEADACHE; This spontaneous report received from a parent concerned a 56 year old female. The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included was that the patient had lot of medical problems but the caller was unable to elaborate (unspecified medical problems). 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 to left arm on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, right after the vaccination the patient experienced severe headache. The patient also had a heart attack couple of days after vaccination. It was reported that the patient made it through the heart attack. On follow up with the parent, it was reported  that the patient did not had a heart attack diagnosed by a doctor and was not hospitalized or seen in an emergency room (ER). It was also reported that the patient did not like to go to hospital and just stayed in bed. The patient experienced severe pain, started in her head as a real deep pain. The reporter was not sure about the symptoms of the reported event heart attack.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart attack on an unspecified date in 2021, and the outcome of severe headache and severe pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210507105-COVID-19 VACCINE AD26.COV2.S -Heart attack,severe pain,severe headache.. This event(s) is considered unassessable. The event(s) 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 event(s).
Fatigue; Dizziness, Light-headed; nausea; diarrhea; swelling of face; muscle pain; chills; joint pain; Overall feeling of unwell; This is a spontaneous report from a non-contactable other HCP (patient). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EK5730, via an unspecified route of administration on 31Dec2020 at single dose on arm right for COVID-19 immunisation. Medical history included fibromyalgia and known allergies: Rose hip tea and Diclofenac. No COVID prior vaccination. No pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included zolpidem tartrate (AMBIEN) and duloxetine hydrochloride (CYMBALTA). The patient experienced fatigue, dizziness, light-headed, nausea, diarrhea, swelling of face, muscle pain, chills, joint pain, overall feeling of unwell; all on 01Jan2021. No treatment received for the events. Outcome of events was not recovered. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
102+ fever for 2 days with chills and severe muscle aches. Severe nausea, headache, and vomiting for 3.5 days.
Weakness; Thoughts are cloudy; Dizzy; Forgetfulness, she will do one thing and then forget what she did; This is a spontaneous report from a contactable other HCP (patient).   A 44-year-old female other HCP (Patient) reported herself who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: FF2588), via injection in left deltoid on 20Sep2021 at 20:30 (at the age of 44-year-old) as dose 1, single for covid-19 immunization at pharmacy facility. Vaccine administered at military facility was reported as no. Medical history included hypertension, asthma, chronic migraine, fibromyalgia and glaucoma (from unspecified date to ongoing). Family medical history relevant to events was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not receive any other vaccine on the same day of BNT162B2 vaccine. The events reported prior to the vaccination was none. After 3 days of first vaccination, on 23Sep2021, patient developed weakness, dizzy, and her thoughts are cloudy as forgetfulness. Stated that she will do one thing and then forget what she did. Provided seriousness of being dizzy as not serious because she was not falling down. Patient was not hospitalized nor visited to emergency room or physician office, due to the events. Stated she was trying to figure out if she should go to urgent care or try to get an appointment at her doctor's office tomorrow, she was trying to figure out if that was normal. Therapeutic measure was reported as no. The outcome of the events was reported as not recovered.
chills primarily 12-24 hours after shot; fever 24-30 hours after shot; This is a spontaneous report from a contactable consumer. The consumer reported for himself that the 68-years-old male patient received second dose of bnt162b2 (BNT162B2, PfizerBiontech, lot number: EM9810,) via an unspecified route of administration on 16Feb2021 11:15AM  on left arm at single dose for covid-19 immunisation. Medical history included heart stents from an unknown date and unknown if ongoing. Concomitant medication included atorvastatin 40 mg, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) 325 mg. The patient previously took first dose of bnt162b2 (COVID 19 PfizerBionTech, lot number: L3247) on 26Jan2021 09:30 AM on Left arm for covid-19 immunisation The patient experienced chills primarily 12-24 hours after shot on 16Feb2021 23:30 with outcome of recovered , fever 24-30 hours after shot on 16Feb2021 23:30 with outcome of recovered. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products.
Pfizer Covid Vaccine was given to patient after sitting at room temperature for 5 days. Patient did not experience any side effects or adverse effect from the vaccination.
Nausea, vomiting x 1, itching, red face, throat swelling sensation, numbness and tingling in hands and face.
urticaria all over body- started on right arm and extended down to her hand, spread to full body. patient also reported that she had hives in her throat but denied any issues with breathing. Fever  reported fever of 101 on 12/14/19. patient went to ER on 12/15/19.
injection site becoming sore and tender. little headache, really tired. low energy, nausea. This is all very unusual for me.
Beginning hours after vaccination, fever and body aches.  Continued to-date 3 days later and on going. Fever, nausea, body aches and headache
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, since 01-MAR-2015, the patients were vaccinated with improperly stored doses of ROTATEQ, (dosing details and lot# not reported). No adverse effects were reporter. The vaccine was exposed to high temperature of 10.3 degree Celsius for a cumulative time frame of 731 hours from 24-NOV-2015 through 26-OCT-2016. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had an syncope episode following a pfizer covid 19 shot. She had shortness of breath and appear to have a seizure afterwards. Gave 1 dose of an epipen and patient vitals was stable.
No adverse event; 11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    It was unknown if the patient receives any other vaccine in the 4 weeks prior to Moderna Pink Cap COVID-19 vaccine. These patients were never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and Expiry Date was unknown), (Lot number 216K22A and Expiry Date was unknown).  Treatment information was not provided.  This case contains information about patient 8 out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Master case
#2 booster given at 2:30 pm 7/25/2022. Felt tired and lethargic within one hour of dose. Woke up 7/26/2022 at 6 am with extreme body aches and pains, fever, sore throat, stuffy nose, headache, chills, lungs hurt, tired, lethargic, extreme fatigue and uncoordinated (almost fell a few times). Injection site: extremely swollen arm and extremely painful. Cannot use my left arm. Too painful. Cannot move my arm close enough to touch my side. Too swollen and too painful. In general, bed bound.
This is a spontaneous report from a contactable consumer (patient). This is the second of two reports of the same patient receiving the second dose of BNT162B2.  A 30-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 17Mar2021 (Lot Number: EN6201) as single dose (at the age of 30) for covid-19 immunization. Medical history included ongoing asthma (diagnosed about 10 years ago), Basedow's disease from 01Mar2021 and ongoing, hypersensitivity, hyperthyroidism, anxiety. First dose of BNT162B2 was given on 22Feb2021 and she felt sick to her stomach, nausea, had no energy, 160 heart rate atrial fibrillation, hand tremors, shortness of breath, she felt exhausted, low grade fever, thyroid storm, felt tired, shaking, flu symptoms.  Concomitant medications included levocetirizine dihydrochloride (XYZAL) taken for allergy from 2020 to 24Feb2021, guaifenesin (MUCINEX) taken for hypersensitivity from Dec2020 to 20Feb2021.  When she got the second vaccine, her heart rate was high again. She did have a thyroid storm the day after the second dose (18Mar2021) and she was in the emergency room again since her heart rate was so high. It was reported that the vaccine did cause her thyroid storm. She knows vaccinations have to do with the immune systems, and if she has an autoimmune disease, she is thinking it may have come from it. States two doctors are certain that it triggered an immune response and wanted her to report this. She could barely stand up or talk, she was so short of breath and is guessing that was from her heart. She had normal flu like symptoms from the vaccine but does not think it was related to her thyroid. She has always had little cold symptoms after getting a vaccination. First night she felt very exhausted, tired. She had a low grade fever that Tylenol took care of and it went away within a day. She felt run down and it was vaccination related. The second day (19Mar2021) she had really bad hand tremors that moved into her body. She thought the shaking was from the vaccination and she took a video of it. She did not really have any other symptoms yet, then started to get really fatigued. She went to ER and her heart was really elevated. Each time she went to the doctor or the ER, her heart rate would be 20 beats faster then 20 beats faster again.  The outcome of her heart rate was high again / heart elevated/her heart rate would be 20 beats faster then 20 beats faster again, short of breath was recovering. The outcome of guessing that was from her heart, exhausted/tired/ felt run down/ really fatigued was not recovered. The outcome of the other events was unknown.
Patient reported feeling like she had increased heart rate. Vital signs at 1420 were as follows pulse 133 bpm, oxygen saturation 100%,  and blood pressure 140/90 mm Hg.  At 1451 RN noted patient had redness to harms ad chest, and vital signs were as follows: pulse 102 bpm, blood pressure 162/90 mm Hg, and oxygen saturation 99%. Paramedics were called to assess patient. Paramedics assessed and monitored patient and reported patient's vitals were okay, and she did not meet medical necessity. Patient signed wavier stating she did not wish to seek medical treatment with paramedics. RN assessed patient at 1510 and the vital signs were as follows: blood pressure 140/89 mm Hg, oxygen saturation 99%, pulse 89 bpm, and RN noted redness was clearing. Patient reported she was feeling okay, and she wished to leave. RN explained to seek medical treatment if symptoms continued/ worsened, and to speak with her PCP regarding her reaction.
Started feeling dizzy, light headed as if my vertigo or equalibrim was off.  I must have either gotten used to it by the time my second shot rolled around on February 27th 2021 or it went away because I really didn't take note of it again until my second dose.  The dizziness came back even stronger shortly that afternoon after my shot. As of today, March 3rd 2021, I am still feeling light headed.
Pt reports 2 days of cough, wheezing, "freezing", general achiness. No fever reported.