chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rebound Covid-19; The patient received previously two doses of Pfizer vaccine as primary schedule; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound Covid-19) and INTERCHANGE OF VACCINE PRODUCTS (The patient received previously two doses of Pfizer vaccine as primary schedule) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer/Biontech (1st dose on right arm at 12:00 pm) on 31-Mar-2021 and Pfizer/Biontech (2nd dose on right arm at 12:00 pm) on 14-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer/Biontech and Pfizer/Biontech. Concurrent medical conditions included Rheumatoid arthritis and Drug allergy (unspecified drug).   On 28-Aug-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022 at 7:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Rebound Covid-19) and INTERCHANGE OF VACCINE PRODUCTS (The patient received previously two doses of Pfizer vaccine as primary schedule). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound Covid-19) and INTERCHANGE OF VACCINE PRODUCTS (The patient received previously two doses of Pfizer vaccine as primary schedule) outcome was unknown.            No concomitant medication was reported. On 01-Jun-2022 at 10:00 PM, the patient had rebound covid. On an unknown date, patient was recovering from the event of rebound covid. Device date was reported as 03-Jun-2022. Company comment: This spontaneous case of concerns a 50-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The event was reported with no onset date. As per source document, she received Paxlovid as COVID-19 treatment 3 days after the last dose of mRNA-1273 vaccine. Interchange of vaccine products case, as it is reported that the patient received previously two doses of Pfizer vaccine as primary schedule and two doses of mRNA-1273 vaccine as the third and fourth doses. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case of concerns a 50-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious  of COVID-19. The event was reported with no onset date. As per source document, she received Paxlovid as COVID-19 treatment 3 days after the last dose of mRNA-1273 vaccine. Interchange of vaccine products case, as it is reported that the patient received previously two doses of Pfizer vaccine as primary schedule and two doses of mRNA-1273 vaccine as the third and fourth doses. The benefit-risk relationship of mRNA-1273 is not affected by this report.
like she had something poured on her tongue as she was injected, patient stated that it was the weirdest thing and it was the nastiest tasting stuff; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN9581, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in right arm on 05Feb2021 at 16:15 hours as dose 1, single (at the age of 68-years-old) for Covid-19 immunisation. Medical history included obese and flu (maybe 5 years ago from being in an elevator with little kids on vacation, she knows exactly where she got it and within no time, she had a fever and was sick) (all from an unknown date and unknown if ongoing). Patient had no relevant family medical history. Patient had no prior vaccinations (within 4 weeks). Concomitant medication(s) included rivaroxaban (Xarelto) taken as blood thinner (at this point, she had been on it maybe 2 years) from an unspecified start date and ongoing. Historical vaccine included patient received Polio vaccine (Batch/Lot number and Expiration date was not reported) via unspecified route of administration on an unspecified date for immunisation and patient stated that she does not remember when but, when they applied the Polio vaccine, they prick the skin and had no reaction. That was the way it was administered. She had no issues. Patient stated that she does not take vaccines and does not take the flu vaccine. Patient stated that she does not take them, she never had any of that stuff other than the Polio vaccine (when she was 6). On 05Feb2021 at 16:15 hours, when patient took the first dose, when they administered it, she could taste the vaccine immediately when it was injected in her right arm. She could taste the vaccine, like she had something poured on her tongue as she was injected, patient stated that it was the weirdest thing, and it was the nastiest tasting stuff. It lingered on her tongue and lasted for a good portion of that afternoon. It was the remainder of that first day. Patient stated that it did not happen the second time. No relevant tests were performed. The outcome of the event was recovered on 05Feb2021.
Itchy Rash on both feet the night of being vaccinated; a single painful welt on right arm crevice next day.  That is so far (24 hours since being vaccinated).
Flu-like symptoms (fever, headache, body aches, weak, knee joint-hot). had to stay home from work the next day.
Muscle aches; Back/flank pain; Back/flank pain; Headache; Low grade fever; Joint pain; Chills; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular on the left arm, on 20Jan2021 10:45 at single dose for covid-19 immunisation.  The first dose was received on 01Jan2021 09:00, intramuscular on the left arm . Medical history included asthma, depression, and in the midst of getting diagnosed with Sjogerns.  Patient was not pregnant at the time of vaccination. Concomitant medication included spironolactone, bupropion, fexofenadine hydrochloride (ALLERFEX) and hair vitamins. The patient experienced muscle aches, back/flank pain, headache, low grade fever, joint pain, and chills on 20Jan2020 17:30. No treatment was received and patient was recovering from the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The events were considered non-serious.  No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information is expected.
patient came in for a Janssen COVID vaccine. After about 5-10 minutes getting the vaccine, the patient started sweating a lot and felt very warm. I put an ice pack on his back and was given some water. He then was nauseous and said he felt like he was going to black out. The emergency response was called and the patient was moved to a provider's room where he was taken care of by the response team. After receiving apple juice, crackers the patient felt better and no longer was sweating and was no longer nauseous.
13-14 days after MMR, DTaP, IPV developed signs consistent with left parotitis/low grade temp at home resolved in 48 hours. (Rx: Augmentin 2 days only).
roughly 10d after receiving 2nd dose of Pfizer had re-activation of Varicella, chickenpox with whole body rash evaluated in ED and had a skin exam consistent with varicella
BLURRED VISION TO RIGHT EYE; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included patient had no known drug allergies and patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced blurred vision to right eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blurred vision to right eye. This report was non-serious.
light headed; tingling and slight numbness (like coming out of Novocain) in left side of face predominantly in the mouth area.; tingling and slight numbness (like coming out of Novocain) in left side of face predominantly in the mouth area; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1283), via an unspecified route of administration at Left arm on 15Jan2021 08:15 at SINGLE DOSE for COVID-19 vaccination. Medical history included osteoporosis and gastroesophageal reflux disease (GERD). The patient was not pregnant. The patient was allergic to Codeine and derivatives. Concomitant medication in two weeks included denosumab (PROLIA), piroxicam (PAXIL), omeprazole, clarithromycin (CLARITIN).  The patient previously took codeine and experienced drug hypersensitivity. On 15Jan2021 08:30, within 15 min after vaccination the patient became light headed, then tingling and slight numbness (like coming out of Novocain) in left side of face predominantly in the mouth area. Light headed went away within another 15 min and numbness within another 45, but the latter came back in the left cheek and forehead in approximately four hours. No treatment received for the events. No Covid prior vaccination, no Covid tested post vaccination. The outcome of the event light headed was recovered on 15Jan2021, of other events was not recovered.
This spontaneous case reported by a nurse, describes the occurrence of mouth ulcers, face swelling (swollen, puffy face), dizziness, pyrexia (intermittent fevers) and chills in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Apr 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 9, 2021, patient experienced dizziness, pyrexia (intermittent fevers), chills, nausea and fatigue. On Apr 14, 2021, patient experienced face swelling (swollen, puffy face) and lymphadenopathy (swollen lymph nodes). On Apr 18, 2021, patient had a generalized rash. On Apr 21, 2021, patient experienced mouth ulcers. On Apr 22, 2021, patient experienced vomiting. At the time of the report, mouth ulcers, face swelling (swollen, puffy face), dizziness, pyrexia (intermittent fevers), chills, nausea, fatigue, lymphadenopathy (swollen lymph nodes), generalized rash and vomiting outcome: unknown. The reporter did not provide any causality assessments.
dizzy; wobbly; can't walk across her floor without gasping for air; can't walk across her floor without gasping for air; Has chest pain upon exertion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 16Oct2021 (Batch/Lot number: unknown) 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: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; BALANCE DISORDER (non-serious), outcome "unknown", described as "wobbly"; GAIT DISTURBANCE (non-serious), DYSPNOEA (non-serious), outcome "unknown" and all described as "can't walk across her floor without gasping for air"; CHEST PAIN (non-serious), outcome "unknown", described as "Has chest pain upon exertion". Relevant laboratory tests and procedures included EKG normal, WBC,X-ray cleared.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (03Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
About 5 mins after vaccine administration, patient complained of a tingling sensation in her face, hands and fingers and mild throat tightening.  No breathing issues identified. She remains alert and oriented to name, place and time; communicated coherently verbally.   Pt continue to lie on the cot during assessment.  A few minutes later,  she started to show some symptoms of sweatiness, agitated, crying and trembling.  After another 15 mins, the client started to feel muscle tightening in her LE and UE; continues to cry, tremble. Body feels cool to touch.  BP: 120/60, HR 30-40s; comfort measures provided; encouraged relaxation breathing, Pulse Ox- range 95-99%. Continued  assessment done; 911 called. Arrived at 2:45 pm and client d'cd to ER via stretcher and remains alert and oriented. HR increased 130 and BP remains stable.
This spontaneous report as received from a nurse refers to a 5 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
chills; fever; nausea; lot of dizziness; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lot of dizziness), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), LANSOPRAZOLE (PREVACID), ATORVASTATIN, LISINOPRIL, PRAMIPEXOLE DIHYDROCHLORIDE (MIRAPEX), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ASCORBIC ACID (C VITAMIN), MAGNESIUM, ZINC, FISH OIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigue). On 08-Apr-2021, the patient experienced HEADACHE (headache). On 12-Apr-2021, the patient experienced DIZZINESS (lot of dizziness). On 13-Apr-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea). On 08-Apr-2021, FATIGUE (fatigue) and HEADACHE (headache) had resolved. At the time of the report, DIZZINESS (lot of dizziness), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.
A couple of hours after receiving the vaccine, I've been suffering an eczema-like rash. It won't go away; it's very itchy and painful. It's located right on my collarbone on both sides. I went to urgent care where I was given a shot of hydrocortisone. I wasn't really interested in receiving any other injection since this was my first bad reaction to a vaccine. No eczema creams or anything I could find including Neosporin was aiding the itch to comfort. As of today, the rash is still present and itching.
Swollen and irritated eyelids. It has been over a week and the swelling has not dissipated and erythema has not got down.
Within 5 minutes after the injection I became extremely  hot, my face turned very red and began experiencing intense lower back pain. The intense lower back pain lasted about 15 minutes. Later in the day and the following day I had chills, headaches and was shaky.
Immediately post vax, the pt developed extreme irritability which persisted for one week by the time the physician saw her. Increasing cough, dx with bronchitis.
Pt recvd Hep B vax on 5MAR92 & w/in 24 to 48 hrs of vax pt devel a fever, generalized erythema, & a h/a; pt seen in ER;
One hour, post vax, pt developed hives and was given epi, Benadryl at the ER
Vaccinated on 4-1-13, pain in Rt arm next day. On 4-3-13 noted marked erythema over injection site, some pain and itching. Today 4/4/13 noted 7 1/2 x 8 1/2 cm induration with overlying erythema on Rt arm injection site. No adenopathy.
soreness in arm, not just to the touch, but hard to lift arm the next day.  Better after day 2.
bronchitis; can't smell good; can't taste anything; more than 35 days passed for second dose; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS (bronchitis), ANOSMIA (can't smell good), AGEUSIA (can't taste anything) and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed for second dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (bronchitis), ANOSMIA (can't smell good), AGEUSIA (can't taste anything) and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed for second dose). At the time of the report, BRONCHITIS (bronchitis), ANOSMIA (can't smell good), AGEUSIA (can't taste anything) and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed for second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided.   Reporter did not allow further contact
I felt like I had the Flu. I was sore and my body ached. I took Tylenol and Advil for the pain but I couldn't get my fever down which was a 103. So I called my doctor and she told my husband to keep a eye on me and the place eye packs under my neck and armpits and the next morning I was fine. The symptoms subsided.
(R) leg with hematoma - large noted. US done. No further treatment other than heat applied.
He says he woke up and couldn?t smell anything or feel textured with his fingers. He then threw up and got a headache and has a fever of 103.2.
Neck and back aches, stomach cramps, joint pain, injection site soreness, severe headache, diarrhea.
I had daily headaches for about 3 months.  They were bad enough to impair my daily routine.  My arms and hands would go numb daily.  I'm an IT person so typing was almost impossible.  My legs would  go numb as well but not as bad as my arms.  I could still walk but with trouble.  This happened after both shots.
Soreness at injection site, asthma began to flare, nausea, light headed, feeling of being in slow motion, shivers, headache, congested nasal and chest, bronchial cough, lips began to swell, diarreah, laryngitis, shortness of breath, elevated heart rate, extreme fatigue. On the 9th day arm began to swell with blistering, took Benadryl.
Pt had extreme redness, swelling, and pain at injection site that was progressively getting worse.  She sought medical treatment on 10/22/13 and was diagnosed with cellulitis.
swollen gland under jaw on same side as shot; extremely tired/Less tired; dull headache; lymph nodes in armpit swollen on same side as shot; This is a spontaneous report from a contactable patient (reported herself).  A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: En6201), via unspecified route of administration, in left arm on 13Feb2021 08:45 AM (at the age of 44-year-old) as a dose 1, single for COVID-19 immunization. The patient had a medical history of treatment with high blood pressure and allergy to penicillin. The concomitant medication of the patient in two weeks included atenolol (ATENOLOL), hctz (HCTZ), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and birth control pills. Patient does not receive any other vaccines within 4 weeks, and it was unknown if patient had COVID prior to vaccination. The patient was not tested post COVID vaccination. On 13Feb2021 10:00 AM patient experienced day one and two extremely tired and day 3 less tired and on day one and two dull headache, on day two patient experienced swollen gland under jaw on same side as shot and on day 4 lymph nodes in armpit swollen on same side as shot. The patient does not receive any treatment for the reported events. Outcome for all the events were not recovered. Follow-up attempts completed. No further information expected.
Vomiting; Body aches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 55-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 right arm on 23Apr2021 at 08:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. The patient previously took bupropion hydrochloride (WELLBUTRIN) and experienced drug allergy. 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 did not receive any concomitant medication within two weeks of 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 unknown date at 08:30 as a single dose for COVID-19 immunisation. On 24Apr2021 at 02:00, the patient experienced vomiting, body aches and chills. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events vomiting, body aches and chills was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
SWOLLEN, RED ARM THAT GOES FROM INJECTION SITE DOWN TO ELBOW. ARM IS HARD AND WARM TO THE TOUCH. PATIENT STATES THAT THE LYMPH NODES IN HER ARMPIT REGION ARE ALSO SWOLLEN.