chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 hours after shot- sore arm, fatigue, stomach upset 12 hours after- above symptoms plus, body aches, rash around injection site and chills, headache 52 hours after- itchy/burning rash on arm, left side of face and ear, stomach and back, and still had all of above symptoms  Benadryl taken for rash and it disappeared-reappearing 5 hours later and disappeared again after more Benadryl. I kept taking Benadryl for 24 hours. Rash did not reappear. Still experiencing fatigue.  Fatigue, headaches and stomachache lasted off and on for 7 days.
Pt developed protracted Chest Pain the evening of vaccination and through next 48 hrs, worse with reclining and better with being up and about and with activities.
This serious initial spontaneous case, was received from other non-healthcare professional on 25-Sep-2017, concerning a male patient of unspecified age. On 13-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient experienced chills followed by fever, in several episodes. On 22-Sep-2017, the most severe episode occurred with fever raised to 103.9 F. The patient also experienced aches and pains and he felt as if he was having the flu. On 25-Sep-2017, at 1:00 pm, chills began and stopped at 03:00 pm. It was reported that the patient wrapped himself in blanket and fever began with flu symptoms. The patient was treated with TYLENOL. Chills were stopped. The outcome of the event flu symptoms was not recovered.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 11/6/2022 --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Dizziness; Headache; patient is 16- years old; A spontaneous report was received from a non-health professional concerning a 16-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the events dizziness, headache, and vaccine given to a 16-year old.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly in their arm for prophylaxis of COVID-19 infection.   On 06 Feb 2021, a father called stating his son was given the Moderna COVID vaccine. His son is 16-years old and had a headache and dizziness after the shot. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events dizziness and headache were not provided. The outcome of the event, patient is 16- years old, was considered resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of  Product administered to patient of inappropriate age for mRNA-1273, lot # 028L20A. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Information has been received from a physician concerning a pt who was vaccinated with Hep-B vaccine recombinant. Subsequently, the pt experienced arthritis symptoms. Follow-up was received which indicated the physician was unable to provide further information. The pt was "unsure of which hepatitis b  vaccine recombinant (MSD)". No further information is available.
Very painful endometriosis pain lasting roughly 30 min.  Patient explained that it was the "worst endometriosis pain she had felt in a long time."  No other contributing factors seemed to cause the flair.
Very sore arm; Overall tiredness; Feeling sluggish; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 14Apr2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included multiple sclerosis. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), VICODIN and PERCOCET on an unknown date and experienced allergy. The patient's concomitant medications included interferon beta-1a (REBIF) and also birth control (unspecified) for unknown indications from an unknown start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 24Mar2021 at 11:00 as a single dose for COVID-19 immunisation. On 15Apr2021 at 08:00, the patient had experienced very sore arm, overall tiredness and feeling sluggish. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse events. The clinical outcome of the events, very sore arm, overall tiredness and feeling sluggish was recovering at the time of this report.   No follow-up attempts are possible. Information about lot number cannot be obtained.
he keeps throwing up and it's just mucus; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient's daughter) reported for her father that an 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 10Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient's daughter said her father has been vaccinated today 10Jan2021 for the 1st dose, and he kept throwing up and it's just mucus since an unspecified date in Jan2020. Outcome of the event was unknown.   Information on Lot/Batch has been requested.
Had difficutly using it for functional activities; Very sore arm in the injection arm after injection; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Very sore arm in the injection arm after injection) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Had difficutly using it for functional activities) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Cerebral palsy (with an atrophied non-dominant arm).    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced VACCINATION SITE PAIN (Very sore arm in the injection arm after injection). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Had difficutly using it for functional activities). At the time of the report, VACCINATION SITE PAIN (Very sore arm in the injection arm after injection) had resolved and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Had difficutly using it for functional activities) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Added Patient Ethnicity, Race information and outcome of event sore arm. Loss of personal independence in daily activities event added.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 29Mar2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Relafen, reaction(s): "Known allergies: Relafen". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 08Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Received vaccine 9/1/21. )n 9/2/21 and 9/3/21 had symptoms of swollen axillary lymph node, fatigue, achiness, and temperature 101. Improved slightly this week, but continued. On 9/10/21,  ER due to shortness of breath, chest pain, and dizziness, hot flashes, and heart palpitations. Labs, CT scan, and EKG done and advised to follow up with PCP. PCP saw her 9/4/21. Swollen lymph nodes remained along with dyspnea and palpitations. Stress Test scheduled for 9/21/2021.
Patient received her booster dose from Pharmacy at an unknown time on 10/15/21.  Her husband reports she had been well throughout the day.  At some point, the patient began to complain of left sided chest pain and then became weak and had to lay down onto the floor.  She then became unresponsive and upon arrival of EMS, she was asystole.  She presented to our ED and we were able to get ROSC, but then the flight crew took off, the patient went into complete arrest again and was brought back to ED where resuscitation efforts continue, but the patient was pronounced dead at 2359.
A 46 year old female reported that she inadvertently received a right forearm, intradermal injection of Diphtheria and Tetanus Toxoids Absorbed, Purogenated on 10/7/00 instead of a tuberculin PPD. That evening, she developed a fever of 100F and itching which extended from "wrist to shoulder area". She also developed an injection site reaction characterized by hives, a "hard lump", pain, redness and warmth.
COVID arm - around a week after receiving the vaccine, I got a rash on the arm of the injection; the rash cleared up within a few days without incident. There was minimal itching.
o 5/6    o 2:15 pm - Second Pfizer dose     o 2:20 pm - Sudden mild headache in top left of head, I rarely have headaches.    o 3:35 pm - Significant increase in ear ringing both ears, the loudest it's ever been. Minor increase in ear pressure and ear pain, noticing some random aches and pains in left arm and top of head. The ringing is louder than it has been previously in the past 5 weeks since first dose.     o 4:15 pm - Flush face and neck, some swollen soreness in neck    o 5:25 pm - More flushness in face and neck, splotchy redness in neck, face feels very warm    o 6:04 pm - Forehead temperature 98.9, neck temperature on left side of neck 101.5 and 99.8 on right side of neck. I don't feel like I have a fever Description of Adverse Event  o 5/6    o 2:15 pm - Second Pfizer dose     o 2:20 pm - Sudden mild headache in top left of head, I rarely have headaches.    o 3:35 pm - Significant increase in ear ringing both ears, the loudest it's ever been. Minor increase in ear pressure and ear pain, noticing some random aches and pains in left arm and top of head. The ringing is louder than it has been previously in the past 5 weeks since first dose.     o 4:15 pm - Flush face and neck, some swollen soreness in neck    o 5:25 pm - More flushness in face and neck, splotchy redness in neck, face feels very warm    o 6:04 pm - Forehead temperature 98.9, neck temperature on left side of neck 101.5 and 99.8 on right side of neck. I don't feel like I have a fever, but it feels more like a sunburn and radiating heat from my face and neck. So the temperature is higher where I'm having the most issues in left ear and neck, and a bit lower on the right side where the issues are less.      o 8:11 pm - Temperatures back to normal but still flush  o 5/7 Back to a baseline ear ringing and ear pressure/pain that continues to present day but is slightly louder than after first does.    So the ringing is louder than it has been to date, but the ear ache is not. On the first does, the ear ringing came first, then the earache was several days later. On a scale of 1-10 with 10 being loud and 1 being soft, right now I estimate my ear ringing to be at a 4 or 5 after second dose when previous highest ringing since first dose was a 2 or 3.
Patient is a breastfeeding mother; Patient is a breastfeeding mother; reduced breast milk production; her breast milk has turned green; This is a spontaneous report from a contactable pharmacist via sales representative. This pharmacist reported for both mother and baby. This is the maternal report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received COVID vaccine and is a breastfeeding mother. She noticed reduced breast milk production and her breast milk has turned green. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s):
On 5/21/01, six days post vax, the child was found dead in her crib. Preliminary autopsy cause of death was attributed to "sudden unexplained non-traumatic infant death." The autopsy report was amended on 8/15/01 to "acute streptococcus pneumonia. Follow-up info received on 09/10/2001 revealed that on 05/20/2001, the child was fussy at bedtime and was given a dose of Tylenol.
One month after the second vaccine she developed slurred speech, difficulty swallowing and frequent falls. She was a healthy, active lady before these events. After much testing, and hospitaliztions, a neurologist  at local Hospital diagnosed her with Bulbar ALS. her symptoms progressed quickly, and she passed away on November 7th, 2022.
Patient was feeling anxious prior to vaccination. As soon as she received her shot she developed mild chest pressure and palpitations. She was brought to the medical tent for evaluation. Her initial blood pressure and heart rate were both mildly elevated (BP 164/97, HR 101). She had an EKG which showed normal sinus rhythm with no ischemic changes. After 10 minutes of observation her symptoms had resolved and her vitals were improved (BP 137/98, HR 86).  She was advised that typical chest pain evaluation includes blood tests that can only be done in ER to definitively rule out ACS, and offered transport to ER, but she felt better and declined, stated she would go to ER if symptoms return.
sore arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (sore arm after 1st dose). At the time of the report, PAIN IN EXTREMITY (sore arm after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided. Patient took 3rd dose on 20-aug-2021. no sore arm and no side effects after the 3rd dose.   This case was linked to MOD-2021-332081 (Patient Link).
Pt's DOB was typed in incorrectly. Pt given a 12+ Pfizer COVID vaccine instead of a 5-11 COVID vaccine.  Father with pt and was notified.
Left arm has a dark red splotch of unstructured shape about 3?x3? in size, about 1-2? diagonally left of the injection site. Red splotch is somewhat painful and warm to the touch. Pain at injection site started soon after vaccine was administered but has slightly improved (was a ?4? out of ten and now is about a ?3?). Redness started about 30 hours after injection. Arm redness pain is about a 6/10.   Additionally, there is a large amount of swelling in the front part of the armpit where the skin connects to the breast. Swelling is about 4-5? in circumference, feels soft, and is very painful, 7 out of 10 (to where it is distracting from duties). Pain is currently radiating into the entire left breast, down the top of the left arm, and up into the neck. Armpit/breast pain has gotten worse every day since the event.   Had a mild fever 12-15 hours after vaccine (101.3) which resolved a few hours later.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011G20 7 or 8) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 19-Apr-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This is a case of vaccine exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.  No Treatment medications was provided by the reporter.; Reporter's Comments: This is a case of vaccine exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
This case was reported by a physician and described the occurrence of injection site induration in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 20 May 2011 the subject received unspecified dose of BOOSTRIX (unknown). On the day of BOOSTRIX administration, 20 May 2011, the subject experienced a local reaction with symptoms of injection site induration, injection site tenderness and injection site redness. The subject was seen on 09 June 2011 and was still complaining of local reaction. At the time of reporting the outcome of the events was unspecified. The physician considered the events were possibly related to vaccination with BOOSTRIX. Follow-up information received via the physician on 06 July 2011 indicated that the subject was a 56 year old, menopausal female. BOOSTRIX was administered at 0.5 ml in the left deltoid on 20 May 2011. On the same day, 20 May 2011, following vaccination with BOOSTRIX, the subject experienced a local reaction with injection site induration, injection site tenderness and injection site redness. The events resolved by 09 June 2011. In the reporter's opinion, the events were possibly related to treatment with TWINRIX.
Started mental two days after shot and never stopped bleeding. Bruising for no apparent reasonHeadaches; Started mental two days after shot and never stopped bleeding.  Bruising for no apparent reasonHeadaches; Started mental two days after shot and never stopped bleeding.  Bruising for no apparent reasonHeadaches; Started mental two days after shot and never stopped bleeding.  Bruising for no apparent reasonHeadaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jul2021 12:00 (Lot number: ew0196) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUAL DISORDER (non-serious), CONTUSION (non-serious), HEADACHE (non-serious) all with onset 23Jul2021 12:00, outcome "unknown" and all described as "Started mental two days after shot and never stopped bleeding.  Bruising for no apparent reasonHeadaches". The event "started mental two days after shot and never stopped bleeding.  bruising for no apparent reasonheadaches", "started mental two days after shot and never stopped bleeding.  bruising for no apparent reasonheadaches", "started mental two days after shot and never stopped bleeding.  bruising for no apparent reasonheadaches" and "started mental two days after shot and never stopped bleeding.  bruising for no apparent reasonheadaches" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heavy menstrual bleeding, menstrual disorder, contusion, headache.  Additional information: On 02Sep2021 Follow-up report received from contactable reporter. No other vaccine in four weeks. No other medications in two weeks. No Covid infection prior vaccination. Covid was tested post vaccination. Covid test post vaccination: covid test type post vaccination was Nasal Swab. Covid test date 28Jul2021. Covid test result was Negative.  Follow-up attempts are completed. No further information is expected.
5/20 34y.o. male with past medical history most significant for IVDU  presents with chief complaint of left toe infection
Pt recv vax on 2/3/97; in 12/97 pt exp rash on upper left arm; on 1/6/98 pt exp rt arm pain, neck &jaw pain, myalgia &flu-like sx, erythema/ tender/ ulceration of rt arm
PATIENT DEVELOPED FEVER, AND SEVERE NAUSEA. FEVER AND NAUSEA SUBSIDED AFTER 48 HOURS BUT AN "ITCHY RASH" AND REDNESS DEVELOPED AT SITE OF FEEDING TUBE AND UNDER THE BREAST AREA. ADVISED CAREGIVER TO ADMINISTER BENADRYL FOR THE RASH TO SEE IF IT ALLEVIATES THE APPEARANCE OR THE ITCHING. ALSO ADVISED THAT DUE TO THE SUPSICIOUS LOCATION OF THE RASH AND IT NOT BEING ANYWHERE ELSE THAT IT MAY BE SHE HAS SIMPLY DEVELOPED A YEAST INFECTION. AT THIS TIME NO TREATMENT FOR THE FEVER OR NAUSEA IS NEEDED BECAUSE BOTH HAD SUBSIDED.