chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stomach didn't feel good; Stomach Cramps; Felt nauseas; Constipated very bad; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipated very bad), ABDOMINAL DISCOMFORT (Stomach didn't feel good), ABDOMINAL PAIN UPPER (Stomach Cramps) and NAUSEA (Felt nauseas) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Heparin allergy), Drug allergy (NSAIDS allergy), Cholesterol on 18-May-1989, Myocardial infarction (MCI(mild)) since 18-May-1989 and Hypertension (High Blood Pressure) since 18-May-1989.   On 10-Mar-2021 at 1:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021 at 6:30 PM, the patient experienced CONSTIPATION (Constipated very bad). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach didn't feel good), ABDOMINAL PAIN UPPER (Stomach Cramps) and NAUSEA (Felt nauseas). The patient was treated with MACROGOL 3350 (MIRALAX) for Constipation, at a dose of 1 UNK and BISACODYL (LAXATIVE [BISACODYL]) for Constipation, at an unspecified dose and frequency. At the time of the report, CONSTIPATION (Constipated very bad), ABDOMINAL DISCOMFORT (Stomach didn't feel good), ABDOMINAL PAIN UPPER (Stomach Cramps) and NAUSEA (Felt nauseas) was resolving. Not Provided          No concomitant medications were reported.  Miralax is used as treatment medication.   This case was linked to US-MODERNATX, INC.-MOD-2021-100579 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up Information received on 18-MAR-2021 : updated product details, treatment medication details,updated outcome of events, added a new event. On 01-Jun-2021: Follow-up Information received on 01-JUN-2021: Facility Information Updated, Patient Demographic  details updated, Vaccination time updated, Concomitant Medications Updated,  Event information Updated On 07-Jun-2021: No new information received; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-100579:2nd dose case
Very high temperature for over36hrs. Over 101. Severe joint pain, back pain, severe headache, blurred vision. Profuse sweating or chills. Inability to get up and function. No appetite. Pain around breast bone, total weakness, occasional breathlessness.
Right side ear completely numb. Tissues surrounding ear including face, neck and head above and behind ear completely numb. Sudden onset ringing in both ears.
Pt recv vax on 11/1/97; on 11/2/97 pt exp hives on arm, throat swelling & burning, itchy eyes
Persistent cough, sneezing, red, conjunctiva 20 min after injection and 5 min after discharge. Albuterol Aerosol Tx BP100/60
Thirty minutes after small pox vaccination, patient developed a body rash and said she felt itchy all over
pt recv vax;mom called hlth unit;states devel high pitch screaming lasting approx 2 hr then went into trance of approx 30 mins;T 101;called ped who instructed her to watch & give apap & to have hlth unit;
Body aches and chills. Requiring Motrin 600mg to relieve pain. Even with 600mg of Motrin, body aches are still felt present. Relieved pain from 8/10 to a 1/10.
23APR97 swelling about1 1/2hr p/vax;25APR97 lt upper arm swollen 7 red, hot seen by MD;med given;
After an hour I got vaccinated, I started to feel nauseated and  started throwing up. Theres pain and heaviness on the injection site. I had a headache as well.
This spontaneous report as received from a pharmacist refers to a 72 year old female patient. The patient's medical history included shingles (herpes zoster), which was treated on 27-JUL-2016. The patient had no current conditions or concomitant therapies. On 25-AUG-2016, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, concentration, via, dose and frequency were not reported). On 26-AUG-2016, the patient experienced "rash across her chest, back, breast and scalp. No pain, just itchy" (rash pruritic). It was stated that the patient sought for medical attention by calling the pharmacy.  At the time of the report, the outcome of rash pruritic was unknown. The causality between ZOSTAVAX and rash pruritic was not reported. Additional information has been requested.
This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On an unspecified date in October 2014, the patient was vaccinated with the first dose of GARDASIL, later on December 2014 the second dose of the series was administered (administration routes, lot numbers and expiration dates were not provided). No concomitant therapies were reported. On 30-MAR-2016, the patient went to the office to receive the third dose of the vaccination series (inappropriate schedule of drug administration). No adverse effect were reported. Additional information has been requested.
Information has been received from an adult female consumer with no pertinent medical history who was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 640981/1050L). Concomitant therapy included "Lexoxol", "Eskaligh" and estrogens, conjugated (Premarin). The reporter indicated that she developed benign biclonal gammopathy after vaccination. Diagnostic studies including "blood assays radio" were performed (results not provided).  It was noted that therapy with pneumococcal 23v polysaccharide vaccine was discontinued. Unspecified medical attention was sought and prescription drug was not required. The event did abate and the pt was "recovering with sequelae." A product quality complaint was not involved. Additional information has been requested.
Patient fainted while seated on immunization bench after receiving vaccination, approximately 30 second after while talking with her. She slouched to her side and lost unconsciousness for about 10 seconds. Patient and parent noted that patient has previously fainted after receiving vaccinations (she mentioned influenza vaccine), and even while seeing injections given on tv. They did not appear to be very concerned about situation. Patient was given water, was observed, and rested for another 15 minutes before she was ready to leave.
52 year old patient goes to the vaccination center to receive her first dose of PFIZER suggested by her doctor, given that she suffers from COPD, high blood pressure and Thrombophilia. Within 2 minutes of receiving first dose of Pfizer, she verbalize feeling dizzy and scratchy in her throat. The patient was taken to the incident observation area and was attended by paramedic to take her vitals: 99% sat, 122FC, 180/90 BP, and 88% dextrose. At 11:25pm the case was consulted with Doctor and the patient was transferred to the hospital
About 10 days after receiving my first dose of the Moderna vaccine, hives developed on the backs of both of my hands and around my right eye. The hives persisted for 6 days (I took Benadryl to stop the itching). After 6 days of hives I went to a walk-in clinic and they prescribed 5 days of Prednasone. Today I am on my 4th day of the Prednasone and the hives are finally starting to clear up.
Local red itchy area with 2 inch diameter at site of reaction.   Told her to watch reaction site at this point.
10-11-10 one hour after receiving the vaccines developed dizziness, H/A, fatigue, shaking & body aches 6-7 hrs.
Urinary Tract infection; arms was sore in that area; headache; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unknown date in 2021 (age at vaccination: 90-year-old) as dose 1, single for covid-19 immunisation. Medical history included macular degeneration from an unknown date and unknown if ongoing (he was almost blind and don't drive because of his macular degeneration, he had for years. His eye problem started 30 something years ago when he was 50) and kidney stones (has tendency to get kidney stones). The patient's concomitant medications were not reported. The patient received his first dose 2 weeks ago on an unknown date and it took him a long time to get the vaccine. Next Friday on 19Mar2021 he was scheduled for his 2nd dose. Caller stated, he went to his doctor and got antibiotics which he would start today. He got an urinary tract infection. He has tendency to get kidney stones, so he has to watch what he eat. This was not unusual. She had quite a few. The first was the worst; almost all of them he has passed. Normally he drink water and he would pass, none were the same, he would to get an ultrasound. It took him a long and long time to get the vaccine. His side effects: first day his arms was sore in that area (it hurt a little bit in the morning and 6-7 hours later he didn't even know it was there). Before he got his flu shot he needed to exercise the arm. He had a little headache and that went away. His pharmacist said it would be alright with his antibiotic but he wanted to make sure. The outcome of the event urinary tract infection was unknown and other events recovered on an unspecified date in 2021.   No follow-up attempts are completed; information about lot/batch number cannot be obtained. No further information expected.
EYELIDS PUFFINESS, RED ITCHY EYES, NASAL CONGESTION, DRY COUGH, COLD SWEATING, CHEST PAIN, MUSCULAR PAIN, RUFF BREATHING
Arm red from elbow to shoulder, very swollen, hot, couldn't move it. 102.5 fever, chills.
Clinic recommended changing MFR for Rabies 3rd shot; IMOVAX given; 2 hrs p/3rd shot pt reported having nausea, muscle aches, chills, fever; no breathing difficulties;
Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
Patient called the pharmacy on 3/10/20 saying her right arm was sore the day after the flu shot was given on 2/19/20, and about a week ago her arm really started hurting..felt like spasms she described it as. Mentioned she has Rheumatoid arthritis as well so not sure what the cause is..advised patient to ice and take acetaminophen otc which she said she was doing. She has an appointment with her doctor this Thursday 3/12/20.
Slowly developed a dry cough. Initially thought was start of a cold but this cough over several weeks deepened and was a continual spasms of a deep unproductive cough.  No other symptoms other than occas sore throat and some sinus drainage (I also have seasonal allergies, dust, etc. which started to kick in towards Oct.)   Went to the doctor and urgent care at least 3 x.  Was in the bronchial and according to drs, not in the lungs (did not do an xray).  I was so bad I could not do my daily activities but remained in my bedroom with humidifier and air cleaner going.  No meds helped and it is still lingering a bit in my bronchials.  I have been to a new allergist also who does not see a relationship to allergies unless it was a reaction to the PREVNAR 13 vaccine. No way for him to tell.  I feel this is directly related to the vaccine (either ingredients or my immune systems response to same or something I don't know about the vaccine and me) since I have never in my life, at 65, having gone through plenty of illnesses and health challenges, had this type of a cough not a cough this persistent and severe.  It seemed more like what I would think of as a "whooping cough" (which I have been vaccinated against about 2 months earlier with a tetanus shot with no known negative response).  I would just cough and cough until I couldn't catch my breath (asthma has been ruled out). Treatment was really to try to loosen the cough.  Nothing really worked.  Eventually guaifenesin helped a bit, took fluticasone propionate, cough syrups, amoxicillin 10 day, and 10 day Levaquin.  I am still coughing occas. each day with a bit of loosened mucus.  Only 1 or 2 x a day usually.  This has been about 8 weeks now.
rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced rash with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician assistant concerning an 18 year old female who on 12-OCT-2007 was vaccinated with the first dose of GARDASIL, the second dose of GARDASIL on 08-FEB-2008, and the third dose of GARDASIL on 02-JUL-2008 (lot numbers and routes were not specified). Concomitant therapy included YASMIN. It was reported that on 02-JUL-2008 after the administration of her third dose the patient experienced shortness of breath and tachycardia upon exertion. The patient has experienced two seizures, the first one was two weeks ago and the second one 3 days ago. An echocardiogram performed on 26-NOV-2008 showed right dilated atrium and ventricle with mitral valve and tricuspid regurgitation. The patient's heart rate increased from 80 to 150 after a short walk in the physician's office on 05-DEC-2008. Patient was admitted into the hospital on 05-DEC-2008. Shortness of breath, tachycardia, seizures, resulted in hospitalization and were considered to be disabling and immediately life-threatening. Additional information has been requested.   12/23/08 Reviewed hospital medical records of 12/5-12/12/2008. FINAL DX: severe pulmonary hypertension, etiology unknown; seizure vs pseudoseizure secondary to hypoxia & tachycardia; mild obesity. Records reveal patient experienced SOB, chest pain x approx 6 wks, syncope & seizures x 2.  Cardiac consult done.Tx w/meds & improved.
This  76  year old female received the 2nd Covid shot on 3/19/21 and died on  4/25/21.  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
Pneumovax was ordered and administered to a 2 month old patient. No adverse reaction has been reported.
localized raised red rash at injection site - given diphenhydramine 25 mg PO x1 - increased monitoring for 30 minutes.  Patient still had rash but it was improved.  Was able to leave clinic to home
very sick; This is a spontaneous report from a contactable consumer (patient). This is a report based on information received by Pfizer from (Mylan) GI-2021-2909, license party for pneumococcal 13-val conjugate vaccine. An 86-years-old female patient received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date (reported as last January, year unknown) (Batch/Lot number was not reported) as SINGLE DOSE for immunisation. The patient's medical history and concomitant medications were not reported. Patient took a Pneumococcal flu shot and was very sick. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Ischemic stroke leading to hospitalization for 4 days. Needed thrombectomy and intubation. The stroke affected the area within right frontal lobe and area between right parietal-temporal lobe. No known residual deficits. There is some brain damage.
Patient was given Menveo vaccine prepared with sterile diluent instead of proper diluent.
Patient complained of headache and nausea, then dizziness/lightheadedness. All symptoms resolved except a fast heart rate. Increased wait time after vaccine. Only complaint remaining was increased heart rate. Heart rate retaken. Patient insisted on driving himself him. Patient called chief nurse upon arrival and did make it home safely.
I received the vaccine after noc shift and woke up with aches, headache, dizzy, mild GI symptoms that lasted for about 2 days.  I used Tylenol, drank fluids and stayed in bed.  Lost of pay 12 hrs
I struggle with persistent debilitating tinnitus- the tinnitus I hear constantly became louder within hours of getting the one Johnson and Johnson vaccine for Covid 19 and to date has not returned to its former baseline. I am concerned because it has been over a week and nothing helps.  I also had mild flu like symptoms for 2 days after the injection which resolved.
Redness & swelling to injection site few hours after delivery. Benadryl taken & swelling improved the next day. That evening (2/5/13) @ 5 PM swelling & pain noted to Left elbow and upper forearm; no fever. Seen 2/6/13: Cephalexin 500mg TID started, along with instructions to ice and elevate arm.  Follow up on 2/7/13 - "SKIN:  decreasing erythema and edema in left UE, decresed central rubor, nontender to touch."
Information has been received from a medical assistant concerning a female patient who on 14-JAN-2009 was vaccinated subcutaneously with the third dose of GARDASIL vaccine instead of intramuscularly. The reporter stated that the patient reported a "burning feeling" down her arm when the GARDASIL vaccine was given, and she did not have this "burning feeling" after the first two doses but only with this last dose. The patient currently had some soreness in the lower triceps of her arm. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Additional information has been requested.
Patient Called pharmacy on 08/18/2020 and reported Swelling, Redness spreading of approximately 2 to 3 inches of diameter from site of injection. Patient also reported muscle pain and hot to touch. Patient tried icing the area but did not help. Pharmacist on duty referred patient to seek care from Primary care doctor for further management of symptoms. Pharmacist also notified the Primary care doctor on 08/19/2020. Pharmacist followed up with patient and according to patient she has seen her primary care MD on 08/21/2020. She also reported improvement and no further signs/symptoms  of swelling/redness on 08/22/2020 to pharmacist.
Not even 24 hours later, hives started on palms of hands, very itchy, VERY red. Fever followed the day after with a runny nose and cough.
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age. On an unknown dates, the patients were  vaccinated with improperly stored doses of VARIVAX lot # M037008 for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). The vaccine was exposed to a temperature of 75°F (fahrenheit) , during a time frame of 4 days wich was called by a data logger. No previous temperature excursions reported. No adverse events were reported.
Sore (R) arm for several days, but now pain (R) arm intense at times, sore upper lateral arm to suprascapular, and lower arm to rest, not increased or relieved by activity or positioning, waking from sleep.
Large, red, hot, itchy round spot around injection site.  Painful and itchy after 4 days still.
dose 1 given 3/28/2021 Lot # ER8727 Pfizer  Patient hospitalized with Covid 19, recovered and discharged home.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient is a 75yo male with PMH significant for ED, HTN, GERD, OA, Allergic rhinitis, Impaired fasting glucose, Anxiety disorder, and Elevated PSA. Patient was fully vaccinated with 2 doses of Moderna. There are no recent notes or notes on cause of death.
Myalgia, Arthralgia, Fever, chills; Temp 101.2 Narrative:
Weak, Weak body rack, No energy; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak, Weak body rack, No energy) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weak, Weak body rack, No energy) and PYREXIA (Fever). At the time of the report, ASTHENIA (Weak, Weak body rack, No energy) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Woke up at 5:30am on April 20 with headache, nausea and body aches. Pain at an 8 out of 10 scale. The injection site had a red circle around it, growing from 2 Inch diameter from the night before to about 4.5 inch diameter. Checked temperature around 4pm, at 101.8 degrees. Around 7pm that night, injection site began to itch slightly. Symptoms subsided with medicine but never fully vanished. Temperature fell to 100 degrees. Woke up 6:00 am April 21 to same headache and injection site itch. Body aches and nausea gone but have now been replaced with vertigo, scale 7 out of 10. Temperature at 101 degrees.
Pink Lesion with scab in the middle; patient states saw dr about issue and they stated no infection-should resolve on its own.  Patient states pink lesion and scab (about the size of a pencil eraser) still remain even after second vaccination in same arm different location on the arm though; thus was  recommended to see a dermatologist for further evaluation.
Information has been received from a pharmacist concerning a female (age not reported) who on 14-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot # not reported).  On 14-AUG-2007 the patient experienced light headed.  Subsequently, the patient recovered from light headed.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Initial and follow-up information has been received from a pharmacist concerning a 68 year old female with no known allergies or pertinent medical history who on 14-AUG-2007 at 14:40 was vaccinated SC with a first dose of ZOSTAVAX (Oka/Merck) (lot # 656858/0356U). There was no illness at the time of vaccination. On 14-AUG-2007 at 14:45 the patient felt lightheaded and also stated that she felt like "waves of heat were going through her". Unspecified medical attention was sought, she sat for 15 minutes, drank water and "was fine". No lab studies were performed. The patient was considered recovered. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Patient was okay when she came in. After getting the shot for about 15 minutes she stated that she did not feel good. She had the feeling of chest pain. The nurse got called in to monitor her blood pressure. After that about an hour or two hours, she mentioned to the supervisor that the chest pain did  not go away but it did not get worse either.