chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever, chills, upset stomach  I'm feeling better a few hours later but not recovered.
On 04/30/00 pt developed a sore throat, runny nose, headache, and fever. On 05/30/00 the pt presented at clinic and was found to have enlarged bilateral parotid glands. On 05/04/00 a mumps titer was drawn and came back equivocal. The health department stated that this a a lab (-) case of mumps. ON 05/12/00, the pt recovered, however, on 07/21/00 a convalescent IgG was drawn which remained at greater than four-fold increase. No further information is expected.
going senile; mental blank; This is a spontaneous report from a contactable consumer (patient). An 84-year-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease and 'run out of breath'.  The patient's concomitant medications were not reported. The patient got the first dose of COVID-19 vaccine. Patient just pulled a mental blank and reported going senile. Patient called it lack of oxygen to the brain. Outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
stated that she had left arm pain down to her wrists; stated that she had left arm pain down to her wrists; stated that her fingers were tingling and numb (left); stated that her fingers were tingling and numb (left); ." Caller reports her blood pressure "really going up"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jul2021 (Lot number: FA7484) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 01Aug2021, outcome "recovering" and all described as "stated that she had left arm pain down to her wrists"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 01Aug2021, outcome "recovering" and all described as "stated that her fingers were tingling and numb (left)"; BLOOD PRESSURE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "." Caller reports her blood pressure "really going up"". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthralgia, pain in extremity, hypoaesthesia, paraesthesia, blood pressure increased.  Clinical Course: Caller received her 1st dose of the Pfizer COVID-19 Vaccination. She received her 1st dose on 29Jul2021 and was scheduled to have her 2nd dose day after. 3 days after receiving the 1st dose, the caller reports having left arm pain, down to her wrist and also notes her fingers were tingling and numb. The patient did go to her HCP who advised that the symptoms she was presenting with could be due to the vaccine administrator hitting a nerve and did expect the side effects to resolve within a few days. He advised that further neurology referral would be necessary if patient's symptoms did not resolve. The caller was now very hesitant to get the 2nd dose of the vaccine due to the "side effects" she has encountered and wants to know why she got these side effects. Caller had an EKG done when she was seen by her HCP for the numbness and tingling she was experiencing and the results were normal and her heart was said to be "good." Caller reports her blood pressure "really going up" thus what prompted the EKG study.  No follow-up attempts are possible. No further information is expected.
Facial muscle weakness, loss of taste, difficulties swallowing.  Suspected vaccine induced multiple cranial neuropathy, most consistent with a Miller Fisher variant type of GBS.  Received IVIG with improved symptoms.
red, itchy, just below and slightly to the front of injection site; lasted about 5 days
About 8hrs prior to the injection I began to have a pain in my arm, nauseous,  and a headache.  I also had slight diarrhea.  As of now (2/11/2021 @ 2:54p) i am still experiencing a headache
Dizziness,inittally, evening of vaccination rash on chest, back ache, and chills.  next day  Cp, throat  tightness . Seen at hospital
Patient presented to ED and was admitted patient c/o cough daily and shortness of breath had been diagnosed with COVID 3 days prior o2 sat 96% had mild fever
Approximately 2 hours after receiving vaccine, patient states her back started burning and she broke out in hive on back and both arms. She self-treated with benadryl for duration of hive (2 days).
None. Please note pt got VARIVAX # 3 today. Had proquad last year and VARIVAX #1 11/12/2003
MOM BROUGHT CLIENT IN FOR LEAD TEST AND FLU VACCINE, DID NOT REALIZED TIL AFTER VACCINE GIVEN THAT CLIENT HAD RECIEVED IT 8 DAYS EARLIER AT ANOTHER CLINIC,  NO REACTION AT THIS TIME.
No additional AE reported; A nurse called to report that VARlVAX had a prior temperature excursion/she was advised the product was supported but to use within 3 months/ new expiration date 17SEP2021/was administered to a patient on 20SEP2021/This was the patient's first dose; Varivax had a prior temperature excursion/she was advised the product was supported but to use within 3 months/short-date new expiration date 17-SEP-2021/administered to a patient on 20-SEP-2021.; This spontaneous report was received from a register nurse and refers to a 32-year-old female patient. Information about the patient's pertinent medical history, concomitant medications, past drug reactions or allergies was not reported.  On 17-JUN-2021, it was stated that the reporter called the Agency to report that the product varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature excursion of 14.6 degrees Celsius (C) during a time frame of 11 minutes. No previous temperature excursion was reported. It was advised that the product was supported to be used within 3 months and was provided with a new short expiration date of 17-SEP-2021 (unspecified if the advised and new expiration date came from manufacturer).  On 20-SEP-2021, the patient was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (mL) (vaccination scheme frequency, route and anatomical site of administration were not provided; lot number T031388, that was verified to be a valid lot number with an expiration date reported and established as 15-SEP-2022) for prophylaxis, after the temperature excursion and the short new expiration date for the vaccine (expired product administered) (product storage error). No additional adverse event (AE) was reported.
Very bad allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Very bad allergic reaction". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
From initial information received on 06/21/04 from a vaccine provider regarding an adverse event occurring in the USA, it was reported that a 19 month old male pt received a DAPTACEL vaccination, Lot # C1698AA administered IM in the right deltoid and an IPOL vaccination, Lot # X0828 administered SC in the left arm on 06/15/04.  Two days later, on 06/17/04, the pt developed localized redness of his right arm from shoulder to elbow. Cool compresses were prescribed. The pt has recovered from this event.
pt reports awakening morning p/shot w/pain in entire lumbar spin & rt sacroiliac & buttock;pt tender in described areas on 20OCT97;
Neck is red; Rash / Waist / Spread to her hips and thighs; Rash at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 62-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 2J3TT, expiry date 30th June 2021) for prophylaxis.   On 9th October 2020, the patient received FluLaval Tetra 2020-2021 season. On 10th October 2020, 1 days after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site rash. On 12th October 2020, the patient experienced rash. On 15th October 2020, the patient experienced red neck. On an unknown date, the outcome of the injection site rash, rash and red neck were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, rash and red neck to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The patient was vaccinated with Flulaval. On next day after vaccination patient developed a rash at the injection site that later went to her waist and on day 3 it spread to her hips and thighs. On 15th October 2020 patient had red neck. Till the time of reporting events were ongoning. This report was given via web chat by an LPN who received a call from the patient reporting the event. At time of reporting physician had not seen the patient rash. The reporter consent to follow up.
This case was reported by a physician to a vaccine distributor and described the occurrence of fever in a 70-year-old female subject who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. Information regarding previous immunization with influenza virus vaccine was not provided. On 8 November 2007 the subject received unspecified dose of Flulaval (unknown). On 9 November 2007, 1 day after vaccination with Flulaval, the subject called the physician and reported that she experienced a fever and flu-like symptoms. The subject had to be hospitalized. The physician doesn't know if the subject has viral encephalitis or if she has meningitis. The subject is undergoing magnetic resonance imaging for the lumbar spine. The physician reported on 14 November 2007 that the subject is now in a near comatose state. At the time of reporting the fever and flu-like symptoms were worse.
This spontaneous report as received from a nurse refers to a 14 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUN-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
The vaccine was injected at 2:30pm on Fri., Feb. 5, 2021. By 3pm my left arm hurt. The pain and lack of mobility increased all day Saturday. Sunday I felt less pain. Monday morning I was fine. Regarding my energy, from Feb.5,2021 to Sunday night I felt very tired, weak. Monday morning I woke up feeling normal.
After the first shot I had the typically named symptoms. But after the second shot (4/27/21) I have other symptoms. Starting 2-24 hours after shot I had paid and swelling under my arms, in the lymph node area. 48 hours after shot I have irregular menstrual bleeding. Not sure if it will be a once time thing, or turn into a full menstrual cycle.
Myalgia, NauseaVomiting, SORENESS AT INJECTION SITE/NECK PAIN /WEAKNESS/NAUSEA Narrative:
Pt. developed an itchy rash with bumps on her back left arm left leg and abdomen. Pt. was advised to take Zyrtec allergy medication and to call if symptoms got worse.
Tested Covid -19  positive 08/16/2021 with onset of symptoms 08/15/2021
The morning following vaccination, the patient noticed that the injection site was red and swollen. Patient was advised that she can place ice on the site and take Tylenol to help with discomfort.
I was approached by a customer today in regards to her flu shot received on 10/23/12. She showed me a large depression/void on the outer side of her bicep and indicated that this occurred as a result of her flu shot.
PATIENT WAS GIVEN MODERNA FOR HER 1ST DOSE. VACCINATOR OVERLOOKED THE FACT THAT SHE WAS ONLY 17 YEARS OLD. WE ONLY DISCOVERED THE ERROR WHEN SHE CAME BACK TODAY(5/6/21) FOR HER 2ND DOSE. ACCORDING TO CDC GUIDANCE WE WENT AHEAD & GAVE HER THE 2ND DOSE OF MODERNA. I INFORMED THE PATIENT OF THE ERROR AND SHE STATED THAT SHE DID NOT HAVE ANY SIDE EFFECTS  FROM THE FIRST SHOT & WAS FINE WITH GETTING THE 2ND DOSE OF MODERNA.
Moderna COVID-19 Vaccine EUA Patient received Moderna COVID Vaccines on 1/30/2021 and 2/27/2021.  Patient presented to the ED and was admitted on 8/02/2021 for lab abnormalities (high uric acid and glucose).  Patient had a previous admission due to AKI and hyponatremia.  Patient tested positive for COVID-19 on 8/3/2021.  Patient's symptoms for COVID-19 were mild/asymptomatic with reports of runny nose, sore throat and mild cough.  While in the hospital, patient was treated with remdesivir.  Patient expired on 8/14/21.
Bad taste in her throat; This is a spontaneous report from a contactable nurse. A non-pregnant adult female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 07May2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. It was unknown if the patient had known allergies. It was unknown if the patient received concomitant medications within two weeks of vaccination. It was unknown if the patient received other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 07May2021 at 12:00, the patient came to vaccination drive through clinic for her second Pfizer COVID-19 vaccination. Lot number, from the reporters recollection might have been EW0710, but the reporter could not recall with certainty. Within 10 minutes of receiving the vaccine, the patient reported of a bad taste in her throat. There was no tongue swelling evident and no problems breathing. The onsite paramedics were summoned and arrived within a few minutes. They took vital signs, the results of which were unknown. The patient was informed by paramedic that this adverse event was known to occur but was not very common. The patient required no further intervention. At the time the patient left the site, at least 30 minutes had elapsed and she had completely recovered from the bad taste in her throat. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event bad taste in throat was resolved on 07May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was here with her mother for influenza vaccine and Covid vaccination - Pfizer #1.  Pt healthy and talkative when presented to room.  Was fussing that she "didn`t want a shot" just prior to immunizations. After vaccinations, pt was talking, choosing stickers, conversing with her mother, reading a book, walking around the room, ate some candy.  Pt was seated in hallway near nurses' desk with mother for the 15 min observation time.  At 1555, patient became pale, nauseated, vomited undigested food from lunch on the chair in the hallway.  Given oral care. Lying down on the chair in hallway. Pt was moved to an individual pt room and assisted to lie down on the mat. Ice pack to posterior neck area for comfort. Pt was quiet, skin pale and cool.  Still nauseated. Was able to focus on mother to commands, but would not verbalize to questions asked of her.   O2 Sat was 95%. Pulse 84. T97.4. Heart auscultated, apical pulse strong and regular. Peds BP cuff too large for pt - unable to obtain reading. Within 10 min, pt was talking and answering questions.  Skin color improving, to normal pink color.  911 called at beginning of event, but since pt was improving, and after consulting with mother, mother opted not to have patient taken to ER by ambulance. Mother feels comfortable continuing to watch her at home.  Mother instructed on signs and sx to watch for.  Continued observation here 15 more minutes.  Pt was up, jumping and playing on the mat. Sat with mother on chair, talking about Christmas presents.  Laughing and playing game with staff. Tried to recheck pt O2 sat but her hands were too cold from ice pack and she was very mobile.  Nurses present.
PT HAD A FEVER WITH RESTLESS LEGS THE NIGHT VACCINE WAS GIVEN. HEADACHE THE NEXT DAY. HAD LEFT AXILLARY EDEMA WITH PAIN TIMES 1 MONTH.
An hour after my shot I felt chest pressure. It was very uncomfortable. It resolved itself within 5 hours. I went to my PCP to check it out a week later. He said my EKG reported pericarditis. I am going to see a cardiologist this week.
staff was attempting to administer the boostrix to a 15-month old patient, but gave the adacel instead with no reported adverse event; Initial information received on 14-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 months old male patient and reporter reported that the staff was attempting to administer the Boostrix to a patient, but gave the Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hib Vaccine Conj (Tet Tox) (Acthib) for Prophylactic vaccination.  On 14-Sep-2023, the patient received a dose of 0.5 ml of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (Strength: standard, Frequency: once, expiry date: 03-Oct-2025 and lot U7905AA) instead of Boostrix (lot number unknown) (strength: not reported) via intramuscular route in the left thigh as immunization (wrong product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt devel a rash on neck 3 hr p/vax; rash spread to face-arms & stomach & legs; fine red rash; rash itchy; seen by MD given DPH & an ointment; 14JUL95 father states it appears to be improving;
pt recv vax 15OCT97 830 to 930AM & same day died;corner states COD massive MI;
Severe Heart ache, Left arm severe pain. Swelling, shortness of breath, hearing loss, low blood pressure, rapid heart rate.
Both thighs and raised swelling Rt thigh, 5cm (+) pain Lt thigh 3 cm
Developed numbness in legs and back of neck.  Swelling on left side of face.  Given Benadryl 50 mg PO and sent to emergency room.
Information has been received from a certified medical assistant concerning a less than 18 month old female who on 05-OCT-2007 was vaccinated with a dose of PNEUMOVAX 23 instead of PREVNAR. There was no adverse event reported. No product quality complaint was involved. Additional information has been requested.
28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen on 14-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-408922 (Patient Link).
Has been feeling sick; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration in left deltoid on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient stated that he has been feeling sick. The event outcome was unknown at the time of the report.  Information on lot/batch number has been requested.
COVID Breakthrough Case, Swollen like a elephant, Headaches, Feeling feverish, Throat was very sore. Everything lasted short term.
pt recv vax & exp local rxn & recurrent apnea next day; discharged apparently well;
First pt of the day was given an expired vaccine that was ?found? in a cooler. RN assumed that the doses were from the first draw of the day, even though she did not visualize the Clinical Lead bring in the first draw of the day. After the pt was vaccinated did the Clinical Lead realize that there were vaccines in a cooler that were expired from an unknown date and time. Incident Command was informed and, Field Lead, was informed. Per RN Field Clinical Director via phone, Pt was informed of the incident and that the pt was vaccinated with an expired vaccine and that we are in contact with our Medical Director to figure out what the next step will be. Dr called and informed us to go ahead and revaccinate the pt after she communicated with the pt and made sure that the pt understood what was happening. Pt was revaccinated and placed in observation. Pt left observation without further incident.   V/S, BP:140/78, HR: 84, SPO2: 96%   2nd set of vitals BP: 138/78, HR: 84, SPO2: 96%
Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25vmL/25ug
Saturday extreme fatigue (day after). Still have fatigue flashes and a weird headache (that flashes up from time to time)
Patient had high fever 6 days after vaccine and had a seizure. Child had a previous seizure 1 month before shot.
Woke up at 1130 pm with Extreme body pain,  all 4 extremity  bones hurt and joints felt on fire. Lasted approx 12 hours. Hurt laying still, hurt more to move , even slight adjustments in body position severely hurt, Then progressed slowly to  generalized aches and pains x 3 days, Headache x 3 days.
I had a fever of 101 degrees for 2 days, headache, chills, and fatigue.  It led to a migraine, which I have a propensity for.