chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stomach aches; chills; sweats; nausea; This is a spontaneous report from a contactable physician (patient). A 65-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration on 29Apr2021 10:30 (Batch/Lot Number: EW0175) as 1st dose, single for covid-19 immunisation. Medical history included haemorrhoids and gastritis. The patient's concomitant medications were not reported. The patient previously took steroid drug and experienced gastritis; Rubella vaccine when the patient is 25-years-old and experienced intense reaction. On 29Apr2021, 5 hours after first dose, the patient experienced stomach aches, chills and sweats, very intense, that was almost like malaria, along with nausea, and a slight stomach ache but had no fever which lasted for 3 or 4 hours. The outcome of event chills, sweats, and nausea recovered on 29Apr2021; stomach aches was recovering; all other events was unknown.  Follow attempts are needed. Further information is expected
severe, painful  swelling in lower extremities, left ankle worse than right. subsided by next morning.
sweating on left arm at injection site; vomitting; nauseous; feeling like to pass out; immediate abdominal pains; Diarrhea; This is a spontaneous report from a non- contactable consumer, a patient.   A 27-year-old Female patient received a single dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) ( Lot number = not known) via an unspecified route of administration in the left arm on 09Mar2021(at the age of 27-years-old) at 06:30pm as a first dose for COVID-19 vaccination. Medical history included that patient was allergic to penicillin bee. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the vaccination. Since the vaccination, patient had not tested positive for covid-19. On 09Mar2021, within two minutes after vaccination, patient experienced sweating and immediate abdominal pain. She also felt like she was going to pass out and was nauseous and sick with vomiting and diarrhea and after putting water on her face and drinking Gatorade it slowly started to pass. she was told it was an anxiety attack. The patient had recovered from the events at the time of reporting. Information about lot/batch number cannot be obtained as it was unable to locate or read the details and no further information is expected.
Tinnitus spiked up quite a bit /tinnitus was reported as worsened /her tinnitus increased a great deal. It increased in loudness; arm was sore; stomach ache; upsetting and distressing; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration at 13:30, on right arm, on 25Jan2021, at single dose for COVID-19 immunisation. The patient relevant medical history included heart condition, she is mostly allergic to antibiotics (She has allergies to several medications; Specific antibiotic names not provided), blood pressure, anxiety, thyroid (thyroid disorder), urinary tract health, I have had tinnitus for 7 years and Bones (bone disorder) and of them were ongoing. The patient concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder and ongoing at 50ug, daily, hydrochlorothiazide tablet for blood pressure and ongoing at 0.25mg (half tablet) once a day, valsartan(DIOVAN) for blood pressure ongoing at 80mg once a day, verapamil for heart issue ongoing at 100mg, metoprolol tartrate for heart, ongoing at 25mg twice a day, alprazolam (XANAX) for anxiety ongoing at 0.25mg, once a day, d-mannose for urinary tract health ongoing at 300mg once a day, vitamin d nos for bones ongoing at 50ug daily, calcium carbonate (CALTRATE) for bones at unknown dose once day, ubidecarenone (COQ10) for heart ongoing at 200mg, magnesium for the heart. It was reported that patient got tinnitus after taking an antibiotic and had for 7 years. After taking the first dose on Monday (25Jan2021), the tinnitus spiked up quite a bit on 27Jan2021 (noticed when she woke up at about 08:00 in the morning). Tinnitus got very much louder, and patient thought that it was from vaccine. Tinnitus increased a great deal. It increased in loudness and was reported as worsened. On an unknown date in Jan2021, the patient arm was sore and got better. The patient also had little bit of a stomach-ache at first and that got better as well on an unknown date in Jan2021. The patient thought that the tinnitus would return to my normal level of loud. The patient reported that it's very upsetting and distressing on an unknown date in Jan2021. The patient was worried about getting the second shot. The patient also stated that had allergic reactions to many drugs and did fine with the vaccine in terms of anaphylaxis. It was reported that prior vaccinations within 4 weeks was none. It was reported that patient had not administered additional vaccines on same date of pfizer suspect administration. The outcome of the events tinnitus spiked up quite a bit /tinnitus was reported as not recovered /her tinnitus increased a great deal. It increased in loudness was not recovered, upsetting and distressing was unknown, stomach-ache and arm was sore was recovering.
Approx 3 1/2 hours after receiving 2 month immunization on 9/29/06. Both thighs became red and swollen, presented to ER, RX'd Motrin. DC home no swelling or redness next day.
Believe it may be COVID arm. Have a small red spot near injection site and about 2-3 inch diameter where there is hardness and firmness
This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. The physician stated that her refrigerator and freezer units began to have temperature excursions as of 05-MAY-2014. ROTATEQ was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range) since 05-MAY-2014 and also to 49F for 12 hours. On unspecified dates since 05-MAY-2014, an unspecified number of patients received ROTATEQ which was improperly stored. No product quality was reported for ROTATEQ. This case is linked to 1411USA001655, 1411USA004432, 1411USA004433, 1411USA004434, 1411USA004436, 1411USA004437, 1411USA004438, 1411USA004439, 1411USA004440, 1411USA004441 and 1411USA004442 (same reporter link).
Information has been received from a physician concerning a 52 year old female patient with fibromyalgia who on approximately December 1999, 9 years ago, was vaccinated with a dose of with PNEUMOVAX and developed a serious reaction at the injection site.  The physician reported that her arm became red and she was diagnosed with an infection in her arm 2 hours after receiving the vaccine.  The patient was given unspecified antibiotics to treat.  The patient sought unspecific medical attention.  No further information is available.
This non serious case was received on 30 April 2009 from a health care professional.  A cluster of four patients (patients identifiers were not provided) received ADACEL (lot number UF452AA) on an unspecified date.  All patients developed injection site warmth and redness 24 hours post vaccination.  The recovery status was unknown.  No further information was provided.  List of Documents held by Sender: none.
SUDDENLY AUTISTIC AT 6 YEARS OLD; A spontaneous report has been received from a consumer. The report concerns a male patient of Unknown ethnic origin (age 11 years).    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal), via nasal route, on an unknown date.     During 2015, the patient experienced suddenly autistic at 6 years old (preferred term: Autism spectrum disorder).     It is unknown if any action was taken with Flumist (influenza virus vaccine live, intranasal).     The outcome of the event was unknown.    The event was considered non-serious.
Nausea (vomited one time), chills, fatigue, vertigo, fever, aches, bowel issues
Had low fever (between 100 - 101 F) for almost 48 hours then broke. On day 3, noticed redness, tenderness and itching on upper left arm, in the entire muscle, which the vaccine was administered.
On 3/31, noticed a bruise (looked like a hematoma?) below my right knee - dark brown with purplish hue. Two days later, I had a bruise above my left knee, milder than the one on my right knee - brownish hue (did not turn purple/ yellow). A couple of days later, I noticed a bruise on my left forearm (even milder than the one above my left knee) and careful examination noticed a faint bruise at the back of my right upper arm. The bruises became faint and disappeared over time - I am scheduled for my second shot on 4/30/ 2021
Right ear started ringing then went numb followed by a rapid loss of hearing. My hearing recovered within 24 hours. This has happened four times now. My Dr. Sent me to an ENT for examination.  I showed a hearing loss in right ear and they he'd me do a MRI of my head. Scan came back normal.
Janssen 3/9/21, Moderna 11/1/21, 4/1/22, Pfizer 9/15/22. Positive on 1/4/23
This case was reported by a other health professional via call center representative and described the occurrence of felt faint in a 20-year-old female patient who received BEXSERO. On 30th May 2018, the patient received BEXSERO. On 30th May 2018, less than a day after receiving BEXSERO, the patient experienced felt faint. On an unknown date, the outcome of the felt faint was recovered/resolved. The reporter considered the felt faint to be probably related to BEXSERO. Additional details were provided as follows: This case was reported by a Medical Assistant and was previously not reported to anyone. After receiving the BEXSERO vaccine, the patient went into the waiting room, where the patient felt faint and woozy while she was in the waiting room and had to lie down. The caller was not sure how long after the dose was administered that this event occurred.
Muscle pain; Back pain; Bad body odor; Tiredness; Severe chills; Joint pain; Fever; Headache; Nausea; Vomiting; Arm burned really bad during administration; This spontaneous case was reported by an other health care professional and describes the occurrence of BURNING SENSATION (Arm burned really bad during administration), BACK PAIN (Back pain), SKIN ODOUR ABNORMAL (Bad body odor), FATIGUE (Tiredness) and CHILLS (Severe chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced BURNING SENSATION (Arm burned really bad during administration). On 23-Feb-2021, the patient experienced BACK PAIN (Back pain), SKIN ODOUR ABNORMAL (Bad body odor), FATIGUE (Tiredness), CHILLS (Severe chills), ARTHRALGIA (Joint pain), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting). On 24-Feb-2021, the patient experienced MYALGIA (Muscle pain). At the time of the report, BURNING SENSATION (Arm burned really bad during administration), BACK PAIN (Back pain), SKIN ODOUR ABNORMAL (Bad body odor), FATIGUE (Tiredness), CHILLS (Severe chills), ARTHRALGIA (Joint pain), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and MYALGIA (Muscle pain) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient took Advil (ibuprofen) and Tylenol (paracetamol).
pt recvd 2NOV94 AM call recvd from parent 4PM 3NOV94 states pt has been fussy & fever-states pt given APAP-awoke from nap w/shrill cry a few mins ago & will not let anyone touch her; t103; inquired about seeing MD & having pt checked;
Within 1 hour felt she had a lump in her throat and had diff. swallowing.  This was gone the next day.  Her eyes also began to itch, whites blood shot, rims red.  Crusty and very itchy the next day.  Saw eye MD 11/6 who thought she may be sensitive to THIMEROSOL (no previous allergy to this) By the 3rd day symptom free.
Patient is was overdue for well child check and overdue for vaccines. Pentacle was ordered and administered.
Client reports to EMT's that she feels nausea, dizziness and mild shortness of breath. PHN's notified and arrive to find client alert and oriented x 4.  Client reports no history of medical conditions and blood pressure is elevated: 160/78, 150/88 and 170/84.Client reports she had a similar reaction an hour after her first dose.  Client was placed in zero gravity chair but unable to be in supine position due to nausea. Patient drank water and was provided with emesis bag.  Clients dizziness improved after water but nausea never improved. Client reports she feels she cannot take a full breath so PHN called 911. Fire and paramedics arrive at 6:33 pm and assumed care. Client declined to go with paramedics and signed AMA. . Client is still pale and nauseous. Client left facility accompanied by EMT in wheelchair  to car and her son drove home.
Information has been received from a registered nurse concerning a 63 year old female with rheumatoid arthritis, hypothyroidism, cataracts, rhinitis allergic, depression, anaemia and IVP dye allergy who on 16-MAR-2007 was vaccinated with Pneumovax (lot #655587/0882F), 0.5 ml, IM in the left deltoid. Concomitant therapy included CALTRATE, LEXAPRO, montelukast sodium, ADVAIR and ULTRAM. On 17-MAR-2007, the day after receiving the vaccination, the patient experienced symptoms of body aches, fever between 100-102F, flu-like symptoms, nausea, fatigue, and a sore left arm. The patient also "felt faint" and stayed in bed from 17-MAR-2007 through 20-MAR-2007. The patient sought unspecified medication attention. On an unspecified date, the patient had the following laboratory tests performed comprehensive metabolic panel (CMP), complete blood count (CBC) with differential, "usual blood work" (including iron, ferritin and TSH) results were not reported. Subsequently on an unspecified date, the patient recovered from body aches, fever between 100-102F, flu-like symptoms, nausea, fatigue, sore left arm and "felt faint". Body aches, fever between 100-102F, flu-like symptoms, nausea, fatigue, sore left arm and "felt faint" were considered to be disabling. Additional information has been requested.
Pt vaccinated with DTP temp 104.5 that evening. Tem 101 on 12OCT90.
Tested positive for COVID on 21Sep using home antigen test (2 tests).; Tested positive for COVID on 21Sep using home antigen test (2 tests).; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 1, single (Lot number: GH9703) at the age of 75 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Sep2023, outcome "unknown" and all described as "Tested positive for COVID on 21Sep using home antigen test (2 tests).". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2023) Positive, notes: Tested positive for COVID on 21Sep using home antigen test (2 tests); (21Sep2023) Positive, notes: Tested positive for COVID on 21Sep using home antigen test (2 tests). Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient Tested positive for COVID on 21Sep using home antigen test (2 tests). First noticed symptoms 20Sep. Began the 5 doses of Paxlovid evening of 21Sep. Took a home antigen test 28Sep (negative). Waited 48 hours and took another, also negative. Felt okay and that I was probably recovered, but a day or two later started to notice a dry cough and feeling a little congested in chest; also tired, like maybe still recovering. Then started to feel like I was getting worse instead of better; so on 05Oct (five days after second negative test), decided to take another home antigen test which came out positive.
Approximately 10 min. after administration, the patient complained of pain in the muscle at injection site as well as tingling sensation from shoulder to hand with some pain in elbow and wrist.
Arm swelled, became red, hard and hot to touch without fever. Pt went to Doctor on 3/14/2003 and received antibiotic for inflammation. Cefaclor 375 mg
awoke 30OCT AM w/sore rt arm;noted quarter area of redness @ site of pneumonia shot;area et swollen;area very tender;
Patient seeking treatment at an urgent care center on 10/30/2018 at 6 PM. Patient has localized swelling, pain, redness since waking on morning of 10/30/2018.
severe rash; swelling; fever; chills; This is like having the flu as a child; been sick; vomiting; This case was reported by a consumer via call center representative and described the occurrence of flu like symptoms in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included measles (the patient even did not know if had the chickenpox as a child, but had the red measles).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced flu like symptoms, sickness, vomiting, rash, swelling, fever and chills. On an unknown date, the outcome of the flu like symptoms, sickness, vomiting, rash, swelling, fever and chills were recovered/resolved.   It was unknown if the reporter considered the flu like symptoms, sickness, vomiting, rash, swelling, fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Afterwards with Shingrix vaccination, the patient had been sick for 2 days with vomiting and not diarrhea. Also the patient had a severe rash, swelling, fever and chills.  This case has been linked to US2019AMR173623, reported by the same reporter.
Administered pneumonia vaccine to right upper arm. Reaction noted 10/24/18 evening. Pt was seen in office with  redness swelling and hot to the touch at vaccine site. MD accessed pt and ordered IM Benadryl 1 mL. Medication administer to patient. Pt left in stable condition.
Developed vomiting, four to five times; Diarrhea; Abdominal pain; Slightly flushed face and minimum facial flowing; Numb ears/Numb body; Bleeding; Anaphylaxis; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2, via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis on 20Dec2020. Clinical course: the patient received the COVID vaccine on 19Dec2020, and since then she had developed onset of vomiting after 3 o' clock this morning on 20Dec2020, four to five times, numb ears, numb body. She also had diarrhea and bleeding. She had some abdominal pain and she also complained of having slightly flushed face and the minimum facial flowing. The outcome of events was unknown.  Information for Lot/Batch number has been requested.; Sender's Comments: There is a reasonable possibility that the event anaphylaxis was related to BNT162b2 based on known drug safety profile. Based on the close temporal relationship, the association between the event bleeding with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
One day post vax pt developed a swollen area 2 in across, with itching and warm to touch. Pt experienced some erythema.
Pt recvd Engerix-B on the following dates 17MAR92, 15MAY92 & 2-3 days post inject exp inject site pain, fever, sweating, chills, not feeling well (mildly flu-like);
I accidently administered Pentacel that had expired two days prior to administration. It expired 04-02-2023. I administered it on 04-04-2023. No adverse events or reactions noted.
Patient had rash on arm down to elbow, a low grade fever and a bruise at the injection site.  She also reported nausea.
A report has been received from a Health Professional concerning a 1 year old, male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 02-Nov-2012. The nurse INADVERTENTLY ADMINISTERED A HALF-DOSE OF FLUMIST TO A 22 MONTH-OLD PATIENT which started on 02-Nov-2012. The patient recovered from the event of INADVERTENTLY ADMINISTERED A HALF-DOSE OF FLUMIST TO A 22 MONTH-OLD PATINET on 06-Nov-2012. The report was considered to be non-serious by the reporter. Corrected report on 28-Nov-2012: the vaccine was administered by the nurse, the reason was oversight. Outcome of the adverse event added.
Extreme pain. Was treated and given Augmentin 875 mg for 10 days Swelling with redness below the injection site. Site was marked and I was told to go to ER if the redness went out of the marked area.
Fever, paleness, struggling to maintain consciousness, drop in both pulse and blood pressure, millions of lights flashing in eyes, everything going white, decreased hearing, hard to talk... paramedics were called. IV fluids started... pushed to stabilize pulse.
7/31/21 chest pain mid sternum, palpitations, pain middle of back, SOB, tachycardia rates to 130
Patient developed wheezing, c/o difficulty breathing.  Denies tongue swelling, no visible rash.  Treated with albuterol nebulizer and transported to hospital.
Pt left clinic @appr 1130AM 26SEP91; no apparent distress; PC from pt 27SEP91AM states about 130PM 26SEP91 started w/difficulty breathing; to ER via car; dx: anaphylactic rxn to Td;
Shortness of breath**; cough; fatigue; slight loss of taste and loss of smell; sore throat; runny nose; vomiting tendency; slight nausea: symptoms started showing late afternoon (after 24 hours) around 4pm on Tuesday, March 30, 2021.   Symptoms were very predominant the day after, Wednesday, March 31, 2021 since 7am.
Myocarditis diagnosed on 6/17. Patient then also diagnosed with a pulmonary embolism on 6/30.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 18May2021 as dose number unknown, 0.3 ml single (Lot number: EW0187) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 0.3mL, Lot: ER8736, NDC/Expiry: Unknown, this is not on the vaccine record card.), administration date: 21Apr2021, for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".  Additional information: The Pfizer COVID Vaccine she was administered on 18May2021 she reported sore arm which lasted for almost 2 months or a little longer before she recovered completely.
Sore arm, bruising, and intense itching on same side thigh, sore throat, congestion in sinuses.
Patient received expired vaccine. Vaccine expired on 4/4 in the freezer but wasn't noticed and sent to clinic who administered expired vaccine to patient on 4/5.