chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3/24/21-3/26/21  headache, fatigue, 99.1 degree temp,  sore arm 3/28/21 veins on lower left leg swelled irregularly like Whack-a-Mol and lump in one of them (diagnosed 4/14/21 as thromboplebitis) 3/28/21 migraine headache 4/3/21-4/9/21 very sore left wrist/wore wrist brace 4/7/21 new black spot on right ankle ( with history of melanoma): later biopsy (6/10/21 at Dermatology Clinic)=hemorrhage on right lateral malleolus, benign. April, May, June: unremarkable and variable ankle swelling in the evenings (have never had this issue before, but didn't note down the specific incidences- didn't think a lot about it.) 6/29/21  ankles swelled to the size of softballs!!! in the evening 7/2/2021 blood tests showed not issues 7/22/21 NutrEval tests done 6/23/21 showed high levels of inflammation
Pt became dizzy. She was laid down on a cot and observerd for 30 minutes, when symptoms resolved
The second dose of Jynneos was administered on day 18 instead of day 28; The second dose of Jynneos was administered intradermally; Case reference number US-BN-2022-002181 is a spontaneous case report initially received on 31-Aug-2022 from other health care professional via Agency (reference number: USBAV22-1237) and concerns a male patient.  The patient's relevant medical history and concomitant medications were not reported.  On 12-Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of 0.5 ml, *administered subcutaneously* at an unknown anatomical site, for monkeypox prophylaxis.  On 30-Aug-2022, 18 days after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of *0.1 ml, administered intradermally* at an unknown anatomical site for monkeypox prophylaxis (explicitly coded as 'Inappropriate schedule of vaccine administered' *and 'Intradermal injection'*).  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received on 31-Aug-2022 from Bavarian Nordic included local BN number.  All follow-up information is blended into the case narrative above, with the latest information pre-sented between asterisks (*).  Follow-up information was received from the other health care professional via Agency on 23-Sep-2022: New information included additional reporter, route of vaccine administration for the first and for the second dose of Jynneos and dosage regimen for the second dose.  The case is linked with US-BN-2022-002180, US-BN-2022-002182, US-BN-2022-002183, US-BN-2022-002184 due to the same reporter.; Reporter's Comments: A male patient, was vaccinated with the second dose of Jynneos (18 days after the first dose), at dose of 0.1 ml, intradermally for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered and intradermal injection. Inappropriate schedule of product administration and intradermal injection are considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient, was vaccinated with the second dose of Jynneos (18 days after the first dose), at dose of 0.1 ml, intradermally for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered and intradermal injection. Inappropriate schedule of product administration and intradermal injection are considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.
Patient reported having pain in the injection arm and the chest. He suspected at first that he was having a heart attack.
FEELS LIKE SHE HAD THE FLU; FELT LIKE WAS DYING; STOMACH STARTED HURTING; FELT SICK; DIARRHEA 2 TIMES; NAUSEOUS; HEADACHE/INTERMITTENT HEADACHE; ARM HURT REALLY BAD/HARD TO LIFT; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 190 pounds, and height was 62 inches. The patient's concurrent conditions included: diabetes mellitus, supraventricular tachycardia, no alcohol use, non-smoker, and penicillin allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient had allergy to a preservative that used to be in contact lenses. The patient experienced drug allergy when treated with alprazolam, and ibuprofen. The patient received covid-19 vaccine suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-SEP-2021, the patient experienced arm hurt really bad/hard to lift. On 21-SEP-2021, the patient experienced feels like she had the flu. On 21-SEP-2021, the patient experienced felt like was dying. On 21-SEP-2021, the patient experienced stomach started hurting. On 21-SEP-2021, the patient experienced felt sick. On 21-SEP-2021, the patient experienced diarrhea 2 times. On 21-SEP-2021, the patient experienced nauseous. On 21-SEP-2021, the patient experienced headache/intermittent headache. Laboratory data included: Body temperature (NR: not provided) 97 F, and Pain scale (NR: not provided) 10. On 22-SEP-2021, Laboratory data included: Pain scale (NR: not provided) 6. On 23-SEP-2021, Laboratory data included: Pain scale (NR: not provided) 4. The action taken with covid-19 vaccine was not applicable. The patient recovered from nauseous, and headache/intermittent headache, was recovering from felt like was dying, had not recovered from feels like she had the flu, and the outcome of arm hurt really bad/hard to lift, felt sick, diarrhea 2 times and stomach started hurting was not reported. This report was non-serious.
Approximately 2 hours after receiving flu vaccine. Patient's lower torso and extremities were covered with whelps. No respiratory problems. Benadryl recommended.  Phone call to parent on 11/3/04. Whelps resolved.
Fever 100.4 controlled with tylenol and advil regimen, severe body aches
No adverse event; Patient administered with Moderna COVID-19 vaccine after the published expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with Moderna COVID-19 vaccine after the published expiration date) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 Moderna for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with Moderna COVID-19 vaccine after the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with Moderna COVID-19 vaccine after the published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered with Moderna COVID-19 vaccine after the published expiration date).    Concomitant medication was not provided. Patient had not experienced any adverse event. Treatment information was not provided.
lost feeling in my legs; my inside was on fire; I couldn't walk; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0171, Expiration Date: not reported), via an unspecified route of administration on 16Aug2021 as dose 2, single for COVID-19 immunization (at the age of 51-year-old). Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER8737, Expiration Date: not reported), via an unspecified route of administration on 23Jul2021 for COVID-19 immunization (at the age of 51-year-old). No medical history was reported. There were no concomitant medications. The patient experienced lost feeling in my legs, my inside was on fire and i couldn't walk on 16Aug2021. It was reported that, she went and had the vaccine done. The first shot was not a problem but the second shot was not as fortunate. The second shot, she lost feeling in her legs 30 minutes after she had it, she could not 'simp'  her leg, her inside was on fire and she lost feeling in her legs, she couldn't walk. No laboratory test was done. The patient did not receive treatment for events. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Received phone call from patient's mother on 1/27/14 at 11:45am that child was awakened from sleep 1/24/14 having a seizure. Received notification from ER 1/28/14 that child had been admitted for evaluation of seizure.
Pt began to feel itchy bumps around injection site and across chest.  After 30 minutes, pt began feeling nauseous and lightheaded.  Husband reports pt was acting very sleepy.  RN assessed pt, did not find any redness or bumps.  EMS called.  Pt refused EMS transport.  Pt left clinic with husband.
I started running a 103 fever, my blood pressure was 189/101 and my pulse stayed around 100. I had severe body aches.
No additional AE; Expired vaccine used; Information has been received from a nurse practitioner via Merck Vaccine Representative regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 21-SEP-2021, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, for prophylaxis, lot number S029455 with expiration date in 19-SEP-2021 (dose, route of administration, strength and anatomical location not reported) (expired vaccine used).  No temperature excursion was reported.  No adverse effects reported.
9PM pt began to cough deeply & frequently; between post-nasal drips (almost flood) & coughing, found breathing labored & difficult; pt told to go to ER: MD stated pt bronchi had spasmed & the medication would help;dx bronchitus;
patient had a feeling of flu coming on for a day after the second Moderna Covid-19 shot; Mainly the flu symptoms were body aches in my back.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (patient had a feeling of flu coming on for a day after the second Moderna Covid-19 shot) and BACK PAIN (Mainly the flu symptoms were body aches in my back.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003B21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, APIXABAN (ELIQUIS), ROSUVASTATIN, BUMETANIDE, SPIRONOLACTONE, CLOPIDOGREL, POTASSIUM CHLORIDE, COLECALCIFEROL (VITAMIN D3) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (patient had a feeling of flu coming on for a day after the second Moderna Covid-19 shot) and BACK PAIN (Mainly the flu symptoms were body aches in my back.). At the time of the report, INFLUENZA LIKE ILLNESS (patient had a feeling of flu coming on for a day after the second Moderna Covid-19 shot) and BACK PAIN (Mainly the flu symptoms were body aches in my back.) had resolved.            The patient slept for a day and felt better.  The patient received her Moderna booster dose on 22-DEC-2021 in her left arm shoulder deltoid muscle (lot number 068H21A). Patient reported no adverse reactions or side effects to her Moderna booster dose.
Dx'd w/viral syndrome. Rash on chest. Sore throat, headaches 72 hrs quarter. Return to clinic 5 days for re-evaluation. Tx'd w/Motrin, Sudafed, Tylenol.
upset stomach; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  An 88 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "upset stomach".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itchy red rashes on upper body (stomach, arms, neck) started on April 11 afternoon and got better after taking 10ml Zyrtec.  Large red hot patches appeared again late night on April 12. This time felt like hot burning skin and it was all over (lower body, arms, chest, neck, back). Again, taking Zyrtec improved the symptoms.
Within minutes of IM admnistration of Pfizer-BioNTech mRNA covid vaccine, pt developed cutaneous rxn on bil arms -- swelling, redness, fleshy papules. Remarkably, there was a marked line where redness stopped at upper forearms bil. 50mg IM diphenhydramine was administered in R deltoid. Pt's signs on R arm resolved almost completely to baseline, L arm remained red and swollen at mid forearm down to fingertips with some mild improvement. L hand had improved. Improved with ice application. Pt reported dermal hypersensitivity reaction occurs with certain foods (including eggs, wheat). No signs of respiratory distress. A 'pinch'   pt words) in her throat which also resolved after diphenhydramine administration. I advised on emergency signs of anaphylaxis, at-home diphnehydramine dosage. She confirmed understanding, she informed me she had diphenhydramine at home. She knew when to call 911 or to go the emergency department. She would be home and with her 13-yr old son for the rest of the day. She has a follow-up appointment with her PCP to investigate allergies (already scheduled).
received the two doses of Shingrix on 2018 and experienced Shingles on January, 2020/Suspected vaccination failure; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In January 2020, 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient received the two doses of Shingrix in 2018 and experienced Shingles on January, 2020 which led to suspected vaccination failure. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Pt vaccinated with DTP/OPV six days after immunization 13APR90 developed lethargy, vomiting was hospitalized 20APR90. Dx Reye syndrome.
Pain, redness, swelling at site of Influenza vaccine injection, pain 8/10 28 days after injection. Refer to PCP for followup.
Initial report received from a healthcare professional on 21 March 2013. The female patient, whose medical history and concomitant medications were not reported, had received a dose of ADACEL vaccine (lot number "C43668A", dose number and anatomical site of administration were not reported) subcutaneously on an unspecified date. On an unspecified date, the patient received ADACEL vaccine with one inch needle subcutaneously. Thus vaccine was administered by wrong route and experienced swelling, redness and itching. The corrective treatment and laboratory investigations were not reported. The patient's outcome was not reported. Documents held by sender: None
25NOV92 sx purpura, petechiae, epistaxis, bleeding gingivae 27NOV-30NOV testing, dx immune (idiopathic) thrombocytopenic purpura (ITP); tx Pred appears non-responsive;
My sister had Covid and came home with it. A few days later I had headaches low grade fever, nausea.
Initial unsolicited report received from a physician assistant on 26-AUG-2016. This case involves a male patient (age not reported) who was vaccinated with a first dose of YELLOW FEVER VACCINE (YF) (batch number: UI293AA, expiry date: 20-Apr-2018, subcutaneously in the left deltoid), a first dose of TYPHIM VI (batch number: L1072-1, expiry date: 17-Feb-2017, intramuscularly in the right deltoid), a dose of HEP A (manufacturer: unknown) and a dose of TD (manufacturer: Mass Bio) (for HEP A and TD: batch number, dose, dose in series, route and site of administration was not reported) on 27-Jul-2016. Patient had no illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergies (Unknown medical conditions). Concomitant medications were not reported. On an unspecified date, few days following the vaccination, the patient developed rash and cold. The same week patient called reporter and was diagnosed with Bells Palsy. The patient required ER/ doctor visit. Lab data and corrective treatment were not reported. The patient was recovered from event cold and rash (improved) and not recovered from event Bells Palsy. Upon medical review, the case was considered as serious due to important medical event: Bells palsy. It was reported that the family MD did not think it was related. List of documents held by sender: none.; Sender's Comments: Bell's palsy was suspected in this case, however diagnosis was not conformed. The cause of Bell's palsy is unknown. Risk factors include diabetes and a recent upper respiratory tract infection. Time to onset is unknown. Additional information on investigation results ruling out a concurrent infection and exploration of alternate etiologies, time to onset and patient's history of reaction after previous vaccinations are needed to further assess this case. However, as four vaccines were administered concomitantly, the role of each component cannot be assessed.
Thiss spontaneous report was received from a Registered Nurse, referring to an unspecified number of patient's of unknown demographics. No medical history nor concurrent conditions were reported. On unknown dates, unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # K021487, expiration date 03-NOV-2016; lot # 026387, expiration date 15-DEC-2016; lot # L001335, expiration date 13-JAN-2017; lot # L002217, expiration date 21-JAN-2017; lot # K008819, expiration date 19-JUN-2016; lot # K007979, expiration date 03-JUN-2016 and lot # K005428, expiration date 15-APR-2016) (strength, dose and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaints were reported. This is one of several reports from the same source. Additional information has been requested.
Body ache; Had redness and swelling at injection site and it wasn't smaller area it was probably a good 15 cm down the arm. The redness on the area was about 15 cm elongated 8 cm across; Had redness and swelling at injection site and it wasn't smaller area it was probably a good 15 cm down the arm. The redness on the area was about 15 cm elongated 8 cm across; Nausea; Fatigues; This is a spontaneous report from a contactable physician. An 18-year-old male patient received the first dose of meningococcal group b rlp2086 (TRUMENBA, lot number: AL8468, expiration date: 01Feb2021), via an unspecified route of administration on 18Jun2019 at a single dose for vaccination purposes. Medical history included ADHD. Concomitant medication included methylphenidate hydrochloride (CONCERTA 27 mg tablet) for ADHD. On 19Jun2019, the patient had nausea, body ache and fatigues and then he had redness and swelling at injection site and it wasn't smaller area it was probably a good 15 cm down the arm. The redness on the area was about 15 cm elongated 8 cm across. Nausea, body ache and fatigues started first and by the evening he had the redness and swelling. The physician asked if the should ahead for the second dose or not. Treatment for the events included ibuprofen and Benadryl. The events recovered on an unspecified date.
Paleness, sweating, loss of consciousness few seconds, nausea, vomiting. Last about 5 min total.
Abrupt onset of macular and elevated multiform lesions with erythema swelling of ears, lips and eyelids. Tx with epinephrine, solumedral and Benadryl
An hour and a half after the injection I started feeling itchy at the site of injection and all over upper body/neck.  I also started wheezing, had difficulty (not exptreme) breathing and was coughing .  I called a medical professional that I know who has assisted at COVID19 vaccine sites about next steps and was advised to take a benadryl, so I did.  About 45 minutes later felt fully recovered.