chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL3249), in left arm, on 04Feb2021 as dose 2, single (Lot number: EL9261), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: FC3183), in left arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfur, reaction(s): "Known allergies: sulfur". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient did not receive other medication in 2 weeks. The patient was treated with Paxlovid from 28Feb2023 to 04Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107504 same patient, different drug/event;US-PFIZER INC-202300108795 same reporter, different patient, product, and event;
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). In 2021, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. In 2021, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter
pt recv vax & that day devel an inj site rxn characterized by swelling, induration & tenderness;pt was improving @ the date of this report;
Two days following vaccination pt. developed "pink, itchy blotches", smaller than a dime on both arms and both legs. Approx. "20 blotches". No other symptoms. Reported by patient's grandmother 2/5/16.
Heart palpitations; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 80-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration on 04Feb2021 at 14:00 as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Feb2021 at 06:00, the patient was awakened or woke up with heart palpitation which lasted less than a minute and then patient got up. Patient reported that last Thursday (2 weeks after administration), she was awakened by heart palpitations again, in which both times they have stopped by the time she was up on her feet. The outcome of the event was recovered on the same day.  No follow-up attempts are possible. No further information is expected.
Arm soreness and hot since injection. On day 5 swollen rash developed with itching.
Itching all over. Benadryl did not improve the symptoms. Went to urgent care
Around 4pm became tired and had headache.  By  8:30pm with chills, muscle ache, headache, fever as high as 103.9, fatigue and headache. Was miserable for about 12 hours. Unable to report to work on 1/26/21 d/t ongoing chills, muscle aches, fatigue and headache. Stayed in bed most of day.  Woke up 1/27/21 feeling okay.
My daughter had a febrile seizure following an MMR vacccine with chicken pox and TB shot.
Headache and fever reported on 4/3/09 via a phone call to the LPN working at the outpatient clinic.  No treatment noted.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The registered nurse reported a temperature excursion dated 02-AUG-2014 of 0 degrees centigrade for 8 hours affecting ROTATEQ. The excursion was supported. The nurse reported that ROTATEQ was administered post excursion, orally (dose and lot numbers not provided) (approximately in 2014). The nurse did not have access to specific patient or product information. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Five days after the vaccine (8/20) I started having a headache but didn't realize what was going on.  I also had a SEVERE ache in my left shoulder and back so bad that I could not sleep. Seven days after the vaccine (8/22) I had a very red eye and strange feelings in my face.  Symptoms started getting worse and worse but I was unable to get to urgent care until 8/28 when I was diagnosed with shingles in my face and left eye.  I had blisters on the left side of my face, could not sleep , blisters in my eye socket and eyeball.  I began steroids and anti-viral meds immediately and symptoms began to subside within four days.  Today I just have some residual discomfort in my face, occasional shooting pains in my head, and scarring between my eyes.
PATIENT PREVIOUSLY RECEIVED PFIZER COVID-19 BIVALENT VACCINE  ON 9/14/22
Initially left eyelid swelling, w/mild right eyelid swelling. Pt tx'd w/BENADRYL 50 mg q 4-6 hours. Presented to clinic for eval day 4 of sx's, at which time her right eyelid was no longer swollen. Left eyelid swollen w/secondary cellulitis.
I was fine that morning at work. Was 7 months pregnant. At Dr. appointment I was told I needed Tdap vaccine, was not told any risk. I went home felt weak, dizzy and stomach pain. The same day my unborn baby died. This happened within 7 hours of the vaccine.
Swelling erythema of injection site with urticaria of legs and face.  Treated with Tylenol, ice pack to injection site, Benadryl per mouth.
This spontaneous report was received from a licensed practical nurse referring to three unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On multiple unspecified dates, the patients were vaccinated with incorrect stored doses of VARIVAX injection (0.5 ml, lot# M035687 expiration date 18-OCT-2018) for prophylaxis (strength and route were not provided). The vaccines were exposed to a temperature excursion between -10 Celsius degrees and 8 Celsius degrees for 10 hours. The call was placed because of a Digital data logger. No previous temperature excursions and no adverse effects were noted. Additional information has been requested.
pt came to clinic 15APR94 later afternoon; swollen upper arm approx 10x4" area very red-looked like giant hive; sent to own MD;
Started with red spots and itching the evening the day the flu shot was given. Redness scattered all over my body (red spots). Applied anti itch cream.
Temp to 105-8days p/receiving vax; dx sinus & ear infect also rash developed lasted 2 days;
Was not there to receive covid vaccine, was there for influenza and was administered wrong vaccine by accident.
Patient admitted with COVID-19 pneumonia and was also found to have an infected seroma following an endovascular AAA repair in early January this year.  Hospital course was complicated by acute respiratory failure with hypovolemic shock needing ICU transfer. Patient received Remdesivir.  Vascular surgery service was consulted. Her exploration of groin was done. She was also started on iv abx. ID service was consulted. Her wound cx grew corynebactrium. Her abx were adjusted. She also required right AKA during her stay. Nephrology service was consulted for AKI, most likely secondary to ATN.. Her renal function improved during her stay. She also had a PEG tube placed. Her condition gradually worsened and she became unresponsive. Her husband decided to make her comfort care and eventually started on hospice. Patient passed away 3.15.22.
severe headache; arm hurting/arm sore; This is a spontaneous report from a contactable consumer. This consumer reported for herself that an 86-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiration date: 20May2021) at the age of 86-years, via an unspecified route of administration in upper right arm on 22Jan2021 at single dose for COVID-19 immunization. Medical history included compromised immune system (diagnosed many years before) and ongoing one kidney functioning. Concomitant medications were none. The patient experienced severe headache and arm hurting on 22Jan2021. It was reported that the first shot wasn't bad, the first all she had was a severe headache and arm hurting. It looks like she had the first on 22Jan2021, the headache and arm hurting started towards the evening on 22Jan2021, the shot was taken earlier in the day, and they started in the evening, her headache was quite severe, but with paracetamol (TYLENOL) it went away, the arm was still sore from the second single dose of BNT162B2 on 12Feb2021 for COVID-19 immunisation, but was slightly better. Outcome of the event headache was recovered/resolved in 2021 while of rest was recovering/resolving.
Nerve sensitivity in 4" band around left side rib cage starting from beneath breast to 4 inches lower. 180 degree wrap around the torso. Feeling of spot bruising in this area every few inches. Skin sensitive to the touch of clothing.
Administered in Left deltoid-sharp pain lifting past 90 degrees.  Decreased ability to lift objects past 90 degrees. Sharp pain  radiates from shoulder to armpit when lifting anything.
extreme dizziness; high blood pressure; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "extreme dizziness"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: "I had extreme dizziness and high blood pressure after the vaccine. Yes, yes, person adverse reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever since evening of the injection, continuous headache, muscle aches, unable to work today, palpitations, general malaise.
01/25/22 presents to ED for "cough and shortness of breath" "diagnosed with COVID-19 5 days ago". PMHx of "AAA, diabetes mellitus, hypertension"
MONONUCLEOSIS; CHILLS; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. 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) dose, start therapy date were not reported 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 an unspecified date, the subject experienced mononucleosis, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and mononucleosis was not reported. This report was non-serious.
Shortness of breath, called 911, admitted to hospital. Put on breathing mask, had heart attack.
mastitis; she is a breastfeeding mom; she is a breastfeeding mom; clogged ducts (she is breastfeeding); This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got her first dose on Friday and mentioned that she is a breastfeeding mom. She ended up with mastitis and her doctor wanted her to start on an antibiotic. She asked if the antibiotic will interfere with her getting the second dose of the vaccine. She added that she got her first dose of the vaccine last Friday, 16Apr2021. Today (Apr2021), she woke up with clogged ducts (she is breastfeeding). Her (initial provided) started her with an antibiotic for 11 days starting today. She asked if she can still take the second dose, after the antibiotic. The outcome of the events was unknown. Therapeutic measures were taken as a result of mastitis and clogged ducts.  Information on the lot/batch number has been requested.
The patient did not experience any symptoms or side effects but was inadvertently given the moderna vaccine 3 months before his 18th birthday.
There is a knot on my left arm. It is warm to the touch and red. Additionally, I am unable to lay on that side. I have also lost range of motion
Information has been received from a Nurse Practitioner (N.P.) concerning a 71 year old female with hypertension and no drug allergies who on 05-FEB-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 658210/1079U). There was no concomitant medication. On 10-MAR-2009 the patient developed shingles. The shingles developed on her "left thorax". At the time of reporting (11-MAR-2009) the patient was not recovered. Follow up information was received from a Nurse Practitioner (N.P.) concerning the 70 year old female who on 05-FEB-2008 was vaccinated in the left arm with the first dose of ZOSTAVAX (Merck) (lot# 658210/1079U). The patient developed shingles 14 months after receiving the vaccine. On an unspecified date the patient was recovered. The patient sought medical attention and was seen by Nurse Practitioner. No further information is available.
Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: 2-3 minutes after the Moderna booster vaccine, patient felt woozy, and states she saw black. patient was immediately laid down VS 84/58, HR 63, POX 96%, blood sugar 117. Patient was monitored for 45  minutes, last set of VS: BP 98/68, HR 78, POX 100%, patient denies dizziness, flushing, Patient states this has happened to her before during vaccination administration.
Fatigue; She said it felt like painful poking/"needle pokes" on the inside of her left elbow and the inside of her left wrist; "Needle pokes" on the inside of her left elbow & left wrist. She said what she was experiencing was like pins & needles, but with just the needles.; This is a spontaneous report from a contactable consumer (ophthalmic technician, also patient herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 29Dec2020 11:44 at single dose on her left upper arm (non-dominant arm) for COVID-19 immunization. Medical history included ongoing lupus from 1993. The patient had no concomitant medications were received. No additional vaccines administered on same date. No emergency room and physician office were visited. The patient had no prior vaccinations (within 4 weeks). The patient took part in a COVID-19 Vaccine program and had fatigue as a side effect. She received the COVID-19 Vaccine on 29Dec2020 at 11:44AM. Reported she started experienced fatigue at around 7:00-8:00PM. She said she all of a sudden became really tired, like she hit a brick wall. She said she could still do stuff, but was really tired. She said the fatigue lasted about 24 hours. She said she generally experiences fatigue in winter, but this fatigue was more than the usual fatigue. Reported she also experienced "needle pokes" on the inside of her left elbow and the inside of her left wrist. She said what she was experiencing was like pins and needles, but with just the needles. She said it felt like painful poking, but the pain was not severe and only lasted a half hour. Reported she recently had full blood work done with her primary care doctor, and all was fine. She said she also had some testing done with her gynecologist, and all was fine, saying there was nothing weird. The patient declined any treatment. The outcome of the event fatigue was recovered on 30Dec2020. The outcome of the event She said it felt like painful poking was recovered on 29Dec2020. The outcome of the rest event was recovered in Dec2020.
Swollen, painful left axillary lymph nodes starting the evening  of 3/22/21. Signs worse on 3/23, stable through the day. Yet unresolved.
This case was reported by a pharmacist and described the occurrence of apnea in a subject of unspecified age and gender who was vaccinated with PEDIARIX. On an unspecified date, the subject received an unspecified dose of PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced apnea. A pharmacist called to check on thimerosal content of PEDIARIX, and stated that she heard of a subject who received PEDIARIX and Experienced apnea. No further information was available at the time of this report. This case was assessed as medically serious. At the time of reporting the outcome of the events was unspecified.
HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (HEADACHE) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    There was no reported medical history.  Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for COVID-19 vaccination.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced HEADACHE (HEADACHE). At the time of the report, HEADACHE (HEADACHE) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication reported.
First chills. Dressed in t shirt, turtle neck, sweater, coat, vest over coat, and wool hat in bed under 4 blankets. Took 3 hours to get warm. Followed by minor nausea which went away with an odansetran. Also followed by tiredness, headache, and later by a fever of 100.8. Took 2 500mg tylenol. Fever still 100.6 four hours later. Took 2 more tylenol after 6 hours. Fever broke after 12 hours.
Started feeling extremely fatigued, then muscle aches and fever of 101.8.  Severe symptoms continued until this morning 10/28/10.  Still fatigued, but fever has gone down - not normal yet - but getting better.  Injection site got huge - red, swelling covered entire upper arm. PLEASE NOTE:  received both the flu vaccination AND pnuemonia shot.
pt recv vax 10yr ago & immed exp myalgia, fibromyalgia, arthralgia, & tendinitis;these sx persist as of the date of this report;
Shortly after taking aripiprazole dose, he was unable to fall asleep, sit still, began pacing/walking back and forth, hallucinating, fidgeting. Mother states he has never had a reaction like this before and is concerned the flu vaccine precipitated the reaction to his usual dose of aripiprazole.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Burning/pain in both inner ears occurred approximately five minutes after the shot.  The burning lessoned as the day went on and then burning and sometimes pain continued intermittently.  After the second dose, I experienced pain and burning in both ears immediately after the shot.  This was intense throughout the rest of the day and began to taper off into the night.  I mentioned the first reaction at my second dose appointment and was told it wasn't a listed side effect, so I didn't report it.  I have had continued burning in both inner ears intermittently ever since.
worst headache; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3247), via an unspecified route of administration in the left arm on 15Jan2021 at a single dose for covid-19 immunisation. The patient has no medical history. Concomitant medication includes hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). On 15Jan2021, 1 hour after the shot, the patient experienced worst headache she ever had in her life. The patient took Tylenol which hasn't done anything for it. The outcome of the event was not recovered.
Swelling occurred on both arms about 2 hours after shots were given, advised her next day to take some Benadryl, if no relief to go see patient first for medical care.
Severe migraine lasting well over a week, still dealing with, can not get it to go away. Slowly started after getting the Covid 19 booster vaccine