chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Regular side effects; Severe chills; Slight fever; Sick for one day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for one day), VACCINATION COMPLICATION (Regular side effects), CHILLS (Severe chills) and PYREXIA (Slight fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetic (it is well maintained, she is not on any medications), Legal blindness, as defined and Constipation (trouble going to the bathroom).Concomitant products included SENNOSIDE A+B (SENOKOT) for Constipation, CYCLOPENTOLATE HYDROCHLORIDE (CYCLOGEL) for Legal blindness, as defined. On 26-Feb-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 ILLNESS (Sick for one day), VACCINATION COMPLICATION (Regular side effects), CHILLS (Severe chills) and PYREXIA (Slight fever). At the time of the report, ILLNESS (Sick for one day) had resolved and VACCINATION COMPLICATION (Regular side effects), CHILLS (Severe chills) and PYREXIA (Slight fever) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.This case was linked to MOD-2021-396251, MOD-2021-396265 (Patient Link).
Noticed trouble shortness and severe chest pain with physical activity after my first dose. After my second dose I had constant shortness of breath, severe chest pain, tachycardia, palpitations lasting for the over a month. I was diagnosed with myocardia and pericardia. I was hospitalized for a total for 4 days and off of work for over a month. Still continuing to have symptoms.
Patient left arm became painful and she observed swelling and redness at the site of injection the following morning after she received vaccines. She returned to the clinic 24 hours after she first noticed the swelling. I observed an area of induration approximately 7 cm in diameter with redness and swelling, mild to moderate pain with palpation. Cold pack applied for 15 minutes, and ibuprofen administered. Pain and swelling decreased but remain evident.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EL9266), in right arm, on 13Mar2021 as dose 2, single (Lot number: EN6206), in right arm and on 08Dec2021 as dose 3 (booster), single (Lot number: FJ1620), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Patient had none known allergies. Concomitant medication(s) included: PREDNISONE, start date: 29Jul2022, stop date: 01Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2022) Negative, notes: 3 days after testing negative; (03Aug2022) Negative, notes: 3 days after testing negative; (04Aug2022) Negative, notes: 3 days after testing negative; (05Aug2022) Positive, notes: Took home test. Resoundingly positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical courses: Paxlovid rebound perhaps. 4 days after finishing 5 day regimen & 3 days after testing negative, symptoms (primarily bad headache) returned. Took home test. Resoundingly positive.  No follow-up attempts are possible. No further information is expected.
5-25-21 3:48PM MOM INFORMED THAT PT IS TOO YOUNG TO RECIEVE VACCINE.  MOM UNDERSTANDS NO ADVERSE REACTION IS EXPECTED. PT IS OK TO RECIEVE DOSE#2 THREE WEEKS AFTER HER 12TH BIRTHDAY.
Employee on vacation, c/o fever, body aches and cough. Tested 1/5/22 with rapid test.  Results were positive
Chills; Panting; Numb fingertips and feet; Slightly nauseated; Felt weird; Three urination between 10:30pm to 2am (very abnormal); felt tired and wiped out; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration on 12Apr2021 10:30 (at the age of 46 years old) as single dose for COVID-19 immunization. Other medical history included was none. Concomitant medication(s) included atorvastatin. Historical vaccine included: The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not re-ported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and experienced just a sore arm. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. On 26Apr2021 22:15, the patient felt weird, panting, numb fingertips and feet, slightly nauseated. On 26Apr2021 22:30, the patient experienced chills and got very bad, No fever but big chills. On 27Apr2021, 2:30am: the Pulse was 100bpm and felt off chills were gone. On 26Apr2021, the patient experienced three urinations between 10:30pm to 2am (very abnormal), for next-16 hours the patient felt tired and wiped out and next day (27Apr2021) was fine. The patient underwent lab tests and procedures which included heart rate was 95 bpm on 26Apr2021 and heart rate was 100 bpm on 27Apr2021 at 2:30 am, oxygen saturation: 99 % on 26Apr2021. The reporter assessed the events as non-serious. The patient did not receive any therapeutic measures for the events. The outcome of the events felt weird, panting and chills was recovered on 27Apr2021, and the other events was recovered on unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that the vaccines were stored in freezer, were taken out one to two vials and were placed in fridge each day as needed.
pt recv vax 28FEB97 & 10min later devel tremors in all 4 limps w/no swelling;pt recovered same day;responsible MD considered the event to be a conversion rxn tot he circumstances leading up to the vax, as the pt has had a similar emotional
Marked erythema on right thigh approx 12 cm. circular around injection sight - swollen.
Feel terrible/feel bad; Chills; Fever; Body aches; This case was reported by a consumer and described the occurrence of feeling bad in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first part of the vaccine did not effect).   On 23rd July 2019, the patient received the 2nd dose of Shingrix. On 23rd July 2019, less than a day after receiving Shingrix, the patient experienced feeling bad, chills, fever and general body pain. On an unknown date, the outcome of the feeling bad, chills, fever and general body pain were unknown.   It was unknown if the reporter considered the feeling bad, chills, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The first part of the vaccine shingrix did not affect the patient at all. The patient received the 2nd dose of shingrix at night and the patent felt terrible, had chills that turned in to a fever of 102.8 degrees F. On 24th July 2019, the patient felt bad body aches and fever dropped to about 99.8 degree F.
A 15-year-old male received 2 prior doses of Pfizer. Arrived to clinic for booster. Patient assigned to table 4 from registration staff. Minors were spread out among the tables. Clarified no adverse events with past medications/immunizations. He verbalized his DOB. When asked his age he said "16." The 7 rights performed. Administered Pfizer booster 0.3mL dose, IM. No adverse reactions noted. Injection tolerated well. Completed observation without incident. Provider notified of incident. He was just outside of eligibility window, and asked to monitor for any reaction. The leader/patient's legal guardian, assistant and safety officer notified. Appropriate action made. No further follow-up needed at this time.
Patient presented to Regional Medical Center on 02/18/2022 with SOB, and AMS. Patient was recently admitted at alternate Medical Center 02/04-02/07/22 with heart failure exacerbation and COVID PNA. At the time the patient was treated with dexamethasone, remdesivir and diuresis. In the ED at local Regional hospital, chest x-ray showed bilateral interstitial opacities consistent with pulmonary edema and bilateral PNA. The patient met sepsis criteria with hypotension and lactic acidosis. He was started on azithromycin and cefepime. Initially the patient required Opti Flow.  Blood cultures grew staph, vancomycin was added but it ended being MSSA. Ultimately, the patient was discharged to hospice services on 02/27/2022 and expired on 03/01/2022.
(1) Pain started from right shoulder on 10/28/08 evening, extended to right elbow joint and right finger joints, next day, and getting worse. (2) Wheezing for 2 days. (3) Local injection site is symptom free.
Patient should have come back 8 weeks later; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 17-NOV-2020 the patient was vaccinated with a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). Patient should have come back 8 weeks later in approximately middle January 2021 for the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) but on 09-DEC-2020, the patient was received the dose (0.5 milliliter (unspecified route) lot # T028093 expiration date 24-APR-2022 for prophylaxis). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T028093; expirationdate: 24-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
BACK SEIZED AND PATIENT COULD NOT MOVE ABOUT 4 TO 6 HOURS AFTER VACCINE, ALSO HAD UPSET STOMCK, HEADCHE AND NOT FEELING WELL. CALLED 911, TRANPORTED TO ER, AFTER SOME TESTING AND EXAMINATION PATIENT WAS TOLD THAT IT WAS BAD REACTION TO VACCINE. BACK GOT BETTER WITHIN 6 HOURS, OTHER SYMPTOMS TOOK LONGER TO RESOLVE.
This spontaneous report as received from a Nurse Practitioner refers to a female of unknown age, also a nurse (L.N.P) and also the reporter, who had VARIVAX (Merck) sprayed on her face and in her eyes while administering VARIVAX (Merck) (dose and lot # not reported) on 20-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The Licensed Practical Nurse stated that she was administering VARIVAX (Merck) when the needle and syringe separated. She experienced stinging of her eyes for 30 minutes to 1 hour after flushing them with water. She also developed a slight headache. The outcome of slight headache and stinging of her eyes for 30 minutes to 1 hour was reported as not recovered/not resolved. The relatedness for slight headache, VARIVAX (Merck) sprayed on her face and in her eyes and stinging of her eyes for 30 minutes to 1 hour was unknown for VARVIAX (Merck). Licensed Practical Nurse sought medical attention via speaking to Nurse Practitioner. Additional information has been requested.
Pt has never received a covid vaccine. She needs a covid vaccine today. If she does not receive the vaccine, she cannot start her new CNA job tomorrow. Per PCP, she should get the Moderna.   Today is Tuesday and the covid injection schedule is open for patients to receive their covid vaccines.   Vaccine Information Statement(s) or the Emergency Use Authorization was given today. This has been reviewed, questions answered, and verbal consent given by Patient for injection(s) and administration of COVID-19 Immunization Moderna COVID-19.     Pt waited 15 mins and tolerated Covid Moderna vaccine well with no issues.   Patient tolerated without incident. See immunization grid for documentation.   Discussed with PCP about pt receiving Moderna Bivalent vaccine instead of Moderna Monovalent. Per PCP, this is fine since the dose is the same (0.5mL). Told this to pt as well. We will be contacting pt in the next few weeks to update her on her on the due date of her booster. Pt voiced understanding. A copy of her immunizations including the Covid Bivalent was handed to pt. Pt needed this to provide to her new job today.
10 to 15 days lymph nodes on right side of neck swelled.  Was placed on antibiotics for 10 days .  No significant change.  Some swelling has gone down however we are now 6 weeks after vaccination.
allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "allergic reaction".  Additional information: Caller mentioned she has a patient that was ordered to receive Darbepoetin (Aranesp is the brand name). This patient had an allergic reaction back in 2021 to a Pfizer BioNTech COVID 19 vaccine (for adults, no formulation was provided). The caller stated that the electronic medical record is flagging a contraindication to receive the Darbepoetin due to the history of allergic reaction to the Pfizer COVID 19 vaccine. Caller was advised to contact the Darbepoetin-Aranesp manufacturer for further information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache, Myalgia, Fever, left side of chest sharp pain, fever 100.9 day 1, 101.8 day 2 and chills, lower abdominal pain Narrative: Day#1 5-6 hrs post vaccine stomach hurt, diarrhea, fever, chills, body ache, headache, persisted until Day #2, when presented to ED, received IV fluid/iv pain med, tylenol. Fever stopped . Day #3 day off work felt tired, dehyrdated, Day #4 worked, felt ok, Day #5 felt fine. in ED discharge papers, lab work indicates low sodium, low WBC, anemia. Employee states that they were anemic prior to the event
joint swelling of the knee & hand 24 hrs p/1st inject; 21DEC92 f/u thumb &fore finger of other hand also swollen w/in 2-3 days p/inject; pt recovered;
Broke out with shingles on the back of my left leg. Also had shingles on the bottom of my left foot.  Left leg and arm extremely ssnsitive.  !it of pain in my left back and foot. Very tired and achy.  Left arm  and armpit had a lot of pain. I lost one week of work .  My breathing changed and was at my pulmonologist. He put me  on symbiotic   .  Overall the pain i had for a week and a half is not worth getting the second shot.  Doctor out me on an antiviral drug, it did almost nothing
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (dyspnoea/labored breathing/lack of air), VISION BLURRED (his sight was blurred), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He had to stop going to work), DYSPNOEA (experienced chest pain, lack of air, very quick heart palpitations. This lasted 5 or 10 minutes and then it went away) and PALPITATIONS (palpitations/very quick heart palpitations) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A, 077A21B, 034F21A and 056M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.        No concomitant medications were provided. There was no diagnosis of Myocarditis/Pericarditis. It was reported that the patient did not experience any symptoms like that before receiving the Moderna COVID-19 vaccine. After receiving his 4th dose (2nd booster), a week later, something strange occurred: patient stated he experienced chest pain, lack of air, very quick heart palpitations. This lasted 5 or 10 minutes and then it went away. But then came back. He never related this to the vaccine, until today, because he received his 5th dose and received some papers that stated that those could be common side effects of the vaccines and the Covid-19. He received some treatments: medicines that worked but then the symptoms started again. Treatment drugs were Clopidogrel and Amlodipino but the patient did not take it.
After receiving the shot I have had severe allergic reactions to bee stings, insect bites and allergens. I never had any of these before. My hand swole up to 3 times its size after bee stings, my legs have huge red welts after any insect bite. Previously to the vaccine I never had issues with either bee stings or insect bites.
I26.99 - Pulmonary embolism  FLANK PAIN COUGING UP BLOOD
I had swollen arm and hot , fever - Booster Covid flu, aches and pains, nausea, headache all for 2 days.  25Dec2021 - I had a stuffy nose, post nasal drip. Took cold medicine and the cough stayed. I got tested on 25Dec2021 and was negative, it could be sinus or bronchitis . Got antibiotics. Everything went away except the cough. On New Year, had virtual visit with urgent care. It still wont go away even with asthma treatment.
Severe dry mouth, unquenchable thirst, swollen lymph nodes, hives, headache, sore, burning throat.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was  refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
This spontaneous report as received from a certified medical assistant refers to a 4 year old patient of an unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) unknown route and strength (lot # K015970 with expiration date 23-SEP-2016 or lot # K021847 with expiration date 03-NOV-2016 or lot # L001335 with expiration date of 13-JAN-2017) which were exposed to temperatures outside of the recommended range. There was no adverse event reported. The reporter could not break out which specific lot number of vaccine was administered to the patient. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient started itching, after administration of vaccine and feeling sleepy. 11:35 a.m. Benadryl was given. 11:47 a.m. Patient is alert and talking and itching is subsiding. Discharged at 12:10 p.m.  vitals were okay per reporting person.
This was second of two shots for the shingles vaccine. The first time I got chills and body aches and was tired. That was it. This time, I have chills no body aches and very strong nausea. I am having to exert control to keep anything down (bananas, oatmeal).
This spontaneous report as received from a physician via company representative refers to a 70 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient completed series of vaccinations with PNEUMOVAX23, VAQTA and RECOMBIVAX HB (dose, concentration, route of administration, lot# and expiration date were not reported for any of the vaccines). On an unknown date in 2002 (reported as 15 years ago), the patient received a liver transplant. On an unknown date, the patient was diagnosed with lymphoma and was treated with an unspecified chemotherapy regimen for an unspecified duration by an unspecified physician. The outcome of liver transplant and lymphoma was reported as recovered (dates of recovery not specified). The causality assessment was not provided. Upon internal review, the events of lymphoma and liver transplant were considered to be medically significant.
Severe headache ("worst of my life") unresponsive to max doses acetaminophen, ibuprofen, hydrocodone. Lasted 2-3 days.
itchy eyes, right eye began to hurt, worsen through the night, foot completely numb, extreme leg pain, constant pain, couldnt walk normally, entire leg still numb, shooting pain in right arm
Swelling on the left deltoid at the site of the vaccine, red streak running down arm, throat itchy and difficulty swallowing.
pain at the injection site; muscle soreness; headache; fever and chills; fever and chills; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247, Expiration date: Not reported), via an unspecified route of administration in left arm on 22Mar2021 at 15:00 (at the age of 31-years-old) as dose 2, single for COVID-19 immunization in a clinic. The patient's medical history was not reported. There were no known allergies reported. Concomitant medications/other medications received by the patient in the two weeks included sertraline. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247, Expiration date: Not reported), via an unspecified route of administration in left arm on 03Mar2021 at 15:00 (at the age of 31-years-old) as dose 1, single for COVID-19 immunization and experienced pain at the injection site, muscle soreness and headache. The patient was not pregnant at the time of vaccination and no other vaccines was received by the patient in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and post-vaccination, the patient had not been tested for COVID-19. The patient experienced pain at the injection site, muscle soreness, headache, fever and chills on 23Mar2021 at 14:00. No treatment was received by the patient for these events. The outcome of these events was recovered on 23Mar2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a Registered Nurse (R.N) regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 26-JAN-2016, the patient was vaccinated with one dose of VARIVAX (Merck), Lot # K026385, (dose and route of administration not provided), which was improperly stored. There were no concomitant medications reported. There were no adverse effects reported. This is one of several cases from the same source (MARRS # 1601USA011654, 1602USA002862, 1602USA002863 and 1602USA002864). Additional information has been requested.