chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; low-grade fever experienced approximately 16 hours after injection.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 16Mar2021 at 09:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included seizures which was controlled with medicine and the patient also reported that there were no seizures in over 8 years. Concomitant medications included carbamazepine (TEGRETOL) 20mg once daily for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The Patient was not diagnosed with COVID-19 prior to the vaccination. The Patient had not been tested for COVID-19 since the vaccination. The patient did not have allergies to medications, food, or other products. The patient previously received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 23Feb2021 at 09:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 17Mar2021 at 01:00, the patient experienced chills and low-grade fever, approximately 16 hours after injection. The patient did not receive treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills and low-grade fever was resolved in Mar2021.  No follow-up attempts are needed. No further information is expected.
Swelling at injection site, fatigue, took Tylenol with some relief, still swollen but slightly less, pink area, trouble lifting her arm, that is better, pinkness is still present, no worse, told to with heat.
The pt experienced stiffening of feet joints, leg joints, severe pain in fingers, brought on by rheumatoid arthritis. The pt is being treated with Celebrex and going to a rheumatologist. 60 day follow-up states the pt had headaches as well as the stiffness in legs and angles. Missing vaccine information not available.
PATIENT PASSED OUT AND APPEARED TO BE HAVING A SIEZURE WITH EYES ROLLING BACK IN HEAD.  HE WAS SLUMPED IN CHAIR.   NON- RESPONSIVE. wAS  ABOUT TO ADMINISTER  EPINEPHRINE , WHEN HE CAME TO.  HIS VOICE WAS WEAK AND SAID NO TO EPI.  HE WAS DIAPHORETIC AND VERY PALE.   EMS CAME ONTO SCENE AND TOOK OVER. BLOOD PRESSURE WAS 80/53 PER EMS.  HE REFUSED FOR THEM TO TAKE HIM.  WIFE WAS CALLED AND CAME TO GET HIM BUT HE HAD TROUBLE STANDING AND HAD TO SIT AWAHILE.   IT WAS ABOUT 45MINUTES BEFORE HE EXITED WITH ASSISTANCE.  ATTEMPTED TO CONTACT HIM LATER AND HAD TO LEAVE MESSAGE
Very Dizzy, vertigo,  very sore at injection site, nausea, chills, headache.
Information has been received from a registered nurse (RN) concerning a white male who on 01-OCT-1998 was vaccinated with a dose of Varivax (Lot #627876/1241H). The RN reported that the patient subsequently developed a generalized rash. It was unknown if medical attention was sought and the patient was not hospitalized. At the time of this report, the outcome was unknown. No further information is available.
Customer rec'd FLUVIRIN - LA and PNEUMOVAX - RA on 8/14/14. Shot was prepared with sterile technique as always. She reported on 8/16/14 pm that RA was hot, red 2" circle and had 103 degree temp on 8/15/14. By Sunday 8/17/14 red circle was 4"-5" around with no fever. Monday 8/18/14, she went to immediate care where she was prescribed doxycycline for cellulitis. No reaction to FLUVIRIN. Spoke with pt. 8/25/14 much better.
fatigue; muscle PAIN; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue) and MYALGIA (muscle PAIN) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No relevant medical history was provided by reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced CHILLS (chills). On 14-Mar-2021, the patient experienced FATIGUE (fatigue) and MYALGIA (muscle PAIN). The patient was treated with IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) at a dose of 800 milligram. At the time of the report, CHILLS (chills), FATIGUE (fatigue) and MYALGIA (muscle PAIN) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included unspecified blood pressure pills.
Large, soft lump around injection site. Not clear when it first started, but discovered it around 3 hours after vaccination.
Angioedema, which consisted of tingling/pressure in lips, chin, roof of mouth, tongue, and pharynx; feeling of swelling and burning in throat; slight difficulty swallowing; hoarseness; pruritus
Pt recv vax in 1998; post vax in 1998 pt exp induration at vax site; tx=Cephalosporin (5/28/98)
Multiple reactions:  Dizzy/Lightheadedness Fast beating heart/heart palpitations Sharp pains in chest near heart Fever Pain in arm, armpit, and down ribs Swelling and redness at injection site
This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 19-NOV-2015, the patient was vaccinated with improperly stored VAQTA lot # L015460, expiration date 20-JUL-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pain at injection site. Has not gone away. No redness or warmth to touch. Patient is medicating with pain meds for some relief.
Radiculopathy that begin 4 days aftr shot #1 in left arm as a tingling in full hand that rushed up the arm.  Next day same thing happened in left leg (began at toes and rushed up leg).  Then the right leg.  Then the right arm.  (So all 4 extremities buzzing pins and needles at once.) Never experienced this before.  Left side was the worst.  The right side resolved after a few weeks.  Left arm persists significantly to this day.  Also no menstruation for 3 months ( had been very regular previously.)  After shot 2 this didn't change, there was just the few days of headache and muscle aches.
Information has been received from a physician concerning a male whose 2 month old daughter was vaccinated with an oral 2 ml first dose of Rotateq on 27-FEB-2007. It was reported that the father was immunocompromised because he was on steroids at the time of the vaccination. Subsequently the father developed rotavirus, which required hospitalization for an unknown length of time. Tests were performed on the father which determined that he did have rotavirus. It was reported that the patient recovered. It was noted that the daughter did not experience and adverse effect. No other information was provided. Additional information has been requested.
pt had Hep B vax 12JAN93 approx 6PM woke AM of 13JAN unable to move neck to left-could turn head carefully to rt & touch chin to chest; neck hurt only when tried to turn or when in process of lying down; c/o h/a & dizziness;
Fell to floor, loss of consciousness, jerking of arms.  Lasted for a few seconds, then was fine.  No treatment.
On 11/30/2021, patient, a ten year old,  came to Pharmacy to receive a second dose of the Pfizer vaccine. Instead of being referred to a facility that offers the pediatric Pfizer vaccine formulation, 10 mcg/0.2 ml, the nurse administered Pfizer 30 mcg/0.3 ml instead.  This was discovered on 01/27/22.  On 01/28/22, the father, was informed and he stated that no adverse reaction resulted from the vaccine given to patient on 11/30/2021 and that he will inform her PCP,  Dr.
Pt reports tenderness to site and when observed, noted large area of redness from shoulder to elbow. Reports area was hot to touch and was seen in ER where doctor gave tx of Rocephin IM>
Raised, red rash (hives?) periodically appearing all over body.  Very itchy, not painful.  Individual flare ups subside after several hours if not itched or irritated.  First noticed 8 days after vaccination.  Continue to appear on day 13 (today) but less frequent.
pt recv 2 doses of vax 27JAN96 & 26FEB96 & 10JUL96 pt exp a negative titer of 0.044 using ELISA test;
This spontaneous report was received from a nurse and refers to a 24 year old patient of unknown gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 13-DEC-2017, the patient was vaccinated with PROQUAD Therapy type rHA (recombinant human albumin), 0,5 ml subcutaneous (lot # N020010, expiration date: 13-JAN-2019) for prophylaxis. The vaccine was administered to a patient of inappropriate age. The reporter stated that there was nothing seriously wrong with patient receiving the vaccination and that the patient has not had any untoward effects since receiving the vaccination.
Redness, hard knot. No fever or child. Did not treat with AX. Kept close eye on arm.
MMR on 05/06/1998, Patient brought to office on 05/15/1998 after a fall from a pool table.  Mom stated baby been fussy since shot.
pt recv vax & 18 hr p/vax pt devel fever of 103.5 & a rash surrounding the inj site; rash resolved w/in 24 hr; 8 days following vax pt presented to MD w/cold sx & lt OM; pt eventually recovered;
now feels like she has a rapid heart beat; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (now feels like she has a rapid heart beat) and NAUSEA (nauseous) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced HEART RATE INCREASED (now feels like she has a rapid heart beat) and NAUSEA (nauseous). At the time of the report, HEART RATE INCREASED (now feels like she has a rapid heart beat) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
This spontaneous report was received from an employee at pharmaceutical company who came across an online article on a social media newsfeed and refers to an unspecified amount of patient of unknown age. The article from News Network and was posted 29-MAY-2017. The author of the article stated that a physician first publicized the link between stomach disorders and autism, and took the findings one step further, the link between stomach disorders and autism and the Measles, Mumps, and Rubella (MMR) vaccine (manufacturer not specified). In recent months, courts, governments and vaccine manufacturers have quietly conceded the fact that the MMR vaccine most likely does cause autism and stomach diseases. The author quoted the physician as saying "There can be very little doubt that vaccines can and do cause autism. In these children, the evidence for an adverse reaction involving brain injury following the MMR that progresses to autism is compelling". The physician also remarked that back in 1996-1997, he was made aware of children developing autism, regressive autism, following exposure in many cases to the MMR vaccine. Upon internal review, autism was considered medically significant. This is one of several reports from the same source. Additional information is not expected. Sender's Comments: US-009507513-1708USA013471.
Headache and Fever 103.8 and some N/V. Treated with Tylenol came down to 99.8. Headache and Fever again morning of 11/4/2014 t max 103.9. Treated again with Tylenol.
diarrhea; injection site pain; tiredness; headache; muscle pain; chills with elevated temp; chills with elevated temp; joint pain; injection site swelling and redness; injection site swelling and redness; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 28Jan2021 at 08:00 AM (at age of 83 years old) at a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was reported as "Other". The patient's medical history included stage 3 kidney, prediabetes, and allergies to sulfa. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received unspecified concomitant medications (patient received other medications within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took hypromellose (GENTEAL; reported as "gen-teal") and experienced allergy. On 29Jan2021 at 02:00 AM, the patient experienced diarrhea, injection site pain, tiredness, headache, muscle pain, chills with elevated temp, joint pain, injection site swelling and redness, nausea, and feeling unwell. The patient did not receive treatment for the events. The patient has not been tested for COVID-19 since the vaccination. The events were reported as non-serious. The outcome of the events was recovering.
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 09-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
pt recv vax 18NOV97 on 20NOV97 mom noticed that lt arm was swollen, reddened, firm & sore to touch;mom called local med clinic & they advised heat to arm;mom called hlth dept on 21NOV;advised to apply cold pack to arm & APAP for discomfort
08:30 on 3/16/08 with c/o severe pain in L arm delt injection site radiating down arm.  Some edema & shoulder ROM.  Neuro Intact NON & sensation.
Dull ache when she is at rest and a shooting pain when she moves her left arm; Dull ache when she is at rest and a shooting pain when she moves her left arm; This spontaneous case was received on 29-Oct-2020 from other non-health professional via Med Communications (reference number: SEQW20-04480) and concerned a 42-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 08-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular; anatomical location: left arm; dose and indication: not reported). The batch number reported was 276567 and expiry date was 30-Jun-2021.  On an unknown date in Oct-2020, within two days after receiving Flucelvax QIV, the patient experienced dull ache when she was at rest and shooting pain when she moved her left arm.   At the time of initial reporting on 29-Oct-2020, the patient had not recovered from events. As reported, the symptoms were still present.   The reporter did not provide a causality assessment.  Company comment: The patient experienced pain and pain in extremity (both reported as 'dull ache when she is at rest and a shooting pain when she moves her left arm') 2 days after administration of Flucelvax QIV. Causality is assessed as possibly related for both events due to lack of another confounder and based on temporal and anatomical plausibility.; Sender's Comments: The patient experienced pain and pain in extremity (both reported as 'dull ache when she is at rest and a shooting pain when she moves her left arm') 2 days after administration of Flucelvax QIV. Causality is assessed as possibly related for both events due to lack of another confounder and based on temporal and anatomical plausibility.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Other HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 45 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: COVID-19 test: Positive, notes: 6 days after recovery from initial infection; Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 21Feb2023 to 26Feb2023.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19  and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Arm hurt a bit; Was fatigue; Nausea; Lip felt feverish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt a bit), FATIGUE (Was fatigue), NAUSEA (Nausea) and ORAL DISCOMFORT (Lip felt feverish) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt a bit), FATIGUE (Was fatigue), NAUSEA (Nausea) and ORAL DISCOMFORT (Lip felt feverish). At the time of the report, VACCINATION SITE PAIN (Arm hurt a bit), FATIGUE (Was fatigue), NAUSEA (Nausea) and ORAL DISCOMFORT (Lip felt feverish) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Headache; Low grade fever; Vomiting; Tremors; This is a spontaneous report from a contactable consumer or other non hcp (Patient mother).  A 22-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration on 23Mar2021 (Age at vaccination: 22-years-old) as unknown dose single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included thioridazine (THIORIDAZINE), omeprazole (OMEPRAZOLE), propranolol (PROPRANOLOL), folic acid (FOLIC ACID), methotrexate (METHOTREXATE), ethinylestradiol, ferrous fumarate, norethisterone (KAITLIB FE), aripiprazole (ARIPIPRAZOLE), escitalopram oxalate (ESCITALOPRAM [ESCITALOPRAM OXALATE]), adalimumab (HUMIRA) all taken for an unspecified indication, start and stop date were not reported. It was reported as 25Mar2021 morning patient had a reaction from the Pfizer vaccine she was vaccinated on Tuesday afternoon. she had a headache, low grade fever, vomiting and tremors. Patient received treatment for the events with Tylenol. The patient underwent lab tests and procedures which included body temperature: seems to be fine. The outcome for the events was reported as resolved on 25Mar2021.   No follow-up attempts are possible. No further information is expected.
He got his first two doses in September and received his booster dose yesterday.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his first two doses in September and received his booster dose yesterday.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his first two doses in September and received his booster dose yesterday.). On 15-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his first two doses in September and received his booster dose yesterday.) had resolved.            No concomitant medications were reported.  No treatment medications were reported.
Pt recvd 2nd dose of Engerix-B approx 6 months ago & devel 3 days of back pain, joint pain, malaise & myalgia;