chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6198), on 03Apr2021 as dose 2, single (Lot number: EN6206), on 01Nov2021 as dose 3 (booster), single (Lot number: 30145BA) and on 06Jul2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: diagnosed for 5-10 years. The patient's family history included: "Covid" (unspecified if ongoing), notes: one of his brothers also had Covid and it took him months to get his taste and smell back. Concomitant medication(s) included: ADARBI taken for hypertension. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, outcome "unknown" and all described as "diagnosed with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive, notes: Tested Positive for COVID after 4 Vaccines. Therapeutic measures were taken as a result of vaccination failure, covid-19. Caller states he was calling to report a benefit of Paxlovid. Stated he was diagnosed with Covid on Monday 18Jul2022, given Paxlovid medication, started the medication on Tuesday morning, 19Jul2022. The patient received Paxlovid (NDC number of Paxlovid: 0069-1085-30, Expiry Date: Mar2023, Batch/lot number: GC9447) three in the morning and three in the evening for COVID-19. Caller reported that by Monday 18Jul2022, he had already lost his sense of taste and smell due to the Covid. Stated that he was only on his fourth day of Paxlovid treatment and his taste and smell are back. States he noticed it a little bit yesterday but this morning when he ate breakfast his apple tasted like an apple and his milk tasted like milk, states he called his whole family to tell them. Caller stated he was worried because one of his brothers also had Covid and it took him months to get his taste and smell back. Caller did not know if it was because of the medication but he wanted to make sure Pfizer was aware of this potential benefit. The sample of the product was not available to be returned. The report was not related to a study or programme.
Administered vaccine. Patient stated he was fine (previously stated he was "nervous" about getting vaccine. Sat for 2 min in chair, but stated he was ok to get up (I offered to let him stay)- got up, lost consciousness after 1 minute, laid on ground for 2 more min, then sat and drank water x30 min and left without issue.
pt had large lump on lt thigh where DTP was given; had high pitched crying lasting 2 hrs;
red mark at the injection site; itching at the injection site; A regulatory authority report was received from a consumer concerning a 70-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed vaccination site redness and itching.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin and folic acid.  On 04 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On unknown date, the patient developed vaccination site redness and itching. Treatment for the event, was not reported.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event, vaccination site redness and itching, was considered unknown.
Localized tingling/numbness of mouth and tip of tongue; started 15-20 minutes after injection; no systemic symptoms (no rash, respiratory issues, tachycardia); symptoms improved over 30 minute period of observation
4 funerals of people who have died 3 to four days after getting the COVID-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer or other non-healthcare professional. This case split for third patient.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, 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 had gone to 4 funerals of people who have died 3 to four days after getting the covid-19 vaccine. The reporter wanted to know now that the Pfizer COVID-19 vaccine was fully approved and enquired if he took the vaccine and had adverse side effects from it who was going to pay for his bills. The reporter stated that he had been doing some research on the amount of people who have died from taking the COVID-19 vaccine and what adverse events they have had after receiving the vaccine. He stated that he had personally gone to 4 funerals of people who have died 3 to four days after getting the COVID-19 vaccine, but stated he doesn't know whether they are moderna or Pfizer or Johnson and Johnson and he doesn't know one person who has died from the actual virus. He just wanted information. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death
It started back about October 2021. I started having pains 3 fingers underneath my breast around to my back and shoulder. A couple months later I had another attack in December. We were retired and we were out of state. In the spring when I came back north, I went to my doctor and we had an x-ray done and it was noted I had a gallbladder stone. I had a couple more attacks. In December 2022 we had another x-ray done and the stone was the size of an avocado pit. That was the sign to take the gallbladder out. I had that surgery done laparoscopically on 03/29/2023. I'm currently in the recovery stage. I'm still in recovery and I'm on restrictions. I'm not fully recovered at this time.
Left arm became very sore, and hot. It was red and blotchy for several inches by the injection site of the flu shot. She said she never felt that bad after a shot before.
A non-serious labeled, spontaneous report of sneezing has been received from a nurse for a seven-year-old female, subsequent to receiving FLUMIST.  No medical history or concomitant medications were provided.  The child received one dose of FLUMIST nasally on 06-Oct-2008.  The reporter indicated that on 06-Oct-2008 the child sneezed immediately after administration of FLUMIST into the first nostril.  No sneezing or event occurred after administration into the second nostril.  The event has resolved.
In the early morning hours after vaccine, woke with itchy legs. Left side worse than right. More itchy at night. Had significant redness. By Thursday morning, itching on legs better but wrists (inside) were itchy. Thursday night elbows started itchy. Friday morning all of arms beginning to itch. Later in day, back began to itch. Friday night spread to neck, then later at night started to break out in rash. Saturday mid-day (after steroid shot) noticed issues with labored breathing while doing some normal activities.
I experienced arm pain, headache, increased difficulty moving, extreme pain and aches all over my, chest pain, body, dizziness, increased difficulty walking, and my whole body curled over in agony when I walked the ten feet to the bathroom. I was stranded in the bathroom for about 20 minutes due to the pain. I went back to bed where I spent the next several days repeating this pattern. I experienced painful swollen lymph nodes under my arm/breast area. I spent 8 days in bed. I also had numbness and weakness in the left side of my body during a Hemiplegic Migraine, which also included loss of appetite, nausea, and vomiting. I had just had my period prior to vaccination, and the following menstrual cycle I experienced two periods with more pain than normal. I have not fully recovered to what I consider my baseline of my day to day chronic illness management. I am having more cardiac symptoms. My menstrual cycle has not returned to normal either, with much heavier flow, frequent clots, and I have become irregular with increased pain.
Headache, fatigue,swollen lymph nodes in neck, under arms. Face and eyes swollen.  Queasy and slight uneasiness in chest.
Daughter reports patient became congested approximately 8hrs after vaccine was administered. Later started with a congested cough. 4 days later patient developed a fever 100.3 and rash on chest .
had arm pain that radiated up that side to my neck; had arm pain that radiated up that side to my neck; This is a spontaneous report from a non-contactable nurse (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that in Dec2020 following the first dose the patient had arm pain that radiated up that side to her neck. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse refers to 4 female patients of 11 to 12 year old. On an unknown date, the patients were vaccinated with a dose of GARDASIL, (lot number, expiry date and route was not reported). No concomitant medications reported. The nurse stated that another nurse told her that within the past year 4 patients have been hospitalized in hospital for several days due to neurological side effects after receiving GARDASIL. She also stated that she saw many reports in the internet that the vaccine causes severe side effects such as deaths. The outcome of neurological side effects was unknown. The patients sought medical attention(hospitalized for several days). Additional information has been requested.
Right deltoid area was a little pale 8/21/2009, elevated intensity/swelling 8/22/09, cool compress, Cephalexin 250/5 mg's i tsp QID.
2 hrs after vaccines given, mother reports R arm turned red from shoulder to elbow and swollen. Child c/o itching. Mom gave Benadryl and Tylenol. Child then threw up.
Morning after vaccine given patient's thigh was swollen, red and had hard knot in area of injection. Was given Amoxicillin prescription on 6/12/15 for 7 day course.
After receiving the vaccine earlier, patient had difficulty swallowing for 3 minutes and also dizziness-- > went to ED for evaluation. Symptoms resolved after rooming in ED.  ED physician DX with possible allergic reaction and he was given diphenhydramine 50mg PO x1 and prednisone 40mg PO x1 in ED-- > discharged home with PRN diphenhydramine, cetirizine 10mg daily and epi pen PRN.
red knot; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6202, Expiration date: unknown), via an unspecified route of administration in arm left on 23Feb2021 at 11:10 (at the age of 71-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history (including any illness at time of vaccination) included high cholesterol, high blood pressure, diabetic. The patient's concomitant medications included aspirin [acetylsalicylic acid] and colecalciferol (VITAMIN D 3). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9810, Expiration date: unknown), via an unspecified route of administration in arm left on 02Feb2021 (at the age of 71-year-old) as a dose 1, single for COVID-19 immunization. Additional vaccines administered on same date of the Pfizer suspect was reported as none. The AE(s) following prior vaccinations were reported as none. It was reported that, the patient had her second shot on Tuesday. Stated that, she did fine on Tuesday and yesterday. Stated that, this morning on 25Feb2021, she woke up around 07:30 AM and she has a big red knot where she got the shot. Stated that, it was warm touch. There was a red circle around it. Stated that, was that something she should get checked and was that a side effect. The caller clarified shot as COVID-19 Vaccine. Stated that, it was more red today. The circle Band-Aid was still on and she took it off. The circle was getting bigger around it and more red. Stated that, she was not sure whether that was something that might happen. Stated that, she has not put any ice on it. Stated that, on the vaccine card, it said BioNTech. The lot number was EM9810 for first dose. Second dose lot number was EN6202, Expiry for both first and second dose was unknown. Stated that, as she was over 70, doesn't want to get it. Also stated that, her grandkids won't let her see them until she gets it. Stated that, she takes 9 pills. She takes medication for high cholesterol, high blood pressure and diabetes. Stated that, she also takes aspirin and vitamin D. She takes three different pills for diabetes. The caller did not provide list of medication names when queried. Treatment was not received for the event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Approximately two weeks after vaccination, he developed a red, bumpy rash at the injection site. The rash persisted for approximately 2 weeks after initial appearance. It did not appear to bother him, no itching or other discomfort.
Soon after receiving Hep A vaccine pt developed sand papery rash, slight irritation.  No fever, cough, sob, and no recent illness.
Lightheaded, body aches, hot flashes, chills, developed a 101 fever, shortness of breath
Patient came in to Mpox event, stated he was here for his 2nd dose, received dose but after reconciliation of previous vaccines into EMR, it was noted patient had already received 2 previous doses and was informed that it not recommended to get 3 doses of Mpox, patient was observed for 15 minutes with no adverse effect.
This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 44-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EL3248), via an unspecified route of administration, on Mar 8, 2021, at 12:45 pm, left arm, single dose, for COVID-19 immunization. The patient medical history and concomitant medications not reported. Other vaccine administered in four weeks: unknown. Patient has no known allergies. Other medications administered in two weeks: unknown. It was unknown if prior to vaccination patient was diagnosed with COVID-19. Since the vaccination, patient has tested for COVID-19. On Mar 9, 2021, patient experienced sore arm, muscle tightness/aches, nausea, headache, chills, fever and heart palpitations. Therapeutic measures taken included Tylenol and ibuprofen. The outcome of events recovered. No follow-up attempts possible. No further information expected.
Breakthrough case admission after 3 vaccines  Pfizer 2/26/21 Lot# EN6202;  Pfizer 3/19/21 lot# EF2613;  Pfizer 9/1/21 lot# FC3183
Within minutes of receiving the shot, I started getting a headache and just feeling generally off...almost a feeling of an adrenaline rush. Felt a bit antsy and foggy for 1 hr. A couple of hours later, I got a small hive on the bottom of my right eye, followed by small hive in my left shoulder. My nose started to run a bit and I called my sister who brought me over some Benadryl. When she arrived, I felt the inside of my bottom lip begin to tingle and mildly swell. Stayed awake for a bit and then took the Benadryl before going to sleep. In the morning, the inside of my bottom lip felt like it had a series of small canker sores which resolved within 24 hours. I had a telemedicine visit with my doctor?s office, and they felt it was a local reaction, perhaps anxiety induced; they ok?d 2nd dose. Discussed with vaccination site coordinator, and they consulted with the County Health Department who will not administer a second dose due to CDC guidance regarding hives, etc.
Injection site reactions: pain, tenderness, and swelling of the lymph notes in the same arm of the injection. General side effects: fatigue, headache, muscle pain, chills, nausea and fever of 101 degrees.
I have been experiencing much heavier menstruation along with dizziness/lightheadedness, nausea, fatigue and blood clotting during my periods following both vaccination shots.  I have never experienced these extreme issues with my cycle before. I am concerned because I have low energy and during the period after my second shot, I passed a massive blood clot about the size of the palm of my hand.  I reported this to my OBGyn and regular doctor.  They put in tests for pregnancy, iron, blood count and platelet for me.  Test results showed I was not pregnant, my blood count and platelets were fine, however my iron is low.  OBGyn says my iron is low likely because of the heavy blood loss during periods.  She advised taking iron supplement, eating more iron-rich foods and taking aleve/motrin to lessen the bleeding.  I am still feeling low energy and dizziness/nausea before, during and after periods.
feeling tired; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional information received were as follows: The patient reported that she was feeling tired. The caller declined to provide any further details or information, including demographics. The reporter did not consent to follow up.
Admitted to acute inpatient hospital from Rehab for new diagnosis COVID-19 with lethargy without hypoxia on 8/6/21. Patient had a sudden event with bradycardia hypotension suspected MI.  Patient was DNR DNI. Patient expired 8/9/21
Patient stated having blurred vision for  about 10-15 minutes after the vaccine. We had her wait around for an additional 15 minutes. She stated it was initially blurry after sitting down then slowly got better. She stated after the 30 minutes that she felt fine and her vision was normal again.
Breakthrough case admission after 2 vaccines Pfizer 9/17/21 lot# FC10312021;  Pfizer 10/8/21 lot# FF2587
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Jan2021 at 10:00 as dose 1, single (Lot number: El9264), in left arm, on 23Feb2021 at 10:00 as dose 2, single (Lot number: En6200), in left arm and on 21Dec2021 at 16:00 as dose 3 (booster), single (Lot number: 6076165) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing), notes: Other medical history: Mono 3x, diabetic. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Joint Pain-Severe, Systemic: Tachycardia-Severe, Systemic: Unable to Sleep-Severe
I'm not sure if it's worth mentioning but after reading an article today, I was prompted to fill this out. In February, unusually, I had two menstrual cycles. I had my second dose of Moderna (Feb 1, 2021, Lot 038k20a, same injection location, L arm). I was sick for 2-3 days after (normal reported symptoms of fatigue, nausea, aches). I had  normal menstrual cycle last month but am on my second one for this month. It's abnormal for me, and I know there could be a million causes, but just in case, I thought it may be worth mentioning.
Pt noted swelling of left upper arm following 2nd dose of Anthrax vaccine. He developed lymphadenopathy of both axilla which lasted about one month.
Patient received an expired dose of FLUZONE HIGH-DOSE QUADRIVALENT/no adverse event; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional via call center via regulatory authority (reference number- 00794775).  This case involves a 77 years old female patient who received an expired vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  On 01-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ482AA and expiry date: 30-JUN-2021) via an intramuscular route in the arm nos for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
I?m still having frequent dizzy spells, nearly two weeks after my first shot. They started more than 24 hours after my shot and are still happening, including a rather severe and long-lasting one today.   Other side effects included a very sore arm ? much more painful than I?d expected ? and that?s all.
Three weeks of extreme fatigue. Exhaustion that didn't let up after sleeping or coffee or anything. And I have what would be considered "brain fog". I'm usually a fast-brained, quick-witted individual and I feel foggy and forgetful.     I also had six weeks of extreme fatigue when I had COVID in early November (and still have not recovered my sense of smell or taste). After about six weeks, my fatigue disappeared.