chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First Dose: was kind of sick at first and it subsided; slept for days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing), notes: The caller clarifies and confirms that she has COPD, fibromyalgia, and is a type 2 diabetic. The caller was diagnosed with all of these conditions prior to receiving any of the Pfizer covid 19 vaccine.; "fibromyalgia" (unspecified if ongoing), notes: The caller clarifies and confirms that she has COPD, fibromyalgia, and is a type 2 diabetic. The caller was diagnosed with all of these conditions prior to receiving any of the Pfizer covid 19 vaccine.; "type 2 diabetic" (unspecified if ongoing), notes: The caller clarifies and confirms that she has COPD, fibromyalgia, and is a type 2 diabetic. The caller was diagnosed with all of these conditions prior to receiving any of the Pfizer covid 19 vaccine. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "First Dose: was kind of sick at first and it subsided"; HYPERSOMNIA (non-serious), outcome "unknown", described as "slept for days".  Additional Information: The caller has breathing problems, she was diabetic, and is in home healthcare. The caller took the first and second dose of the Pfizer covid 19 vaccine. The caller clarifies and confirms that she has COPD, fibromyalgia, and is a type 2 diabetic. The caller was diagnosed with all of these conditions prior to receiving any of the Pfizer covid 19 vaccine. Because of these conditions the caller was in the red zone and so she had to go get the vaccines. After the first dose the caller was kind of sick at first and it subsided and with the second dose she didn't feel effects. The caller got both doses in the left arm. After the first dose the caller slept for days and didn't feel too bad. When the caller got the second one she was fine and doing everything the next day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
painful left arm for 2-3 days, starting the night I got the injection (most painful the day after the injection) The next day: sore throat, headache, & just didn't feel good (all mild symptoms) Day 8: rash (two small circles: dime to nickel size) on arm of injection but closer to my body than the injection site starting about an inch away from the site. Today is Day 9 and the rash is worse). It is red and blotchy, and the two spots are each about the size of a quarter. There are also some dots in a line in a few areas around the bigger spots.  I also had a migraine with nausea yesterday and the nausea has continued today. I have a mild headache today. (I will visit the doctor if get dramatically worse.)
approx 3 days p/vax exp an urticarial react; No further details are available;
really achy; nausea; really tired; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (really achy), HEADACHE (really bad headache), NAUSEA (nausea) and FATIGUE (really tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Crohns disease aggravated.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (really bad headache). On 12-Feb-2021, the patient experienced PAIN (really achy), NAUSEA (nausea) and FATIGUE (really tired). At the time of the report, PAIN (really achy), HEADACHE (really bad headache), NAUSEA (nausea) and FATIGUE (really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Moderna Covid-19 Vaccine EUA Was vaccinated Thursday morning 9am or so and awoke Friday morning with muscle ache, joint pain, cramping muscles, chill, sweats etc, These lasted 24 - 36 hours and then I had a severe allergic reaction on my tongue which swelled up worryingly, this was about 5pm on Saturday. I took 4 Benadryl over 3 hours and slept until Sunday morning. I awoke Sunday morning with quite a lot of muscle pain, like after a workout. I took 2 Motrin and felt fine after about 30 minutes. I do have pictures of how swollen my tongue got on the Saturday evening
Pt. had respiratory distress 3 days after flu shot. Admitted to hospital. Dx pneumonia. Sent to another hospital where she required intubation. Discharged 10/2/10.
- Around 5pm joint pain in legs, shortly after I also felt back pain...joint pain lasted for about 30 hours but was eased with Tylenol and Ibuprofen on 4/23 - same day around 9:30pm I started to feel the chills, afterwards felt very hot, this was gone the next morning but started again the next night (4/23) around 7pm - morning of 4/23 strong dull headache on left side/front of head...1000mg of Tylenol did not help, took another 800mg of Ibuprofen 3 hrs later which eased the pain - my skin felt very sensitive to the touch for about 48 hours (like a burning sensation) - felt very light headed for stretches as of morning of 4/23 until evening/going to bed on 4/24 - pain and swollen lymph nodes under left armpit (started the night of 4/22 and lasted until 4/25) - felt dizzy from time to time...did last for a couple of hours each day - muscle ache in both arms and tummy started 4/27 in the afternoon ( haven't done any sport) - jaw muscle ache left side when opening mouth (started 4/26 in the evening) - cramps in my feet (started first 4/25 in the afternoon and have it at least twice daily since then)
now has a headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (now has a headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Headache tension.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Apr-2021, the patient experienced HEADACHE (now has a headache). At the time of the report, HEADACHE (now has a headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Swollen upper arm in sight of shots and hot to touch.  Swollen lips and face.  Fever. Called Dr. at 6:35 AM, he prescribed a steroid, Advil, and Benadryl.
After 15 minute observation period patient experienced weakness in arms and legs, sweating, loss of vision, and pupil dilation.  Patient was brought back to the pharmacy around 6:15pm, after a few minutes of sitting the patients pupils returned to normal and the patient regained vision. After 15 minutes the patient was able to stand without issue. An ambulance was called, paramedics monitored the patient and took the patient to a near by hospital.
This spontaneous report as received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB injection (lot # L038018, expiration date 13-SEP-2017 and lot # L016427, expiration date 13-APR-2017) for prophylaxis (strength, dose and route were unknown). On unknown dates, the following temperature excursions were registered : between 46 Farenheit degrees and 77 Farenheit degrees for 20 minutes and between 46°F and 77°F for 10 minutes. There were no previous temperature excursions. Digital Data Logger was involved. No adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008578: US-009507513-1701USA008577: US-009507513-1701USA008576: US-009507513-1701USA002579: US-009507513-1701USA008579:
INCORRECT STORAGE OF VACCINE (VACCINE WAS REFROZEN); OUT OF SPECIFICATION PRODUCT USE (ADMINISTRATION OF REFROZEN VACCINE); This spontaneous report received from a health care professional concerned a 34 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 20-MAY-2022) dose was not reported, administered on 04-APR-2022 for prophylactic vaccination. Age at time of vaccination 34 years old. No concomitant medications were reported.  On 04-APR-2022, the patient experienced out of specification product use (administration of refrozen vaccine). On an unspecified date, the patient experienced incorrect storage of vaccine (vaccine was refrozen). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect storage of vaccine (vaccine was refrozen) and out of specification product use (administration of refrozen vaccine) was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220537548, 20220539045, 20220538425, 20220537688, 20220538379, 20220537507, 20220538627, 20220537341, 20220538437, 20220538573, 20220537444, 20220538292, 20220538347, 20220538411, 20220538693, 20220539045, 20220537532, 20220538146, 20220538316, 20220538210, 20220538758, 20220538238, 20220538297, 20220538480, 20220538149, 20220538666, 20220540435, 20220540524, 20220540474, 20220538890, 20220540853 and 20220540611.
Blood clot in left eye Loss of vision in left eye for two days Headaches and brain fog for 2 weeks +
Patient experienced redness, inflammation, tenderness in the area directly below the vaccination area on the deltoid. Patient returned to pharmacy two days after receiving the vaccination, noting that the area of redness had increased in size. Patient was recommended to take diphenhydramine to calm down any allergic reaction, and to follow up with a prescriber in 2 days if no improvement.
pain in the midsternal region and in an area of the left side of her chest. Constant pain, unable to describe.  she gets intermittent sharp/stabbing, burning pains in her chest.  She has shortness of breath described as difficulty taking in a deep breath.  She feels more fatigued than normal.  She also complains of whole body tingling and feels like she's having "an out of body experience."
Vomiting, dizziness, stabbing lower stomach pain, exhaustion, diarrhea.
This spontaneous report as received from a health professional refers to a 4 year old patient. On 26-JUN-2014 the patient was vaccinated with a dose of MMR II (HSA, lot # J011332, EXP date: 13-SEP-2015, dose and route not reported) and a dose of (oka/merck) VARIVAX (lot # J014229, expiration date: 08-NOV-2015, dose and route not reported), both vaccines were stored improperly. There was no adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Headache on the left side of forehead; Pain behind left eye; pain behind my left eye and along my left face stopping at the cheek area; dose 1 and dose 2 administered on 24Mar2021; This is a spontaneous report from a contactable other HCP (the patient). A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 09:00 (at the age of 57-year-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162), via an unspecified route of administration in the right arm on 24Mar2021 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and right leg neuropathy. Concomitant medications included labetalol (MANUFACTURER UNKNOWN), amlodipine besilate (NORVASC), benazepril (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient did not have a history of any past drug therapy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 12:00, the patient experienced headache on the left side of forehead, pain behind left eye and left face stopping at the cheek area. Patient did not received any treatment for the events. On 11Apr2021, the patient underwent lab tests and procedures which included atila iAMP NAAT RT-PCR COVID-19 detection (nasal swab) test and the result was negative. The clinical outcome of the events headache on the left side of forehead, pain behind left eye and left face stopping at the cheek area were not recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated reporter details (occupation), updated vaccine details (start and stop time of dose 1, state and end date for dose 2) and event medically confirmed. Corresponding data field and narrative was updated to reflect that patient did not receive any treatment for events. Added event (Extra dose administered).  Follow-up attempts are completed. No further information is expected.
In the middle of night on the next day when receiving my vaccine, half of my body went numb on my left side. I started to get weird nerve sensations same side where I got the vaccine, lasted few hours. I have been feeling really tired after that. Lately I have been having peripheral nerve sensation to my hands and feet in the end of July, and it comes and goes. They did blood tests and could not find anything wrong with me, I do not know whether it is related to the vaccine or not. The peripheral nerve sensation to my hands and feet have gotten worse. I had covid in September in 2020. The burning pain in my hands and feet comes and goes.  After covid in the end of September 2020, I developed trigeminal neuralgia and I do not if this is connected to my symptoms. I had blood tests done and everything came back normal except for high inflammation markers, due to covid that I had last year.
I got the shot at 5pm.  When home and I was relaxing watching tv.  At 8pm, my heart was racing very fast and took blood pressure,  It was very high, 152/105 pulse 74.  I called 24hr nurse on call.  She said call 911. Ambulance was on site within 5 minute and transported me to hospital.  I was in the ER at least 6 hours, moderating my heart.  They said I had an A FIB attack.  They got it down and admitted me to the hospital.  I also experienced pain in my bladder, I could not urinate.  They had to drain it 2 times.  I was released from the hospital at 8pm the next day.  Any questions, don't hesitate to ask me or my doctor.
is a 74 year old female who has completed a 45-minute observation period with the following signs and symptoms of an adverse reaction: loss of consiousness. Pfizer-BioNTech COVID-19 vaccine  #3 in series administered.  o Action(s) taken: Recommended transfer to higher level of care, risk and benefits explained to patient, patient declined  With daughter ,  Family declined  Per family, patient always has episodes of fainting whenever she "enters" the hospital premises Blood sugar checked 94 o Allergy to COVID-19 vaccine documented in Allergies activity: No,  Vitals:   11/23/21 1050 11/23/21 1051 11/23/21 1102 11/23/21 1110 BP: (!) 201/95 (!) 203/110 (!) 191/87 (!) 175/86 BP Patient Position:   SITTING   SITTING BP Location:   RA-RIGHT ARM RA-RIGHT ARM LA-LEFT ARM Pulse: 91 95 66 76 Resp: 18 18 18 15 SpO2: 99% 100% 100% 100%    family and patient refused to go to ER or urgent care. signed
SEVERE FATIGUE, VOMITING AND WEAKNESS FOR FOUR STRAIGHT DAYS. YOUR POISON VACCINE ALMOST KILLED HER.
Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA266375 (Same Reporter). This case involves a 6 months old patient of an unknown gender who received a dose of PENTACEL which was mixed with wrong diluent. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE for Immunization; and PNEUMOCOCCAL VACCINE for Immunization. On 26-Jun-2018, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE lot C5422AA expiry date: 15-Sep-2019 via intramuscular route in the right thigh. It was case of actual medication error due to wrong solution used in drug reconstitution as PENTACEL was mixed with sterile water. No adverse event was experienced. 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 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.
This spontaneous report was received from a Licensed Practical Nurse, referring to a 4-year-old patient of unknown gender. There was no information reported regarding the patient's medical history, concurrent conditions or concomitant medication. On 21-DEC-2018, the patient was administered an improperly stored dose of PROQUAD (strength, route and dose not provided) lot # R017628 and expiration date 18-DEC-2019, for prophylaxis. The dose was reconstituted with a properly stored sterile water diluent (MERCK) (lot # and expiration date not provided). No adverse effects reported. It was reported that the storage temperature of the vaccines was 6 to 14 Fahrenheit degrees and the time frame was 18 minutes. There was no previous temperature excursion and the call was because of a "data logger". This case is one of two from the same reporter (Information captured in MARRS # 1812USA011839). Sender's Comments: US-009507513-1812USA011839.
2.5 inch redness, swelling, itching, painful with a couple of hive looking spots at injection site  Also headache, fever, malaise
Rashes/hives around trunk (belly and chest) appeared the day of vaccination. Still present today (April 24) - 3 weeks post vaccination. It is a little itchy and appears worse at night.
Daughter states mother woke up at 4:50 a.m. with leg cramp in left leg.  Got out of bed to work cramp out and when she started out of bed, she felt something was wrong - balance was off, things "swaying", noticed tingling in face and lips and weakness in left arm & left leg.  States mom said she was able to look in mirror and was able to smile at that time and didn't see mouth drooping to one side or the other.  EMS called and she was taken to KDMC (Ashland, KY). 11/16/09:  ED & Hospital Records received for dates of service 10/31/09 to 11/4/09.  Dx:  TIA, Atypical Chest Pain, HTN, Hyperlipidemia, Tobacco Abuse, Diabetes mellitus. Assessment:  Awoke with leg cramp, tried to stand and could not control the left side of body, felt heaviness in left arm and leg, ataxia of gait and slurring of speech at onset.  Also had some left periorbital numbness in the face.  Sx. had improved by the time of presentation to ED.  Pt. reports some shooting chest pains lasting a few minutes a few days prior to admission and occurring occasionally.  Family member reports a similar episode of decreased arm function 2 months lasting 30 min. and resolving spontaneously.  Smokes 2 packs per day x 48 years.   BP 152/72.  12/01/09 DC summary and rehab consultations for DOS: 11/04/09-11/24/09  DX: Right basal ganglia infarct with left hemiparesis; Patient c/o left-sided weakness, admitted to rehabilitation unit to address mobility and self-care deficits via PT. OT and speech therapy.  Able to ambulate with large base quad cane by discharge;Stable status.
little soreness where they put the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Feb2021 (Lot number: EL3302) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing); "Diabetes" (ongoing). Concomitant medication(s) included: IRBESARTAN; METFORMIN; HYDROCHLOROTHIAZIDE. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "little soreness where they put the injection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer stated, the first shot (Captured as Unspecified medication) she didn't had any reaction other than little soreness where they put the injection for few days. Consumer stated, she took an antacid pill twice a day it was an just over the counter. Consumer stated, She had blood work at doctor's office but that was in general for what he was treating her not in reference to the shot, She did not had the results back (not clarified further). Consumer was informed about Pfizer Medical Information Consumer further stated, she already went through, she did not go through this much detail but she talked to someone and they gave her medical information number she thought got the medical department. Consumer was provided with the number of Pfizer Medical Information. She thought she was talking to medical department. Consumer was babysitting a little 2 yr old so they can talk as long as he was watching his show. Patient was taking medication for both high blood pressure and sugar diabetic  No follow-up attempts are possible. No further information is expected.
Pt had varicella shot, fine during administration, joked with brother who was also getting shots during brother shots.
I had two RSV exposures from my daughter, both were negative COVID exposures - I became sick seven days after the second daughter did. I had headache and pain in all of my sinuses. I had a mild fever. I was treated (at Urgent Care) a course of amoxicillin and my symptoms were better once I started antibiotics (about 24 hours after). I never lost my sense of taste or smell. I did have a runny  nose but no cough. I got a secondary infection: a sinus infection: I developed the sinus pain etc. and so that was the bacterial infection that was treated. Pregnancy history: I have  had three pregnancies and two live births. Estimated date of delivery - March 6th and I delivered on March 8th, 2021. Birth weight was: 8 lbs and 6 oz. - she was a good healthy baby.