chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose was fine. No symptoms except sore arm x1day.  2nd dose symptoms: 1-27-21:   10:00pm - runny nose and sore left arm and Lt Palm of hand 1-28-21 2:00am- woke up with extreme chills/ body shaking. Body aches. Sore joints (knees, hips, pelvis, low back, shoulers). Fatugue.  4:00am- woke up with sweats. Took oral temp 101.3°F. Took 500mg tylenol.  5:00am- chills shaking. Sweats soreness. Oral Temp 100.3.   Chills, shaking, body aches and sweats came and went throughout day in waves.  At 730am temp was 98.9.    Took tylenol again at 2:00pm  4:00pm headache  By 7:00pm- symptoms lessened.   1-29-21:  12:00am- no symptoms except woke up drenched in sweat.   2:00am- no symptoms  except woke up drenched in sweat   6:30am-  slight headache but everything else was 100% gone
HPV vaccine for right palm verrucae vulgaris;    This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 78 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen and curettage. The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for right palm verrucae vulgaris (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  The patient's immune status was reported as none. The patient was followed up for treatment for 8 months. There was no resolution of patient's condition.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.  Follow-up information was received via telephone call on 02-APR-2020.  A request was made for patient identifiers, events experienced and causal relationships.; Sender's Comments:  US-009507513-1912USA001729:
27oct89 pt vax 2nd hepta B. in the left deltoid.  in jan90 pt ex. left upper arm discomfort and noticed indentation assoc. w/ vax. 01feb90 pt presented to MD worse indentation and tenderness in arm. See worm...
Extreme headache, fever, chills, body aches, nauseous, vomiting for 6 hours
This medically confirmed spontaneous report (initial receipt: 24-Jul-2012) concerns an adult female patient, who had a medical history of an appendectomy at age 7, C-section in 1992, lasek in 2001 and stereotactic biopsy in May-2006. On an unspecified date in 2010 the patient received a flu shot (manufacturer and batch number not specified). The patient was previously exposed to the flu shot yearly. Within 4 hours of receiving the flu shot the patient experienced an anaphylactic reaction. The patient could not swallow, her tongue, periorbital and face were swollen and she experienced pain in her chest and throat. The events were considered life threatening and the patient sought medical attention. The event outcome was recovered. Reporters comment: The reporter considered the events as life threatening. Follow-up #1 (21-Aug-2012): The influenza vaccine administered was FLUZONE, not FLUVAX. FLUZONE is not a CSL product. Follow-up #2 (04-Sep-2012): Symptoms of anaphylactic reaction, outcome, medical history and serious criteria. Manufacturer of flu shot administered in 2010 was unknown.
Pt recvd Heptavax series in 1987; JAN90 was surface negative; 4th dose given w/Recombivax in MAR90; JAN91 pt was non reactive; 5th dose given w/Engerix-B 18APR91 & 19JUN91 titer reactive;
Patient reported feeling dizzy and having a headache. No antidote nor supportive treatment provided. Symptoms resolved within 30 minutes.
On July 21, 2022 I tested positive for COVID-19 at my doctor office. I tested twice, the rapid test came back negative and the PCR test came back positive.  My Dr. prescribe me Paxlovid on the same day.
7/17 Acute maxillary sinusitis (5 days), runny nose, watery eyes 7/20 Acute pharyngitis (1 day), throat pain, white spots at the back of my throat  Both these events were possibly a result of an RSV infection
Vaccines 1/5/9 no problems. 1/6/9 - Circular welts with blisters- itching back, legs, arms, buttocks - worse on 1/7/9. Went to ER 1/7/9 - placed on BENADRYL and medicine to control react.
Janssen Covid-19 vaccine EUA Extreme aches, chills, sustained fever of 101, fatigue, nausea, headache, weakness and dizziness. Heart palpitations/racing heart. Vaccine site soreness. Onset was 8 hours after receiving vaccine and has continued for 24 hours.
On 2/14/11 received call from patient stating that approx 6-8 hours after receiving Hep A/Hep B vaccine, awoke from sleep w/temp of 102.9, chills, cough. Had symptoms for 4-5 days w/temp as hi as 104.4. Did not seek medical care. Pt is bipolar, injected IV Heroin on 1/30/11.
LOSS OF APETITE; TINNITUS RINGING IN EARS; HEADACHE; LEG PAIN; HEAVINESS; LOSS OF ENERGY; CHILLS; FEVER; TIRED; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced leg pain. On 06-MAR-2021, the subject experienced heaviness. On 06-MAR-2021, the subject experienced loss of energy. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced tired. On 07-MAR-2021, the subject experienced tinnitus ringing in ears. On 07-MAR-2021, the subject experienced loss of apetite. On 07-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg pain, heaviness, and chills on 07-MAR-2021, and fever, and headache on 09-MAR-2021, was recovering from tinnitus ringing in ears, and had not recovered from tired, loss of apetite, and loss of energy. This report was non-serious.
Bilateral tinnitus 4/20/2021 (Twelve days after first injection): onset of mild tinnitus (buzzing, high pitched sound). No previous history of tinnitus. 6/20/2021:  Dramatic increase in tinnitus symptoms. Sleeping impaired for approximately two weeks. Over time (1 month), tinnitus symptoms reduced. Tinnitus persistent throughout day and night to the present (1/26/2022)
No other information or concern noted; Nurse calling to report that a patient was administered expired dose of MMR II on 11/7/2022.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-NOV-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live rHA (M-M-R II) valid lot #T034389, expiration date: 08-OCT-2022 (strength, dose, frequency, anatomical location, and route of administration were not provided) for prophylaxis. Additional information or adverse event were not reported.
Raised swollen red knot at site of injection accompanied by severe itching at site over past 3 days after vaccination received one week ago.
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: Patient passed out approximately 3 min after given the dose. While getting ready to conduct CPR, the patient started responding. Patient was able to be seated. Called 911 and the paramedics arrived. After examining the patient, paramedics told me that patient told them that she was only afraid of needles and they think the reaction is Psycho-Somatic. Patient blood pressure was low for a little while.
tinnitus has become unbearable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "borderline glaucoma" (unspecified if ongoing); "Minimal Tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, After my first 2 injections, my glaucoma has increased and I'm partially blind now.), for Covid-19 immunization, reaction(s): "glaucoma has increased", "partially blind"; Bnt162b2 (DOSE 2, SINGLE, After my first 2 injections, my glaucoma has increased and I'm partially blind now.), for Covid-19 immunization, reaction(s): "glaucoma has increased", "partially blind". The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus has become unbearable".  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Patient described racing heart, difficulty breathing, disorientation, and numbness in the arm and face. Patient wanted pharmacy to call 911, and EpiPen 0.3mg was administered in the thigh. After EMS evaluation patient declined to go to the hospital.
Information has been received from a pharmacist concerning a patient who in June 2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 665524/1374Y). The patient's relevant medical history, concomitant medications and past drug history were unknown. On an unknown date, in June 2010, the consumer reported a reaction, more than the normal localized reaction which include redness, swelling, and inflammation. It was unknown if there was any relevant laboratory data. As of 19-JUN-2010 it was unknown if the consumer still had redness, swelling and inflammation. It was unspecified if the patient sought medical attention. Follow-up information has been received from the pharmacist who reported that the patient experienced reactions that occurred about 24 hours post-vaccination and involved a silver dollar size rash with redness and swelling at the injection site. The patient did not receive medical attention. At the time of report, the patient's outcome was unknown. The pharmacist commented that they vaccinated 300 patients with ZOSTAVAX (Merck) without any issues and then they had 5 patients who all had the same delayed injection site reactions which occurred the same week and from the same lot. The pharmacist did not think this was a coincidence since they had no problems with the other patients, plus each of these 5 patients were vaccinated from the same ZOSTAVAX (Merck) lot number 665524/1374Y. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
8/26 within an hour:  numbness covering left arm and hand.  By 5PM, mild numbness left side of neck and left jaw.  Night of 8/26 into 8/27 morning, insomnia and brain fog. 8/27 through 9/4; arm and hand numbness persist, but not severe enough to hamper motor skills.  Facial numbness (all left side only) in jaw, left ear, back of tongue, and eyelid.  Numbness felt like novocain injection at dentist office that had nearly worn off. 9/5 through 9/11: most numbness gone, only a little in left hand and left jaw
1040 pt recvd Td 21AUG92 fell off chair to floor; mom broke the fall so did not hit head; BP 90/70, P-80 reg, c/o feeling dizzzy; also fever;
soreness at the injection site; redness at the injection site; fever of 101.2 degrees Fahrenheit; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and PYREXIA (fever of 101.2 degrees Fahrenheit) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and PYREXIA (fever of 101.2 degrees Fahrenheit). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and PYREXIA (fever of 101.2 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 101.2 (High) 101.2 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  On 14-Dec-2021, the patient received the booster dose of Moderna COVID-19 vaccine in the right arm.  The patient had experienced no side effects or adverse events to the booster dose.  Treatment information was not reported by the reporter.   This case was linked to MOD-2022-568117 (Patient Link).
Numbness on the right side of my face after having spent 35 minutes after having the vaccine, the duration was 45 minutes after this time it was waking up little by little.
No adverse effects. Reporting vaccine was administered past the beyond use date. Beyond use date 1/3/22, administration date 1/19/22. Pfizer contacted had no recommendations and referred us back to provider and CDC.
6 hours following vaccine, noticed intense itching at vaccine site. 8 hours later whole body itching began, Site was firm, tender, and warm to the touch. Upon waking the next morning, a large welt appeared, approximately 2.5inches wide by 1.5 inches tall. Intense whole body itching continued but most prominent at vaccine site, and pain at ?welt? site began. Ibuprofen and Benadryl taken around the clock. Cortisone cream and Neosporin applied to injection site. To date, itching continues and growth of welt continues.
Awoke from sleep the night of vaccine administration, disoriented, rapid breathing, skin hypersensitivity, dizzy, nausea, vomiting. Next day, diaphoresis. Sx resolved by day 2-3.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 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 included: "hypertension" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs; "migraines" (unspecified if ongoing); "IBS" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; HYDROCHLOROTHIAZIDE; TOPIRAMATE; PANTOPRAZOLE. Past drug history included: Doxazosin, reaction(s): "known allergies: Doxazosin", notes: known allergies: Doxazosin. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 26May2022, outcome "unknown", COVID-19 (medically significant) with onset 26May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: The patient began having recurrence of COVID-19 symptoms 23May2022. Sinus congestion, scratchy throat, loss of taste and tested positive again for COVID-19 26May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Information has been received from a physician concerning a 17 year old female patient who on 21-JUN-2007 was vaccinated IM with her third dose of GARDASIL. A short while later, the patient experienced severe pain at the injection site. She went to the ER due to the pain. She was not hospitalized. Her treatment and outcome were unknown. Additional information has been requested.  Follow up information has been received from the physiican and from medical records concerning the female student with celiac disease (gluten free x 3 weeks) and chronic abdominal pain "her whole life" who on 21-JUN-2007 at 11:15 a.m. was vaccinated IM in the left arm with her third dose of GARDASIL. Concomitant medication included birth control pills and LAMICTAL. The patient's mother reported that the child's arm hurt very bad hours after vaccine administered. Child waited 15 minutes prior to leaving office. Per mother child was taken to ER ddue to pain. Per medical records the patient presented to ER on 23-JUN-2007 complaining of pain in arms and abdominal cramping. The patient thought the symptoms were a side effect of the injection. She was without fever and positive for nausea and vomiting with mild abdominal cramping with onset the night before. She was positive for muscle pain in arms. Abdomen was soft to palpitation, nontender, nondistended, positive bowel sounds in 4 quadrants. Abdominal pain was diffuse, pain was described as cramping, continuous. On a scale of 0-10 the patient rated pain as 10. A chemistry panel was drawn and revealed low potassium, calcium osmolality, alanine aminotransferase, alkaline phosphate, total protein and albumin (values illegible). She was given IV fluids and 4 mg ZOFRAN given IVP into right hand and 1 mg DILAUDID given IVP into right hand. She was to follow up with PCP and given VICODIN PRN. The patient recovered on an unspecifiied date.  The ER physician suspected the patient's symptoms were secondary to GARDASIL.  Additional information is not expected.
Red, Swollen, Sore, Itching. Redness went down arm to elbow and around,  Bumps like hives. Used Cortizone Cream and Allergy relief Diphenhydramine, Hydrochloride, Antihistamine.
Possible intussusception. Patient presented following an episode of lethargy with emesis and had 3 bloody stools (guaic confirmed).
We were advised to give our patients 0.25ml Moderna Bivalent for non-immunocompromised patients. After this vaccine was given, we were told this was changed with CDC and patients were to have 0.5ml. Per manager, we were to report VARES for this event.
Tinnitus in left ear, no treatment, still have after more than 6 months after 2nd vaccine.
Within 24 hrs post vax, pt developed a fever of 104. A copy of this report has been forwarded to Merck, manufacturer of MMRII.
Redness and warmth radiating down arm that shot was received in (going underneath arm to backside of arm.). Feels sore, not aching, just tender.
Began with fatigue and progressed to fever 101.7, severe body aches, severe headache, malaise, cough lasting 24 hours at which time fever subsided with symptoms resolving. Headache persistent.
Student walking back fo class in hallway after getting flu shot.  Teachers in hallway holding student asking for someone to get the nurse as school nurse turned the corner.  Student was standing, skin pale and clammy - student alert and obeying commands.  Student lowered to the ground flat on his back and elevated legs.  Front office notified to contact mom to check on student and Health Department nurses notified by teacher - 3 Health Department nurses responded to the student's side as well.  Vital signs at 9:10 AM Temp 98.0 BP 98/50 oxygen 99 percent HR 96.  Student obeying commands remains alert and oriented.  Small snack provided to student .  Color returned quickly after fluids and snack.  Student reported that he felt better.  Student walked to nurses clinic.  Reassessment at 9:16 AM: HR 83 oxygen 99 percent , B/P 96/52, rr 16.  Mom arrived to side at 09:18 AM.  Mom reported that she has a condition where she also passes out after injections.  Mom checked student and reported that he was okay to return to class.  Teacher states she will watch closely and return student to nurse as needed.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 15-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Onset of body aches 12h after vaccination, lasted for 24h; This is a spontaneous report from a contactable other healthcare professional reporting for a patient. A 26-year-old female patient (no pregnant) received her dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EH9899), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced onset of body aches 12h after vaccination on 21Dec2020, lasted for 24h. No treatment received for the event. The event was reported as non-serious.  The most recent COVID-19 vaccine was administered in Hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 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 outcome of the event was resolved in Dec2020.
2 days after injection, nausea, projectile vomiting, 1 episode of unwitnessed syncope
Systemic: Dizziness / Lightheadness-Severe, Systemic: Saw black and blue dots-Severe, Additional Details: After administration of vaccine, pt complained of feeling dizzy then stated that she was seeing black and blue dots. She sat down for 10 minutes and after when I checked on her, she said she felt ALOT better and left with her partner. No further followup info available. Pt is afraid of needles too.
I passed out immediately after the shot and had seizure like activities, then proceeded to vomit for 2 hours. The night of incident I was not able to sleep because I felt very energetic. I was off of work a day due to feeling very tired, running a temp of 100.4, and having diarrhea. For two days after the event I was really tired.  A week after the event my throat and chest started to tighten.  On November 1st hives started forming on my arms. On November 13th hives spread all over body.