chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately flush, hot, tired.  Later on, after about 1 week, joint pain, tendonitis, headache, tinnitus in left ear which all persist.  I had COVID in May 2021.  Most concerning is some kind of positional arrhythmia when I lay down, which seemed to start a few weeks after IM.  Vaccinologist did not aspirate the needle as I asked.  Still have frequent headaches, joint pain, get out of breath easily, and the arrhythmia.  Getting doctor's appt.
This case was reported by a health professional on 31 August 2007. A 25-year-old patient with a history of migraine received an intramuscular left arm injection of Fluzone (U2436AA) on 30 August 2007 at 2:00pm. The patient had a mild headache at the time of injection, and after receiving Fluzone took Relpax to treat the headache. Three hours later, at 5:00pm, the patient noticed "tense muscles", "throat swelled", and difficulty drinking/eating. The events resolved. No additional information was provided.
This spontaneous report was received from a doctor of pharmacy and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant medications were not reported. ON 26-OCT-2015,, the patient was vaccinated with an expired dose of PNEUMOVAX23 (dose and route of administration were not reported; lot # K006681 and expiration date on 21-OCT-2015). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient complained of tingling/numbness/weakness of right arm, stated could not feel fingers or arm very well. Onset of symptoms approximately 3-5 minutes after administration of vaccine. Ice pack applied to right arm at site of injection, assessed and compared strength of hand grips bilaterally. Patient started feeling relief of symptoms after 10 minutes. Strength increased of right arm. Spoke with patient 9-24-09, states numbness and weakness gone, arm is just sore at site. Described soreness as normal reaction.
Tonsillar inflamation; Something in the throat, it was sort of inflamed; Ear pain; Sore arm; Fever of 37.6°C; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR INFLAMMATION (Tonsillar inflamation), RESPIRATORY TRACT INFLAMMATION (Something in the throat, it was sort of inflamed), EAR PAIN (Ear pain), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever of 37.6°C) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (Fever of 37.6°C). On an unknown date, the patient experienced TONSILLAR INFLAMMATION (Tonsillar inflamation), RESPIRATORY TRACT INFLAMMATION (Something in the throat, it was sort of inflamed), EAR PAIN (Ear pain) and PAIN IN EXTREMITY (Sore arm). At the time of the report, TONSILLAR INFLAMMATION (Tonsillar inflamation), RESPIRATORY TRACT INFLAMMATION (Something in the throat, it was sort of inflamed), EAR PAIN (Ear pain), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever of 37.6°C) outcome was unknown.            This case was linked to MOD-2021-118729 (E2B Linked Report).; Sender's Comments:  MOD-2021-118729:
Information has been received from a physician concerning a female patient who on 02-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 663894/0129Y) 0.65ml, subcutaneously in the left side. On approximately 02-MAR-2009 the patient experienced rash at the site injection. On 16-MAR-2009 the patient was seen in the office with shingles. The patient rated pain a 4 out of 10 (10 being the most pain). The patient had vesicles on left side of abdomen. The patient did not have any other systemic symptoms. The physician did not know if the patient was exposure to chickenpox or herpes zoster. There were no Laboratory Diagnostics Studies performed. Additional information is not expected.
Extremely sick; Constant diarrhea; Severe stomach pain; Sweating; Shortness of breath; Hands went numb; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Extremely sick), DIARRHOEA (Constant diarrhea), ABDOMINAL PAIN UPPER (Severe stomach pain), HYPERHIDROSIS (Sweating) and DYSPNOEA (Shortness of breath) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Extremely sick), DIARRHOEA (Constant diarrhea), ABDOMINAL PAIN UPPER (Severe stomach pain), HYPERHIDROSIS (Sweating), DYSPNOEA (Shortness of breath) and HYPOAESTHESIA (Hands went numb). At the time of the report, ILLNESS (Extremely sick), DIARRHOEA (Constant diarrhea), ABDOMINAL PAIN UPPER (Severe stomach pain), HYPERHIDROSIS (Sweating), DYSPNOEA (Shortness of breath) and HYPOAESTHESIA (Hands went numb) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
This spontaneous report as received from a consumer refers to his mother: currently 85 year old female patient with asthma, high blood pressure, eczema and allergy to sulfur. On an unspecified date around May 2015, the patient was received first dose of ZOSTAVAX (dose, frequency and route of administration were not reported). The patient was vaccinated a second time with ZOSTAVAX around August of 2015 because her pharmacy inadvertently gave her ZOSTAVAX again when she was supposed to get a Pneumonia vaccine in August. The reporter also mentioned that his mother developed a "bad infection" in her knee in between the time she had received the two vaccinations of ZOSTAVAX (in approximately 2015). Reporter stated that his mother ended up going to the emergency room to treat the infection but she was not admitted to the hospital. The infection was treated with potent, unspecified antibiotics. Unspecified lab work done every year. The outcome of the knee infection was reported as recovering (the patient was still experienced pain in her knees). Causality assessment was not provided. Additional information has been requested.
A PATIENT WHO HAD RECEIVED FLUMIST QUADRIVALENT BECAME POSITIVE FOR (FLU A) A WEEK AFTER FLU MIST WAS ADMINISTERED TO THE PATIENT; LACK OF EFFECT; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.    The report described lack of effect for Flumist Quadrivalent. The reported term was "lack of effect" (Preferred term: Drug ineffective).     On an unknown date, the patient experienced a patient who had received flumist quadrivalent became positive for (flu a) a week after flu mist was administered to the patient (preferred term: Influenza).     The outcome of the event(s) of a patient who had received flumist quadrivalent became positive for (flu a) a week after flu mist was administered to the patient and lack of effect was unknown.     The events were considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
administered the DTaP/IPV vaccine instead of reconstituting with the HIB to make it a Pentacel; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old patient who was vaccinated with administered the DTAP/IPV vaccine instead of reconstituting with the HIB to make it a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (formulation: unknown, the reported lot numbers for DTaP/IPV, Lot: U6469AB, Expiration Date: 11-Oct-2020, HIB, Lot: UJ134AA, Expiration Date: 11-Oct-2020, Box, Lot: UJ134AAA, 11-Oct-2020) via intramuscular route in the left thigh  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) FOR IMMUNISATION.  It was an actual medication error due to inappropriate reconstitution technique  It was unknown whether the patient had any adverse event.  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.
Patient got cramps and aches all over the body after getting the shot. He laid down and rested. Cramps and aches were gone after 3-4 hours.
Patient came in today with severe arm pain and she could not lift her arm up. She said it started after she got the shot and Ibuprofen did not help the pain.
This spontaneous report was received from a Registered Nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-JAN-2018, the patient was vaccinated with the first dose of properly stored but expired GARDASIL 9 for prophylaxis, lot # reported as L036302 and expiration date on 20-DEC-2017 (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. No product quality complaint was involved.
Patient was seen in the ER on 07/15/2001 due to being sleepy, limp and blue extremities. The patient could be wakened by shaking, but fell back to sleep quickly. The patient could not be awakened enough to eat breakfast but did take 12 oz of formula at 9:30 am, more than usual. The patient's breath had a ketone odor. Glucose was 73 to 85. Diagnosis is possibly hyporesponsive hypotonic episode of 1 1/2 hours.
Day after vaccine was given had chills, body aches & felt sick x 3 days. 4th days started feeling better has nausea & dizziness & that is decreasing.
Throat started hurting, by Saturday morning could hardly swallow, white spots inside mouth, bright red, when to walk in clinic, which prescribed an antibiotic, which I don't think will help. Jaw and right face lymph nodes involved.
DEATH; This spontaneous report received from a consumer via a company representative via social media concerned three patients. No past medical histories or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose were not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number were not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients experienced death. Reporter stated that "I know of three that died after taking it." On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220200402-covid-19 vaccine ad26.cov2.s-Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration; The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration) in a 43-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 066H21A and 066H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 265. No concomitant medications were provided. The patient received 1st and 2nd dose.  HCP stated they administered expired doses of the Moderna COVID-19 Vaccine to 27 patients. Dose administered after 30-day Use By Date or after manufacturer date of expiry. The vial was initially stored in the refrigerator and was thawed same day of administration. The vials did not undergo any temperature excursions. No adverse events were reported. No treatment medications were provided.
NO ADVERSE EVENT; GARDASIL syringe broke off of the syringe during GARDASIL 9 administration to a patient; after the administrarion was completed, the nurse inspected the tray that the GARDASIL 9 syringe came from and discovered that the rest of the finger flange was there in the tray; Product quality complaint; This spontaneous report was received from a registered nurse and concerns to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.          On 30-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R029512 and expiration date 08-JUL-2021, for prophylaxis (dosage schedule, route, and anatomical location were not reported).  During the administration a piece of the finger flange of a pre-filled hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) syringe broke off of the syringe (product quality issue and poor quality device used). However, the patient received the complete dose. After the administration was completed, the nurse inspected the tray that the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) syringe came from and discovered that the rest of the finger flange was there in the tray (product physical issue). The syringe don't have any crack but the syringe was broken into 2 or more pieces, the finger flange was broken into several pieces, some pieces were found later in the plastic syringe tray. The exact location of the breakage was between the finger flange and the body of the syringe. Also the finger flange itself was broken into several pieces. The  tip of the syringe or Luer was not lock adaptor loose or broken off of the syringe tip. The cellophane cover of the syringe tray was intact and completely sealed.   The outcome of poor quality device used, no adverse event, product quality issue and product physical issue was unknown.  The causality between product quality issue and product physical issue and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  was not provided.
Bell?s palsy, right side of face is numb, with difficulty closing eyes, smiling, raising eyebrows, eating, drinking, swallowing.
I rec'd my Flu vaccine on 10/1/13 at the drive thru employee health clinic.  I suffered from left arm stiffness a few hours after the injection.  The left arm pain, tenderness and difficulty with range of motion remains 10 days post injection without relief to heat/Motrin/Tylenol.
This spontaneous report was received from a healthcare worker refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II, lot # L000459, expiry date 06-JAN-2017, (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of five reports received from the same reporter. Additional information has been requested.
difficulty breathing, high fever, numb limbs, sore eyes, back ache, leg ache 1/12/22
I had a little soreness in my arm after receiving the vaccine. On 09/12/2022, I took a home test for COVID-19 and it was positive. I contacted my doctor on 09/16/2022 to get an appointment but was unable. I had a virtual visit with my doctor on 09/20 and my chief complaint was upper respiratory issues. I was informed that if my symptoms got worse to go to the emergency room. As of today I continue to have congestion which is being treated with nasal sprays.
This spontaneous report has been received from a certified medical assistant (C.M.A) referring to an unspecified number of patients. On unspecified dates since 02-JUN-2015, these patients were administered an unspecified number of improperly stored doses of (Oka/Merck) VARIVAX, lot # K009757, subcutaneously. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
a screaming episode that started 3hr p/the vax it lasted for >12hr;pt had a fever of 104 that started 24hr p/inj & lasted 72hr p/the inj;
her blood pressure was up to 138/103.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her blood pressure was up to 138/103 on 16Feb2021. Caller asked if it was ok to take Aspirin after receiving the vaccine. DSU: Potential AE discovered after call, thus, e transmitted. Female consumer received Pfizer's COVID vaccine yesterday on 16Feb2021. She saw the doctor in December where they told her that her blood pressure was normal and advised her to take Aspirin. She said she had been taking inflammatory medications that caused her blood pressure to go high and that the doctor recommended her to take Aspirin. She stated yesterday, her blood pressure was up to 138/103. The patient underwent lab tests and procedures which included blood pressure measurement: high on unspecified date, blood pressure was normal on Dec2020, blood pressure was 138/103 on 16Feb2021. Therapeutic measures were taken as a result of her blood pressure was up to 138/103. The outcome of event was not recovered.   Information about lot/batch has been requested.  Follow-up attempts are completed. No further information is expected.
This case is linked to 2013SA106326, 2013SA105996 and 2013SA106341 (same reporter and same product). Initial report received from a healthcare professional on 18 October 2013. A patient (whose demographics and medical history was not reported) had received a dose of FLUZONE ID (batch number: UT4720AA, intradermally, site of administration not reported) on 01 October 2013. On an unspecified date, the patient went to urgent care due to body rash. lab investigation and treatment medications were not reported. At the time of this report, the outcome was not recovered. List of documents held by sender: none.
Immunization clinic note: Patient reported feeling dizzy after about 20 minutes post-vaccination. Patient had a blood pressure of 140/100, had pulse and was breathing well. She was in and out of consciousness and non-responsive. EMT arrived about 10 minutes later and she was transported to ER. ED  note: Pt observed while in the ED - ambulating about dept, maintains stable vitals, no recurrence of syncope. Remains symptoms free. Discussed with pt that syncope - likely vasovagal in light of covid vaccine administration. We discussed possibility of allergic reaction - at this time, no signs for airway compromise and pt remains comfortable on RA. We will dc home with rx for benadryl and 4 additional days of prednisone.
Developed Tinnitus after the Pizer booster shot.  Have seen 3 separate doctors to qualify diagnoses. Have had 3 Audio graphs performed. Have gone through a battery of Prednisone and currently on Betahistine and a battery of supplements.  Have lost a considerable amount of hearing in my left.  Have developed a sleeping issue.  This is truly impacting the quality of my life
mild fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6-month-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "mild fever". Therapeutic measures were taken as a result of pyrexia.  Additional information: children, vaccinated at 6 and 7 months, also Pfizer, had the kind of mild fever "that a single paracetamol solved"  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient experience swelling/warmness on the injection arm NOT at the injection site, swelling and redness occurred lower on the arm than where the vaccinations were received
I started having tingling in my right leg. It spread to my left leg. I had light headedness/dizziness. I started experiencing muscle spasms/twitching, as well as muscle cramping. Progressed into a full body nerve pain. I also started experiencing chronic dry eyes. I was given steroid eye drops. I developed psoriatic arthritis. Also have Neuropathic pain.
WBC was low; felt lethargic; This is a spontaneous report from a contactable consumer. This 61-year-old female consumer (patient) reported for herself. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported she is taking 125mg tablets for two weeks on followed by two week off, then starting Ibrance 100mg after September 1st due to chronically low WBC count. Reported after her first Covid vaccine, her WBC was low and she felt lethargic, but it did not occur with 2nd vaccine. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.