chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was in store and top of chest started hurting and down left arm. Patient states that they called 911 and ambulance took her to the hospital. She was tested and found to have mild heart attack with blood clot in vein of her heart. Had procedure to remove clot was put on blood thinner and is now wearing a heart monitor for the next 30 days. Is on Brelinta for the next 30 days as well.  Patient went back to ER on Tuesday night (4/13/21) due to SOB spent 12 hours at ER before being transferred back to hospital. She spent another day and half before discharge diagnosed with fluid buildup.
Patient only received the vial containing MenCYW-135 liquid. Vaccine was never reconstituted.
Chills, having trouble getting warm; I had fever of 100.3; My joints were sore or aching; Injection site is a little sensitive but it does not hurt; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6208; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in left arm on 15Mar2021 (at the age of 79-year-old) as dose 2, single for covid-19 immunization. It was unknown the patient was pregnant or not. The patient stated, she was probably 5 foot 4 inches and 220 pounds. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (solution for injection) via an unspecified route of administration, administered on 22Feb2021 (at the age of 79-years-old), as dose 1 single for COVID-19 immunization. On 15Mar2021 the patient experienced chills, having trouble getting warm, early morning about 5:30 had fever of 100.3, her joints were sore or aching and on an unspecified date in Mar2021 injection site was a little sensitive but it does not hurt. The patient underwent lab test and procedures included body temperature result was 100.3 on 15Mar2021. Treatment received with 2 tablets Tylenol (Acetaminophen) 500 mg at around 5:30 for fever, temperature went down to 98.5, The brand was extra strength pain relief. She took it orally. Outcome of the event Injection site was a little sensitive but it does not hurt was unknown and outcome of rest all events were resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Moderna 2/1/21, 3/1/21. Positive on 8/15/22
Initial discomfort subsided within 24hr (Sx pain, fever and fatigue). Tx was ibuprofen 800 and hydration.   Lingering side effects,  1. I am an avid jogger/runner (5k and 10k and 13.1 miles). Since the vaccine was taken, I have not been able to run at the previous rate. Cannot complete a single mile without having to stop and massage legs muscles and stretch the joints.   The week prior to the second dose I was running 4 miles every other day and a long distance run weekly.  Also have not been able to complete my normal weight training routine. Arm, chest and back muscles shot in pain doing a previous dominate routine.  example, from doing a 100 repetitions with 25pounds dumber, I cannot do 20 repetitions with 15 pounds dumber without having to stop in pain. To be able to run, take pain killers and rub muscles with pain relieving creams before a run. 2. Fatigue, without changing diet or sleep habits, raising from the bed is hard. Feel weak and struggle to get out of bed. Not mental health issues, just physical weakness.
day 8, post injection - red, swollen, rash-like around injection site.  burning/itching/painful day 9, post injection - worsening, more red, getting larger in size.  Went to dr, was given antibiotics day 10, post injection - less redness but growing in size.  still painful/swollen
I did not bleed during my menstrual cycle from February to August 2021. My period has been regulated with OBCPs for years, and never before the COVID vaccine did I not bleed at all. At the end of September, I finally bled albeit very very lightly for only 24-48 hours during my period.
Injection site pain moderate - aggravated by elevating arm. Fatigue/weakness. Chills. Dizziness.
Tested (+) for COVID infection after being fully vaccinated - vaccine failure.  Patient presented to Urgent Care with cough, chills & nausea after known COVID-19 exposure. Patient was offered treatment with single dose of Regeneron on 7/19/21, which was accepted and received also on 7/19/21.
Information has been received from a nurse referring to a 17 years old female patient. The patient was allergic to BACTRIM. The patient had no pertinent medical history or concomitant therapy. On 26-JUL-2016, the patient was vaccined with VARIVAX (lot # M004330, expiration 23-JAN-2018) 0.5 ml/x1, subcutaneously. On an unknown date in July 2016, after receiving VARIVAX, the patient's injection site (11.5 cm by 6.2 cm located on the right upper arm) became raised, warm, itchy and painful to touch. On 28-JUL-2016, the patient went to the office for follow up and was advised to follow up with the clinic again if the side effect worsened. Unspecified treatment was given to the patient. No lab test was done. The outcome of the adverse event was reported as not recovered. The causal relationship between the VARIVAX and the events was not reported. Additional information has been requested.
I had the chills; I was tired for a day; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (I had the chills) and FATIGUE (I was tired for a day) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20 and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Hormone replacement therapy in January 2015. Concurrent medical conditions included Cholesterolosis NOS since January 2000, Heart disorder since January 2015, Eye disorder since September 2008 and Bone disorder since January 2015. Concomitant products included COLECALCIFEROL, MENAQUINONE (D3 +K2) for Bone disorder (NOS), MONASCUS PURPUREUS (RED YEAST RICE) for Cholesterolosis NOS, XANTOFYL, ZEAXANTHIN (I CAPS) for Eye disorder NOS, UBIDECARENONE (COQ-10) for Heart disorder, ESTRADIOL BENZOATE (ESTRADIOL [ESTRADIOL BENZOATE]) for Hormone replacement therapy.   On 08-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (I had the chills) and FATIGUE (I was tired for a day). At the time of the report, CHILLS (I had the chills) and FATIGUE (I was tired for a day) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-419421, MOD-2021-399886 (Patient Link).
The patient received her vaccine at 12:06pm.  At around 12:40-12:45 she came back to the pharmacy complaining of her throat feeling strange.  She was talking fine with no physical symptoms other than that complaint.  She was given 2 teaspoonfuls of Benadryl and was monitored for 30 minutes.  At her time of departure she said she was feeling better and was okay to go home.  Her mom bought more Benadryl prior to leaving.
Pt received small pox vaccine on 03/21/2005. Pt came into clinic at about 9:45 on 03/22/2005 complaining of severe arm pain from the shoulder to the elbow he said that it hurts to bend the elbow and he couldn't raise his arm above his head.
3-31=fever, body aches, headache, nausea, fatigue 4-1= fever, higher fatigue, SOB, palpitations, red painful spot with heat at inj site. 4-2= red painful spot with heat a little worse than previous day  4-3= redness decreasing, no heat, soreness better
Patient received vaccine on 11/20/06 and experienced mild pain on 11/20-11/21 which went away.  On 11/28/06 patient started having severe pain at injection site.  The pain was severe enough to wake her up at night.  Also a nodule was noted at the injection site.  She reported this to her Safety Officer at the company where she works. (The flu shots had been administered at the company through the health department)  The Safety Officer contacted a health center who recommended heat and exercise.  At the time of interview with the patient on 12/11/06 she reports sx have significantly improved to where she only has a slight ache when moving in certain positions.
Pain near eye that resolved within 24 hours, area of about 2 inches by 4 inches around injection site that became warm, red, slightly swollen and painful. As of date of this report patient is still experiencing injection site reaction.
Information has been received from a nurse referring to a patient of unknown age and gender. On 24-AUG-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L008057, expiration date 01-DEC-2016, dose and route were unknown). The vaccine was stored under 0.4 degree centigrade for 18 hours. It was called because of a data logger. There was no previous temperature excursion. No adverse effect was reported. No PQC was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Pfizer 4/3/21, 4/24/21, 12/29/21. Positive on 2/18/23
About 3-4 days after my second injection, with no alteration of my environment, products, or allergen exposure, I started getting patches of hives in different locations on my body.  The ease up when I take Benadryl, and after having spoken with my younger sister who is a nurse, she indicated that I should ride it out and if it lasts longer than a week to contact my allergist.
Erythematous papules truncus and face. Fever 100.6 x 2 days.
Mild Right arm pain at site of injection; Mild Right arm pain at site of injection, which ran underneath right scapula around  10-11 hrs post injection; Moderate malaise; Headache; Chills around 24-30 hrs post injection; Dose received: 3; This is a spontaneous report from a contactable reporter (physician). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 17Dec2021 at 12:00 (Lot number: FF8839) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Allergy to antibiotics" (unspecified if ongoing), notes: Known allergies: Quinolones. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EL3247, Anatomical location: Left arm, Administration time: 11:00, Route of administration: Intramuscular), administration date: 26Apr2021, when the patient was 44 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3247, Anatomical location: Right arm, Administration time: 11:00, Route of administration: Intramuscular), administration date: 05Apr2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 at 12:00, outcome "unknown", described as "Dose received: 3"; VACCINATION SITE PAIN (non-serious) with onset 18Dec2021 at 04:00, outcome "recovered" (an unknown date in Dec2021), described as "Mild Right arm pain at site of injection"; BACK PAIN (non-serious) with onset 18Dec2021 at 04:00, outcome "recovered" (an unknown date in Dec2021), described as "Mild Right arm pain at site of injection, which ran underneath right scapula around  10-11 hrs post injection"; MALAISE (non-serious) with onset 18Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Moderate malaise"; HEADACHE (non-serious) with onset 18Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Headache"; CHILLS (non-serious) with onset 18Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "chills around 24-30 hrs post injection". Therapeutic measures were taken as a result of vaccination site pain, back pain, malaise, headache and chills.  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The treatment for the events vaccination site pain, musculoskeletal pain, malaise, headache and chills included PARACETAMOL.
Pregnant at time of vaccination on 04/07/21.  Delivered on 12/05/21, discharged home.  Presented in ER on 12/9/21 with SOB that is increasing with her COVID infection.  Requiring 1 L nasal cannula on arrival with oxygen saturation 90% prior to arrival.  Significant shortness of breath with exertion.
I had a full menstrual cycle about a week after my first shot. I?m on continuous HRT and I don?t have cycles. I have occasionally had spotting, but very rarely. After the vaccine I had a full-on, week-long, needed-several-tampons-a-day kind of period. That was at the end of April. I just had another one at the end of June, which was slightly less heavy and shorter, but still not typical. And no, it isn?t just a coincidence or me confusing  it with something else. It is incredibly insulting when some doctors say things like that?if there is one thing most biologically-born women know intimately and very well it is our own cycles and bodies.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDCA22-01987 (Moderna).  A female patient (pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 24Jan2022. The patient was 24 weeks pregnant at the event onset. The patient is expected to deliver a baby(s). Concomitant medication(s) included: LEVOTHYROXINE; DICLECTIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "unknown" and all described as "COVID-19 confirmed by positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Positive.   Clinical course: She states she is 34 weeks and 3 days into her pregnancy. No allergies, Concomitant product code: Prenatal vitamins 100 U.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
DRY THROAT; DRY NASAL PASSAGES; SORE THROAT; SEVERE HEADACHE ALL OVER HEAD; SEVERE SINUS CONGESTION; BODY ACHEYNESS; ARM FELT LIKE GOT HIT WITH BASEBALL BAT/MUSCLE SORENESS; FATIGUE FOR 1 DAY/FATIGUE; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 252 pounds, and height was 73 inches. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies/had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820096 expiry: UNKNOWN) dose was not reported, administered on 15-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the patient experienced fatigue for 1 day/fatigue. On 16-JUL-2021, the patient experienced arm felt like got hit with baseball bat/muscle soreness. On 14-NOV-2021, the patient experienced severe sinus congestion. On 14-NOV-2021, the patient experienced body acheyness. On 14-NOV-2021, the patient experienced severe headache all over head. On 15-NOV-2021, the patient experienced dry throat. On 15-NOV-2021, the patient experienced dry nasal passages. On 15-NOV-2021, the patient experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm felt like got hit with baseball bat/muscle soreness on 18-JUL-2021, had not recovered from severe sinus congestion, severe headache all over head, body acheyness, dry throat, dry nasal passages, and sore throat, and the outcome of fatigue for 1 day/fatigue was not reported. This report was non-serious.
10:20am  reports feeling "lightheaded" post vaccination; BP 90/50  P 78  rest, snack and juice given, monitored x 30 minutes No additional complaints / symptoms subside released from facility/ home with mom
Client presented requesting booster vaccine.  2 vaccines listed on card.  Dose given on 01/05/2022 but realized was 4th dose when entering in Osiis.  No complaints during 15 min wait time.  Spoke with client today, 01/06/2022.  He denies any issues or concerns.
The bivalent Pfizer vaccine was given to the patient instead of the primary series, monovalent, vaccine. Patient did not report any adverse effects and was notified immediately of the error.
Mistakenly gave Pfizer bivalent as first dose. Patient is aware and had no side effects. He is aware that when he comes for second dose he will receive monovalent as second dose.
maculopapular rash all over the trunk and back and the back of the legs; non pruritic.
Severe pain at being injection 20 minutes later, dizziness, loss of control feeling,  heavy sweating at neck only, chills. Severe at indigestion at next meal in evening; breathing trouble after eating -- (2 week symptom occurring) --  constipation for next 3 days. Sharp pain from injection to inside of chest. Upper leg/hip and chest cramps.  3rd daily ingestion causing black and tarry stools, ringing in R ear. Ringing, pulsing in ear still present.  Dr from f/u on 10/28/20 -- Knot in head with fluid (still present). PCP  f/u 12/18/20 for ENT referral.
Idiopathic thrombocytopenic purpura - brusing, petechiae (also in the mucous membranes) low platelet count. Treated with Prednisone, 10 mg, 4 times/day. Began 05/02/2000. Was noted that pt is recovering.
After receiving booster shot on 4/20, fainted 3 times within 24 hours.
One day after receiving vaccine, 2-1-11, whole upper arm was red & swollen & painful. Also reported back and abdominal pains & diffuse aches all over. Lasted 2wks. felt better 2-13-11.
Per EE she got flu vaccine on 10/16/18 in left deltoid: flu infromation: FLULAVAL multi dose 0.5mL 2B55B Manufacturer: ID Biomedical Corporation at 11:58am. On 10/18 EE started to feel "off" during the day at work. She had dizziness, and felt as if " the world was spinning", she had nausea, no vomiting, and every now and then would have to hold onto railing or the computer cart to keep from falling over. She also states she has episodes during the dizziness where she would go to stand up and start walking and her toes, fingertips, and jaw would tingle like it was going to go to sleep or become numb. This lasted the whole time from 10/16-10/29 as well. On 10/29 EE reports feeling 100% better. Over this period of time EE reports constant dizziness that was intermittently worse at times. She did have a doctor on the unit look in her ears and no fluid was seen. She had to take ZOFRAN and PHENERGAN for the nausea to keep from vomiting. EE does have a history of dizziness in general, no specific diagnosis of vertigo. Also has had fluid in her ears before but not within the last year. No viral illness before flu vaccine. No diarrhea or other symptoms. No doctor visit.
Continued left arm injection site pain, left sided neck neuropathy, and feeling of very mild ache to the anterior throat (feeling of swelling) but not having short of breath or trouble talking.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: 6149693), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: P220395-0074L), in left arm, on 23Feb2021 as dose 2, single (Lot number: P220395-0077L), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: P220395-0089L), in left arm and on 13May2022 as dose 4 (booster), single (Lot number: FM999Z), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: Jan2019 (ongoing); AMLODIPIN [AMLODIPINE BESILATE], start date: Jun2022; OLMESARTAN, start date: Jan2019 (ongoing); PRILOSEC [OMEPRAZOLE MAGNESIUM], start date: Jan2012 (ongoing); ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Feb1996 (ongoing).  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Test for Covid-19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
I felt fatigued and my arm was achy for about a day. I had congestion and sneezing on 03/23/2023. I tested positive for COVID-19 on 03/24/2023. I contacted my doctor and got a prescription for PAXLOVID but I did not take as I was feeling better. I am feeling better with no lingering symptoms.
Migraine like headache; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Migraine like headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced MIGRAINE (Migraine like headache). At the time of the report, MIGRAINE (Migraine like headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Information has been received from a consumer concerning her son, a 5 year old male with no known allergies and no pertinent medical history, who in 2005 was vaccinated with a dose of MMR II (lot # not available). There was no concomitant medication. The patient had unspecified autism tests performed. The patient was diagnosed with autism 4 months after receiving the vaccine. At the time of the report, the patient had not recovered. Upon internal review, autism was considered to be an other important event. Additional information is not expected.
1st dose of ROTATEQ was given at 5 month and 29 days; This spontaneous report was received from a medical assistant referring to a 5 months and 29 days old patient of unknown gender. The patient's historical condition, concomitant drugs and allergy to drugs were not reported.   On 16-OCT-2020, the patient was vaccinated with the 1st dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2 milliliter, strength, route, lot number and expiration date were not reported) for prophylaxis at 5 month and 29 days(inappropriate age at vaccine administration).
Day 14, injection site became hot to the touch. Skin was incredibly sensitive to the touch and painful, chills, headache, muscle pain, and pain at injection site.