chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Jan 11, 2021?.First Mederna COVID-19 Vaccine Jan 21, 2021?.Had episode of head feeling like it was whirling                                                             around. BP was extremely high. ER was running                                over with COVID patients and no rooms. I took                                     her to see. Not having classic signs of                             stoke and EKG was done it was fine. Caroitid us                             and ECHO was ordered. All were NEG. Referred                              to Dr. for a Heart Cath.  Feb 25, 2021  Heart Cath was NEG.                                Followed up with Dr.  and he ordered a Ct                              Scan of her head with and without contrast. He                                Also wanted her to see Dr.  or                              Dr.  to have her eyes fully examined.                             Dr.  couldn't find anything wrong with                              her eyes. He said they looked healthy. Mar 12, 2021?.CT of head was done this was a Friday. Mar 15,2021?. Dr  called me at work and told me Mama                                               had had a stroke. A Rt Frontal Lobe Infarction                             She continued having these episodes                                   throughout  the weekend with                                                    her eyes not being able to focus and feeling.                              like her eyes where getting hung in their                               socket.    Mar 16, 2021 Seen Dr  and he ordered a MRI to see what                               It would show. Mar 18, 2021 MRI done and the results were NEG? (That?s                                                                                  complete BULLCRAP if you ask me)! April 14, 2nd reading was requested by FNP 2nd IMPRESSION read by Dr.  although there are no acute intracranial abnormalities detected, there is a small area of encephalomalacia in the right lentiform nucleus extending to the right caudate head with ex vacuole dilation of the anterior horn of the right lateral ventricle. Ekg- Jan 21,2021 Echo- a week after the EKG Carotid Ultrasound- same as ECHO Heart Cath- Feb. 25, 2021 Cardiologist- Dr. - had to follow up with him due to having a heart cath and BP continuing to spike at random times Optometrist Dr. -  twice to rule out anything going wrong with eyes- NEG both visits Now we are waiting to follow up with Dr Neurologist
Pt developed papular rash consistent with drug reaction 16 days post 2nd dose of COVID VACCINE.
Case number PHEH2014US019178 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 45 year old male patient. His medical history and concomitant medication was not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLURIVIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. No adverse event was reporter following this medication error (overdose).
right after vaccine, she went to the observation area.  Once there she stated having heart palpitations and chest pain.  She was taken to the ED for evaluation
Patient reported feeling ill within hours of injection, saw PCP that day, was sent home, went to hospital by ambulance next day. Patient reported "blood poisoning," received blood transfusion in hospital and spent 3 days in hospital. Patient could not give name of PCP.
This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unspecified dates between September 2016 to October 2016, the unspecified patients were vaccinated with improperly stored doses of PROQUAD (lot # M021731 and expiry date 29-OCT-2017) (lot # M031941 and expiry date 27-DEC-2017) (dosing regimen unknown). On an unspecified dates between September 2016 to October 2016, PROQUAD with lot number M021731 was exposed to temperature excursion of 6.7 Fahrenheit for 2 hours and 3 minutes, 18.7F for 3 hours and 39 minutes, 11.9 F for 2 hours and 37 minutes, 10.3F for 1 hour and 22 minutes, 9.5F for 3 hours and 32 minutes, 9.4F for 2 hours and 53 minutes, 8.8F for 56 minutes, 9.7F for 4 hours and 42 minutes and with lot number M031941 was exposed to 10.3F for 1 hour and 22 minutes, 9.5F for 3 hours and 32 minutes, 9.4F for 2 hours and 53 minutes, 8.8 F for 56 minutes and 9.7 F for 4 hours and 42 minutes. No previous temperature excursion were reported. The call was due to digital data logger. No symptoms were reported. No product quality complaint was filed. Additional information has been requested.
Fever within 24 hours -up to 99.6.  Swelling of Lymph gland under  armpit in the same arm as injection.
Patient reported tightness in arm at night; morning had increased pain, redness, and swelling but not at injection site (actually right on bicep); patient took Advil and applied an otc pain patch on bicep, then played golf, still painful so came back to pharmacy to report.
Sore arm; body aches; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Apr2021 15:30 (Lot number: EW0162) at the age of 50 years as dose 2, single and intramuscular, administered in arm left, administration date 27Mar2021 15:30 (Lot number: ER8733) as dose1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE taken for hypertension (ongoing); OLMESARTAN taken for hypertension (ongoing); ALPRAZOLAM taken for anxiety (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Sore arm"; PAIN (non-serious), outcome "unknown", described as "body aches"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  Additional information: The first 2 shots He got from Pfizer, he just had a few side effects, sore arm and body aches, and tiredness, they all went away after a few days. The booster he bet at (pharmacy name), had a much shorter expiration date then first two shots, She didn't know it this means anything or not. He also gave blood from the same arm that he got the booster shot in the same day. All he knew, he had the same reaction , few body aches next day and sore any different was that he had pain in that arms veins since shot, that had not gone away . It was like either his muscles or nerves on veins +arteries hurt. They feel thick mostly in that arm, but also in other arm as well as lees behind knees down calves it was like my nerves, veins, or muscles are enflamed and irritated. He told his doctor, he did nothing that is why he was asking you could this be the side effect from booster. He have had this pain since shot.  Follow-up attempts are completed. No further information is expected.
did not get the second shot, was told by three separate doctors no to get due to; intermittently, she would be tired, but then she would get over it; it's almost to my elbow/wide area, probably 3 inches; burning and itching started on my arm; burning and itching started on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (it's almost to my elbow/wide area, probably 3 inches), PRODUCT DOSE OMISSION ISSUE (did not get the second shot, was told by three separate doctors no to get due to), VACCINATION SITE PRURITUS (burning and itching started on arm), FATIGUE (intermittently, she would be tired, but then she would get over it) and VACCINATION SITE PAIN (burning and itching started on my arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (burning and itching started on arm) and VACCINATION SITE PAIN (burning and itching started on my arm). On 21-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (it's almost to my elbow/wide area, probably 3 inches). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get the second shot, was told by three separate doctors no to get due to) and FATIGUE (intermittently, she would be tired, but then she would get over it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site reaction, at a dose of 1 dosage form and CORTISONE for Vaccination site reaction, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE DISCOMFORT (it's almost to my elbow/wide area, probably 3 inches) and VACCINATION SITE PRURITUS (burning and itching started on arm) had not resolved and PRODUCT DOSE OMISSION ISSUE (did not get the second shot, was told by three separate doctors no to get due to), FATIGUE (intermittently, she would be tired, but then she would get over it) and VACCINATION SITE PAIN (burning and itching started on my arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       No concomitant medications were reported.  The patient needed to put ice and cortisone on it in order to sleep.  The patient did not get the second shot. It was reported that the patient was told by three doctors no to get due to reaction.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Telephone contact report (TCR) was received. Action taken was updated. Additional event was added.
No wheal formation with initial administration.  Dose repeated.  Same lot, 1" from original administration site.
very weak; tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2(PFIZER COVID-19 VACCINE ,Solution for injection, Batch/Lot number was not reported, expiry date was unknown), dose 1 via an unspecified route of administration on Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had experienced on Aug2021 patient got the Pfizer shot last Saturday and patient have been very weak and tired and wanted know if that's normal. The clinical outcome of the events were unknown.      The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
vaccine given 02/09/09. on 02/10/09 mother reported swelling and redness at injection site, RN advised mom to alternate cool and warm compresses to site and give diphenhydramine Q 6 hours as needed. mom to monitor site and report if worse on 02/11/09. on 2/11/09 mother reports that swelling and redness circle arm and warm to touch. RN offered mom appts on 2/11/09 and mother declined. Appt set for 2/12/09. Seen in office with irregular borders covering deltoid area of upper L ext measuring 20cm X 18cm at largest area. Advised mother to continue above care she verbalized understanding and is to call if site worsens or no better in 3-5 days.
Besides the general flu like symptoms, I had daily horrible migraines every day for about three weeks starting the day after the vaccine shot.  I saw a neurologist and pain specialist and received bilateral greater occipital nerve block, which was not particularly helpful.  Also, prior to second vaccination, menstruation was extremely regular, every 3.5 weeks.  Last menstrual period began the day after the second shot (4/21/2021) and lasted about 5 days, and has not recurred since; the vaccine seems to have triggered menopause.
? tiredness ? headache ? muscle pain ? chills ? joint pain ? fever ? nausea ? feeling unwell
Stated at entrance to clinic that he faints w/ vaccines/injections, sat on table; after Tdap he laid down, after Menactra he said "I am going" then fainted.
no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 13-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. Since 04-NOV-2015, on unspecified dates, the patients were vaccinated with unspecified dose of improperly stored ROTATEQ (oral, strength and dose were unspecified). No adverse effects had been reported. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax & vomited 2 hrs after vax vomited thru noc approx q hr; pt had fever of 103; fever broke w/ apap;
several days p/vax pt devel aching in joints, especially shoulders;although most pain is gone, shoulder pain persists, mostly of noc;it is relieved w/chest & does not bother pt much during day;
Sore Arm, chills, fever, shivering, joint pain, headache, extreme fatigue. Lasted 24 hours.
Patient reports lip swelling in the evening of flu vaccine, resolved 3 days later. She did not call the clinic or go to ER, she came in on 12.07.18 and was positive for strep infection antibiotic was given.
Shortly after getting the 2nd vaccine, I started getting Fecal Incontinence. I would get no cramps, no indication that I needed to use the bathroom, NOTHING. The feces just flowed right out of my body like a waterfall or kitchen faucet and ran down my legs and all over me. I had a mess that I could not control.
Started noticing big clumps of hair in the shower after about 1 week after getting the vaccine and it never happened like that before.  Every day I brush my hair and the brush is heaping with hair.
moderate stroke in the front of his brain - complete loss of speech, disorientation Outcome - mild aphasia
Fatigue, myalgia, fever, chills, headache lasting at least several hours. I am still experiencing them and it has been 5 hours. Minimal improvement with Tylenol.
Syncope, vomiting.  EMS called to evaluate. Pt refused transport.  Sx resolved.
We think an empty syringe was administered to a patient; A spontaneous report was received from a pharmacist concerning a 51-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) who experienced empty syringe administered to patient.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The pharmacist reported that they thought an empty syringe was administered to the patient. They wanted to administer a confirmed dose to the patient, so a second dose was administered.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, empty syringe administered to patient, was resolved on 08 Jan 2021.; Reporter's Comments: This report refers to a case of 51- year-old female patient who experienced non-serious unexpected event of empty syringe was administered to the patient (Product dose omission in error). There were no reported AEs associated with this case of product dose omission in error.
Baseball size knot in arm....high fever. chills. metal taste in  mouth, weakness, dizzy,  hashimotos has spike up again. Was stable before vaccine.  On going since vaccination. High dose of Benadryl. Motrin Tylenol
Pt received the flu shot on Tuesday. She then called on Wednesday complaining of bruising, swelling on redness. On Thursday she called again complaining of redness the size of a baseball, swelling, warm to touch and bruising. Pt was instructed to call MD however pt refused.
A few days after the Moderna vaccine, I started having a persistent daily headache.  I have been to the doctor and emergency room.  It has now lasted 2 months with no improvement.
Right deltoid inflamed, swollen 9cm's x 15 cm's - redness, tender.
Patient called 05/10/2003 due to redness and swelling at DTaP site.  Progressing unchanged.  05/11/2003 given Keflex x10d for cellulitis
outbreak of oral herpes 5 days post vax;hx of oral herpes-tx w/zovirax course per personal MD
I have noticed decreased sex drive and impotence. Ejaculation had become increasingly harder to reach. I also have signs and symptoms of myocarditis and pericarditis.
The patient reported that she received an Imovax Rabies and an Imogam vaccination on 24-Oct-2000. Reportedly 2 days later she experienced heavy vaginal bleeding. Patient was told by emergency room doctor "he never heard of this and it was not vaccine related". Patient refused to be evaluated by a physician or examined by a gynecologist.
Patient was administered Moderna Third dose of 0.5ml. Monitored for 15 minutes. No adverse reactions. Patient was dischardged from office.  Dose to be administered Moderna Booster 0.25 ml. Covid vaccine manager and pharmacist notified. Per CDC guidelines, if administered 0.5ml as booster do not repeat dose. No adverse reactions listed. Patient notified of error. All questions  answered. Pateint was given  HCF Clinical Coordinator contact information for further concerns.
This spontaneous reported as received from a physician via company representative refers to a 62 year old female patient with no drug reactions/allergies. Medical history was not reported. On 14-JAN-2014, the patient was vaccinated with ZOSTAVAX 19400 plaque-formin units (PFU), for to prevent shingles. Dose, route and lot number were not reported. No co-suspect and concurrent therapies were reported. The physician reported that patient, who failed to report she had a rash on the day she received ZOSTAVAX (on 14-JAN-2014), developed shingles the day after receiving ZOSTAVAX (on 15-JAN-2014). The physician stated the patient's rash was worse and more painful the next day and the rash was confirmed to be shingles. At the time of this report the outcome was not recovered. The patient sought medical attention, office visit. No lab diagnostics studies was performed. "Unspecified antiviral medication" was given to treat the adverse event. The causality was not reported. Additional information has been requested.
Fever over 102F beginning about 15 hours after vaccine administration, chills, muscle aches. Symptoms lasted over 8 hours.
I had my shot on May 1, 2021 and a couple weeks later around May 21, 2021 I noticed red spots on both of my arms. A day or so after I noticed them, I contacted Dr. and spoke with him about it, and he told me that it is a reaction to the vaccine ramping up my immune system. I made an appointment with my doctor, he verified that it was a reaction to vaccine no medicine was prescribed. On the night of 05/25/2021 you could barely see them.
I had my booster Covid - Moderna shot on the 27th of December, the adverse events I have had as of Friday the 31st, was a dichotomy on the inside of both of my cheeks and mouth sores all over the mouth.
The pt experienced a red lesion with mass indurated below with an abscess to the right proximal thigh that covered an area of 1.5 x 2 cm. Temp of 101 for over 3-4 days. Treated with Keflex.
Severe body aches; Tiredness; Sore arm; Fever; This is a spontaneous report received from a non-contactable consumer. A 58-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 16Mar2021 at 11:00 (at the age of 58-years-old), as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient was allergic to sulfa antibiotics (MANUFACTURER UNKNOWN), trimethoprim (MANUFACTURER UNKNOWN), meperidine (MANUFACTURER UNKNOWN), penicillin (MANUFACTURER UNKNOWN) and amoxicillin (MANUFACTURER UNKNOWN). Concomitant medications were not reported. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 16:00, the patient experienced tiredness, sore arm, fever and severe body aches. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events tiredness, sore arm, fever and severe body aches. The clinical outcome of the events tiredness, sore arm, fever and severe body aches was recovering.   No follow-up attempts are needed. No further information is expected.
vaccine-associated EM; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown.), for COVID-19 immunisation; Covid-19 vaccine (Dose 2; manufacturer unknown.), for COVID-19 immunisation. The following information was reported: ERYTHEMA MULTIFORME (medically significant), outcome "unknown", described as "vaccine-associated EM".; Sender's Comments: Based on the known safety profile and information in the case report a casual association between reported event Erythema Multiforme and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate