chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna  COVID-19 VACCINE Fever, chills, cough, sweating overnight and then loss of taste and smell the next morning. Soreness at the site of the  injection. Extremely fatigued. Tmax 100.5 Bodyaches, Headaches , Nasal congestion, Shortness of Breath, Chest Pain. Four days after 2nd Moderna vaccination his loss of taste and smell is still affected. His left arm soreness still persists. Bodyaches and fatigue still persists.  Headaches comes and go. Nasal congestion persists  Resolved Shortness of breath,Chest Pain, Fever and cough
Tender arm with large pinkish area (31cm x 22cm) around injection site and warm for 2 days.
Rash, itchy ness, and swelling at injection site 7 days after.
This is a spontaneous report from a contactable physician (who reported for her daughter) via a sales representative. A child female patient of unspecified age received TRUMENBA on unknown date in FEB2015 (mentioned as the week before the report), at single dose. Medical history and concomitant medications were not reported. On unknown date in FEB2015, while transporting the vaccine on her own, the physician mentioned that it froze. In FEB2015, the patient experienced allergy in palate with outcome of recovered. The patient also experienced allergic reaction with itching in her mouth that improved with BENADRYL. Follow-up (17FEB2015): new information received from a contactable physician via sales representative includes: new events. Follow-up (27MAR2015): Follow-up attempts completed. No further information expected.
Had his primary series of your vaccine and he caught Covid; he thinks he also had it in February of 2023; tested himself when he got back and the test came back positive; symptoms were very mild; Had his primary series of your vaccine and he caught covid; Caught covid; flew to Private airport and stayed with his family for Dec. holiday, he believes he contracted it then; back in December; he also had it in February of 2023 when he flew down to alternate location; Symptoms were very mild; same symptoms he had back in December; This non-serious initial spontaneous safety report was received by Novavax on 07-MAR-2023 from a consumer via a contact center.  A male of approximately 74 years was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 and dose 2 on an unspecified date in a pharmacy.  The following medical history was reported: Seasonal allergy (hay fever) and Blood cholesterol increased.  The following concomitant medications were reported: Claritin (loratadine).  On an unspecified day in DEC-2022, after vaccination with his primary series of the vaccine, the individual caught Covid (PT: Breakthrough COVID-19). The individual flew to Private airport and stayed with his family for Dec. holiday, and believes he contracted it then and also had it in February of 2023 when he flew down to alternate location (PT: Exposure to SARS-CoV-2). The individual tested himself when he got back and the test came back positive. The individual's symptoms were very mild and he had the same symptoms he had back in December (PT: Unevaluable event).  Relevant lab tests included: SARS-CoV-2 test (Result: Positive; FEB-2023).  At the time of reporting, the event outcome of Breakthrough COVID-19 was unknown, the event outcome of Exposure to SARS-CoV-2 was recovered/resolved with a partial stop date in FEB-2023 and the event outcome of Unevaluable event was recovered/resolved with an unknown stop date.  Lot number was requested but was unknown to the reporter.  On 13-MAR-2023, a significant case correction with Day 0 of 07-MAR-2023 was identified. The following information was updated: Event 'Vaccination failure' with an onset date of '2022' was added. The outcome of 'Vaccination failure' was recovered/resolved with a partial stop date in 2022. This case was upgraded to serious based on the new information.; Sender's Comments: This 74 year-old male experienced: Vaccination failure, Breakthrough COVID-19, Exposure to SARS-CoV-2 and Unevaluable event after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Vaccination failure was reported as serious. The events Breakthrough COVID-19, Exposure to SARS-CoV-2 and Unevaluable event were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
expired vaccine administered; This spontaneous report as received from a licenced practical nurse, via a company representative, and refers to a 6 year old patient of unspecified gender. No information was reported concerning the patient's medical history, concurrent conditions or concomitant medications.  On 26-JAN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot T025508 for prophylaxis (dose and route of administration were unknown). The vaccine expired on 23-JAN-2022. The reporter  was not sure how effective vaccine was. She requested any additional information or if the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was still effective.
Left leg edema, erythema, ecchymosis 48 hrs post vax.
Medical Assistant calling to report a limited adverse event on a dose of PROQUAD; PROQUAD that was administered improperly stored during a temperature excursion; This spontaneous report was received from a medical assitant referring to a  patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided      On 13-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T034614, expiration date 10-APR-2022 (route of administration not provided) for prophylaxis (product storage error).  On that same date, the patient experienced a limited adverse event.      The outcome of adverse event as well as its causal relationship with measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) were not reported.  The vaccine underwent a temperature excursion between 6 degrees Farhrenheit (°F) and 14°F, with an average of 8.5°F for 18 minutes, and between 6 degrees Farhrenheit (°F) and 14°F, with an average of 11.9°F for 1 hour. No previous temperature excursions reported.
She states on day 18 she noted unusual sensations to her hands. She was seen at sick call, who instructed her to wear gloves. She states there may have been some tiny papules but the more significant lesion eruptions and involvement to her ears started day 21. They were pruritic, but not painful. Sites include her hands including bilateral palms, wrists, left elbow, bilateral ears, and a small site on her lower lip, although that singular site did not itch. She denies lesions to oral cavity, torso, back, legs, groin or genitals. She reports systemic symptoms of myalgias arthralgias feeling feverish over the past week. She reports cough increased shortness of breath with increased mucus production over the past 2 weeks which she attributes to mild viral illness. She denies chest pain, chest tightness or pressure. She denies any eye symptoms including erythema, edema, discharge or crusting, blurred vision, pain or vision changes. Physical exam noted: Skin: Erythema across helix bilat, with tiny papules, one site of coalescent lesions on each ear appears papular versus early vesicle formation. Scattered papules singular & discrete to hands including palms, wrists with several clustered groups below left elbow; erythematous to flesh-colored. Treated with topical steroid and cetirizine. On follow up at one week (day 27) She reports the lesions are overall improved, in particular the ear lesions are much improved. Her hand lesions however have some sites that look bruised. She has developed new lesions above her left knee and one on her lower lip, but not at the original site of concern. Per P/E: Skin: helix bilat tiny papules, erythema resolved, no vesicles, pustules, crust or drainage. Scattered papules singular & discrete to hands including palms, wrists with several clustered groups below left elbow and above left knee; erythematous to flesh-colored. Several finger sites, particularly distal #3 5 digit left hand, and 2 digit right hand with erythematous ecchymotic/vasculitis appearance at the lesion base, blanches, non-palpable. Lip lesion left lower, papule, not erythematous or vesicular. SPV site dry, pink open wound bed, not epithelialized. Treated with prednisone 60x5 then taper over 6 days. Mostly resolved at day 34. Fully resolved without recurrence per report on 48. DX BAPE, but atypical timing & presentation.
Tinnitus, like ringing in ear; dizziness really very bad; sense of like off balance; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus, like ringing in ear"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness really very bad"; BALANCE DISORDER (non-serious), outcome "unknown", described as "sense of like off balance".  Additional Information: The patient got something very similar to many diseases which were tinnitus, dizziness, and all of that the patient had it for approximately 9 months. The tinnitus, dizziness like many other diseases could be ENT kind of problem. The patient had Tinnitus like ringing in ear, dizziness really very bad and sense of like off balance. The side effects were terrible and horrendous. The patient was in back control, but it was terrible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
flu like symptoms; Mouth dryness; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DRY MOUTH (Mouth dryness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 12-May-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and DRY MOUTH (Mouth dryness). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved and DRY MOUTH (Mouth dryness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Investigation: Normal. On 18-Jun-2021, Investigation: Normal. On 18-Jun-2021, SARS-CoV-2 test: (Negative) Negative. On 07-Jul-2021, Antimicrobial susceptibility test: Result not provided. On 07-Jul-2021, Culture: Cephalexin presented. On 07-Jul-2021, Investigation: zinc normal folate high. On 07-Jul-2021, Thyroxine: Normal.         Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  I was reported that she had patches on tongue and extreme xerostomia with burning sensation in her mouth, mouth was burning, burning pain in her mouth, dry mouth, strange reaction with her mouth. It started off very dry and gradually got worse, dryness. It was acute for at least 8 weeks. Patient also experienced chills, lot od oral issues, she did not feel well due to COVID vaccine. Her tongue and throat were swelling hard and hard to eat, difficulty in swallowing. Sore and tender spot at the base of the neck. Alterations in tongue textures, tongue changed. She has smooth areas in her tongue, and she had a feeling that her throat was closing up and difficulty in swallowing. It was like someone switched the saliva, switch of yeast infection, loose some sleep, patches on tongue.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Pruritus, unspecified (L29.9) that lasted over the course of the week
Acute Bell's Palsy; Information has been received from a lawyer referring to a male patient (pt) of unknown age. The pt's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 14-FEB-2011, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, shortly after receiving the vaccine, the pt suffered left facial paralysis, sharp pain and inability to close his left eye completely. The pt was diagnosed with Acute Bell's Palsy. As a further proximate result, the pt has suffered and will continue to suffer physical limitations, mental and emotional distress, sustained severe progressive and permanent personal injuries, as well as significant medical expenses, pain and suffering, and other damages. The outcome of the event was not recovered and it was considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, Acute Bell's Palsy was considered a medically significant and disabling event.
don't feel normal/not feeling good; feel like I'm getting cold; achy; feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (don't feel normal/not feeling good), FEELING COLD (feel like I'm getting cold), MYALGIA (achy) and FATIGUE (feeling very tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood pressure since an unknown date.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced FATIGUE (feeling very tired). On an unknown date, the patient experienced FEELING ABNORMAL (don't feel normal/not feeling good), FEELING COLD (feel like I'm getting cold) and MYALGIA (achy). At the time of the report, MYALGIA (achy) and FATIGUE (feeling very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Event outcome updated and Patient denied contact
positive for covid on 4/17/22, routine testing for L&D, asymptomatic
Facial numbness, tingling, redness on face and neck area treated with 50 mg of Benadryl.
Swelling in neck and behind left eye.  Note fromMD: Female who complains of swollen feeling on neck and behind eye. Now improved. No other complaints. Exam: No swelling observed, no other findings. Plan: Home with primary care provider follow up. Unlikely to be significant allergic reaction.
Pt recv vax on unspecified day; hr post vax pt exp urticaria; tx=Benadryl
While on Tylenol, the patient experienced a fever of 102F within two hours of receiving vax. The patient developed lethargy, redness at the injection site, labored breathing, stiffening of the body, staring an average of 15 minutes and a blue tinge to the lips and around the eyes. The patient was taken to the hospital and to an MD and there was no diagnosis made. After 6 weeks, the patient was taken to a chiropractor who states the patient's body shut down and this could be due to the vax.
Rash (bumps) 5-7 @ injection site for six days. Pruritic on 2/17/06, no fever, positive swelling/redness; patients 11 month old infant came down with "mild" case of chicken pox on 2/20 (pt. breastfeeding infant)-resolved
very itchy; developed a rash below injection site on the right arm about 2 inches in diameter; bumpy; sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE RASH (developed a rash below injection site on the right arm about 2 inches in diameter), VACCINATION SITE SWELLING (bumpy) and VACCINATION SITE PAIN (sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE RASH (developed a rash below injection site on the right arm about 2 inches in diameter), VACCINATION SITE SWELLING (bumpy) and VACCINATION SITE PAIN (sore). At the time of the report, VACCINATION SITE PRURITUS (very itchy) had resolved and VACCINATION SITE RASH (developed a rash below injection site on the right arm about 2 inches in diameter), VACCINATION SITE SWELLING (bumpy) and VACCINATION SITE PAIN (sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information included, Benadryl  was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: follow up information received on 22-apr-2021 added Reporter's address and email ID  was updated
Bell's palsy; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9269/expiration date: not provided), via an unspecified route of administration, on 04Feb2021 08:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included attention deficit hyperactivity disorder (ADHD). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 14Jan2021 at 08:45 (at the age of 41 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021, the patient experienced Bell's~ palsy. The event resulted in an emergency room/department or urgent care visit and received treatment which included CT scan, EKG, blood tests, and steroid prescribed. The outcome of the event Bell's palsy was not recovered. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of  Bell's palsy due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI  and viral serology, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Fever on 6/9 night and body aches the next morning. Morning of 6/11 at  6-6:30am complained of chest pain. Fever of 99-100.5 F on 6/11 that resolved that morning without medication. Decreased appetite.
Mother states that the child had a systemic rash all over his body and seemed to "Zone out"
2/23/10 Baby had an early WCC visit and given vaccine update of #3 RECOMBIVAX. When did daily AM check of refrigerator temps, found this refridge out of range-thermometer record showed too cold @ 30 degrees F from 5p-9:30 when found. Merck advised re-administer vaccine.
woke up extremely thirsty, more thirsty than normal; she almost fell; she couldn´t even walk, she thought she was going to fall, she couldn´t get her; dizzy, so dizzy; a little flu like symptoms but not as much; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (a little flu like symptoms but not as much), THIRST (woke up extremely thirsty, more thirsty than normal), FALL (she almost fell), GAIT DISTURBANCE (she couldn´t even walk, she thought she was going to fall, she couldn´t get her) and DIZZINESS (dizzy, so dizzy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (a little flu like symptoms but not as much). On an unknown date, the patient experienced THIRST (woke up extremely thirsty, more thirsty than normal), FALL (she almost fell), GAIT DISTURBANCE (she couldn´t even walk, she thought she was going to fall, she couldn´t get her) and DIZZINESS (dizzy, so dizzy). At the time of the report, INFLUENZA LIKE ILLNESS (a little flu like symptoms but not as much), THIRST (woke up extremely thirsty, more thirsty than normal), FALL (she almost fell), GAIT DISTURBANCE (she couldn´t even walk, she thought she was going to fall, she couldn´t get her) and DIZZINESS (dizzy, so dizzy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. Patient had event about 12 hours after receiving the dose.   This case was linked to MOD-2022-447163, MOD-2022-447122 (Patient Link).
arm hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm hurts) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced LIMB DISCOMFORT (arm hurts). At the time of the report, LIMB DISCOMFORT (arm hurts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided