chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Allergic reaction to vaccine; Arm went numb; arm cold; arm tingly; Lightheaded/Dizziness; very weak; Felt like death; Nausea; Muscles hurt/was in a lot of body pain; developed a rash in the arm; Vision fuzziness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction to vaccine), HYPOAESTHESIA (Arm went numb), PERIPHERAL COLDNESS (arm cold), PARAESTHESIA (arm tingly) and DIZZINESS (Lightheaded/Dizziness) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction to vaccine), HYPOAESTHESIA (Arm went numb), PERIPHERAL COLDNESS (arm cold) and PARAESTHESIA (arm tingly). 15-Jan-2021, the patient experienced DIZZINESS (Lightheaded/Dizziness), ASTHENIA (very weak), MALAISE (Felt like death), NAUSEA (Nausea) and MYALGIA (Muscles hurt/was in a lot of body pain). In January 2021, the patient experienced VISION BLURRED (Vision fuzziness) and RASH (developed a rash in the arm). At the time of the report, HYPERSENSITIVITY (Allergic reaction to vaccine), HYPOAESTHESIA (Arm went numb), PERIPHERAL COLDNESS (arm cold), PARAESTHESIA (arm tingly), DIZZINESS (Lightheaded/Dizziness), ASTHENIA (very weak), VISION BLURRED (Vision fuzziness), MALAISE (Felt like death), RASH (developed a rash in the arm), NAUSEA (Nausea) and MYALGIA (Muscles hurt/was in a lot of body pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Patient was give shots of diphenhydramine for treatment   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.
PE on May 26th 2021, Lots of pain/fatigue in sensitive areas of the body for 5 months.
Felt sluggish, nose draining could not sleep well with stuffy nose.  I can manage OK but it is a sense of not feeling well.
Elevated fever, vomiting 24 hours after vaccines for 1 day.  Redness 8x6cm, firmness, swelling, hot, tenderness at injection sites.  Left deltoid onset that evening with red, warm, swelling.
Very bad arm pain on injection arm; tiredness; mild headache; chills; feeling unwell; This is a spontaneous report from a contactable consumer (patient herself).  A 67-year-old female patient received bnt162b2 (BNT162B2 also reported as COVID 19 vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration in arm on 16Jan2021 10:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included allergy to latex, iodine, motrin. No other vaccine in four weeks. There were no concomitant medications. On 16Jan2021 15:00, the patient experienced very bad arm pain on injection arm, tiredness, mild headache, chills, feeling unwell overall for 4 solid days. No treatment was given. The outcome of events was recovered on 20Jan2021.  Information about lot and batch number was requested.
joint pain; This is a Follow-up spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, Expiration Date: unknown), dose 2 via an unspecified route of administration on 08Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing nodal marginal zone b-cell lymphoma, neoplasm malignant and arthritis. Concomitant medication(s) included ibrutinib (IMBRUVICA) taken for neoplasm malignant; valaciclovir hydrochloride (VALTREX) taken for neoplasm malignant. Historical vaccine included BNT162B2 on 20Jan2021 for covid-19 immunization. The physician reported, he has no antibodies against Sars-CoV-2, he waited a little over a month and saw his oncologist who ran a blood test to see what antibodies he had. He has CLL (chronic lymphocytic leukemia, he is on medication for cancer (Imbruvica and Valtrex). Since he tested negative for antibodies to protect from the virus caller would like to know if possibly the vaccine gives you or helps your immunity with elevated T cells. Also, he added that he experienced joint pain causing pain at the back and knees, but did not have any adverse events such as fever, tiredness etc. after taking the vaccine and he can't identify if it is joint pain due to his arthritis or the side effects of the Covid-19 vaccine. Outcome of events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021421720 Same product and event, different patient
Missed 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-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 PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) had resolved.            No concomitant medications were reported..  No treatment information was reported.
Syncope approx 15 min after injection of GARDASIL. Laceration to chin possible neck injury secondary to fall.
Pt became pale and diaphoretic post administration. Pt remained conscious. Pt placed in reclining position with feet elevated and cool compress applied to forehead and back of neck. Pt vs taken and pt give water to drink. Pt recovered and denied chest pain, no s/sx resp.Distress. Pt denied feeling dizzy after interventions. No swelling no urticaria.
"on both arms where I got my injections, there is a big red welt"; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA ("on both arms where I got my injections, there is a big red welt") in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Blood pressure fluctuation. Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN C [ASCORBIC ACID] and POTASSIUM for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA ("on both arms where I got my injections, there is a big red welt"). At the time of the report, URTICARIA ("on both arms where I got my injections, there is a big red welt") had not resolved.            Additional concomitant product use included thyroid and blood pressure medications.  No medications were taken to help the symptoms.  Patient received both scheduled doses of mRNA-1273; therefore, the action taken in response to the events was not applicable.  Patient gave consent for safety follow up, however, denied consent to follow up with her physician.
Vaccine was put below muscle toward the side of right arm , within a few minutes of vaccine I felt  a lot of arm / shoulder pain  , by the next day I had increased pain , swelling and numbness radiating from right side of my neck , arm and shoulder down to my hand . Still to date pain and swelling .
Aside from normal sore arm.  The right side of my neck began hurting the day after vaccine. Real stiff and sore. Hard to turn. That got a little better by day three.   On day three my right testicle began hurting intensely.  Like if someone grabbed and yanked on it.
A legal complaint was received from an attorney alleging that a child received series of HibTITER, DTP, and Engerix B vaccines "from October 2000 through at least January 2002." The complaint alleges that "As a result of the mercury in the Thimerosal-containing vaccinations that Minor Child received, Minor Child now suffers, and in the future will continue to suffer, from the toxic neurolgoical effects of mercury poisoning." According to the complaint, the child "has sustained mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments." The complaint alleges that the child "has sustained permanent, severe physical injuries, requiring medical care ad treatment." No further info was available at the dat eof this report.
Diarrhea; Chills clammy; Vomit; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), CHILLS (Chills clammy) and VOMITING (Vomit) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills clammy) and VOMITING (Vomit). At the time of the report, DIARRHOEA (Diarrhea), CHILLS (Chills clammy) and VOMITING (Vomit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details not provided.   Reporter did not allow further contact
The pt experienced hives with generalized blotchiness. The pt experienced questionable swelling in right hand.
101.5 degree fever at 2:30am on 9/8, coupled with chills, severe body aches and fatigue, headache, chest pains and 110 bpm heart rate. Took 600mg ibuprofen. Fever went down but peaked again to 101 around 3pm the next day. Chills were intermittent but severe body aches and fatigue continued. Heart rate dropped to 90 bpm at 3 pm. Took another 600mg ibuprofen. 9/9 at 10am fever is gone, no chills, heart rate is 75 bpm (normal), lingering fatigue.
mother reported blood in infants stool, no abdominal pain, no diarrhea, no vomiting
Body Aches, Chills, Vomiting, Extreme tiredness, Swelling at the injection site.
Pain in my right elbow when I move it. The pain extends down my forearm and aches intermittently. The joint is stiff and sore sometimes and then it goes away for a few hours and then comes back for a few hours. It feels like I have part time arthritis in my elbow. I had no pain after the first shot, not even a sore spot on my arm but two hours after the second one, my arm became stiff and sore and it is still stiff and sore. My arm is still functional but if I leave my arm in a bent position for too long, the joint starts to ache and movement becomes painful. I've also lost strength in that arm. Even when it doesn't ache, there is a noticeable difference in my ability to grip and a noticeable loss of strength. I am right handed and I have to do most of my heavy lifting with my left arm now. I developed a sore spot and some bruising after my second shot as well. I didn't have a headache or fever or any other symptoms with either shot.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Hypotension-Severe, Additional Details: Blood pressure dropped 94/33, heart rate 43. Epi-pen 0.3mg wagiven. (911 team) confirmed patient recovered, vital stable, Ok for parents take Pt to ER or home. Dr confirmed patient had vagal response on 7/12/2019 after vaccinated HPV.
Initial report received from a consumer who is also the patient's parent on 12 SEPTEMBER 2013. A 2-year-old male patient, had received a second dose of FLUZONE SV 2013-2014 (lot number: unknown and site of vaccination was not reported) intramuscularly on 07 SEPTEMBER 2013. The patient had no illness at the time of vaccination and had no known allergy. The patient concomitant medications were not reported. On 10 SEPTEMBER 2013 the patient had black tarry stool early in the morning and "past 3 days" and the patient had not experienced any symptoms prior to receiving the flu shot. Laboratory details and corrective medication as not reported. The patient outcome was not recovered. Documents held by sender: none.
Headache, racing heart rate, high blood pressure, right side of face went completely numb, swollen.
lab data of patient showed ALT 538, AST 238, alk phos 197, Tbili 2.3; fatigue; loss of appetite; constipation; nausea; This is a spontaneous report received. A contactable physician reported for a 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 06Feb2021 (at the age of 46-year-old) as single dose for covid-19 immunisation. Patient had historical vaccine (at 46-year-old) BNT162B2 on 16Jan2021 for Covid-19 Immunization. Other medical history included, colitis ulcerative, Primary sclerosing cholangitis and allergies from amoxicillin (Allergies to medications, food, or other products: Amoxicillin (prior DILI)). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included mesalazine (LIALDA) (within 2 weeks of vaccination), 1.2 g twice a day (BID) taken for colitis ulcerative. The event of patient reported as Patient had PMH significant for quiescent UC on Lialda with recent diagnosis of PSC without history of cholangitis, prior DILI Dec2019 2/2 amoxicillin. Patient had first COVID vaccine (Pfizer) on 16Jan2021 with second on 06Feb2021. Patient works in healthcare and is testing weekly for COVID as part of his job and has been negative. 10 days after first dose he developed fatigue, loss of appetite, constipation and nausea. Patient got the second dose on 06Feb, symptoms persisted so he reached out on 10Feb2021. On 11Feb2021 lab data of patient showed ALT 538, AST 238, alk phos 197, Tbili 2.3. No herbals, new meds, NSAIDs, APAP, alcohol. No fevers or chills or pruritus. Full serologic workup negative (viral, etc). Patient had Liver biopsy on 12Feb2021 showed mild cholestasis, mild portal inflammation of lymphs, eos, rare plasma cells and neutrophils. Mild bile ductular proliferation. Trichrome and reticulin with focal portal/periportal fibrosis associated with the bile ducts. Peak labs: bili 3.9 (direct 1.7), alk phos 179, ALT 594, AST 249. Adverse event result the doctor or other healthcare professional office/clinic visit. No covid prior to vaccination, Since the vaccination, the patient has been tested for COVID-19. Patient did not received any treatment for the events. The outcome of all events was Unknown.  Follow up information has been requested for Lot/Batch no.; Sender's Comments: The event of hepatic enzyme abnormal is assessed as more likely due to concomitant medication mesalazine. although suspect product  "BNT162B2" role 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.
Migraine. Migraine with loss of central vision. Felt sickly. Diarrhea. Slight headache. Fatigue. Chills. Aches. Report received from a consumer on 05-Nov-2008. An adult female patient (initials: SW; DOB: unknown) received FLURIA (CSL influenza vaccine) on 29-Oct-2008 at 8:00 am. At 4:00 pm on 29 Oct-2008, the patient had a migraine with loss of vision (patient could not see clearly out of both eyes). For the next day and a half, she felt sickly and had diarrhea. She saw her family physician on 29-Oct-2008 and her blood pressure was fine and had no droopy eye. No treatment was given but physician may prescribe IMITREX. On 03-Nov-2008, the patient saw an eye specialist and everything was fine; no detached retinal. Patient complained of a slight headache on 05-Nov-2008, but feels much better. A brain MRI is scheduled for 06-Nov-2008. Patient has had 1/2 dozen migraines in her life. She has received flu shots in the past with no problems. ASSESSMENT: No serious criteria mentioned. The company considered events as possibly related to the suspect drug. Follow-up information received on 11-Nov-2008 from the consumer. A 59 year old non-pregnant female received AFLURIA, lot 02549111A, IM arm on 29-Oct-2008 at 8:00 am. At the time of vaccination, she had no illness. Patient does have a history of hypothyroidism and osteoarthritis. Concomitant medications include SYNTHROID, MOBIC, PREMPRO, doses unspecified. On 29-Oct-2008 at 4:00 pm, patient reported that she had a migraine headache, loss of central vision, fatigue, aches, and chills. Patient had an MRI of brain and orbital sockets, and a complete blood count (CBC) and ferritin level was obtained. Blood work was done on 10-Nov-2008; results not yet received. She is being tested for anemia. If anything is not right with her blood work, she will report back to us. Patient stated that she recovered by 04-Nov-2008 from all reactions. No further information is expected. No change in assessment. Information derived from this AE report does not change the current safety profile of AFLURIA (CSL influenza vaccine).
Rapid or abnormal heart rhythms (arrhythmias). Chest pain. Shortness of breath, both at rest and during physical activity. Fatigue.
My knee is in pain, I cannot walk long distance. The pain moves around the joints, sometimes it's my knee and sometimes it's my hip. The pain also hurts the joints in my fingers. I went to the doctor and he gave me a blood test and X-Ray, he prescribed me Ibuprofen, Voltaren and scheduled physical therapy for a later date once pain is minimal.
Developed pseudo-gout of 3rd digit, PIP, left hand and right elbow
22y/o AD male c/o Chest Pain since 4am today, Mid-sternal radiates to back. PT states Shivers/chills and anxious. PT is in Quarantine right now recieved J&J vaccine last night at 2300.
Patient received Jynneos vaccine while symptomatic with monkeypox (rash and fevers). 3 weeks after symptom onset and one day after let out of isolation, patient woke up with new pox like lesions on his chest and back
extremely tired, more than usual; soreness of the body; very little soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extremely tired, more than usual), MYALGIA (soreness of the body) and VACCINATION SITE PAIN (very little soreness in the arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]), PARACETAMOL (TYLENOL), CELECOXIB (CELEBREX), ACETYLSALICYLIC ACID (ECOTRIN) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (extremely tired, more than usual), MYALGIA (soreness of the body) and VACCINATION SITE PAIN (very little soreness in the arm). At the time of the report, FATIGUE (extremely tired, more than usual), MYALGIA (soreness of the body) and VACCINATION SITE PAIN (very little soreness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included High blood pressure medication and Two different eyedrops for glaucoma. Treatment medications were not provided by reporter.
Patient complained of flu like symptoms during night of 10/14. Cold chills, body aches, upper arm and back area swollen. When she reported symptoms at 3:30 PM on 10/15 she was feeling better with a few body aches. Arm swelling was decreasing. On 10/19 patient states the redness and swelling was gone on 10/18/15 AM.
Sweats within 12 hours lasting 4 hours, very sore arm, dizziness lasting 2 days.  9 days later, redness with slight swelling and itching lasting 10 days.
Developed rash all over my body. From head to toe. Fire hot to touch, itchy. Went to many skin doctors who couldn?t help me, a few weeks later it turned into full blown psoriasis all over my body. From my scalp oozing and flaking to not being able to open my eyes and bend my fingers. It lasted a whole year and still now suffer residual affects of it.  Also became allergic to different foods and got severe hay fever which I needed to be medicated for months for.
Patient who is 12 years old received Pfizer-BioNTec COVID 2023 dose for children 5-11 years of age.
nausea-1 day loss of appetite-1 day fever-1 day muscle pain/weakness-2 days insomnia-5 days excessive sweating-5 days pain at injection site-5 days
had both shots and still got shingles/Suspected vaccination failure; had both shots and still got shingles; nerve pain in his right leg; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and nerve pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 31-July-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The reporter's hubby had both the shots and still got shingles. The patient has had nerve pain in his right leg still. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Expired vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number HN5BE, expiry date 16th September 2021) for prophylaxis.   On 17th September 2021, the patient received Engerix B 10 ug. On 17th September 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received expired Engerix-B 10 microgram vaccine, the vaccine was expired on 16th September 2021, which led to expired vaccine used. The pharmacist was not allowed to provide patient´s details The reporter consented to follow up.