chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My sinuses started draining  (10 minutes after getting the shot) in my throat & making me voice hoarse & I had to keep tying to clear my throat. Then the severe pain started setting in from my left shoulder all the way down to my wrist & fingers. I couldn't move my arm with holding it with my other hand. The pain in my wrist y felt like I fractured it. The following morning I was able to move my arm just a little. At the same time the pain went into the upper left front rib cage of my chest also felt like I fractured some ribs  & was so sore even to touch or breath.  Also the inside roof of my mouth was sensitive & felt like it was burnt & raw like I had burned my mouth from eating something  hot. I had this sensitivity for at least 3 to 4 days
Developed side effects and symptoms after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Developed side effects and symptoms after second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION COMPLICATION (Developed side effects and symptoms after second dose). At the time of the report, VACCINATION COMPLICATION (Developed side effects and symptoms after second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: decreased (Low) Decreased. On an unknown date, Platelet count: decreased (Low) Off. On an unknown date, White blood cell count: decreased (Low) Decreased.         No concomitant medications were reported.   Treatment information was not provided. On 12 Apr 2021, the patient reported she  had developed side effects and symptoms and has been going to several doctors which have been unable to diagnose what is wrong. Patient reports her hemoglobin was low, platelets were off, low white blood cell count which  has to do with the blood.
second dose of rabiesx vaccine was scheduled on 13th Aug, but that patient may not be able to receive this dose because of Covid-19/ no ae; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a female patient who missed second dose of suspect RABIES (HDC) VACCINE [IMOVAX RABIES], due to Covid-19 which was scheduled on 13-Aug-2020 for (Product dose omission) for pre-exposure immunization.  Medical history, concomitant therapy, past medical treatment, past vaccinations and family history were not provided.  This was potential medication error case due to missed dose.  It was not reported that the patient had start her pre-exposure rabies vaccine series and second dose was scheduled for the 13th, but she had not received that dose because of Covid-19. The patient had reported no adverse event at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  There will be no information on the batch number for this case.
This spontaneous report as received from a healthcare worker refers to a 12 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 08-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K007828 expiration date 02-MAR-2017. On 12-AUG-2015, the patient was again vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K011562 expiration date 08-APR-2017. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
About 30 hours after 2nd vaccine, extreme joint, bone, muscular pain. At the same time, sensation of burning skin. Within 5 minutes of the pain, took 2 tylenol and shower, but shower was extremely excruciating burning. When tylenol kicked in, everything dissipated, very fatigued, extreme tiredness and heavy sleeping. Had an extreme itching since then, has been determined to be neurological (no redness, no heat) just a nerve sensation. Now on gabapentin, has reduced symptoms of itching, but the itching is still there, just less severe. Went to General Practitioner and Dermatologist, both said was neurological.
administered an expired dose with no reported adverse event; Initial information received on 02-Nov-2023 regarding an unsolicited valid non-serious case received from via other health professional.  This case involves a 15-month-old female patient who had administered an expired dose of vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 01-Nov-2023, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength, expiry date: unknown) (lot: UJ786AA, expiry date: 12-Oct-2023) via unknown route in the left thigh for immunization and administered an expired dose with no reported adverse event (expired product administered) (latency: same day).  Action taken with diphtheria, tetanus, AC pertussis, IPV and HIB vaccine (pentacel (VERO)) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown for the 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
12/29/2020 6:00 PM- 12/30/2020 10:30 AM Chills, bodyache, headache, vomiting
Otherwise in normal state of health when she presented to have her first vaccine today. In observation area she developed jerky movement of right upper extremity and called to be taken to first aid bay. As soon as she was transported to the bay she exhibited myoclonic jerks. She reports this has happened in past and that as long as she does not lose consciousness it is normal for her. Jerky movements lasted for about 15minutes and resolved spontaneously. She was not post ictal and was awake and alert and conversive throughout episode. She reports history of seizures but not on any medication. She likely has pseudoseizures. Her vitals were stable. She reports her full blown myoclonic jerky movements have not happened
Shortly after receiving immunization developed a sore arm. Arm soreness with tingling in wrist and hand occured as day progressed. At approximately 5:00 PM patient developed a headache, nausea, and dizziness. Patient reports difficulty sleeping that night. Patient reports taking Ibuprofen that evening.
Vaccine participant received Moderna dose 2 fewer than 24 days after the first dose.  Moderna dose received on 03/27/2021
Woke up after nap very tired.  Cried getting diaper changed. Refused snack/drink. Started to fall, eyes rolled back, skin tone looked gray/blue, body went rigid for about 2 minutes. EMS arrived within 10 min. HR at 180 bpm. Febrile 102F. Blood sugar 112 mg/dL
STENT THROMBOSIS; This spontaneous report was received from literature. This report concerned a 54 year old adult male of an unspecified race and ethnicity The objective of this study was to describe evidence of thrombotic events after Janssen & Janssen COVID-19 vaccine. Although the vaccine is effective to prevent serious COVID-19 infections. The patient's height, and weight were not reported. The patient's past medical history included: coronary artery disease (PCI) (percutaneous coronary intervention) to the left anterior descending artery (LAD) six years prior presented with substernal chest discomfort.), and stent, and concurrent conditions included: hypertension, hyperlipidemia, and type two diabetes mellitus The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after 3 weeks of vaccination, the patient experienced substernal chest discomfort for three hours, vital signs were in normal limits, and his electrocardiogram showed two-to-three-millimeter ST elevation across the precordial leads with reciprocal ST (Stent thrombosis) depressions. The patient was brought emergently to the cardiac catheterization lab where coronary angiography revealed a large thrombus within the previously placed LAD (left anterior descending artery) stent. The patient underwent aspiration thrombectomy, balloon angioplasty and stenting of the LAD (left anterior descending artery). The patient was discharged in good condition on dual-antiplatelet therapy after three days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stent thrombosis. The authors emphasized on the possibly related temporal relationship of stent thrombosis with Janssen & Janssen COVID-19 vaccine by providing the evidence of an case study so that we can learn more about the 2019 coronavirus and the COVID-19 vaccines.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220409369-COVID-19 Vaccine Ad26.CoV2.S- STENT THROMBOSIS. The event(s) 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(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Patient almost immediately felt nauseous and started coughing. She does have a history of asthma, so she took a couple puffs of her inhaler. After a period of time she stated her chest started to feel tight and felt like her airway was tightening. she was given 0.5ml of epinephrine and almost immediately felt better.
Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 077C21B, 006B21A and 022M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient received Moderna Covid-19 vaccine that underwent a temperature excursion. The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna Covid-19 vaccine was stored in. The reporter had used the online Temperature excursion tool and was comfortable that her patient was valid and that the affected vaccine was viable for future doses. Side effects after any doses was unknown. The temperature in the refrigerator that the Moderna Covid-19 vaccine reached 13.1 degrees Celsius on 28-Jun-2022. Excursion vaccination date was 08-Jul-2022 with batch number 014B22A. No treatment medications were reported.  Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2022: Follow up received included significant information added patient demographics and narrative updated.
Weakness; Episodic cold sweats; Itchiness; soreness in the arms; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HYPERHIDROSIS (Episodic cold sweats), PRURITUS (Itchiness), VACCINATION SITE PAIN (soreness in the arms) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (Weakness), HYPERHIDROSIS (Episodic cold sweats), PRURITUS (Itchiness), VACCINATION SITE PAIN (soreness in the arms) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), HYPERHIDROSIS (Episodic cold sweats), PRURITUS (Itchiness), VACCINATION SITE PAIN (soreness in the arms) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood pressure measurement: high (High) elevated BP.         Concomitant products included blood pressure medication and eye drops. ?No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable
She is in her third trimester, baby is due on 16 AUG 2020; This is a prospective pregnancy case. This 35-year-old female subject was enrolled in an open label study. The subject received Boostrix on 21st July 2020, for prophylaxis. The subject's estimated date of delivery was 16th August 2020. The subject received Boostrix at an unknown time during the pregnancy.   On an unknown date, unknown after receiving Boostrix, the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.    Additional details were reported as follows: The patient received Boostrix in her third trimester and was due on 16th August 2020.  The last menstrual cycle unknown.  The patient did not experience an additional adverse event. The reporter did not consent to follow-up. caller does not give permission to contact HCP.   Follow up information was received on 21st April 2021: After completion of all the follow up attempts the case was considered as pregnancy lost to follow up.
Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 26-MAY-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
12hrs post injection extreme muscle fatigue, aching joints in all areas, pounding headache, left side front and back chest pain,rapid heartbeat, facial swelling, joint swelling, nausea, about 24 hrs later headache, nausea and joint pain continued, sore throat and insomnia developed and nausea worsened and has lasted since the initial onset. Today, approximately 60 hours later I have been vomiting and have diarrhea with nausea and continued headache with joint pain.
Approximately 24 hours after her 1st Pfizer vaccination she showered and as soon as the water hit her skin around the injection site she felt a burning sensation.  The area sort of bubbled up  and bled.  The burning sensation lasted throughout the shower whenever water hit the area.  The next morning the area was scabbed and depressed.
Hot and cold; Weakness; Fever; A spontaneous report was received from a consumer concerning herself a 93-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed fever/pyrexia, weakness/ asthenia, and she was also cold and hot/ feeling of body temperature change.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 25 Jan 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unspecified date, the patient developed fever, weakness, and she was also cold and hot. She was sick for about 4 weeks Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   The outcome of events, fever, weakness, and she was also cold and hot were unknown.
Fever x 3 days, decreased appetite, decrease urine output. Denies localized pain, diarrhea or vomiting.
Severe Itching tingling skin rash  , red and very itchy especially arms and trunk but could be every where
Vaccine was administered too high on the arm and poked the nerve.  Patient reported tingling and numbness down the left arm.
This spontaneous report has been received from a healthcare worker/practice manager referring to an unspecified number of patients of unknown age and gender because of a "data logger". Between 06-APR-2016 and 19-MAY-2016, the unspecified number of patients received unspecified doses of VARIVAX (dose and route unspecified) (lot # L034372, expired on 08-SEP-2017 and lot # L032391, expired on 29-AUG-2017), which were improperly stored. The temperature of excursion was 11F and the time frame was 15 minutes as reported. There was no previous temperature excursion. No adverse effect was reported. No further information provided. This is one of 2 reports received from the same source. Additional information has been requested.
A WEEK AFTER THE VACCINATION I NOTED AN ITCHY SPOT, SIMILAR TO A SPIDER BITE REACTION, WHICH INCREASED IN SIZE OVERNIGHT.  OVER THE NEXT WEEK IT BECAME A LARGE WARM, ITCHY RASH ON UPPER LEFT ARM.  I UNDERSTAND THAT THIS IS NOW CALLED COVID ARM. BENADRYL CREAM HELPED WITH ITCH INITIALLY,  BUT THE RASH HAS STILL INCREASED IN SIZE AND IS STILL ITCHY, RED AND WARM.  COLD COMPRESS DIDN'T SEEM TO HELP.
Information has been received from a Licensed practical nurse (L.P.N.) concerning a patient of unknown age and sex. On 05-SEP-2012, the patient was inadvertently vaccinated subcutaneously with a single dose of ZOSTAVAX (dose, route and frequency were not reported) (lot# not reported), while patient was intended to received the second dose of VARIVAX (Merck). There were no adverse effects. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
A report was received from a health care professional on 12 November 2003, concerning a number of vaccine who inadvertently received 2 doses of Fluvirin on unspecified date.  On unspecified dates, within approximately a one-month period the vaccine received 2 doses of Fluvirin.  No adverse symptoms were exhibited at the time of reporting.  There was insufficient information to determine the reporter's causality assessment.  Follow-up pending.
Bilateral swelling below eyes occurring 18 hrs after immunization. Resolved in 2 days with residual skin hyperpigmentation and dryness.
Hives on Legs - got similar reaction last year. Taking BENADRYL and will monitor if it gets better or worse.
1) Left thigh (DTaP) hot, hard, red knot 2) Left deltoid red, hot, hard knot (HIB); 2 days after injections.
The first 48 hours after the injection I had a fever 99.4. Body aches headache fatigue. And my arm hurt to the touch. Then a week after the injection I had body aches soreness in the injection site. Redness and itching on the injection site.  Today  I have a slight cough and the injection site is swollen and red and itches a. Lot.
Approximately 1 hour after receiving the influenza vaccination, she felt an aching sensation in her Left hand below her thumb. She states that the ache has been constant and when she lifts things the ache radiates to her left wrist area. No visable or apparent inflammation upon inspection.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to am unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 15-year-old female patient with attention deficit/hyperactivity disorder (ADHD), Diabetes Mellitus Type 1, scoliosis, who was allergic to penicillin, dust mites, and shellfish. It was not reported whether the patient had any other illness at time of vaccination. The reported informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 28-JAN-2014 at 3:40 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient was informed and declined to revaccinate. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown, although date of recovery was written as 18-APR-2014. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.