chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very tired; Diverticulitis after first dose; A spontaneous report was received from a consumer concerning a 86-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diverticulitis and fatigue.  The patient's medical history included mononucleosis. No relevant concomitant medications were reported.   On 14 Feb 2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 006M20A) for prophylaxis of COVID-19 infection.  On 02 Mar 2021, the patient was diagnosed with diverticulitis. Treatment information included two different type of antibiotics.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events diverticulitis and fatigue was considered as unknown at the time of the report.  Follow up: Follow-up received on 22 Mar 2021 included concomitant medications of ticaglor Twice a day - for heart, Pepsin Twice a day,Blood pressure medicine twice a day and sertraline15 mg once a day.  On 14-Feb-2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 006M20A) on right arm for prophylaxis of COVID-19 infection.  On 02 Mar 2021, the patient experienced with ball irritation problem, diverticulosis as diagnosis.  Laboratory details include,CAT on abdomen on March 2nd and diagnosed that there is minimal fat stranding adjacent to the diverticula. Suggested of mild-acute uncomplicated diverticulosis.Treatment information included,Doxycycline 100 mg, twice a daystarted on 12 Mar 2021. This is for 14 days. In addition then in March 15th started to have Metronidazole 500 mg, 1 tablet three times a day For 14 days.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events diverticulitis and fatigue was considered as unknown at the time of the report.; Reporter's Comments: Based on the known etiology for diverticulosis and the  fact that patient stated that she was fatigued from the antibiotics, a causal association between the reported event and the administration of mRNA-1273  is assessed as unlikely.
Received first dose of vaccine on 4/30/21. The next day on 5/1 noted itching and a burning sensation to the right side of his face in the nasal and orbital area. 2 days later a rash appeared to the right sided nasal and orbital area of face, that has gradually spread down the cheek and up the forehead. Painful and sensitive to touch.
STROKE; LEFT SIDED PARALYSIS ( (INCLUDES FACE AND BODY); This spontaneous report received from a consumer concerned a white and Not Hispanic or Latino, 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included down's syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported,1 total, administered on left arm on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-MAY-2021 stroke and left sided paralysis on face and body. Ambulance was arrived around 20:00. The patient was hospitalized over night.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke, and left sided paralysis. This report was serious (Other Important Medical Condition).; Sender's Comments: V0: 20210532320- Covid-19 vaccine ad26.cov2.s- Stroke, left sided paralysis- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Red and swollen area on right arm, 3x5 inches surrounding injection site of Pneumovax, nausea and general malaise. Pt started Cipro 250 BID for VTL on 10/08/2001.
10 year old patient rec'd Fluzone High Dose, no treatment necessary, no adverse reaction.
insomnia, disorientation, feeling "manic", pain and swelling at injection site, perioral pain and erythema, painful oral lesions (possible lupus flare). Present x 6 days
This spontaneous report was received from a licensed practical nurse regarding unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since unspecified dates starting on or after 05-MAY-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (dose and route were not reported, lot #L038018 with expiration date 13-SEP-2017). The temperature was 11 Fahrenheit degrees during 11 days (digital data logger). There was no previous temperature excursion. There was no adverse events reported. This is one of several reports received from the same source. Additional information has been requested.
severe pain in muscles in right hip. Muscle cramps in right hamstring, calf and foot at about 1 am the following morning. Bleeding gums in the morning. Saturday fever and chills. Sunday (was dizzy enough not to function), Monday, Tuesday dizzy.
During the beginning of my period in June, I had heavier bleeding than usual, including a blood clot the size of the palm of my hand, including two other additional blood clots slightly smaller.  This all happened in one day at the beginning of my period.  Around this time I also had more bruising and having petechiae.  These things have never happened to me before.  This only happened for my June period, the following months I have not had blood clots as large as these.  I started taking aspirin and K2 again to try and help the bruising and petechiae, as a protective measure.
Moderna COVID-19 Vaccine EUA.  Eight days after vaccine, I had "COVID Arm", an itchy reddish swollen area at the site of the injection.  It is now 2 days later, the itching has subsided some.  It is an area about 4 inches by 8 inches.  I tried a couple of topical treatments for the itching (the worst of the symptoms), but they did nothing.
New onset ovarian cyst about 5 cm as seen on renal ultrasound. Been having pain in right lower abdomen noted in April, saw OBGYN in June, no follow up done at that time. Also feeling of fullness and nausea after eating. more frequent urination.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 11-AUG-2017, the patient was vaccinated with GARDASIL 9, intramuscular for prophylaxis.  Other suspect therapies included GARDASIL. In 2017 the patient experienced vaccination site mass.    The outcome of vaccination site mass was reported as not resolved.
the adverse event started on 2/12 around 5pm and i got cold down to the bone and it lasted and I never got warm all night. 2/13 my arm was sore and slightly swollen arm was warm and i got really tired, then the headaches started went across the head and got worse and worse. on 2/14 - 2/28 I had diarrhea headache and bone chills, loss of taste and smell,  2/16 dizzy, sore throat, runny nose, cough and fever, 24th brain fog started, 25 vomiting started, on 3/1 I had just headaches, I'm still tired but I can stay away today
1 month after the booster I woke up and could not breathe. I had several scans and eventually had to have a stent implanted and was placed on oxygen and several new medicines which I never needed prior to this booster. I was prescribed several new medicines afterward as follows: Bumex 0.5-1.0 mg, Montelukast 10 mg, Carvedilol 3.124 mg, Entrtesto 49/51 mg, Plavix 75 mg, Jardiance 10 mg
Diarrhea, severe sinus headache and pressure all threw head an neck, stomach cramps, dizzy, blurred vision, achiness, fatigue, sinus pain, sore throat.
This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (night sweat), SOMNOLENCE (sleepy), LETHARGY (lethargic), ILLNESS (started getting sick) and DIZZINESS (dizzy) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Foot surgery (on Friday prior to Bivalent vaccination and had to keep feet up). Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First Primary monovalent dose) on 06-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd Primary monovalent dose) on 27-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (Shot 3 and First Pfizer Monovalent Booster overdose (4 doses in one shot)) on 08-Oct-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, P
Major rash, appeared like bleeding on arm of injection site night of shot and rapidly dissolved on day 2 after shot.
Dizziness, Headache, Sedation, HYPERtension, Fatigue Narrative:
17year old patient received the vaccine in the left arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient received the vaccine in the left arm) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient received the vaccine in the left arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient received the vaccine in the left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 29-NOV-2016, the patient was inadvertently vaccinated with a dose VARIVAX intramuscularly (product use issue) in the deltoid (unspecified arm) instead of subcutaneously, ( lot # M033211 with an expiration date in 13-JUL-2018), (dose, dose number and frequency were not provided) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Pain from left knee replacement; Pain from left knee replacement; This is a solicited report received from marketing program 'Facilitated Collect' based on the information received by Pfizer (MFR Control No. # 21K-163- 4026604-00) from a consumer (patient). The consumer reported two reports for same patient and different doses, this is the second of two reports for second dose.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 10Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for Covid-19 vaccination; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. In 2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer BioNTech. She had covid a couple of weeks after the first vaccine for covid. On 10Jul2021, patient received 2nd dose covid-19 vaccine manufactured by Pfizer BioNTech. On 21Jul2021, the patient had knee replacement and experienced pain from left knee replacement. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. The patient was still having pain from left knee replacement done on 21Jul2021. In 2021, the patient experienced pain from left knee replacement. The action taken in response to upadacitinib for events was unknown. The patient outcome was not recovered from the pain, of other events was unknown.   Causality for RINVOQ(UPADACITINIB): The reporter's causality for the events of pain from left knee replacement onset 21Jul2021, pain from left knee replacement onset in 2021 and covid was not provided. AbbVies opinion is that there is no reasonable possibility that the events of pain from left knee replacement onset 21Jul2021, pain from left knee replacement onset in 2021 and COVID are related to RINVOQ (UPADACITINIB).  Causality for vaccine: The reporter's causality for COVID-19 was possible, for other events was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, the events of Joint injury and Procedural pain are  assessed as not related to BNT162B2, and more likely due to  underlying medical condition of Rheumatoid arthritis for which patient underwent Knee replacement.,Linked Report(s) : US-PFIZER INC-202101170219 same reporter/ patient, different dose/AE
pt recv vax 24SEP95 & devel an inj site rxn characterized by redness & swelling;1OCT95 the rxn had worsened & was described as indurated, red, warm & itchy
Information has been received from a registered nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's past medical history, concurrent condition, or concomitant medication.The patient was vaccinated with RECOMBIVAX HB (lot number, dosage, and route of administration not provided) and PEDIARIX (GlaxoSmithKline) (lot number, dosage, and route of administration not provided) at the same time on the same unspecified day. No adverse symptoms reported. No further information was provided. Additional information is not expected.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: she said she had swelling on her side-Medium, Additional Details: i dont know if she went to urgrent care or er but strongly recommeneded. she stated she didnt want to pay a copay and asked me for otc treatments but i suggested she have a physician check it out
Rec'd Flu vaccine in RD on 11-5; on 11-6, began having extreme pain to right side of back, right axilla, right chest wall, voices pain upon moving right arm, decreased ROM; sxs cont today but are improving.
Physician clinic staff gave a child the adult dose of HAVRIX - Hepatitis A vaccine-instead of the pediatric dose. This has happened several times at our associated clinics so I think there is lack of appropriate labeling on the products from the manufacturer.
Soreness/swelling at injection site, fever 102 degrees Fahrenheit for 24 hours, severe chills at times, headache, mental fogginess/forgetfulness, generalized aches.
This spontaneous report as received from a registered nurse refers to a 27 years old female patient. The patient was vaccinated with the first 0.5 ml dose of RECOMBIVAX HB (Lot # not reported) IM on 16-JUL-2012 and received a second 0.5 ml dose of RECOMBIVAX HB (Lot # not reported) IM on 17-SEP-2012. No adverse effects was reported. Additional information has been requested.
After given series of shots, patient was found on the floor outside of bathroom and complaining of dizziness and fainting.  Suspect Gardasil.
Day after patient received the vaccine, (9/26/20) patient woke up with much swelling on the left arm where the vaccine was given. Patient reports painful to move arm and painful to touch, with red, raised border around where the vaccine was given roughly 2 inches in diameter. Patient drew a line around the rash to see if spreading , started applying ice and taking oral advil to alleviate. The next day, 9/27/20, patient came to pharmacy to discuss with me what had happened. From the previous day the patient reports the rash around the area has gotten smaller and has gotten a little bit better but was still there when i viewed it. Patient reports still taking advil and medication to help with symptoms.
Post Vaccine COVID.  2/4/21, onset of congestion and funny taste.  PCR + 2/5/2021.  Had multiple family members in the home +
patient was suppose to receive Menactra but mistakenly received ActHIB with no reported adverse event; Initial information received on 06-Apr-2021 regarding an unsolicited valid non-serious case from a non-health care professional (lead medical assistant).  This case involves male patient of unknown age who was suppose to receive MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] but mistakenly received HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiration date for both the vaccines were not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (wrong product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was a case of actual medication error due to wrong vaccine administered (same day latency).  Reported that lead Medical Assistant was requesting for guidance and receptionist states she was out for the rest of the day. Left call back.  It was not reported whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
DEATH; This spontaneous report received from a consumer via social media via a company representative concerned two patients of unspecified demographics. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the reporter stated that "Before or after the vaccine was available. No control until the vaccine was available. And no one wants to put out any numbers on deaths or serious side effects of the Vaccinated Ones. I personally know of 2 who died of the vaccine and another Lady right now that is going downhill fast within a day or two of getting it. She was a very healthy woman and, a daily walker" On an unspecified date, the patients died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220200910.  Version created to amend previously reported information on 31-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events. 20220200358-COVID-19 VACCINE AD26.COV2.S-Death.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Extreme joint pain and burning - extreme fatigue - muscle tremors, shaking, muscle tightness - slight fever (very low grade).
After shot #1 on 3/5/21: tenderness at injection site lasted for weeks. Fatigue on 3/6/21 only. Intermittent heart racing.   After shot #2 on 3/25/21: pain at injection site. Severe depression and anxiety lasting the day of injection. Intermittent racing heart. Chills, fatigue, overall malaise starting 3/26/21. Moderate headaches starting 3/26/21. Numbness/tingling in tips of fingers on right hand starting 3/26/21.
Vaccine was administered after the beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was reported.  The patient did not report any adverse reactions after the administration of vaccine.  Vaccine number code was reported as 80777-0273-99.
UrticariaPruritus This is to report that the intense itch in bilateral hands and feet continues. Also I have been getting more and more itch all over my body and yesterday had two episodes of intense burning in all my chest area. Also, any piece of jewelry or clothing that I ware leaves a very intense red and inflamed area such like my skin is hypersenstive.
c/o fussiness, pulling on ears, cough, emesis, diarrhea;no fever; tx prior to spinal tap w/48 hrs of ceclor; CSF antigen + for H. influenzae B ? vax failure;immune w/u pending
Immediately after vaccination, face tingling, arm, hand and neck spasms, blurred vision lasting about 5-10 minutes, alleviated after elevating legs
Pain immediately after vaccination at the site then developed soreness, redness, hot to touch, and a small blister approx 1 inch from inj. site - developed over following 24 hrs after vax. Began to improve after that.
Headache; Site where the injection was that is the little sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache and site where the injection was that is the little sore on 09Feb2021. It was reported patient had Pfizer Vaccine earlier this morning and right about patient having a headache and site where the injection was that was the little sore. Would you suggest that patient could have Tylenol, that's all patient can really take everything else upsets stomach (further clarification unknown). The outcome for events was unknown.   Follow-up attempts are completed. No further information is expected.
Developed rash @ each site w/raised macular rash which is where each inject given x/RMLT & rash is @ site also noted on side of leg;