chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body Aches; Fever; Mild Fatigue; This is a spontaneous report from a contactable nurse.   A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), intramuscular, administered in Right arm on 12Feb2021 11:00 (at the age of 69 year old) as dose 2, single for COVID-19 immunisation.  Medical history included latex allergy.  The patient's concomitant medications were reported as none.  Prior vaccination, the patient did not receive any other vaccines within 4 weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN3248, intramuscular, in right arm, on 15Jan2021 12:00, as single dose for COVID-19 immunization and the patient had mild sore arm; that started hurting a little bit more, and got the flu like body aches, with temperature 100 (low grade fever), and rash on chest that lasted 5 days and had fatigue. On an unspecified date, within 24 hours, the patient experienced slight body aches, mild fatigue for a day, and fever. No treatment was received for the events. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Pneumovax given in Right Deltoid Subcutaneous on 11/1/06.  On 11/2/06 the patient had right arm edema spreading up to right chest/neck and down to wrist.  Patient with no history of receiving med or allergies.  Steroids and antihistamines given Intravenous, ice and elevation utilized as well.
Maternal  exposure during pregnancy; Past the recommended dosing interval of the second dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy) and PRODUCT DOSE OMISSION ISSUE (Past the recommended dosing interval of the second dose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 14-Feb-2021 and the estimated date of delivery was 11-Nov-2021. On 10-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the recommended dosing interval of the second dose). On 23-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 10-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Past the recommended dosing interval of the second dose) had resolved. On 23-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient received the first dose of the Moderna vaccine on 10Mar2021. Patient then saw her primary doctor on 23Mar2021, who confirmed and said it was unplanned pregnancy. Patient was worried about the vaccine because it was an unplanned pregnancy. Doctor then recommended to postpone vaccination until second trimester, due to patient concern for pregnancy complications. Also on 9Apr2021 patient had a confirmed pregnancy at the OBGYN doctor outpatient office.  No treatment information was provided.
Swollen, red, hot to touch, rash that spread.  Diagnosed with Cellulitis, prescribed antibiotics.
Patient has has muscle soreness from the top of her neck down to her knee since the morning after her vaccination. There is erythema distal to the injection site that has warmth to it. She reports no fever, but will continue to monitor.
About 5 minutes after receiving the vaccine, she began to experience a dry cough and tickling in the back of her throat. Also reported some shortness of breath. 25 mg of Benadryl was given IM in the R deltoid. Her symptoms subsided after approximately 15 minutes and she was able to return home.
Vaccinated arm was sore, red and warm. Not really swollen. Unable to move around. Felt weak and nauseated with headache, body aches and pains.
Asthma; I got sick to my stomach and was throwing up; I got sick to my stomach and was throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EL9264), administration date: 01Apr2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "First two shots, I fell and had hard time getting up"; BNT162b2 (DOSE 2, SINGLE; Lot Number: EW0171), administration date: 29Apr2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "First two shots, I fell and had hard time getting up"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: 0308D), administration date: 10Dec2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "asthma", "I got sick to my stomach and was throwing up", "I got sick to my stomach and was throwing up". The following information was reported: ASTHMA (non-serious) with onset 2022, outcome "unknown"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 2022, outcome "unknown" and all described as "I got sick to my stomach and was throwing up". Therapeutic measures were not taken as a result of asthma, nausea, vomiting.  Additional information: The patient was taking blood pressure medication and stopped after the second dose as it may drop the blood pressure. After receiving the vaccinations couple of hours later, the patient got sick to stomach and was throwing up. The patient was not taking any regular medications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201375592 same patient/reporter, different vaccine;
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Patient reported red blotches on face during the mandatory 15 minutes wait time post vaccination. There  were no reports of wheezing, difficulty breathing, dizziness  or any other  adverse reactions.  The administering pharmacist dispensed 2 capsules  of Benadryl 25mg  and requested the patient to wait another 15 minutes.   He reported feeling better before leaving the pharmacy. He was advised to call the pharmacy to report any other effects.
Pain & swelling of joints, especially knees & feet; rash, swollen neck glands, required MD visit given Naprosyn for joint inflamation;
headache X 3 days after 1st and 2nd vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 16:00 (Lot number: EN6205) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Perennial allergies" (unspecified if ongoing), notes: Other medical history: Perennial allergies; "horseradish allergy" (unspecified if ongoing), notes: Known allergies: Seldane, horseradish. Concomitant medication(s) included: CLARITIN; FLONASE; NEXIUM; MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]. Past drug history included: Seldane, reaction(s): "Allergies: Seldane", notes: Known allergies: Seldane, horseradish. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache X 3 days after 1st and 2nd vaccines". The event "headache x 3 days after 1st and 2nd vaccines" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: The patient had headache X 3 days after 1st and 2nd vaccines. No COVID prior vaccination. No other vaccine in four weeks.   No follow-up attempts are possible. No further information is expected.
Thurs, July 31st got 2nd hepatitis B shot.  Mon Aug 4 twisted knee.  Wed Aug 6 diarrhea began.  Thurs Aug 7 missed work & diarrhea.  Flu like symptoms (muscle aches all over, chills, hair on head and legs hurt).  Fri Aug 8 missed work & diarrhea.  Sat Aug 9 diarrhea.  Sun Aug 10 diarrhea.  Mon Aug 11 missed work 2 hours (left early) and diarrhea.  Tues Aug 12 diarrhea and knee pain began.  Wed Aug 13 missed work and diarrhea.  Went to doctor.  He thought the diarrhea might be from food poisoning.  He did blood work.  Prescribed Ciprofloxacin (500 mg), Naproxen (500 mg), Propoxyphen (100-650 mgtev).  He x-rayed the left knee and made an appointment with doctor (?), an orthopedics doctor.  Patient asked doctor if he thought this could be a reaction to the Hep B shot, and doctor said no.  Thur Aug 14 missed work and diarrhea.  Chills.  Fri Aug 15 missed work and diarrhea.  Went to doctor at orthopedic.  Got brace.  Set up appointment for MRI and meeting with surgeon.  Sat Aug 16 diarrhea.  Sun Aug 17 knee pain going away; swelling gone; good BM.  Mon Aug 18 MRI.  Wed Aug 20 doctor's office called; blood work good.  Thur Aug 21 pain began in ankle; pain in wrist.  Missed work 1 hour (left early).  Fri Aug 22 noticed swelling in ankle.  Right index finger painful and swollen.  Went to ortho surgeon.  He recommended physical therapy.  Sun Aug 24 swelling in ankle gone.  Mon Aug 25 diarrhea.  Tues Aug 26 missed work 30 minutes (left early) and diarrhea.  Wed Aug 27 lower back pain began.  Swelling in back.  Missed work 1 hour (left early).  Thur Aug 28 missed work.  Fri Aug 29 missed work 30 minutes (left early).  Back and knee sore.  Entire left arm itched for about 10 minutes.  Sat Aug 30 could hardly get out of bed; stiff all over.  Left leg very sore; could not move it when went to bed at night.  In afternoon, fingers sore and neck sore.  Once again I started wondering if this could be a reaction from the Hep B shot since there seems to be no pattern to what is going on.  Looked up reaction to Hep B shot on the internet.  See info attached.  Sun Aug 31 back and neck still sore, but subsiding.  Pain in shoulder, wrist, fingers, thumbs.  Severe pain in left knee and swollen.
recently got shingles; did not receive the 2nd shingles shot in 2018 &; This case was reported by a consumer via interactive digital media(Chatbot) and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reporetd by patient. The age at vaccination was not reported. In 2018, patient received 1st dose of Shingrix and experienced shingles. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.
Received flu vaccination approx 4:30pm on Sun. 10/1. By Mon. am 10/2 had chills and aching. In afternoon fever to 100 degrees. On Tues. 10/3 at 0400am fever spiked to 101.5. 10/5 Seen in Employee health service. Injection site had slight bruise in appropriate area for injection but upper arm swollen, red and warm to touch. Sent to Urgent Care to be seen. 10/13 reports was given antibiotics and is improving.
Two days post vax pt experienced systemic reactions of headache, general malaise, fever, nausea, vomiting and myalgia. Pt also experienced a low grade fever, stiffness, coughing with mucous, hoarseness and headache.
Pt presented to MD with reddened throat, sore throat, and rash on back, hips and groin.  Pt also experiencing fatigue.  Symptoms have not resolved.  Pt never had a flu shot previously.
Developed rash on both arms extending the entire length of both arms several days to 1 week after administration.  Very itchy.  Pt was given prednisone and referred to dermatologist
Vision was currently blurry in her left eye; ocular pressure is slightly high; Dry eye; Eyeballs got a throbbing pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE PAIN (Eyeballs got a throbbing pain), DRY EYE (Dry eye), VISION BLURRED (Vision was currently blurry in her left eye) and INTRAOCULAR PRESSURE INCREASED (ocular pressure is slightly high) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 03-Jan-2021, the patient experienced EYE PAIN (Eyeballs got a throbbing pain).   On 11-Jan-2021, the patient experienced DRY EYE (Dry eye). On an unknown date, the patient experienced VISION BLURRED (Vision was currently blurry in her left eye) and INTRAOCULAR PRESSURE INCREASED (ocular pressure is slightly high). The patient was treated with DEXTRAN (MOISTURE EYES [DEXTRAN]) at an unspecified dose and frequency.   On 03-Jan-2021, EYE PAIN (Eyeballs got a throbbing pain) had resolved. At the time of the report, DRY EYE (Dry eye), VISION BLURRED (Vision was currently blurry in her left eye) and INTRAOCULAR PRESSURE INCREASED (ocular pressure is slightly high) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is using moisture drops in mostly the left eye.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Dry itching rash on bilateral  entire back of hands, started suddenly within a week or two of 2nd vaccine, lasted for over 5 weeks. Rash did not respond to OTC hydrocortisone cream or lotions, but did mostly clear after I switched to a natural shea butter bar soap (was using Softsoap liquid handsoap for the past year without any skin irritation/rash prior to 2nd Covid vaccine dose). After 1 week of using the shea soap, my hands are visibly healed, but still have mild itching at times, and skin is still thinner. I have never had a rash like this before, but have had a remote history of stress dermatitis (30 years ago) on hands, and herpetiform rash on face, neck and elbows due to gluten intolerance (now cleared after going on gluten free diet 4 years ago).  I am a retired RN.  I came across this "back of hand rash"  yesterday as a Covid vaccine side effect that others were reporting, and did not realize until then that it was related to Pfizer Covid vaccine. I have already fully participated in the CDC VacSafe reporting, and did not report this on the app as I didn't realize it was related to Covid vaccine.
This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A 16-year-old female patient received first dose TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient fainted immediately after receiving meningococcal group b rlp2086 vaccine. Patient recovered quickly and did receive the second dose of meningococcal group b rlp2086 without incident. The outcome of the event was recovered on an unknown date. Information on the batch number has been requested.
11pm arm got really sore. In the morning temp was 100.5. H/A, nausea, body ache.
Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.    This case was linked to MOD-2021-046006 (Patient Link).
No adverse reaction; got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
No additional adverse event reported; RECOMBIVAX HB that underwent a temperature was administered.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-AUG-2021, the patient was vaccinated with improperly stored dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 84.0 degrees Fahrenheit for 2 hours and 45 minutes. There was no previous temperature excursion reported. No additional adverse event was reported.
Awoke day after receiving vaccination feeling lightheaded and nauseous. Felt faint and had to lie down. Began to experience headache and chills as the morning progressed. Could not work or care for grandchild that day. Started to resolve by next morning.
Allergic reaction of swelling and redness to lips, required minimal monitoring and resolved without interventions.
Seventeen year old received  Moderna covid 19 vaccine. No, adverse reactions reported or  witnessed per mother of patient
Patient was administered a full bottle of 6 doses by the immunizing pharmacist on 10/18/21. As of 10/19/21 the patient was contacted and was not reporting any symptoms other than a sore arm at the site of injection.
Patient vomited in car and one ear became red.  He then experinced increased work of breathing and was brought back into the clinic where his room air oxygen satuation was 100%.  He was given Benadryl with improvement of breathing and did become red in color all over and remained playful.
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid infection) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051FZ1A) for COVID-19 vaccination.     Patient had no known allergy.  Concurrent medical conditions included Diabetes mellitus (Diabetic under control). Concomitant products included SIMVASTATIN (ZOCOR) from an unknown date to 10-May-2022 and METFORMIN HYDROCHLORIDE (GLUCOPHAGE) from an unknown date to 10-May-2022 for an unknown indication.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2022, the patient experienced COVID-19 (Covid infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 15-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. On 16-May-2022, COVID-19 (Covid infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 17-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 23-May-2022, SARS-CoV-2 test: positive (Positive) positive: faint line appeared..         On the third day of COVID infection the patient started Paxlovid and became negative on day 9 and day 10. Then on day 16 was tested again positive using Rapid test kit.  Device date : 23-May-2022  Company comment: This spontaneous case concerns a 72-year-old male patient with medical history of diabetes mellitus, who experienced the unexpected non-serious of Covid-19, 6 months after receiving the 3rd dose of mRNA-1273 vaccine. The patient was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. A day after the completion of course the SARS-CoV-2 test was negative. A week later, the patient was tested positive again. The outcome of the event was reported as resolved and recurrent test positive was reported as resolving. Details of previous two doses were not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 72-year-old male patient with medical history of diabetes mellitus, who experienced the unexpected non-serious of Covid-19, 6 months after receiving the 3rd dose of mRNA-1273 vaccine. The patient was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. A day after the completion of course the SARS-CoV-2 test was negative. A week later, the patient was tested positive again. The outcome of the event was reported as resolved and recurrent test positive was reported as resolving. Details of previous two doses were not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Thrombocytopenia, Thrombosis (DVT, PE, Cerebral Vein Thrombosis)
On April 9 in the afternoon, a severe headache began, which I had never experienced. This led me to vomit and even then the pain was unbearable. The pain persisted despite taking an analgesic and the next day still felt throbbing that was reflected in the head in general and in the eye area.
dose 1 as lot J7H40  given 9/24/2020 and dose 2 as lot J7H40 given 11/16/2020  were both given to patient as the 10mcg  dose which we came to discover was too low of a dose for patient age when we went to administer the third dose which we withheld to consult with doctor
Patient called on 9-29-13 and stated her right arm hurts, it's painful and unable to move. I told her to put ice on it and start ibuprofen. I called her back after 3 hrs and she stated she felt better. I called again on 9-30-13 and she stated it's much better.