chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had Colon surgery, removed 6-8 inch of colon and reattached; He also got an infection and is on antibiotics now; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SURGERY (Had Colon surgery, removed 6-8 inch of colon and reattached) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Years back).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced SURGERY (Had Colon surgery, removed 6-8 inch of colon and reattached) (seriousness criterion medically significant) and INFECTION (He also got an infection and is on antibiotics now). At the time of the report, SURGERY (Had Colon surgery, removed 6-8 inch of colon and reattached) and INFECTION (He also got an infection and is on antibiotics now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included blood thinners. Treatment for the event included antibiotics.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely.
Pt vaccinated with Influenza developed abd cramps, runny nose, no fever, fell on floor, unable to get up for 2 hrs, fell again, couldnt move for 4 hrs, saw MD dx asthmatic bronchitis, rx to Flu vaccine, E. Coli in blood-poss bladder infect.
mental confusion; extreme difficulty concentrating; lethargic; patient slept constantly; she had a reaction after receiving the Tenvac; Initial information was received on 13-Oct-2020 regarding an unsolicited valid serious case from a consumer or other non-professional.  This case involves a 75 year old female patient who experienced mental confusion (confusional state), extreme difficulty concentrating (disturbance in attention), lethargic (lethargy) and patient slept constantly (somnolence), had a reaction after receiving the DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (local reaction).  It was reported that, a years ago, the patient had to receive TETANUS VACCINE and had symptoms of mononucleosis.  Medical history, medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a second dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious mental confusion (confusional state), extreme difficulty concentrating (disturbance in attention), lethargic (lethargy) and patient slept constantly (somnolence) (unknown latency) and had a reaction (local reaction) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.   Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  On an unknown date, the patient was recovered from all reported event. (duration for the events: 48 hours plus)  There will be no information available on the batch number for this case.  Additional information was received on 13-Oct-2020 regarding an unsolicited valid serious case from a consumer or other non-professional.  Event local reaction was added.  corresponding fields and narrative updated accordingly.
3 days after receiving Td arm rash from deltoid area to antecubical area. Painful red area, warm to touch. Treated for cellulitis with Levaquin, and Prednisone no fever.
The first shot I immediately received tingling in my hands then within an hour the left side of my lips, tongue and throat became numb, and felt swollen as if I had lidocaine injection at the dentist.  But only the left side.  The numbness lasted about 36 hours with the first injection.  It did not however effect my ability to swallow.  With the second shot, my hands did not tingle but within 30m the left side of my lips, throat and tongue went numb and felt swollen as before but this time it also included my left cheek, my left nostril, a small portion of my left lower jaw, all the way over to my left ear, and my left ear.  There was a spot on my cheek closest to my nose that went completely dead to the touch.  Had a different, more intense numb feeling.  The reaction lasted about 6 hours this time.  It never effected my ability to swallow.
PT EXP A FEVER AND AN INJECTION SITE REACTION WHICH INCLUDED PAIN AND DISCOLORATION (BRUISING) WITHIN 24 HRS AFTER IMMUN.  NO TREATMENT GIVEN. REACTIONS RESOLVED APPROXIMATELY 1 WEEK AFTER IMMUN. WITH NO RESIDUAL SEQUELAE.
On 7/8/19 while preparing for vacation, patient began acting a bit unlike her usual self the night before leaving.  The morning (4:30am) of the trip she said she was not feeling great but we all seemed to think this was due to lack of sleep.  When we drove to the airport about 2 hours later she began showing signs of confusion and had obvious trouble with word finding. She also had some occasional "tick like" jerking of her arms/legs.  She could not tell what year it was.   We were taken to hospital.  Stroke was ruled out from MRI.  An abnormal EEG indicated a weakness toward seizure activity. A lumber puncture the next day indicated inflammation in the spinal fluid with an slightly abnormal high viral count.  After 24 hours her symptoms had cleared completely.  She was released from the hospital after 2 nights.
Patient presents with red, slightly raised area measuring 2 inch x 1 inch circular area at injection site. No symptoms associated - no streaks, warmth, fever, itch, or pain.
hard time breathing; she felt her neck tied, her neck felt very tight; sneezing; I feel like my voice is kind of going; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot Number: EN6204) via an unspecified route of administration on an unspecified date (at the age of 44 years) as dose1, single for COVID-19 immunisation. The patient's medical history included hypertension, lightly elevated blood pressure, severe sinus (before patient had the pfizer vaccine she had travelled to urgent care for severe sinus) and allergies (experience having allergies) from an unknown date and unknown if ongoing. Past drug included Benadryl. She took benadryl before she got her vaccine. The patient's concomitant medication included blood pressure meds. The patient had covid 19 check out before vaccination. On unspecified date, patient received her first Pfizer shot that night and the following it felt like she was struggle like a hard time breathing like struggling to breath and was so severe that she honestly contemplated going to ER, she didn't go to the ER, she ended up not going because she thought it was her allergies, she feel like her voice was kind of going and she started sneezing, she felt her neck tied, her neck felt very tight and she don't know if the vaccine made her symptoms worst. Patient also stated that when she took benadryl and she felt 80 percent better but she just want to report it that if anyone takes it for her, her experience having allergies and then taking the vaccine it's like increased it to where she literally was having a hard time breathing. No treatment received for adverse events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Flu-like symptoms for 24-36 hours. Chills, exhaustion, muscle aches, fuzzy head. Also sore arm persisted for 5 days
Patient came into pharmacy on 11/15/18 to tell us about the pain in his arm that he has had for the past month where he got the high dose flu vaccine. He said he has gone to doctor's office and they informed him to ice it. He has also been taking TYLENOL or ibuprofen and still has pain at injection site and he said he is bruised at injection site area.
On 11/10/2017 the patient reported the following reactions. She stated on the morning after receiving her vaccination, she experienced significant swelling in her right arm, hand and fingers. She reported the swelling was severe enough for her not to wear her rings. She did not seek medical attention, and the reaction subsided after a few days. She also detailed severe redness at the injection site.
Myalgia, Arthralgia, Fatigue Narrative:  Other Relevant History:
Initial case was received from a healthcare professional, who was also the patient, on 23 October 2012. A 37-year-old female patient received a right deltoid intramuscular injection of FLUZONE SV, sanofi pasteur Inc., lot number unknown, on 04 October 2012 at 9:00AM. By 3:00pm, on 04 October 2012, the patient had arm pain, for which she stated "had to use my other arm to lift the right one", and arm pain persisted. On 23 October 2012, she was diagnosed with tendonitis "tenoditis". Laboratory or diagnostic testing were not reported. Treatment included Naproxen 500 milligram (mg) twice a day (BID) for 72 hours and to be seen for follow-up on 05 November 2012. The patient stated the "shot is very high in my arm, right on my shoulder", but she also reported site as right deltoid. The patient had no past medical history or allergies and denied illness at time of vaccination. The patient's outcome was reported as not recovered. Documents held by sender: None.
States that post 4th vax, pain in knees.  Tried building muscles around knee per dr request. Pain still persists.
had slight soreness and redness at site of injection after vaccine was administered, but one week later it flared up with discomfort, redness, swelling,  larger than diameter of softball. the site was hot to touch.  it has improved but upper L arm is still red with slight ache.  informed Employee health of problem.
the day after the shot my armpit on the side I got the vaccine got swollen and it hurt, it lasted 2 days before it started to calm down.
Extreme tiredness within 6 hours of injection. Still present 36 hours later.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies. Concomitant medication(s) included: GABAPENTIN; LEVOTHYROXINE; CRESTOR. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 4, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 14Sep2022 at 12:00, outcome "not recovered", described as "Extreme tiredness within 6 hours of injection. Still present 36 hours later.". Therapeutic measures were not taken as a result of fatigue.
Vaccine has made dementia worse; A spontaneous report was received from a consumer (patient's husband), concerning a 91-years-old, female patient who experienced vaccine has made dementia worse.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 28JAN2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 032L20A] intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 29JAN2021, the reporter claims after his wife was vaccinated her dementia has got worse and she is in fantasy world. Treatment information was not provided. The event worsening dementia due to vaccine was assessed as medically significant.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event worsening dementia due to vaccine was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
no adverse event; the patient was vaccinated with an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 19-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) lot number R024015, expiration date on 19-FEB-2020 for prophylaxis (strength, dose number, anatomical location and route of administration was not reported). The sterile diluent used to reconstitute Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) was properly stored.  The temperatures were from 6  degrees Fahrenheit (°F) to 14°F for a timeframe of 10 hours and 35 minutes with a previous temperature excursion of 6°F to 14 °F for 9 hours and 5 minutes and from 15°F to 46°F for two hours and 30 minutes.  The temperature excursion was called because of a data logger and no adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA002418: US-009507513-1903USA011545:
p/vax pt exp a rash that resembled measles all over body, fever 103.6 R, irritability, scratching, & dec appetite;pt seen by MD;
Upper arm swelled and painful, unable to use right arm starting Sat. approx. 2 hours after shot until the following Monday.   Had instant  tingling down arm to the fingers.  Also had instant headache. I do know that this was the first time the lady had given a shot.
This spontaneous report was received from a healthcare worker refers to 7 unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L008034, exp. 05-AUG-2016). No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter link. Additional information is not expected as the reporter did not wish further contact.
blood pressure went much too high; blood glucose went high also; After the first shot, I experienced very bad GI problems. Did not associate this with the vaccine at the time. Received the second shot on 2/27/21 and condition worsened. Not only did I experience ter; This is a spontaneous report from a contactable consumer (patient). This 86-year-old male patient receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (Lot: EL3247) on 27Jan2021 06:30 PM at single dose on Left arm, second dose on 27FEB2021 at single dose on Left arm, both for COVID-19 immunization. Medical history included Diabetes mellitus. The patient was not diagnosed with COVID-19 prior to vaccination. Allergies to medications, food, or other products was no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications the patient received within 2 weeks of vaccination. After the first shot, the patient experienced very bad GI problems. Did not associate this with the vaccine at the time. Received the second shot on 27FEB2021 and condition worsened. Not only did patient experience terrible GI problems, his blood pressure went much too high and blood glucose went high also. The events onset date was reported as 28JAN2021. The adverse event "GI problems" result in doctor or other healthcare professional office/clinic visit. There was treatment received for the adverse event, medications to lower blood pressure and blood glucose. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was Recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The Sat or Sun after I got the vaccine, a quick pain shot around my eyeball in my right eye. It kind of radiated around my eyeball. Then, about a minute later, I experienced a second episode that was less intense. About a week later, I had another quick pain behind my left eye. I had no vision changes or any other symptoms afterwards.
pt recv vax 27OCT95 & 6NOV95 pt devel a gen macular-papular rash which was evident when pt presented to MD 10NOV95
upper abd pain, nausea & vomiting x 2 days whenever food was ingested;6x7cm erythema/edema to inj site rt upper arm;
I experienced Hip Bursitis in my right hip, pain in my lower back and thigh and it is most noticeable if I am in the process of sitting down and getting up.
tongue swelled; shaking like Parkinson's- she was cold; shaking like Parkinson's- she was cold; Headache; This is a spontaneous report from a contactable consumer.  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) (at 74 years of age), via an unspecified route of administration in the arm on 01Feb2021 at a single dose for protection against COVID-19.  She will be 75 in September, date of birth unknown. Medical history included cancer in which she doesn't know when was diagnosed but was supposed to be cancer free and hypertension. The patient's concomitant medications were not reported. The patient got to the ER last night (01Feb2021), she went to the health department to get the shot, then the ER. It was reported that last night, the patient was shaking like Parkinson's- she was cold, her tongue swelled, and she had a headache. The patient was not admitted. Shaking like Parkinson's, cold outcome: the patient felt better, she was a little quivery, but was given a steroid and IV last night, and her tongue was not swollen now. Headache: is still ongoing, but improving, she still has it. The outcome of tongue swelled was recovered on an unknown date; shaking like Parkinson's- she was cold and headache was recovering. Therapeutic measures were taken as a result of the events.
Redness, swelling, tenderness to site, ? early cellulitis vs leg local reaction
immediate light headed feeling and nausea.  She sat down and then went to bathroom about 15 minutes later and said felt much better.  She stayed for 30 minutes until we were comfortable with her leaving.  I put wet rag on head and neck.  She went home and laid down and took zoran.  I checked on her 4 times that day and she was fine later.   The next day she was still fine.
Patient received 1st dose COVID-19 vaccine moderna on 11 Mar 2021 and second dose on 09 Nov 2021; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose COVID-19 vaccine moderna on 11 Mar 2021 and second dose on 09 Nov 2021) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    There was no reported medical history.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose COVID-19 vaccine moderna on 11 Mar 2021 and second dose on 09 Nov 2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose COVID-19 vaccine moderna on 11 Mar 2021 and second dose on 09 Nov 2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      No concomitant medication details were provided. No treatment medication details were provided.   Formulation for HUMIRA was given as Solution for injection in pre-filled pen.  On an unknown date, the patient reported that HUMIRA was not working for her.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
My son began whole entire face, neck, and arms area broke out in hives, his face became swollen. Began to complain about his breathing a little bit.
Fatigue, feverish, migrating joint pain, lymphadenopathy (generalized);
1st dose (lt arm) of Engerix B onset of fatigue, general malaise broke out in a cold sweat, shortness of breath, condition lasted 10-15 min. Recovered /w out treatment
This spontaneous report was received from the administrator referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. 21-APR-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M000442; expiration date, dose, route of administration and anatomical location were not reported) and with an improperly stored dose of ROTATEQ orally (lot# M041181; expiration date, dose and anatomical location were not reported). The vaccine doses were exposed to a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There were no digital data logger or previous temperature excursions involved. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1705USA012988: US-009507513-1705USA012990: US-009507513-1705USA012992: US-009507513-1705USA012995: US-009507513-1705USA012999: US-009507513-1705USA013000: US-009507513-1705USA013001:
Patient c/o tingling and numbness of teeth and swelling of tongue, along with rash on chest. Seen at hospital at around 14:15.
CHIEF COMPLAINT/REASON FOR VISIT COVID-19.   I visited with the patient in her hospital room this evening, and I discussed her care with a family member. Please see her note dated October 12, 2021, for further details regarding her evaluation.   HISTORY OF PRESENT ILLNESS a 92-year-old woman with sleep apnea, coronary artery disease, atrial fibrillation, hypertension, ulcerative colitis, chronic kidney disease, and a history of pulmonary embolus, myocardial infarction, and atrial flutter. She has been taking metoprolol and warfarin for her atrial fibrillation. She has received 3 rounds of vaccination for coronavirus. Three days ago, she began to experience respiratory symptoms including dyspnea and productive cough. Coronavirus testing yesterday was positive. Upon presentation to the emergency department today, her oxygen saturation was 88% on room air and she was noted to be tachypneic with atrial fibrillation with ventricular rates in the 150s. She received IV diltiazem which helped control her heart rate. When we visited with her in the hospital room this evening, she had no shortness of breath on supplemental oxygen. She has had no recent episodes of loss of consciousness, and she has no chest discomfort.
Patient got car sick on the drive back home and shortly after passed out in the bathroom. No one was around to see her fall. She complained of vomiting before falling onto the floor.