chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No symptoms or additional adverse effects reported.; Nurse reporting patient received unspecified dose of PROQUAD that was improperly stored.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 24-JUL-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection (lot number T003714 which has been verified to be valid, expiration date reported and validated as 29-JUL-2021) (dosage, vaccination scheme, frequency, route of administration and anatomical site of injection were not reported) as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). The administered dose of the vaccine was stored at a temperature of -9.2 degrees Celsius, during a time frame of 3 hours and 20 minutes, as recorded by a digital data logger. There was no previous temperature excursion. No symptoms or additional adverse effects were reported in the patient.
Monday night unto Tuesday night :  chills, cold sweats, fever, fatigue, bodyache Wednesday:  swollen lymph nodes on neck; tender "ball" like spot bulging; random sharp needle like pain that shoots up through the neck into side of head/ear Thursday: lymph nodes still swollen, rashes appear near neck and on lower face. PCP advises of shingles Today: piercing pain still continues on and off, sore body, rashes are hot and inflamed, lymph nodes still inflamed  Currently on day 2 of antibiotics and vitamins to re-up the immune system..
PATIENT RECEIVED COVID 19 VACCINE FOR 12 AND UP INSTEAD OF 5-11 DOSE.
runny nose; felt sick; colds; GI symptoms; tired/fatigued.; sars-cov-2 test: positive on 15Feb2021/formally tested positive on 22Feb2021; sars-cov-2 test: positive on 15Feb2021/formally tested positive on 22Feb2021;  This is a spontaneous report from a Pfizer-sponsored program via a contactable nurse reporting for herself. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number E13302/expiration date: not provided), via an unspecified route of administration, on 01Feb2021 at 15:00 as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included smoker. Concomitant medication included varenicline tartrate (CHANTIX) from 25Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced runny nose, felt sick, colds, GI symptoms, and tired/fatigued. On 15Feb2021, she took a home sars-cov-2 test and tested positive. On 22Feb2021, the patient formally tested positive. The events did not require an emergency room or physician's office visit. Treatment received for the events runny nose, felt sick, colds, GI symptoms, tired/fatigued, and tested positive for COVID-19 included Dayquil and she was on steroids for cold. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Feb2021, sars-cov-2 test: positive on 15Feb2021, sars-cov-2 test: negative on 15Feb2021, sars-cov-2 test: positive   on 22Feb2021, sars-cov-2 test: positive on an unknown date, sars-cov-2 test: negative on an unknown date. The outcome of the events runny nose, felt sick, colds, GI symptoms, tired/fatigued, and tested positive for COVID-19. was unknown.  The reporting nurse assessed the event "sars-cov-2 test: positive" was unrelated to BNT162B2 (COVID vaccine).; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Had sever cough that the patient couldnt really sleep; Itchy throat; Coughing; Pain; Sore throat; Nasal discharge (yellow mucus); Tiredness; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jun2021 at 10:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) on an unknown date and unknown if ongoing. The patient was not allergic to medications, food, or other products. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Jun2021 at 17:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. On 23Jun2021 at 23:00, the patient had common symptoms like pain, tiredness, chills and fever for 1 day. The patient also had some sore throat and nasal discharge (yellow mucus). On 24Jun2021, most symptoms disappeared except for sore throat, nasal discharge and instead the patient had new symptoms including itchy throat and coughing. On 25Jun2021 night, the patient had sever cough that the patient could not really sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, tiredness, chills and fever was recovered on 24Jun2021 after the duration of 1 day. The clinical outcome of the events sore throat, nasal discharge (yellow mucus), coughing, itchy throat and had sever cough that the patient could not really sleep was not recovered at the time of this report.   The lot/batch numbers for BNT162b2, were not provided and will be requested during follow up.
Patient experienced left arm numbness. Visited emergency room and then her doctor. Patient is now on VALIUM to help her sleep through the nite and is scheduled for an MRI.
Treatment of COVID-19; Treatment of COVID-19; Janssen Dose Number: 1, Pfizer / BioNTech Dose Number: 2, Moderna Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Dec2021 as dose 2 (booster), single (Lot number: 33036BD) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies : Nasal Allergies" (unspecified if ongoing); "vocal chord dysfunction" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; LAMICTAL; SINGULAIR; SPRINTEC; VIT D3; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "Janssen Dose Number: 1, Pfizer / BioNTech Dose Number: 2, Moderna Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (2022) Positive, notes: Covid rebound. Paxlovid was taken as therapeutic measures for drug ineffective, covid-19 from 16Nov2022 to 21Nov2022.
At 1030 hours an 11yr old male patient was given covid vaccination.  Within 5 min patient began to have shortness of breath with cool and clammy skin. Pt was given .5 epi IM and symptoms were relieved. A full set of vital signs were taken and remained stable. Pt remained a/o x 3 and calm.   Appropriate authority was advised of the incident. RA 39 responded and transported to hospital.
Pt. was being observed for a 30 minute period when on 25 minute mark nurse noticed a rash around the client's neck. Vitals where taken and 25 ml of Benadryl was administered. Vitals were within normal parameters.  As the rash spread on the client's neck and face, a second dose of 25 ml Benadryl was administered 15 minutes later. Patient was kept in observation for an additional 15 minutes afterwards where redness begin to resolve gradually. Patient was advised not operate heavy machinery and a friend came to the vaccination site and picked up  the client. Rash and redness fully resolved by the end of observation period.
Myalgia, Arthralgia, Fatigue, and describes just not feeling right.  Narrative: Is seeing her pcp regarding the way she is feeling, per this employee her pcp does not think it is due to her vaccine due to time of onset from the vaccine.
pt inadvertently recv booster dose of vax 11SEP97 p/receiving a booster dose on 1AUG97 & emergency dose in 1994;in the evening of 11SEP97 pt devel a fever of 101, chills, nausea, soreness @ inj site;recovered;
Nov 12 booster Moderna #3 Nov 20-27 was in SoCal for Thanksgiving Nov 22 started to get runny nose, took Claritin at night and the next day was fine Nov 25-26 noticed itchiness on the tops of the feet, resolved Nov 27 drove back, that night had itchy scalp Nov 28  experienced full body itching (not on face, palms, bottom of fee)t. Itchiness would start. Hives (urticaria) rash throughout my body.  Notably on arms, legs, back, neck, scalp, behind ears, etc.  The rash would last 30 - 60  min and resolve, and then appear at a different body part.   Nov 29, 30 took 2 cap of benadryl to sleep, which helped  Dec 1 stopped medication, itchiness started again. Dec 2 - prescribed cetirizine (ZYRTEC) 10mg Tab; hydrOXYzine HCl  (ATARAX) 25mg Tab, REFERRAL TO ALLERGY, INT
I started having a runny nose and a sore throat with post nasal drip. I went since my son had been exposed to COVID as a bartender. I was about to be traveling to take care of my parents so I went and went got tested for COVID and I was. I had symptoms for 3 days and then made a complete recovery.
hives on bottom of foot, chest and back of leg. Tx: Benadryl tablets, neosporin
Pt recv vax & 2wk later 9SEP96 pt exp chickenpox w/over 100 lesions & a fever of 101;
C/O left arm pain since had tetanus shot. Limited ranged of motion on exam - mild tenderness over upper arm. Rx Anti-inflammatory.
Administered orally Rotavirus (RotaTeq) vaccine, aproximately 1/3 of dose.  Client immediately began to projectile vomit.  Withheld remainder of dose.
Client reported this was their second dose but after vaccine was given, it was found that there were 2 previous Pfizer doses already given, so this would be client's third dose.
Tight throat, dry red eyes, fever, and severe vomiting including dry heaves, exhaustion, dizziness. It lasted about 48 hours.
Pt felt left upper arm, wrist, forearm pain, as well as neck pain with headache, felt left arm weakness. Pt took penicillin (his own dose) without much relief.
Client received vaccine and 5 hours later began experiencing a fever and ached from head to toe.
No symptoms reported. No additional AE/PQC; inadvertent administration of VAXELIS and ROTATEQ after TE; This spontaneous report has been received from a consumer referring to a 4-month-old patient of unknown gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 01-MAY-2023, the patient was inadvertently vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) via unspecified route for prophylaxis (both strength, exact dose, dose number, lot number and expiration date were not known) after temperature excursion (TE) (product storage error). The storage temperature and time frame were not provided. No symptoms were reported. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Patient flinched at vaccination and lost less than half of vaccine for administration. CDC recommended revaccinating with no lapse in time recommended.
Fever (101.6); chills; body aches; headache; swelling and redness around injection site; redness around injection site; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular at Left arm on 05Jan2021 15:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included epilepsy and prior to vaccination, the patient got COVID-19. The patient concomitant therapy was reported as Yes (patient received other medications in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. The patient experienced Fever (101.6), chills, body aches, headache, swelling and redness around injection site on 05Jan2021 22:30. No treatment received for the events. Since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Jan2021.
Initial unsolicited report received from an office person medical assistant on 30-May-2018. This case involves 12 months old patient (gender was not reported) who was vaccinated with a dose of DAPTACEL (batch number, expiration date, dose, dose in series, route and site of administration were not reported) instead of ACT-HIB (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient was previously vaccinated with a dose of DAPTACEL. It was a case of an actual medication error due to wrong vaccine administered. No adverse event was reported. 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 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. Documents held by sender: none.
At 1 am on 10/3/23, I woke up due to chest pain. The pain worsened rapidly and affected my entire chest and neck. It felt like I could not breath. The pain was a 10 on a scale of 1-10. My entire chest wall felt very tight, like it could not move. I took some tylenol at 1:15am. The pain continued to come in waves of varying intensity from a 7 to 10. I was awake for 2 hours with the pain, and then it subsided and I fell back to sleep around 3am. The following day my chest continued to be sore from the inside out, but it was bearable. The lymph node in my left armpit swelled up and became painful. The chest pain and soreness has ceased as of the morning on 10/4, but the lymph node is still swollen and painful.
Patient is fully vaccinated.  COVID + on 12/6202179-year-old female presents the ED after a fall. Patient reportedly dizzy when moving from chair to bed. Patient landing onto her right side and hitting her face. Patient is not on a blood thinner and did not lose consciousness. Patient denies any chest pain, shortness of breath. Reports pain with palpation over right-sided chest. and presented to ED. Patient's daughter called and said she recently tested positive for COVID 19. Daughter lives with patient. BP 180/79  | Pulse 68  | Temp 98 °F (36.7 °C) (Oral)  | Resp 18  | Ht 160 cm (5' 3")  | Wt 76.7 kg (169 lb)  | LMP  (LMP Unknown)  | SpO2 97%  | BMI 29.94 kg/m² Patient ordered a pulse oximeter with discharge. Patient's information sent to monoclonal antibiody clinic for possible outpatient treatment.Patient in stable condition with stable vitals for discharge and outpatient follow up.
24 yo F present to observation area with her service dog. Patient notified staff member that she was feeling a little dizziness and needed to lie down. Patient was lowered to the floor by her boyfriend. EMS was notified .  Patient was evaluated by on-site EMS and NP.  It was found via PT's boyfriend that she suffers from a condition called POTS.  Patient has a medical Hx of Syncope and anemia. , Allergies to PCN.   Patient was moved to triage area and reevaluated by NP. After receiving oxygen patient stated she was feeling better. EKG and Glucose test was perform by EMS, all within normal limits. Patient was released via wheelchair accompanied by staff.
8/29/18 AM - R upper arm became red, swollen, warm to touch and painful. Mother applied ice and gave TYLENOL. 8/30/18 PM - mother brought child to office to be seen. Child examined right upper arm with mild redness, moderate edema and warmth mid-way (R) upper arm to elbow. BENADRYL ordered - elevate, ice, TYLENOL or NSAIDs.
states had 2nd vax 7MAY96 & looked in mirror & noticed was blue all around lips, & was nauseated-has been nauseated, tired & sleepy since;still has few blue spots
insidious onset of asymmetric sensory polyneuropathy (axonal not demyelinating) sx began in mid JAN93 w/marked exacerbation; numbness, viral illness, upper resp tract infect;
Hep B, first shot, no prior Hep B vaccination;  Hives on face, hands, abdomen; minor case so treated with only Benadryl; resolved at 72-96h.
This is a spontaneous report from a contactable consumer (patient) and physician. A 50-year-old female patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Apr 24, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration on Apr 3, 2021, single dose, for COVID-19 immunization. On an unspecified date in 2021, patient experienced chills, fever and headache. Verbatim event description: Patient received both the 1st and 2nd dose of the Pfizer COVID-19 vaccines on Apr 3, 2021 and Apr 24, 2021, respectively. Patient called to report adverse events (such as chills, fever and headache) after taking the 2nd dose. The patient wanted to know if it is okay to take OTC pain relievers. The outcome of all the events: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
12/27 I had a very bad sore throat. By 12/30 I had chills and a slight fever (99). Went to urgent care where I tested positive on a PCR COVID-19 test. The 7 consecutive, prior days, I was negative on an at home COVID-19 test. Symptoms felt very cold like. Doctor determined there was an infection using a blood test. Prescribed azithromycin, and a mouthwash consisting of a mix of lidocaine, MAALOX, and BENADRYL. I was able to get a prescription as well for PAXLOVID that evening when the PCR results came in. Jan 5 I felt like improving. Symptoms tapered off after that with a cough that lingers to time of reporting.
Joint pains.  1) Left should pain with shooting pain down the arm to the wrist. Occurs infrequently 2) Wrist pain will occur when using the joint.  3) Knee joint pain in both knee - stiffness after sitting or from waking up with difficulty standing 4) Lumbar back pain - have had issues with this area prior
Stuffy nose; kind of cold; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported for herself that a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated, "Yes, so my question was I early receive my first dose of the vaccine and I am scared to receive the second dose on Friday and I am just making sure is it safe to receive my second dose, if I have like a stuffy nose kind of cold (Apr2021) you know is there will be any problem." Further probing could not be done as consumer don't want to share further information. Hence, limited information available over the call. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Seven days  after second shot develope without prior history Bell's Palsy,, Facial droop,, patient was rush to ER on 5/26/21 at 6:09pm  issue/diagnosis is ongoing was prescribed Prednisone 20mg three tabs onces a day. and Valacyclovir 1 mg tab three times a day as of date patients condition has not improved
1525 received 2nd dose Covid Moderna 130 30 c/o dizziness flush, reported similar hot flash with first dose Moderna, as this time with also dizziness, lasting approx 1 minute 1532 164/95 96 VS monitored 1551 nausea, dizziness 182/101 96 1556 172/101 Dr. updated, famotidine 20mg taken VS monitored 1618 168/96 92 hot, room temp turned down,  ice pack provided, famotidine taken 20mg   1629 170/106 89 VS monitored 1637 166/96 89 nausea famotitide 20mg taken 1640 "kind of a wave" VS monitored 1652 reported "wave of coldness, fingers left and tingling" 1658 167/100 94 sitting, warm 1702 187/119 94 standing "Wabbily feeling in legs" 1725 199/99 8 1731  metoprolol 25mg once 1734 168/94 94 taken metoprolol 25mg 1732 145/80 90 1813 "feeling good" 150/88 84 sitting 1814 148/91 94 standing "feel good, a little headache" released from observation VS/observations assist by RN/CNO/NM/DOP. 1900 left for home, reports able to drive.
After giving me the flu vacine, the nurse took her fingers and massaged the area really hard.  She was massaging it so hard, it was painful.  Since that time, I have had severe muscle pain in my arm at the site of the injection.  The pain so severe, I have a hard time using my arm.
Patient reports that her eyes became red and swollen about 12 hours after receiving Novel H1N1 injectable vaccine (Novartis). Patient states that her eyes remained red and swollen for 24 hours.
pt recv vax 4NOV95 & 2JUN97 pt devel about 50-75 vesicles which were gen pruritic;pt seen by MD dx w/chickenpox;
Extreme abdominal  pain. The pain is sharp, stabbing, severe and short repeated  pain. Comes in waves. Reminds me of menstrual cramps. Nothing helps the pain. The is unusual for me at age 68.
TENDERNESS AND SWELLING AT INJECTION SITE, SOB Narrative: EXACERBATED ASTHMA AND CAUSED INFECTION TO THE INJECTION SITE DECADRON, TORADOL, CEFIN PO, PREDINSONE PO X 5 DAYS, ALBUTEROL
Started mild vertigo that steadily increased during the week where lying down was very sickening. Vertigo lasted four days. Sense of balance was lost for one and a half weeks. MRI was done for possible tumor of 8th nerve but it was negative. No tx was done. Left ear is now profoundly deaf and sense of balance is slowly returning after 3 weeks and had to take time off work with no pay.