chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot Number: Unknown), via an unspecified route of administration, on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had side effects on an unspecified date. The patient has not had the second shot. Patient was asking "if you have an allergic reaction, does Pfizer advice you to get second shot or should not take the second shot" (further clarification unknown if consumer had an allergic reaction). Outcome of event was unknown.  Information about lot/ batch number has been requested.
pt recv vax 20OCT98 & the next day pt devel facial edema, tightness in the jaw & nausea;pt self treated w/DPH & recovered;
?Covid rash? Rash on injected arm, currently 4 inches high and 3 inches wide. (I had the same thing with my 2nd dose, lasted 7-8 days post injection.) Itchy, red, warm to the touch, and tender.
Pain at injection site for a few days with redness and swelling. I started to become very ill 4 days after receiving the vaccination.  I was tested on 01/02/2021 for Covid and tested positive for Covid. I was off work from 01/02 - 01/24 due to lasting symptoms.
running fever/Temperature is 100.8; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 01Jun2021 09:30 as, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on an unspecified date (about four weeks ago as reported), as single dose for COVID-19 immunisation. Patient had the reactions. The patient had the Pfizer Shot on 01Jun2021 (yesterday) about 9:30 in the morning then she started running fever last night about 7 o'clock (01Jun2021). This morning (on 02Jun2021) her temperature was 100.8. This was the second time she has a reaction to this shot and last time was about four weeks ago, when she got her 1st shot. The outcome of event was unknown.   Information about lot/batch number has been requested.
Patient developed a slight non itchy red rash on face. I immediately advised her dr who advised just BENADRYL. She spoke with dr who said she's fine. I spoke with her 5/21 4 pm still fine with last dose BENADRYL 5/20.
AT around 1;30 am after i received the injection i become very chilled with a fever of 102 , and my whole body was feeling very sore  to touch and very weak. I am still  running a fever off and on and its been 28 hrs since the injection. the body is not as sore as previously reporting. it seems to be getting better. To control the fever i took aspirins .
Date of Admission: 7/31/2023   Medical Diagnosis: Covid-19 infection, DM1 hypoglycemia   Date of Surgery/Procedure: not applicable    Precautions: Enhanced Respiratory Precautions (Droplet + Contact + Eye protection)   PPE Worn:  Provider: Gown and PAPR Patient masked? Yes   Covid-19 Testing:  Lab Results Component Value Date/Time   CORONAVIRUS COVID DETECTED (A) 07/31/2023 02:14 AM
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 02-SEP-2014 the patient was vaccinated with PNEUMOVAX23 (lot# J007060; expiration: 28-AUG-2014), dose: 0.5 ml, intramuscular. No concomitant medications were reported. On 02-SEP-2014, PNEUMOVAX23 was administered to the patient that had expired. No adverse effect reported. The outcome of PNEUMOVAX was administered that had expired and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Sep-2021 at 12:29 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Red, itchy rash appeared at site of injection on 8th day after vaccine. Matches description of "COVID arm".
systemic urticaria found-toe for 48-72hr noted 24hr p/vax on 2 separate occasions 22MAR96 & 7MAY96;no resp sx;
swelling of lymph node; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling of lymph node) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LYMPHADENOPATHY (swelling of lymph node). At the time of the report, LYMPHADENOPATHY (swelling of lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.Concomitant medications was not provided by the reporter.  The patient received developed lymphadenopathy under his right arm. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Consumer gave consent for follow up
Patient stated had redness and swelling at site of the injection after the immunization. She said it has disapated but is still some soreness. She stated she had no other signs of allergic reaction.
She had red blotches all over her skin, She was running 102 temp for a short term, The doctor put her on Zyrtec for a 10 day treatment.
Neck was swollen; Neck was knotted; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Neck was swollen) and NECK MASS (Neck was knotted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Neck was swollen) and NECK MASS (Neck was knotted). At the time of the report, SWELLING (Neck was swollen) and NECK MASS (Neck was knotted) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was not provided.
CHESTPAIN; poor digestion; Light Headed; profusely sweating; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (CHESTPAIN), DYSPEPSIA (poor digestion), DIZZINESS (Light Headed) and HYPERHIDROSIS (profusely sweating) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced CHEST PAIN (CHESTPAIN), DYSPEPSIA (poor digestion), DIZZINESS (Light Headed) and HYPERHIDROSIS (profusely sweating). At the time of the report, CHEST PAIN (CHESTPAIN), DYSPEPSIA (poor digestion), DIZZINESS (Light Headed) and HYPERHIDROSIS (profusely sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-261753 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: No new significant information for dose 1
My COVID-19 symptoms started on 12/16/2022. I have fever, congestions, fatigue, runny nose, cough, labored breathing, and headache. I went to my doctor's office on 12/22/2022. They did COVID-19 test which was positive. I told my doctor about the symptoms I had but since it was more than 5 days of the time frame she didn't prescribe me any medication. I used my inhaler for labored breathing I experienced. I tested negative a week after testing positive with a home COVID-19 test. I had mild COVID-19 symptoms.
Patient received Moderna COVID vaccine on 4/7/21 (lot # 032B21A), 5/3/21 (lot # 004C21A), and 11/7/21 (lot # 012F21A).  On 1/17/22, patient tested positive for COVID. On 1/18/22, patient admitted to our med/surg unit for a G-tube placement 2/2 inability to tolerate PO with mouth pain/thrush secondary to radiation treatment. On 1/18/22, during attempted IR placement of PEG tube under moderate sedation, patient had two episodes of emesis and the procedure was aborted. On 1/19/22, patient underwent PEG tube placement  under general anesthesia without complication. Patient is planning to be discharged home later today (1/21/22). During admission, patient was asymptomatic even though she was COVID positive.
2 days p/vax fever to 104, severe all over rash, nausea, fatigue, auditory changes, photophobia, aching, lasting 4 days; given APAP, rest; missed work 2 ER visits; pt known by titer to be immune to mumps & rubella;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-JUL-2017, the patient was vaccinated with 1 dose of improperly stored PROQUAD (route was not reported) (lot # M043306, expiration date 24-APR-2018) which was reconstituted with sterile diluent (manufacturer unknown) (lot# reported as M034582, expiration date: 27-APR-2019) (dose, units, frequency, route and indication were not reported) that was properly stored.  The administered dose of PROQUAD experienced a temperature excursion of -12 degree Celsius for 1 hour and 13 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported.
pt recv vax 19MAY97 & 37hr later pt reportedly exp anaphylactic rxn;24hr post anaphylactic rxn the reporting MD feels that the pt has devel hepatitis because of LFT results;
At injection site, patient developed an approx. 4 inch red rash on the left arm.
2nd dose appointment for 21Mar2021 but could not attend; Fractured his femur; Fell down; This spontaneous case was reported by a consumer and describes the occurrence of FEMUR FRACTURE (Fractured his femur) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced FEMUR FRACTURE (Fractured his femur) (seriousness criterion medically significant) and FALL (Fell down). On 21-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose appointment for 21Mar2021 but could not attend). At the time of the report, FEMUR FRACTURE (Fractured his femur), FALL (Fell down) and PRODUCT DOSE OMISSION ISSUE (2nd dose appointment for 21Mar2021 but could not attend) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking an unspecified blood pressure medication concomitantly.   Patient needed surgery for the fracture. No other treatment information was provided.  Company Comment - This report refers to a case of Product dose omission issue for mRNA-1273, lot #unknown with no associated AEs.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot #unknown with no associated AEs.
Patient was given the vaccine and within 5 minutes she showed me a rash on her arm with a welt at site given. She was given a dose of Benadryl and watched for 15 minutes.
Pt recv vax on 2/9/99; on 2/11/99 pt exp red & swollen LA area (cellulitis) w/ rash, itching, discomfort; on 2/12/99 area became round & warm
Patient received mixed vaccine types (1st dose Pfizer, 2nd dose Moderna), no treatment was given.
Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021; vaccine administered past its 30-days expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 10:58 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 10:58 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Vaccine administration time 10:58:21. The patient was administered booster dose that went into 2-8c thaw state on or above 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. It was unknown if the patient had acute illness at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long lasting health conditions. No treatment medications were reported.
Extreme fatigue, body aches, headache, fever, shooting nerve pains, SOB, dizziness
03/07/2021  16:20 pm patient complained of feeling faint and light headed after 10 minutes in the observation. Observed sweating on the patient sit additional 15 minutes fer close observations. Gave water and had lay down fer 5 minutes and sit up with legs crossed 5 minutes. 16:30 pm V/S. BP 115/75. HR 60. At 16:41 pm patient said he felt good to leave.
Tuesday (2/26) vaccine - Wednesday prickly feeling - Wednesday morning rash involving forehead/eyelid on right side - rash started to crust over on Saturday (3/11), headache the whole time, but patient has h/o cluster headaches.
BONE PAIN; HEADACHE; This spontaneous report received from a consumer concerned a 39 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bone pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bone pain and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210459724 and 20210459703.
Patient received a COVID-19 vaccine on 07MAR21 @ 1900.  At 2111, he complained of a scratchy throat and shortness of breath.  He has a history of asthma and uses Prednisone and nebulizers at home.  He was given Benadryl 25 mg po at 2111 by our onsite nurse and was monitored an additional 30 minutes.
12 hours after having the shot, I had flu-like symptoms.  I took ibuprofen and they went away.  See more details in an earlier field of this application.
Some background info: I had shingles the month of April. Went on Famciclovir anti-viral medicine immediately and had to reschedule my COVID-19 vaccine. It was originally schedule for April 1st. Did not wait 90 days, only about 2 weeks before getting the Moderna shot on April 15th 10:30. The nurse practitioner said it should be fine to get the shot then. 2nd shot was May 13th. 1:00. First shot COVID-19 reaction was delayed, was a large red (about 2.5?), inflamed and sore area at the shot site. Lasted about 4-5 days. The second shot reaction occurred about 12 hours after the shot and was intense. The worst was uncontrollable shaking with my heart feeling like it was bursting out of my chest with irregular, fast pounding palpitations and intense shingles like pain everywhere. Especially in my lymph nodes and chest. My hands were so stiff and swollen I couldn't move them! Bones were grinding with shooting pain everytime I tried to reposition to try and get in a position that didn't hurt. Impossible...I thought I might be having a heart attack it woke me from a sound sleep at 1:30 in the morning. When the shakes subsided in about an hour, I decided not to call 911, figured I was going to live! It was really scary. Worst pain I've ever been in, would rather wear a mask all the rest of my days then get another moderna shot! Now I am having lots of arthritis like pain in my hands, neck and shoulders, even my toes. I?m having trigger finger  everyday in one or the other of my hands and had a one time strange cramping and paralysis in both my hands at the same time that started at the base of my thumb and flowed up my index finger making my hands look deformed. It lasted a few minutes then subsided. Also headaches are constant and more painful than before shot. I am still having some random heart palpitations and tightness, and pain in my chest. I tire more easily, especially after lifting and exercise. Waking up at night more between 1-3 am. Much more body aches and pains in general, but especially in my hands, head, chest, neck, shoulders and lymph nodes.
This spontaneous case was initially received on 22-Sep-2015. The case report was received from a Health Professional and concerns a 4 years 5 months old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 22-Sep-2015 - 22-Sep-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml, in the right deltoid. The AFLURIA was inadvertently administered to a patient who was 4.5 years old. No additional drugs suspected. On Sep-2015, after treatment with AFLURIA the patient experienced crying from pain from the injection. The patient appeared to be fine - no flushing or anaphylaxis. Action taken: not provided. Event treatment: not provided. For relevant test results see appropriate report section. Reporter's assessment: The reporter reported the term 'off-label use' and assessed the events as non-serious.
massive nausea; headache; vomiting; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Oct2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; WELLBUTRIN. Past drug history included: Known allergies: reglan, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 18Jan2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "Massive nausea", "Headache", "Low grade fever"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), for Covid-19 immunization, reaction(s): "Headache", "Massive nausea". The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "massive nausea"; HEADACHE (non-serious), outcome "unknown", described as "headache"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, headache, vomiting, diarrhoea.  Additional Information: Patient occupation other health professional. Lot number was unable to locate or read the details. Facility type vaccine reported as hospital. It was unknown if other vaccine in four weeks. Adverse event reported as first dose, massive nausea and headache, second dose same, with low grade fever, third dose same, with nausea, vomiting and diarrhea. Have had daily headaches since first dose. No if covid prior vaccination. Covid was tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
the injection site started to inch and it got a red blotch about 2 inches in diameter; the injection site started to inch and it got a red blotch about 2 inches in diameter; soreness; This is a spontaneous report from a contactable consumer reported for himself. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. Medical history included idiopathic thrombocytopenic purpura (ITP). Concomitant medications included romiplostim (NPLATE) for ITP. The patient stated he received his first dose of the vaccine on 15Jan2021, some soreness on 15Jan2021 afterwards but nothing that noticeable and about a week later on the 22Jan2021, the injection site started to inch and it got a red blotch about 2 inches in diameter. Just about it started a week after the injection. So, he was wondering if that was to be expected or was it unusual or how he should proceed. The events were reported as non-serious. No treatment received for events. Due date for the next shot was 05Feb2021. The outcome of event the injection site started to inch and it got a red blotch about 2 inches in diameter was not resolved, and of soreness was unknown.
Date and time close to occurrence - Patient lost most words he knew following vaccination and high temperature. Developed stomach pains and was tested for food allergies. 9/18/2015 test showed allergy to soy bean, vanilla, broccoli, Apple, dairy, cinnamon, gluten, lactose, onion.
The day after vaccine administered, patient came to clinic complaining of soreness, redness, warm to touch area around injection site. Patient's temperature was 98.2. Redness started last night.