chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am aching and pain; 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 received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 (Lot number: FE3590) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing); "Acid Reflux" (unspecified if ongoing); "Gout" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; DEXILANT; ESCITALOPRAM; ALLOPURINOL; VITAMIN D2. Past drug history included: Prolixin injection. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization; Bnt162b2 (Dose:2), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 06Nov2021, outcome "unknown", described as "I am aching and pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  Additional information: Consumer stated, I am having a reaction from taking the Pfizer booster shot vaccine, 2 days ago on Friday and I am aching and pain. I was wondering, what could I do for pain. I have taken something for pain. I took some for-pain Ibuprofen (Intent: Treatment) about 4 hours ago and I just took 2 more Ibuprofen just about 30 minutes ago for the pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
5ml syringes that had been provided by health authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/23/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
Developed a rash on my back about 48 hours post 2nd covid vaccine administration.  The the rash then progressed to my chest and within 5 days I developed 2 lesions on my anterior chest that I saw a dermatologist for who felt this was a fixed drug reaction from the vaccine. No new environmental factors.  Did not develop rash following the first vaccine
About 3 hours after receiving vaccinations I got the chills really bad for about 4-5 hours. Could not get warm for all this time and then felt exhausted for the next day. Temp. 100.5 degrees afterwards.
I just went blind in my right eye for about 30 or 40 minutes; Headache; Fatigue; I was sleeping 12-14 hours/I slept for long time; I cannot reach my legs; I could not hardly walk; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. The patient stated had this Pfizer shot in Apr2021. Patient took the second Pfizer, the first shot patient had no problem. Patient got second shot, the same day the very same day patient just started getting headaches, started getting fatigue and for about 8-10 days patient was sleeping 12-14 hours. Patient cannot reach his/her legs, patient cannot walk and then patient went blind in his/her right eye. Patient thought that he/she had had physicals before the shot everything was excellent on his/her physical. Patient knew when he/she took the shot, he/she was like Oh man, what was going on? Patient meant it just gave him/her fatigue because of that patient could not hardly walk, patient couldn't reach legs, patient slept for long time and then patient just went blind in right eye for about 30 or 40 minutes. Outcome of events was unknown.  The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.
Dose 4/5/2021 Pfizer EW0151 Pt has Covid 19 8/11/2021
Reports 1 hr. after shot, of pain, redness, swelling, heat to (R) arm/shoulder. Pain, swelling moved down arm over 3 days to below elbow (inner aspect) to ER same day (9-17-13) Dx: cellulitis - gave her 2 antibiotics. S and S left after 3-4 days.
G3P1011 at 19wks EGA given Pfizer Covid-19 vaccine 17 days after first in series. Within 24 hours of administration, developed fevers exceeding 104 degrees (104.7 max, tympanic), tachycardia to 130s, rigors with fevers not responding to maximal doses of oral acetaminophen and ibuprofen, requiring hospital admission for IV fluids and IV antipyretics and anti-inflammatory agents.
This case was reported by a healthcare professional (medical assistant) via a sales representative and described the occurrence of injection site induration in a 5-year-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). In 2014 the subject received a dose of INFANRIX (unknown details). In 2014, within weeks of vaccination with INFANRIX, the subject experienced injection site induration (described as "knots at injection site") and injection site redness. The reporter noted that "the timeframe was is the past 2 weeks." The reporter stated that after the subject received INFANRIX, the subject "developed huge red knots at the injection site." No other events were reported. It was unknown if the immunization series was discontinued. Per the medical assistant, the subject was evaluated by the doctor. At the time of reporting the outcome of the events were unknown. The healthcare professional considered the events were probably related to vaccination with INFANRIX. The medical assistant reported 4 other cases with INFANRIX. See A1060686A, A1060686A, A1060686A and A1060686A for details on the other cases.
Symptoms: blurred vision, clogged ears, migraine, fever, stiff neck, high blood pressure   Adverse effect of COVID-19 vaccine Acute nonintractable headache, unspecified headache type Trapezius muscle spasm Pseudotumor migraine  Migraine cocktail and CT scan performed  Symptoms were much better after
Given 9 hours post expiration date. Notified Moderna for information to obtain as to outcomes.
pt recvd vax 6NOV, 8NOV RTC c/o pain & swelling @ site, erythema, induration, & tenderness lt triceps area; pt advised to apply warm compresses;
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Lot number: 30135B4) at the age of 28 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing), notes: other medical history Depression; "Anxiety" (unspecified if ongoing), notes: other medical history: Anxiety; "Allergies" (unspecified if ongoing), notes: other medical history: Allergies. Concomitant medication(s) included: FLUOXETINE [FLUOXETINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" 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 drug ineffective, covid-19 and treatment included Paxlovid.; Sender's Comments: Based on the information currently available, a causal association between the reported event COVID-19 and BNT162b2 cannot be excluded.
After I received my first dose, I had headaches, exhaustion, and body aches for about 24 hours on 1/7/2021.  With my second dose, I  started having symptoms at between 6 and 7 PM on 2/3/2021. I had pain at the injection site this time, but I hadn't with the first. I had received lip fillers on 12/23/2020 or 12/24/2020. After the second vaccination, I noticed there were internal bumps on my lips and external bumps where the filler had been injected. When I woke up the next morning on 2/4/2021, the swelling was more pronounced. My lips were so swollen, sore, and red, I couldn't bear to touch them. I called a medical facility, and they prescribed me a 5-day prednisone pack. They also recommended that I take over-the-counter antihistamines. This relieved the symptoms until the prednisone ran out, and then the swelling returned. I called them again, and this time they prescribed me a 2-week pack of prednisone, which ended up lasting 30 days, as they had recommended that I cut the doses in half. I also stayed on the antihistamine for 3 months. After that, everything was fine and the symptoms were gone.
Localized muscle soreness and mild skin tenderness. Localized mild edema. Reddish/ tan skin blotch below injection site and wrapping around the bicep but not the skin inside the bicep - gone by Day 4. Mild swelling and soreness of lymph nodes in the axilla of injection arm - gone by Day 4. Mild body aches and malaise which resolved fully within 24 hours.
Started with itchy hands then I hand itchy bumps and a rash all over my body. This lasted for 7 months and I was given generic antihistamine (allergy medication). I was forced to take the medication every four hours because that's how long the medication worked. First the serval months then I gradually was able to decrease the amount.
abdominal pain, leg swelling-- but all of these resolved on their own, also with shortness of breath resolved with albuterol
After about 15 minutes s/p injection, patient verbalized feeling his heart racing. Vital signs at 14:32 BP 143/83, spo2 98% on room air, HR 102. No acute distress noted. Patient stated he felt his heart racing after his first dose but it resolved without intervention. We waited about 15 minutes more for continued observation. Patient ambulated to restroom and collapsed, diaphoretic and verbalized his heart was racing. Rapid response called and patient assisted to the ED via wheelchair.
Headache, Fever, ErythemaMultiform, extreme fatigue, arm soreness Narrative: Had COVID-19 less than one month prior, PCP recommended to NOT take vaccine for 90 days. Reports Facility staff encouraged her to take the vaccine anyway. Now with 102.6 fever, headache, diarrhea, extreme fatigue and arm soreness; keep PCP aware.
Received Pfizer booster at approximately 10:01am. At approximately 10:33am, began feeling shortness of breath, sensation of throat tightening/closing, chest pressure, rash and itching. Stopped by nearest drugstore at 10:42am and purchased Diphenhydramine and Famotidine. At10:45am, self administered Diphenhydramine 25mg and Famotidine 20mg by mouth, then drove myself to Emergency Department. Was given Diphenhydramine 25mg, Famotidine 20mg, and Solu-Medrol 125mcg intravenously. Monitored post medication administration and then released home.
This spontaneous report was received from a nurse via the patient's parent, concerning a 5 month old patient of unknown gender. The patient's historical condition, concurrent condition, concomitant therapy, historical drugs or allergies were not reported. On 20-JUL-2018, the patient was inadvertently vaccinated with GARDASIL 9 (strength, dose, route, frequency, lot# and expiration date were not reported)  for prophylaxis, at an unspecified office location. No adverse effects were reported. No product quality complaint was filed.
Temperature (100.9+ Fahrenheit) Body/muscle aches Headache Fatigue
Patient received the first dose of pfizer vaccine on 3/19/21 and second dose on 4/9/21. Ten days after the first dose patient developed boils/abscess on her buttocks. Patient had been off Humira and MTX 3 weeks before the 1st dose of the pfizer vaccine. Patient resumed Humira injection on 4/2/21. On 4/10/21 patient had to go to a hospital emergency department for treatment of the boils/abscess on her buttocks. The boils had spread to the pubic area, armpits, and legs. Patient was treated with bactrim and doxycycline after the boils had been drained. Patient reported black scars left in the sites where the boils/abscess had been drained. Patient required several months to recover. Patient stopped Humira treatment.
Patient experienced rash on lower face/jaw, itching, and feeling lightheaded and a little dizzy.
The powder portion was reconstituted with sterile diluent.; received a partial dose of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA436A, expiry date 31st October 2021) for prophylaxis.   On 24th May 2021, the patient received Menveo. On 24th May 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows:  The patient received a partial dose of Menveo as the powder portion was reconstituted with sterile diluent, which led to solution used in drug reconstitution and inappropriate dose of vaccine administered. The medical assistant consented to follow up.
A non-serious spontaneous report of fever has been received from a physician concerning a seven-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 30-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 03-Dec-2009, the patient developed fever of 105 F and was experiencing re-occurring fever at the time of reporting. The outcome of event was not resolved.
Narrative: COVID infection following COVID vaccine series 01/7, Moderna , dose #1 02/04, Moderna , dose #2 09/14 pt cc: cough, loss of taste or smell, rhinorrhea, dyspnea exposure: unknown 09/23 COVID swab, result: detected 09/23 SARS-COV-S Variant Sequencing results: pending
Sore injection site Tiredness, muscle aches and pain, chills, mental fogginess
Swollen lymph nodes on left side, my doctor said to ice and continue my Mobic prescription.  It has been 5 days since the first symptom and it has reduced in size but is still somewhat swollen.  The first few days the site was sore but the pain has also subsided.
Patient presented to consultation on 04/14 stating reports of numbness in left big toe and calf over the "past few days." They further clarified it improved throughout the day each day and they noticed an improvement in these symptoms with a "leg cramp PM" OTC product containing Tylenol and Benadryl.
Rash all over my body except face; itch; began Thursday and continued; the family doctor prescribed Prednisolone (20MG)over a course of 7 days -- does per each day> 3,3,2,2,1,1,1/2,1/2. Outcome = too new to know
within 10 minutes of injection, heart racing, vision vaded to black, face and left side numbness
I started sneezing and got a little bit of shortness of breath and it made me think it was my Asthma and I was doing a lot of walking on my trip and my ankles were swollen and I also had a stuffy nose and had congestion with a cough.  I wore a double mask on the plane on the way home. I never ran a fever the whole time. My blood oxygen was running low and I was keeping an eye on that. I was put on Prednisone and PAXLOVID and had to stop my supplements. I came down with thrush because of the medication. It felt like my lungs were filling up with fluid. I started feeling better about a week ago. I was sick for about 2 to 2 1/2 weeks.
Dizziness; Sporadic increase and decrease in blood pressure; Sporadic rapid heart rate; Vertigo; Arm was sore; A spontaneous report was received from a consumer concerning a 61years old female patient .  The patient got the first Moderna COVID-19 vaccination on Wednesday 13-Jan-2021 in her left deltoid muscle at Hospital. Her arm was sore for the first 24 hours and then went away.   The patient's medical history was not provided  On 16-Jan--2021 she started to experience dizziness, sporadic increase and decrease in blood pressure, sporadic rapid heart rate and vertigo. She has been laying down because when she gets up she cant walk from her vertigo. She has a background in speech and hearing so she did some exercises because she thought it might be an imbalance in her ear but they didn't help so she figured it must be from the Moderna COVID-19 vaccine. Today she noticed a red welt on the injection site that is bigger than a silver dollar. She wanted to know what she should do because the vertigo concerns her.  Consent for safety to follow-up with her- Yes, she prefers cell phone over email.  Consent for safety to follow-up with her healthcare provider- Yes YNS21Jan2021; Reporter's Comments: This case concerns a 61-year old female patient who experienced non-serious events of dizziness, injection site pain, blood pressure abnormal, heart rate increased, and vertigo within 4 days of the mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fever; Fatigue; Body pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included LEUCOVORIN CALCIUM for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body pain) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient experienced chest "heaviness" approximately 5 minutes after getting vaccine. BP 156/79, Pulse 76, Respiratory 20, Pulse Ox 99%. Called a Code 10 and patient transported to ED in hospital.
Red, painful, itchy spot approx. 4 inches in diameter - presented 4 days after administration.
IMMEDIATELY AFTER VACCINATION, PATIENT BECAME PALE AND BEGAN SWEATING. HE COMPLAINED THAT HE DIDN'T FEEL WELL. WE USED AN AMMONIA INHALANT AND IS SEEMED TO HELP AT FIRST BUT THEN HE COMPLAINED OF FEELING WORSE. WE HAD HIM PUT HIS HEAD DOWN AND HE DIDN'T SEEM TO BE DOING BETTER. WE TRIED TO SHIFT HIS WEIGHT IN THE CHAIR WHILE WE WAITED FOR THE AMBULANCE TO ARRIVE AND HE IMMEDIATELY PASSED OUT. USED A SECOND AMMONIA INHALANT ON HIM AND IT STILL TOOK A MOMENT FOR HIM TO REGAIN CONSCIOUSNESS. THE AMBULANCE CREW TOOK HIS BLOOD PRESSURE AND EKG AND SEEMED FINE. HE REFUSED TRANSPORT TO HOSPITAL OR TO HAVE HIS BLOOD SUGAR TAKEN.
Redness Near Injection site -- > Lead  to bumpy  uneven rash, rash got worse, after developing cold like symptoms (post-nasal drip, sore throat,  sinus headache and cough)
I rapid tested positive for Covid today 3/16/21.  It was not totally surprising as my boyfriend (who is not vaccinated) was  rapid tested positive yesterday.  I realize that this is not so much an adverse effect - but I was instructed by higher ups to report here as it was unexpected and perhaps has something to do with my CML medication Sprycel?
11/17/22 presents to ED for "chest pain" "COVID 4 weeks ago". PMHx of "HTN"
Mild chills, headache, body ache all over, fever comes and go, fatigue. Still occurring.    What happened as a result of the adverse event? Caller stated she took Ibuprofen this morning, this helps with the chills for a couple of hours but chills comes and go.   Note: Since caller denied being or taking any current medications, and no current medical history to report. Recommended her to rest, hydrate and take another ibuprofen to help with the body aches, headache and chills just as long as the last dose taken has been at least 6 hours. Advised caller that these are common side effects that occurs more with the second dose. If her symptoms does not let up recommended her to contact her PCP, or if her symptoms worsen to seek medical help asap.  4/2-Follow up: Patient went to urgent care on 4/2/21 she states she feels a lot better then when the symptoms originally started. Urgent care MD stated what she feels is from the vaccine. Advised to continue the ibuprofen for the fever/body aches. As of 8am on 4/2/21 symptoms have subsided and patient is getting better.
PATIENT GOT VACCINE ALONG WITH HER 15 YEAR OLD DAUGHTER, DAUGHTER HAD REACTION AND AFTER 15-20 MINUTES DUE TO THE WHOLE PANIC SITUATION PATIENT STARTED FEELING DIZZINESS. WE ALREADY HAD PERAMEDIC HELPTING PATIENT'S DAUGHTER SO THEY CHECK HER BP AND TOOK PATIENT TO THE HOSPITAL
Information has been received from a relative of an 86-year-old female patient with high blood pressure, shingles for the last year, and has no allergies who "3 months ago" was vaccinated with a dose of Zostavax (Oka/Merck).  On an unspecified date, the patient experienced nerve pain and her mouth broke out with a rash.  It is reported that her physician gave her the vaccination to try and prevent the nerve pain from the shingles.  The lot number was not provided.  Unspecified medical attention was sought.  There were no laboratory diagnostic studies performed.  The outcome is reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
I had the 2nd vaccine on Friday night and had a headache and arm pain. I woke up on Saturday morning with arm pain again and a red, raised rash where my injection site was. about the size of a half dollar and it was warm to the tough  Arm pain went away by Sunday but the rash grew to about the size of a golf ball in diameter and it was egg shaped and became darker red.  Monday the rash did not grow anymore but was still warm to the touch and there was pain if I pushed on the rash. It was getting lighter in color.  Right now on Tuesday, rash has gotten even more lighter to just a pink/almost skin color, it has not grown in size.
Patient received her first dose of Pfizer on 1/28/21 and then second dose of Pfizer 2 weeks later on 2/12/21
Body Aches; Dizziness; Chills; A spontaneous report was received from a consumer concerning a 77 year old male patients who received   Moderna's  Covid 19 vaccine(mRNA1273) experienced chills, dizziness, body aches. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    The patient received first of two planned dose of mRNA-1273 intramuscularly on 02-FEB-2021  for prophylaxis of Covid 19 infection.  On 03-FEB-2021 patient had chills. The patient also developed dizziness and body aches. The treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event were unknown.