chrisvoncsefalvay/vaers-outcomes huggingface dataset:
joint pain; chilling; This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced joint pain and chilling on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
sx started 4 hrs p/immun; pt noticed h/a, flushing @ first & took APAP; awoke in middle of night w/shaking, chills, dizziness, & unsteady on feet, weakness, fatigue & sl nausea sx cont x 24 hrs;
heart razing; terrific headache; vomiting/ uncontrollable vomiting; high fever; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (heart razing), HEADACHE (terrific headache), VOMITING (vomiting/ uncontrollable vomiting) and PYREXIA (high fever) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059e21a) for COVID-19 prophylaxis.     Concurrent medical conditions included Migraine, Hypothyroidism (takes medication.), Hypercholesterolemia (takes medication), Heart disorder and Immunocompromised. Concomitant products included METOPROLOL for Heart disorder.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart razing), HEADACHE (terrific headache), VOMITING (vomiting/ uncontrollable vomiting) and PYREXIA (high fever). At the time of the report, PALPITATIONS (heart razing), HEADACHE (terrific headache), VOMITING (vomiting/ uncontrollable vomiting) and PYREXIA (high fever) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included hypothyroidism medication and high cholesterol medication.  Reportedly, patient was not sick at all. Patient received a third full dose of Moderna vaccine.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reported events resolved 24 hours after the event started.  No treatment information was provided.   This case was linked (Patient Link).
Local injection-site cellulitis (swelling, redness, and/or soreness) developed day after vaccine administered.
48 hr sp/vax given devel h/a, severe muscle & joint aching-lasted 3 days;
Very tired and weak slept for 2 days the third day flu symptoms 4 th day tried to go to work had hard time catching my breath dizziness while at work went to lab at work were my blood pressure was taken the first one was 138/98 the nurse was called told her my symptoms they took my blood pressure again about 5 min apart it was higher148/98 at this time I was feeling pressure in my chest and dizziness I was sent home once I was home I slept again for another 24 hours
Vomiting and high fever one loose stool the vomiting did not stp until 10am on 1/7/10 he was vomiting and dry heaving unable to keep things down, highest temp 101.2   Tylenol rest clear liquids.
fatigue; headache; muscle and joint pain; muscle and joint pain; memory impairment; brain fog; depression; anxiety; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 11Jun2021 (Lot number: EW0217) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "known allergies; Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: pfizer, prev dose brand unknown: False, prev dose lot number: EW0187, prev dose lot unknown: False, prev dose administration date: 21May2021, prev dose dose number: 1), administration date: 21May2021, for COVID-19 IMMUNIZATION. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "fatigue"; HEADACHE (non-serious), outcome "not recovered", described as "headache"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "muscle and joint pain"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered", described as "memory impairment"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "brain fog"; DEPRESSION (non-serious), outcome "not recovered", described as "depression"; ANXIETY (non-serious), outcome "not recovered", described as "anxiety". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of fatigue, headache, myalgia, arthralgia, memory impairment, feeling abnormal, depression, anxiety.  Clinical course: 2nd shot fatigue, headache, muscle and joint pain, memory impairment, brain fog, depression, anxiety within 24 hours and has continued for 6 months.  Additional information: If covid prior vaccination: No. If covid tested post vaccination: Yes. Known allergies: Yes. Other medical history: Blood pressure, weight. Language: EN. Reporting type: AE. If other vaccine in four weeks: No.  No follow-up attempts are possible. No further information is expected.
102F-103F fever and a severe total body rash lasting for over 2 weeks.
immunization; severe headache in back of head; Dizziness/ Feeling of passing out; Neck pain; exhaustion; nausea; chills; This is a spontaneous report from a contactable other health care professional (patient). A 58-year-old non pregnant female patient (nurse) received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration, administered in right arm on 27Oct2021 at 13:15 (at the age of 58 years) as dose 3 (booster), single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration, administered in right arm on 18Jan2021 at 14:15 as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration, administered in right arm on 28Jan2021 as dose 2, single for COVID-19 immunization. The patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test for COVID post vaccination. On 27Oct2021 the patient experienced Dizziness/ Feeling of passing out, severe headache in back of head, neck pain, exhaustion, nausea, and chills. On   27Oct2021 at 13:15  patient reported booster. The events resulted in emergency room/department or urgent care. Tornadol, benadryl, ibprophen, fluids, all IV were taken as therapeutic measures for the events. The outcome of the events was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided  and plausible temporal association, the causality between BNT162B2 and Headache, Dizziness, Neck pain, Fatigue, Nausea, Chills  cannot be completely excluded.  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.
Pt felt lightheaded & dizzy - increased BP - chest tightness, acid reflux like symptoms/ RN assessed/ family was called - son called MD - MD advised ER.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The reporter was reporting 2 doses of M-M-R II (lot # L026551, expiration date 16-JUL-2017) (dosage, strength and route unknown), that had been improperly stored (temperature and time frame: 34 degree F for 3 hours 24 minutes and 47 degree F for 6 minutes), were inadvertently administered to the unspecified patients on unspecified dates. No adverse effect was reported. Follow up information has been received from medical assistant via phone call on 26-APR-2016. The patient was vaccinated with improperly stored M-M-R II on 08-MAR-2016. This is one of several reports received from the same reporter. Additional information has been requested. Patient tab, product tab, event tab and narrative updated.
Delayed response ... swollen arm and rash at site .. 8 days after vaccine was given
Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose Number: 1, 2, 3, 4; Pfizer, Dose Number: 5; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (PFIZER / BIONTECH COVID-19 VACCINE), on 07Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 04Nov2021 as dose 3 (booster), single (Lot number: 039D21A), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: 003J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). No known allergies. Concomitant medication included: METFORMIN HCL, start date: 01Jan2019. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Oct2022, outcome "unknown", described as "Moderna, Dose Number: 1, 2, 3, 4; Pfizer, Dose Number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.
NERVOUSNESS; TINGLING SENSATION IN BODY/TINGLING IN THE ARMS AND FEET; FELT FAINT; HYPERVENTILATION; SHORTNESS OF BREATH; HEAD FELT COMPLETELY SWOLLEN; TACHYCARDIA; PAIN IN ARM; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced tingling sensation in body/tingling in the arms and feet. On 2021, the subject experienced felt faint. On 2021, the subject experienced hyperventilation. On 2021, the subject experienced shortness of breath. On 2021, the subject experienced head felt completely swollen. On 2021, the subject experienced tachycardia. On 2021, the subject experienced pain in arm. On 2021, the subject experienced headache. On 13-JUL-2021, the subject experienced nervousness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in arm, tingling sensation in body/tingling in the arms and feet, headache, felt faint, hyperventilation, shortness of breath, tachycardia, and head felt completely swollen, and had not recovered from nervousness. This report was non-serious.
Vaccines given 9/5/2018. Fever started 9am  on 9/9/18 and ended 9/10/18. Also felt achy and tired. Slight cough. Rash started morning of 9/11/2018. Fine pink macular rash over arms, legs and trunk. Also has spots on his face that are open and honey crusted lesions. Facial rash is getting better.
pt in SNF due to Parkinson's Disease; poor prognosis; on hospice. 6/23/22 pt had a positive COVID test; placed in isolation; O2 supplementation via NC; antiviral medication given; pt's condition worsened and he passed away on hospice in the SNF
Rheumatoid arthritis (RA) flare up/RA was pretty intense; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis (RA) flare up/RA was pretty intense) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20M) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 09-Aug-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis (RA) flare up/RA was pretty intense) (seriousness criterion medically significant). On 25-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis (RA) flare up/RA was pretty intense) outcome was unknown.            Concomitant medications includes medications for blood pressure and Cholesterol.  No treatment medications reported.  Patient experienced a Rheumatoid arthritis flare up that started on same arm. On 26 Aug 2021 and 27 Aug 2021, it was pretty intense. Patient had 2nd shot with batch number 0022MZ0A or 00ZZMZ0A.  Patient's medical history included blood pressure abnormal and cholesterol abnormal  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event of Rheumatoid Arthritis was automatically upgraded as a serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious. Follow up information is expected for  further assessment of this event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event of Rheumatoid Arthritis was automatically upgraded as a serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious. Follow up information is expected for  further assessment of this event.
devel fever 104; was seen in ER 20APR95; was noted by RN pt had sz-limp for 1 min
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 15-OCT-2012 the patient was vaccinated first dose of GARDASIL (dose and route were not reported, lot # 0652AE). On 05-AUG-2016, the patient was vaccinated the second dose of GARDASIL 9 (dose and route were not reported, lot # M007764). No adverse event was reported. Additional information has been requested.
Information has been received from a registered nurse referring to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In November 2016, the patients were vaccinated with improperly stored ZOSTAVAX (lot # M033910, expiration date 17-OCT-2017; lot # M018593, expiration date 28-JUN-2017) was stored in the temperature of between 5 and 14 degrees Fahrenheit for 142 minutes, with no previous temperature excursion; dose and route not reported) for prophylaxis. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA007360: US-009507513-1703USA007362: US-009507513-1703USA007363: US-009507513-1703USA007364: US-009507513-1703USA007365: US-009507513-1703USA007063: US-009507513-1703USA000989.
a vaccine given to a patient that was reconstituted wrong; a vaccine given to a patient that was reconstituted wrong; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number ZM749, expiry date 22-AUG-2025) for prophylaxis.   On 27-JUL-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On 27-JUL-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: a vaccine given to a patient that was reconstituted wrong) and inappropriate dose of vaccine administered (Verbatim: a vaccine given to a patient that was reconstituted wrong). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUL-2023 Nurse reported that a vaccine given to a patient that was reconstituted wrong (Inappropriate reconstitution technique).  This was 2 of 2 cases, reported by the same reporter. The reporter consented to follow up. The Shingrix antigen was mixed with a regular sterile diluent and not the corresponding adjuvant and was administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023103550:Same reporter
Numbness & tingling of fingers on right hand right after injection. Next day palM & thumb involved as well. On 9-23-10 sensation continues.
Dizziness; This spontaneous report as received from a nurse practitioner refers to a 25-year-old female patient. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. The patient's concurrent condition included asthma. On 14-MAR-2020, the patient underwent insertion with etonogestrel implant (NEXPLANON) 68 milligram 1 every three years (1 dosage form , lot#, expiry date were not reported) subdermally for contraception. The patient was administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot#, expiry date, dose, route of administration and anatomical locations were not reported) for prophylaxis. On 16-MAR-2020 (reported as 5 weeks ago), the patient started experiencing dizziness. On 20-APR-2020, the patient was called for a post-partum check-up and the patient reported she experienced unspecified dizziness 5 to 7 times a day since the implant was inserted. She was instructed to drink more water just in case the dizziness was caused by dehydration. Nurse Practitioner reported they were not seeing patients in the office right now due to the coronavirus and felt if she could see her in person and she could do on a diagnostic level. No additional information. Therapy with etonogestrel implant (NEXPLANON) was continued. The outcome of dizziness was reported as not recovered/not resolved.
Muscle twitching/spasming predominantly in legs and feet, lightheadedness, palpitations   Still ongoing since vaccination 10 days ago at time of submission
Headache developed after vaccine was administered Fever: 102.1 Fatigue: spent the whole day away  Felt like I had no energy Site is red , tender to touch, and swollen
At 1050 patient presented to clinic for immunization accompanied by mother. Nurse performed a pre-screening assessment for vaccine contraindications. Patient and patient's mother reported no history of allergies, seizures, or other medical comorbidities. Patient reported a history of fainting after receiving vaccine and nurse decided to administer the vaccinations while patient is lying down on the bed. At 1100, nurse administered Tdap and VZV on the patient's left arm. After administration, patient complained that she felt hungry, so mother went to get a granola snack. When mother came back into the room, nurse noticed that patient was pale and patient started sliding down the bed. Nurse ensured patient was safe on the bed and could not fall off. Mother then took patient's legs and lifted them. Patient then became agitated, started squirming around and then started to snore loudly. Patient's face turned red and nurse assessed she was still breathing and attempted to wake the patient up. Nurse then immediately called for help from the clinic next door and called to bring the vital machine. Nurse then had patient smell an alcohol pad and patient quickly awoken. 2 other nurses from the other clinic came in and brought the blood pressure machine. BP: 105/65 HR: 65, RR: 16. Patient states she does not remember what happened and said she felt like she "had a dream." Nurse determines that patient's syncopal episode lasted about 1 minute. Patient was given apple juice from the clinic next door and the granola snack from her mother and encouraged to stay in clinic to monitor for 20 minutes. Patient denied any shortness of breath, throat tightening, itching, headaches, pain, or injuries. Patient sustained no injuries and left the clinic in a stable condition. ER precautions given to patient.
Information has been received from a health professional concerning a 4 year old male who on 05 Dec 2006 was inadvertently vaccinated with a dose of Zostavax (lot # 652936/0981F) instead of MMR II. Concomitant vaccination included influenza virus vaccine (unspecified), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. The nurse was told they had the "new MMR varicella vaccine", she grabbed a vial and administered it to the patient without reading it and then realized it was Zostavax. No symptoms were noted. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Partial facial paralysis; This is a spontaneous report from a contactable pharmacist via medical information team.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacy has been notified by the guardian that on an unspecified date patient has experienced partial facial paralysis. The pharmacist did not have any further details to provide. The reporter voiced she wanted to reach out to Pfizer before contacting the patient. The reporter asked if facial paralysis has been reported. The outcome of event was unknown.  Information on lot/batch number has been requested.
PMS symptoms (bloating, headache, acne, cramps, tender breasts), delayed or possibly missed period, headache directly after getting first dose of pfizer, sore arm.
Headache, swelling and bruising with pain at injection, nausea. Treated with TYLENOL and ice pack.