chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced itching on the arm of the injection site 10/9/16 and then developed a rash on 10/10/16 about 3 inches by 2.5 inches below the injection site.
He got his vaccine, he was in the garage put his hand up to his head, said that he was dizzy, went down and his wife got him sitting and fell down and leaned against the boat that he was on, and keeled over.  She called 9-1-1 a neighbor started CPR and his eyes opened for a minute, and she knew that he was gone as there was no life in his eyes.  They kept pumping him full of medicine and continued to shock him, and took him to the hospital and said they had something, and transferred him to the hospital and had a cath and had him on four different medicine and they could not get any signs of function, and she asked them to stop all efforts, which he did not want to be kept alive.  This happened around 5:00 PM at home.    He had just gotten back from a week long fishing trip, was a very happy person and retired and being with his people he liked to fish with.  They were having work done, new deck and got paint to paint the deck, got a new grill.  He was working on the grill and she was in and out of the garage and she helped him with the grill, and that's when he had the violent pain and over quickly.  He has had some health issues in his life, family history of heart disease, very healthy man.    He was taken to the hospital, he was sent to local Hospital.
Feeling of pressure points on top back of head. Loss of balance and coordination. Blurry vision. Very sore soles of feet and neck. Muscle twitching and muscle spasms. Fatigue.
Information has been received from a registered nurse concerning her 25 year old daughter who on 04-APR-2008 was vaccinated with a third dose of GARDASIL (lot# 654539/0742U) prefilled syringe and had a severe reaction. Concomitant therapy included YASMIN. The patient had no problem with the initial 2 doses. On 04-APR-2008 about 25 minutes after receiving the third dose the patient developed hives that completely covered her body and began vomiting. The patient vomited 5 times that day and only had water before the appointment. The patient was seen at the Emergency Room and was given epinephrine, cortisone, and BENADRYL. The patient was sent home with CLARITIN and has been taking since 04-APR-2008. The vomiting had stopped and the hives were almost completely gone. There are a few on her face but they are fading. At the time of reporting the patient was recovering. No further information was available. The reporter felt that vomiting and urticaria were an other important medical events. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Bilogics Evaluation and Research and was released. Additional information has been requested
head cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (head cold) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced NASOPHARYNGITIS (head cold). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (head cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-072032, MOD21-072083 (E2B Linked Report).; Sender's Comments:  MOD21-072032: MOD21-072083:
Sore arm at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the site of injection) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for Ache.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the site of injection). At the time of the report, VACCINATION SITE PAIN (Sore arm at the site of injection) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The concomitant medications were not provided.
FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 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 2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
This is a probable COVID Pfizer vaccine long term effect. I took the Pfizer shots in Jan & Feb. 2021. I took the booster in Sept. 2021. My age is 80 and I have had no health problems. On Feb. 11, 2022, I experienced the onset of a 3rd Cranial Palsy on the left side that left my eye out of focus (rotated to the left corner). In March, 2022, I had a bilateral temporal artery biopsy that identified the cause as Temporal Arteritis. I now have to cover the left eye to prevent disorientation. Prognosis is for the eye to recover focus ability in a few months. I am taking Prednisone to eliminate the inflammation. My opinion is that the COVID vaccine overwhelms the immune system such that it 'forgets' to handle anything other than the COVID, permitting long term problems. Since there is 'long term COVID' associated with those who actually had the disease, it makes sense that the vaccine can have the same detrimental effects. I have 2 friends who have suddenly developed heart problems: a-fib (Moderna); and arrythmia (Pfizer) after taking the vaccines.
Client started developing snorting tics the day she received her first COVID-19 vaccine. Prior to the COVID-19 vaccine, she was asymptomatic. She received her first COVID-19 vaccine on Nov 6th. While they were in the observation area, she started sniffling. Later that day, she started making snorting noises. No other sick symptoms (no actual nasal congestion, rhinorrhea, cough, fevers, etc). Snorting tic continued and seemed like it also go worse right after the 2nd shot on 11/27 (though mother not sure of exact timing).    She is certain the snorting tics have been ongoing since Nov 6th, after Chloe received first COVID-19 vaccination.
Anaphylactic Reaction: 12/15/2021 @ 1425 Staff received Moderna COVID-19 booster dose (0.25 mL).  Staff/Pt arrived at our COVID-19 vaccine booster clinic requesting her third dose.  Prior to receiving the dose, she reported to Dr. a hx of airway constriction and N/V after receiving prior COVID-19 vaccine doses. Dr. then reported this information to me prior to administration. Despite of her history, the staff/Pt insisted on receiving the dose because it was important to her, and she took a dose of Benadryl beforehand. I called staff/Pt back, we discussed the risks, she wanted to proceed with the vaccination which she received in her left Deltoid @ 14:25.  During her 15-minute observation period, staff/Pt began coughing, reporting tightness in the throat, and tachypnea. Dr. sat next to staff/Pt with the emergency med kit. Staff/Pt initially declined assistance, then with some persuading, was relocated to a private area. Dr. spoke with staff/Pt as her condition worsened. Staff/Pt was still declining assistance including emergency medication and EMS intervention. The staff repeatedly refused medication and medical intervention stating I'm not going to the hospital. At 14:38, I received a verbal order from Dr. to give the patient a dose of Epinephrine due to her worsening condition. Dose was given in her left thigh. Nurse was close by, helping to console Pt, affectionately referred to Pt's work mother. EMS was called and I used a wheelchair to relocated Pt (with the assistance of Nurse) to the front door where EMS was waiting. In route, Pt continued dry heaving making statements of I'm fine and I can't believe I'm this person. A plastic bag was provided despite her refusal. The staff, Nurse, and I met EMS in the first-floor lobby area, she remained in the wheelchair as EMS took her VS which were: BP -150/93, HR 144, RR 18, O2 99% RA, ECG? Sinus Tachy @ 14:50. EMS recommended that the staff/Pt receive further medical treatment, staff/Pt continued to refuse. EMS had staff/Pt sign a waiver refused medical treatment, staff/Pt signed. VS were taken again before EMS departure: BP 138/93, HR 127, RR 16, O2 98 % RA @ 14:55. I escorted staff/Pt (still in the wheelchair) and Nurse to their office. In route to her office, staff/Pt continued dry heaving into the plastic bag but improving airway constriction. I left the two @ 15:05 in their office.
has small,red raised bumps around nose,palms of hands & feet;c/o itching & pain;has fever for 3 days;
Large local reaction from left elbow to over left shoulder including underside of arm. Red, hot to touch, skin hard and swollen, painful, no enlarged axillary nodes, no fever. Per physician, parent to continue with Tylenol, ice pack, Benadryl if desired, return to clinic if increasing redness or fever. Line drawn on child's arm to mark redness and swelling.
Immediately  after administration, patient stated tingling in throat, sweating and shakiness. Asked if patient is diabetic ( she did say no to all chronic health conditions on question form). stated she could be hypoglycemic and nervous. We monitored for 5 minutes and she complained of difficulty breathing upon which I asked if she wants me to administer EpiPen and she said "yes". I  administered EpiPen 0.3mg in right tight. After EpiPen she seamed to calm dowm. 911 was called as the EpiPen was administered. After EMS came, patient walked on her own to get her vitals checked. Shortly after leaving, pharmacy received call from patient her self that she is home and feel normal. Followed up with patient an hour later and she is still doing well.
9/4/21 PMH most significant for DM2, CAD s/p CABG, PVD; presents to Hospital for AMS 9/5/21 pt transfered to other Hospital via EMS for AMS and elevated trops
May 1 -  4:00 pm started with the chills, fever, headache and body. Lasted until Midnigth May 2  - Headache and body aches all day May 3 - Headache still persists
Fever of 101 degrees fahrenheit from 3am on 2/10/21 to 8pm on 2/10/21. Migraine headache, muscle aches, nausea, extreme fatigue, and  dehydration, on 2/10/21.  2/15/21 large itchy bright red rash appeared on right arm. Has gotten less itchy and red, but still present on 2/17/21.
Thigh was swollen and was also red and hot for approximately 2 days.  There was also a bruise around the injection site.  This also happened last year when he received the flu shot.
This happens every time I take one of the vaccine, but it was the 3rd dose when I really noticed that it was happening with the vaccines. It starts with discomfort in my joints and stomach, that's not hard enough to be a stabbing pain but it happens abruptly and its bothersome. Dr. told me to take BENEFIBER, which helped a bit after a week or so, but my doctor can tell that my bowel gets irritated. This is something that I have to deal with after the vaccine for about two weeks. It tends to happen a week after I take the vaccine. When I tested positive for Covid the same symptoms happened.
Swelling, redness, Hot, tedernes on upper right arm redness moved down arm by FRI 10/4
CONFIRMED COVID-19 INFECTION; BRAIN FOG WHICH WAS REALLY BAD; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTRATION; This spontaneous report received from a patient (Health care Professional) concerned a 67 year old female. Initial information was processed with the additional information received on 02-FEB-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient is HCP. The patient previously received bnt 162 (Pfizer vaccine) (Dose number in series 1) (form of admin, route of admin, and batch number: EN5318, expiry: unknown) dose was not reported, administered on 25-JAN-2021 for prophylactic vaccination. On an unspecified date, following vaccination with Pfizer vaccine, the patient experienced unspecified adverse reaction (Dose number in series 1). The patient had a reaction to the Pfizer vaccine, so the Janssen Covid-19 vaccine was used to complete the primary series. The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-APR-2021 on left deltoid for prophylactic vaccination which was off label use, and inappropriate schedule of vaccine administered. No concomitant medications were reported.   On 04-JAN-2022, the patient experienced bad cough, congestion, shortness of breath, muscle aches and pain (coded to confirmed covid-19 infection) and brain fog which was really bad (dose number in series 2).  On 07-JAN-2022, the patient experienced fever which raised to 104 body temperature, for which the patient took Advil (ibuprofen) and Tylenol (paracetamol) around the clock as needed which helped to reduce the temperature and underwent a COVID-19 Binax now test (NR: not provided) Positive (dose number in series 2).  On 09-JAN-2022, the patient performed a COVID-19 PCR (polymerase chain reaction) test which came out to be positive. The patient visited a walk in clinic for her symptoms on 16-JAN-2022 and returned to work on 17-JAN-2022 with diminished symptoms and all symptoms from covid-19 resolved around the 31-Jan-2022. She was asked if she had monoclonal antibody therapy.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and brain fog which was really bad on 31-JAN-2022, and the outcome of off label use, and inappropriate schedule of vaccine administration was not reported. This report was non-serious. This report was associated with product quality complaint: 90000215902.
AGGRAVATED SHOULDER  ARTHRITIS; CANNOT LIFT ARM WITHOUT PAIN; INTENSE PAIN IN RIGHT SHOULDER; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced aggravated shoulder arthritis. On 2021, the subject experienced cannot lift arm without pain. On 2021, the subject experienced intense pain in right shoulder. Laboratory data included: X-ray (NR: not provided) arthritis in both shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intense pain in right shoulder, and the outcome of aggravated shoulder arthritis and cannot lift arm without pain was not reported. This report was non-serious.
I had my usual redness/soreness on after an injection that went away after a couple days. Now, 8 days since my vaccine, my injection site is itchy, and developed a red rash and welt.
Information has been received from a nurse practitioner concerning a 15 year old female who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). The patient received the first dose of vaccine 11 years ago. It was reported that two days after vaccination, the the patient developed "significant induration and redness in about 3 inch diameter around injection site." Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Achy, sore of lymphnodes; Lymph nodes swollen under the armpit and down the side to rib cage; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Achy, sore of lymphnodes) and LYMPHADENOPATHY (Lymph nodes swollen under the armpit and down the side to rib cage) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Hysterotomy (Patient had a hysterotomy in July).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LYMPH NODE PAIN (Achy, sore of lymphnodes) and LYMPHADENOPATHY (Lymph nodes swollen under the armpit and down the side to rib cage). The patient was treated with PARACETAMOL (TYLENOL) on 04-Mar-2021 at a dose of As needed. At the time of the report, LYMPH NODE PAIN (Achy, sore of lymphnodes) and LYMPHADENOPATHY (Lymph nodes swollen under the armpit and down the side to rib cage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided.  Treatment information also included cold compress on injection site.
Approx 14 days after After Moderna bivalent booster red blotchy itchy rash on right arm (injection arm) then left arm. No such rash with 4 prior Pfizer shots
Chills, headache, nausea, muscle aches, high blood sugar for 11 days. Took a BENADRYL on the 9th day and claims that improved symptoms. Patient did not have any side effects after the first dose of the vaccines. The reaction happened after the second vaccine in series.
Severe migraine attack lasting  over 48 hours despite utilizing migraine remedies and prescription migraine medicine.
loss of taste and smell; loss of taste and smell; tested positive for Covid; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. This consumer reported similar events for two patients. This is the first of two reports.   An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose of Pfizer BioNTech Covid 19 vaccine, along with his wife on 04Mar2021 and three to four days later, they developed symptoms including loss of taste and smell and both tested positive for COVID. They were unable to receive the second dose on 25Mar2021 due to quarantining. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377390 same reporter/drug, similar events, different patients
a four years old female patient received a expired dose of Quadracel on 28-Aug-2019/No AE; Initial information received on 29-Aug-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a four years old female patient who received a expired 0.5 ml dose of IPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5248AA, expiry date: 21-Aug-2019 via unknown route in the left thigh on 28-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR).  It was an actual medication error due to Expired vaccine used.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Aside from the usual chills, body aches, etc, I ended up calling my doctor over a separate concerning issue - very high heart rate. I woke up at 8am the day after getting my 2nd Pfizer dose, walked to use the restroom, walked back to bed, and laid back down. Within a couple minutes I noticed my heart felt like it was racing and I was out of breath as if I had just come back from a jog, not a trip to the restroom.  Heart rate continued fluctuating from 105-115bpm just laying in bed. Was also feeling fatigued, nauseous, dizzy when standing up, and with slight difficulty breathing. Called advice nurse after 30min of no change. They had me check heart rate manually (had been going off FitBit), and timing was consistent with what FitBit was reading . Nurse advised to keep resting and drink lots of water, scheduled follow-up with a Doctor later in the morning.  It should be noted that I had been alternating between water and Pedialyte constantly all day, starting 5/17 through when this happened (and then the next few days as well), so I should not have been dehydrated. Follow-up call with Dr. (on-call Dr., not my usual one) was scheduled for 11:45am, and by then all concerning heart symptoms had passed. The Dr. basically reiterated what the nurse had told me, in keeping up with fluids. And that sometimes temperature change, even if you don't completely get a fever, can cause a high heart rate. As more information is coming out regarding younger people developing myocarditis after the mRNA vaccines however, I wanted to mention this in case it could possibly be related.
At 7:00 am patient's mother notice a red, raised, itchy area at site of injection. Applied BENADRYL gel at 9:00 am. Will give BENADRYL orally this pm, cont. CLARITIN tomorrow.
Per Department of Health: Regarding The Database for Health Authority on the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.