chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two days after injection, I started a terrible flare of my autoimmune disorders. My body was so sore, my pancreatitis symptoms flared up. 5 days later I was in the emergency room , the pain from either the pancreatitis flare or IBS flare was incapacitating.
colon, causing lack of function, some pain; cannot have bowel movements; lower bowel regions became inflamed; Felt some normal symptoms of illness; Inflammation of colon; causing lack of function; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for Injection Batch/Lot number was not reported) via an unspecified route of administration in arm right on 01Apr2021 as dose number unknown, single at the age of 64 year for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Anti-inflammatories, stool softeners, laxatives were the other medications the patient received within 2 weeks of vaccination. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unknown date in Apr2021, first 30 hours after vaccination it was reported that the patient felt some normal symptoms of illness. Then lower bowel regions became inflamed, had months of symptoms since. Inflammation of colon, causing lack of function, some pain, cannot have bowel movements, said this condition is very rare. My neighbour just one block from here also is reporting same lower bowel symptoms. Cannot have bowel movements without laxatives and softener etc. The clinical outcome of the events on an unspecified date 2021 was resolved with sequel.  Information about lot/batch number has been requested.
No adverse event; 20 month old given monovalent for first dose and then given bivalent vaccine as the second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (20 month old given monovalent for first dose and then given bivalent vaccine as the second dose) and NO ADVERSE EVENT (No adverse event) in a 1-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     The patient received no other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 21-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (20 month old given monovalent for first dose and then given bivalent vaccine as the second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (20 month old given monovalent for first dose and then given bivalent vaccine as the second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (20 month old given monovalent for first dose and then given bivalent vaccine as the second dose).    The 20 month old male patient was given monovalent vaccine as the first dose. There was no harm to patient with no side effects.  The concomitant medication was not reported. The treatment medication was not reported.
patient is reporting that the next morning after receiving her vaccine that she is experiencing severe dizziness, severe ringing in both ears, and that she can barely stand up.  She said when she does try to walk that she only makes it a few step and then needs to hold on to something--she is very weak.  This has been going on for 3 days now.
Anterior left thigh red and feels hot with swelling; non tender, nonindurated.
BACK ACHE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201a21a, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced back ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache on 10-APR-2021, and had not recovered from back ache. This report was non-serious.
Fever, rash (face only), irritability, congestion developed two days after MMR injection.
Patient potentially received higher than the recommended 0.3ml dose of the Pfizer vaccine. As of Sunday 4/4, patient reports soreness at injection site and fatigue.
knocked her out; uncontrollable shaking; terrible neck pain; terrible neck stiffness; pain down spine; sternum hurt; toes hurt; fingers hurt; overwhelming fatigue; chills; nausea; joint pain; body pain; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, and joint pain.  The patient's medical history was not provided. Concomitant medications reported were Paxil, melatonin, red yeast rice supplement, fish oil, Hydrochlorothiazide for drug use for unknown indication.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain.  Treatment details included Tylenol and ibuprofen  Action taken with mRNA-1273 in response to the events was not reported.   At the time of reporting, the outcome of events include, overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
First dose on 3/5/2021 received with minor issues of slight pain in injection site later, but also some tingling in injection site. SECOND DOSE on 4/2/2021 was a different story.  About 15 hours later at 3:00 am I woke up with 100.5 fever, SEVERE pain at injection site (like someone had punched me in the arm and bruised my arm), and SEVERE level 9 (out of 10) pain in all joints in my hand and two big toes.  Fibromyalgia muscular pain SEVERE level 9.  Headache, SEVERE fatigue - could not get out of bed very well.  SEVERE brain fog - I could barely think logically.  I tried taking 50mg full spectrum CBD oil to avoid taking an NSAID (I was concerned it would affect proper immune response).  At 6:29 am the fever was lower, but I could no longer take the pain, so I took 400mg Ibuprofen (Advil).  4-6 hours later took another 400mg Ibuprofen (Advil) and stayed in bed and slept several times that day.  For the next two days the severe brain fog and severe fatigue remained.  I continued to take 400mg Advil as needed.  The brain fog was so severe that if I picked up my keys (or any other object), I would immediately ?lose? them and not know where they were because I had placed them somewhere else and could not remember anything.  I stayed home for at least 72 hours due to the fatigue and the fear of driving and possibly getting in an accident.  It seems the high severity of the issues lasted 72 hours, but all of the above reported issues continued for several weeks at a lower severity - with fatigue being the worst - requiring one or two naps per day.  As of today, April 29, there is still slight pain in all hand joints and some fatigue, but there seems to be gum issues (hurting) since about April 26th.  I am brushing my teeth lightly, using ?Smart Mouth? zinc oral rinse, and sucking/chewing on a whole clove every once in a while for pain relief and for the anti-biotic properties.  I did not contact my physician because I read online that people with Fibromyalgia have worse side effects and I figured the effects would subside over time.  I have an upcoming appointment with my doctor on May 26, 2021 at which time I will report these side effects and my strong concern about any future booster shots and the severe side effects I may encounter.
Headache , fever within 12 hours of vaccine Swollen, painful and redness at site
elbow below injection site became kind of bumpy and very red with a rash circling the joint; later that day there was some of same behind knee, then towards ankle.  Wherever it developed on the left side, it developed in the same spots on the right side.  The left elbow below injection site lasted quite a while and was the most inflamed and painful.
flareups after getting a covid-19 shot/ dermatitis re-appeared; skin redness; Itching; Swelling; This spontaneous case was reported by a patient and describes the occurrence of DERMATITIS ATOPIC (flareups after getting a covid-19 shot/ dermatitis re-appeared), ERYTHEMA (skin redness), PRURITUS (Itching) and SWELLING (Swelling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis.    The patient's past medical history included Atopic dermatitis.   In 2019, the patient started DUPILUMAB (DUPIXENT) (unknown route) at an unspecified dose. In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, DUPILUMAB (DUPIXENT) (unknown route) dosage was changed to at an unspecified dose. In 2021, the patient experienced DERMATITIS ATOPIC (flareups after getting a covid-19 shot/ dermatitis re-appeared), ERYTHEMA (skin redness), PRURITUS (Itching) and SWELLING (Swelling). At the time of the report, DERMATITIS ATOPIC (flareups after getting a covid-19 shot/ dermatitis re-appeared) had not resolved and ERYTHEMA (skin redness), PRURITUS (Itching) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's family history and concomitant medication were not provided.  It was mentioned that patient said she originally started on dupixent in 2019 and stopped taking the medication in 2020 after her atopic dermatitis got better. She restarted the medication after her dermatitis re-appeared after taking a COVID shot. Patient restarted dupixent on 29-Aug-2021. She said that her face has been more red and swollen. She also mentioned that she had gotten a sample of medication from her doctor's office. The last dose of medication was 09-Nov-2021. Patient was wondering if she should be taken her next injection and if it was common to have a flare up after taking a COVID injection.  It was not reported if the patient received a corrective treatment for the events.  It was mentioned that a product technical complaint was initiated on 16-Nov-2021 for dupilumab (lot/batch number: 1L135A, expiry date: 28-Feb-024) with global PTC number.  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
Nausea, chills, extreme fatigue, intense pain at site of injection, headache, unable to lay on left side, unable to lift arm.
SCREAMING IN THE MIDDLE OF THE NIGHT, TEMP OF 104, WENT TO ER AFTERWARD LOST SPEECH AND FINE MOTOR SKILLS. WAS REFERRED FOR OT, PT AND ST.
SOME PAIN ON SHOULDER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced some pain on shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of some pain on shoulder was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was subcutaneously vaccinated with a dose of ZOSTAVAX (lot # 665215/1172Y, Exp 14-FEB-2011, dose unspecified) on 31-JUL-2012. No other co-suspects were reported. No concomitant medications were ported. Reporter noted that the patient was administered an expired dose of ZOSTAVAX on 31-JUL-2012. No adverse effect reported. It was unspecified the patient had sought medical attention or not. NO treatment information was reported. The outcome was unknown. Additional information has been requested.
He got Covid-19 virus; This is a spontaneous report received from a contactable consumer (patient relative) via a medical information team.   A male patient of unspecified age (51 unit unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown), via an unspecified route of administration, on 05Apr2021 at SINGLE DOSE for COVID-19 Immunization. Medical history and concomitant medication were not reported. It was reported, reporter Husband got his first dose of the vaccine last Monday (date unspecified). He got COVID-19 virus and she asked if he has to start all over or if he can get his second dose as scheduled on 19Apr2021. The outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
DID NOT KNOW I COULDN'T GIVE PEDIARIX AT AGE 4 YRS.
Moderna vaccine given; patient with fevers and fatigue the next day; symptoms persisted for six weeks; fever with any physical activity; diarrhea comes and goes; liver tests abnormal with bilirubin 2.1; ALT;AST of 134:82  on June 23 and then bilirubin 0.8; ALT: AST  115: 132 on July 9, 2021.
Pt. presented at walk in clinic on 1/3/18 w hx of fever, cough, myalgia and vesicular rash for duration of 1 day. Vesicles in various stages, some crusty, some new lesions, greater than 250 lesions. Recommendations were AVEENO, BENADRYL, CALAMINE, TYLENOL. No ASA.
Pt reported a rash and itching that started Monday after receiving her vaccine on Friday (3 days later).  fine erythematous itchy rash on hands, neck, forehead
The patient received a Flulaval Quadrivalent vaccine on 9/27/2023. The patient also received a FluZone High Dose vaccine on 9/21/23 at a different facility. The patient did not experience any adverse events and is aware of the situation.
Dermatologist said he has seen patients who has similar side effects her her husband.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Dermatologist said he has seen patients who has similar side effects her her husband.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Dermatologist said he has seen patients who has similar side effects her her husband.). The patient was treated with FLUOCINONIDE (FLUOCINONIDE F) ongoing since an unknown date at an unspecified dose and frequency; CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE E) ongoing since an unknown date at an unspecified dose and frequency; HYDROXYZINE HCL ongoing since an unknown date at an unspecified dose and frequency; LORATADINE (CLARITINE) ongoing since an unknown date at an unspecified dose and frequency; CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE SHAMPOO) ongoing since an unknown date at an unspecified dose and frequency; CLOBETASOL PROPIONATE (CLOBETASOL [CLOBETASOL PROPIONATE]) ongoing since an unknown date at an unspecified dose and frequency; TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) ongoing since an unknown date at an unspecified dose and frequency and PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) at a dose of 5 days course. At the time of the report, VACCINATION COMPLICATION (Dermatologist said he has seen patients who has similar side effects her her husband.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow up Received on 21-Sep-2021, contains no new information. Patient identifiers added from initial versions document.
He was in Hospice. He died as a veteran. He had a constant lack of appetite. Has no additional information
felt ill for a day or two following every flu shot when he/she ever got; Initial information was received on 04-Feb-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient). This case involves a patient (unknown demographics) who felt ill for a day or two (malaise) while he/she received INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  Past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient felt ill for a day or two (malaise) (unknown latency) following the administration of INFLUENZA VACCINE. This event is non-serious.   It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from the event.  There will be no information available on batch number for this case.
Nauseous, weak, drowsy, then in the evening shakes, throbbing headache, chills, fever/flu like symptoms, then the next day still having those symptoms and a rash all over my body.
fever; chills; This is a spontaneous report from a contactable healthcare professional via a sales representative. This healthcare professional reported same events for two patients. This is the first of two reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2 reported as Pfizer COVID-vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of received bnt162b2 (BNT162B2 reported as Pfizer COVID-vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The reporter mentioned that she had two X-Ray techs call in sick due to fever and chills with their second dose on an unspecified date. She said there have been a ton of people who have not gotten sick with their second dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021084275 same reporter/drug/events, different patient
Information has been received from a medical assistant concerning 3 child patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (dose, strength and route were not reported, lot #: K022444, expiry date: 13-MAY-2016 and reported as K19100, expiry date: 15-APR-2016). No adverse were reported. Additional information is not expected because the reporter did not want to be contacted.
Fever reaching 103.1 by 3:00 am 8/20/21. Symptoms began around 6:00 pm on the day of the vaccine (8/19/2021) and by 11:00 pm she had all of the following symptoms: chills, cold arms and hands but forehead was very warm, face very pale, hands and arms very pale and blotchy, extreme fatigue, weakness, feeling faint, trouble standing without assistance, trouble hearing/sounds were muffled, headache, muscle ache/soreness, stomach pain, nausea, loss of appetite, sleeping more than usual, swelling on left arm at location of vaccine injection, sore and painful to touch.
some local arm tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: like 7 years before reporting. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, lot EL9262, expiry date 31May2021), administration date: 24Jan2021, when the patient was 67-year-old, for Covid-19 Immunization, reaction(s): "some local arm tenderness", "chills"; BNT162b2 (Dose 2, lot EM9810, expiry date 30Jun2021), administration date: 14Feb2021, when the patient was 67-year-old, for Covid-19 Immunization, reaction(s): "some local arm tenderness"; BNT162b2 (Dose 3, lot 30155BA), administration date: 29Sep2021, when the patient was 67-year-old, for Covid-19 Immunization, reaction(s): "some local arm tenderness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "some local arm tenderness". Therapeutic measures were not taken as a result of pain in extremity.   Additional information: She did not have any significant reaction to any of them regarding her Pfizer covid vaccines and states she had no reactions just some local arm tenderness and thinks the tenderness of the arm she had that from all of the Pfizer Covid vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271774 Same reporter/patient, same drug, different dose, different AE;
2/27/2021 Palpations off and on during the day stopped at night 2/28/2021 Pain in chest or front rib cage like indigestion twice then went away 3/06/2021 Joint pain the the hips lasted a few days then stopped