chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had non related COVID19 health conditions; not receiving 2nd dose/patient couldn't receive the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Patient had non related COVID19 health conditions) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose/patient couldn't receive the 2nd dose) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (Patient had non related COVID19 health conditions) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose/patient couldn't receive the 2nd dose). At the time of the report, UNEVALUABLE EVENT (Patient had non related COVID19 health conditions) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose/patient couldn't receive the 2nd dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Within 24 hr of vax pt devel swelling of right thigh from the hip to the knee. Md tx w/Atarax & Motrin
Swelling of the lymph nodes in the left armpit. The lymph nodes are still swollen about 6 weeks later
About 12 hours after the vaccine I started having some mid back pain. The pain felt deep, at first it just felt like pins and needles and it progressively got worse. Laying down in fetal position and massaging the area helped my back feel a bit better but it didn?t go away. My kidneys felt like they were swollen, and the only thing that relieved the pain was 1000 mg of Tylenol.  I almost went to get checked at an urgent care but it was very late at night and hoped Tylenol would help. I avoided Advil since it?s processed in the kidneys and didn?t want to make them work more. The very next day, but my kidneys felt very sore (the same way they felt when I had a reaction to a medication).  Over the next few days, this soreness feeling eventually went away. It took maybe 3-4 days for it to fully go away.   I also felt a weird sensation in my heart for a few days (maybe about a week) but has disappeared since then (my brother has the same vaccine lot, and had to go get checked and was diagnosed with intermittent myocarditis due to the vaccine)
Ocular migraine.  I occasionally have them, but had not had a migraine in 2 months prior.
polyarthralgias & myalgias starting 3 wks p/2nd MMR vax; sx were significant for the 1st 4 wks & has had near resolution @ 6 wks;
My daughter came home from school complaining of aches, cough, sore throat, sweats by next morn at 5AM had fever of 101.5 all other symptoms worsened.
About a 2-3 inch in diameter rash with heat emitting from surface. It has been 60 hours, and patient is taking ibuprofen with antihistamine.
RED, ITCHY, ROUND, 4 INCH DIAMETER RAISED, WARM RASH
I started to get mild, dizzy spells about 2 weeks after the first dose. They only lasted a moment, and it only happened a few times a day.
Patient received Comirnaty for 12 and older instead of pediatric COVID 19 vaccine
Patient states he has soreness in his arm from the date he received vaccine up until at least October 1 (prolonged soreness at injection site).
Syncopal episode immediately after standing up from vaccination. Likely vasovagal type reaction. Hit head on wall on the way down. Was cared for immediately by onsite paramedics who witnessed. He was transported by ambulance for evaluation both due to reaction and assess for head injury. Did well, was released from Emergency Department about 2 hours later.
sicker; Initial information was received on 16-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer or Non-health care professional.  This case involves a patient (unknown age and unknown gender) who experienced sickness (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event sickness (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  The patient reported that got one once and was sicker that year than he/she ever was with the flu, haven't been sick with the flu since he/she stopped drinking almost 4 years ago. It is unknown if the patient physician provided consent to be contacted. It is unknown if the patient experienced any additional symptoms/events.   At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Arm swollen and sore around the injection site for about 5 days. No treatment.  Rash broke out around the injection site on 2/28/21. Applied hydrocortisone to site.
4 year - Post Menopause cramping, bloating, and spotting.  Have not had a period since 5/2017. 'Spotting' 4/29-5/1.  Minor cramping off and on 4/29-present.   Bloating 4/29 (possibly prior) - present
1st Rotavirus given after 12 wks of age. No adverse reaction from vaccine.
5 DAYS AFTER RECEIVING VACCINE PATIENT COMPLAINING OF MUSCLE PAIN IN BOTH THIGHS, ONGOING FOR 1 MONTH NOW.
This spontaneous report was received from a health professional (medical assistant) and refers to an unspecified number of patients of unknown age and sex. No pertinent medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL. No adverse effects reported. The outcome of incorrect product storage was unknown. Additional information has been requested.
Patient had a sore arm a day after the vaccine was given. No other event, patient felt fine 2 days after.
The pt. received ZOSTAVAX injection 6-16-11. The following afternoon, her arm began to hurt and kept her up all night. She was also vomiting. She came into the Rx on Sat 6-18-11. Her arm had a well-defined red spot approximately 1" in diameter and was surrounded by a lighter shade of red approximately 5" in diameter, extending down to her elbow. I sent her to Urgent Care where she had a mild fever. They started her on IV antibiotics & gave her a KEFLEX Rx. She returned the following day, Sun. 6-19-11 to the clinic per their recommendation. Pt was afebrile, but the reaction was worse. They IV antibiotics, give CLEOCIN Rx. Pt will return 6/20/11 to clinic (tomorrow) for F/U.
Vaccine administered 12/30/2020, no complaints of side effects until 1/8/2021. Injection site became red, not itchy with lump. Redness worsens with exercise or after shower. No improvement as of 1/12/2021 (today).
threw up 10 times within a 12 hour period; motion sickness has gotten worse post the vaccine; motion sickness has gotten worse post the vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the parent.  A 6 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2022 (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: VOMITING (non-serious), outcome "recovered", described as "threw up 10 times within a 12 hour period"; MOTION SICKNESS (non-serious), outcome "recovered", CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "motion sickness has gotten worse post the vaccine". Therapeutic measures were taken as a result of vomiting, motion sickness, condition aggravated.  Additional information: My 6-year-old was vaccinated with Pfizer Covid19 vaccine in Jan2022. She had an adverse reaction to the vaccine (threw up 10 times within a 12-hour period). We sought medical advice from her pediatrician who prescribed zofran and my daughter was fine after the first dose. I would like to know if there was a follow up study she can be enrolled in to gauge the side effects for younger children post vaccination. I have noticed her motion sickness has gotten worse post the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
severe chills, almost passed out, anxiety, dizzy, rapid heart rate, thick tongue x 10-20min;
PATIENT RECEIVED SECOND DOSE OF PFIZER COVID-19 VACCINE AT APPROXIMATELY 5:00 PM . ABOUT 5 MINUTES LATER , WHILE SITTING ON THE BENCH IN FRONT OF THE PHARMACY  , PATIENT EXPERIENCED A BLACKOUT FOR 5 TO 10 SECONDS . PARAMAEDICS WERE CALLED AND EVALUATED PATIENT , RELEASING HER TO FATHER'S CARE AT APPROXIMATELY 5:45 PM .
violent rash on both arms, hands, torso, behind the knees, buttocks; lips also started to swell; This spontaneous case was reported by a consumer and describes the occurrence of RASH (violent rash on both arms, hands, torso, behind the knees, buttocks) and LIP SWELLING (lips also started to swell) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced RASH (violent rash on both arms, hands, torso, behind the knees, buttocks) and LIP SWELLING (lips also started to swell). The patient was treated with PREDNISOLONE at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, RASH (violent rash on both arms, hands, torso, behind the knees, buttocks) and LIP SWELLING (lips also started to swell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Dizzy, even when turning over in bed. Chills, shaking, though it was not cold weather. Muscle spasms from waist, down the legs ( like restless legs) Headache Very sore arm
3/29-Redness and warm to touch at site of injection, localized to 2 inches in diameter: Started 03/29/2021 morning - Still occurring
Hives on back, arms and neck immediately after vaccines given - Provider - ordered BENADRYL x 1 dose of 1 tsp given - no further reaction noted.
The day after the shot I was nauseous and fatigued! Full body aches continued throughout the day, but were managed with ibuprofen and Tylenol. I lost my sense of taste and smell as well! Two weeks out and I can smell some, but I still have no taste!!
Does not remember things well and has confusion; Pain in the body and hands; Pain in the body and hands; Does not remember things well and has confusion; Fever; Nausea; Pain in the shoulder; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Does not remember things well and has confusion), DIZZINESS (Dizziness), CONFUSIONAL STATE (Does not remember things well and has confusion), PAIN IN EXTREMITY (Pain in the body and hands) and PAIN (Pain in the body and hands) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0162B1A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart valve replacement.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nausea) and ARTHRALGIA (Pain in the shoulder). On 08-Apr-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Does not remember things well and has confusion), CONFUSIONAL STATE (Does not remember things well and has confusion), PAIN IN EXTREMITY (Pain in the body and hands) and PAIN (Pain in the body and hands). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 2 UNK. On 12-Apr-2021, ARTHRALGIA (Pain in the shoulder) had resolved. At the time of the report, MEMORY IMPAIRMENT (Does not remember things well and has confusion), DIZZINESS (Dizziness), CONFUSIONAL STATE (Does not remember things well and has confusion), PAIN IN EXTREMITY (Pain in the body and hands), PAIN (Pain in the body and hands), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 100.5 (High) 100.5 ° F.         No concomitant medications were provided by the reporter.  Patient also applied towel with cold water to treat the fever.   This case was linked to MOD-2021-075688, MOD-2021-075591 (Patient Link).
Headache; Real fatigued; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after the first dose of vaccination, the patient had headache; was real fatigued; had muscle pain; and joint pain. The outcome of the events, 'headache', 'fatigued', 'muscle pain' and 'joint pain', was unknown. The patient was asking if the side effects will be worse after the second dose, and if she should get the second dose.  Information on lot/batch number has been requested.
Tachycardia up to 150 resting; Nausea; Vomiting; Diarrhea; Headache; Migraine; Body aches; Chills; Fever up to 102; This is a spontaneous report from a contactable nurse (patient). This 26-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), intramuscular on 08Jan2021 at 07:45 AM at single dose on right arm for COVID-19 immunisation. Medical history included anxiety and depression. No known allergies. Concomitant medication included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), diphenhydramine hydrochloride (ZZZQUIL). No other-vaccine-in-four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730), intramuscular on 22Dec2020 at 08:00 PM on right arm for COVID-19 immunisation. The patient experienced tachycardia up to 150 resting, nausea, vomiting, diarrhea, headache, migraine, body aches, chills and fever up to 102. Symptom onset around 7PM on 08Jan2021 and stopped around 12PM 09Jan2021 except for headache which was still persisting as of 9PM 09Jan2021. No treatment was received for the events. The outcome of headache was not recovered. The outcome of other events was recovered on 09Jan2021 at 12PM. The patient did not have COVID-prior-vaccination. The patient did not have COVID tested post vaccination.; Sender's Comments: The reported tachycardia was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Facial numbness radiating down left side of neck to left arm, elbow and chest. Went to ED, admitted for observation overnight.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 17-JUN-2016, the patient was treated by a physician for a persistent vesicular rash, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed naproxen and VALTREX for management of his painful and chronic symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
The pt received DTaP, IPV, MMR, Hep A vaccines and PPD test. The pt experienced a red, swollen and painful area. Pt experienced moderate erythema, increased warmth. Pt was prescribed Atarax.
Patient died on 2/25/21 in the AM after receiving his COVID-19 Moderna vaccine #1 at approximately 2:30P on 2/24/21. I do not have a time of death. I contacted the County Medical Examiner's office who stated that they received his body after he was determined to be deceased at the shelter.  No autopsy was performed and his body was released to a funeral home on 2/26. The ME's office said that "permit for burial/cremation is pending" and no other information on COD was available. Per staff, he was also tested for COVID as part of shelter protocol on 2/24 and PCR was negative. He arrived to the shelter on 2/19/21.
Fever, chills, body aches, confusion, dizziness, neck pain, back pain. Symptoms were worst on 5/1 (1 day after shot), but none have gone away as of today (5/11).
The patient received their first Covid vaccine on 3/21/2023. This was the MODERNA SARSCOV2 Vaccine (Age 6m-5y) (25mcg/0.25 mL) which is the monovalent formulation. On 4/18/2023, the monovalent Covid 19 vaccines were no longer authorized to be used. On 4/19/2023, CDC's ACIP recommendations for Covid 19 vaccines changed. The recommendation at the time is to provide the BIVALENT Moderna vaccine. Patients who are unvaccinated or only received 1 dose of the monovalent Moderna should receive MODERNA SARSCOV2 BIVALENT (6M-11Y: 25MCG/0.25ML) [blue cap with grey border].  This situation is considered an incorrect product resulting in a lower-than-authorized dose being administered as 10 mcg was given when 25 mcg was indicated. The CDC recommends repeating the correct dose (25 mcg) immediately with no minimum interval.
no apetite; itchiness; tiredness; fever; chills; achiness; This is a spontaneous report from a contactable consumer, a patient. A 70-year-old non-pregnant female patient received second dose of BNT162b2 (Pfizer BioNTech COVID-19 mRNA Vaccine Lot no: ER8730) on 24Mar2021 at 05:15 on left arm as a single dose for COVID-19 immunisation. Facility where the COVID-19 vaccine was administered was pharmacy. Medical history was included breast cancer. The patient was allergic to tree pollens, dust, perfumes. Concomitant medications included LIPITOR. The patient previously received first dose of BNT162b2 (Pfizer BioNTech COVID-19 mRNA Vaccine Lot no: en6200) on left arm on 24Feb2021 at 04:45 AM, as a single dose for COVID-19 immunisation. The patient has not had any symptoms associated with COVID-19. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 24Mar2021, the patient experienced fever, chills and achiness. On 25Mar2021 at 07:00 AM, the patient experienced tiredness. On 26Mar2021, the patient experienced no appetite and itchiness. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of this events fever, chills, achiness, tiredness, appetite and itchiness was recovering.  No follow-up attempts are needed. No further information is expected
Nausea, stomach pain, joint pain, chills, headache, fatigue, sore and inflamed injection site.
diarrhea; This is a spontaneous report from a contactable consumer.  A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown) on 31Jan2021 via an unspecified route of administration at SINGLE DOSE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient experienced diarrhea on 04Feb2021. Event took place 4 days after injection. Not sure if food related. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
LPN mixed Rotarix with sterile H20 diluent and inadvertently administered IM to patient.  No adverse event took place.
Swelling in right arm 8 inch by 5 inch patch around bicep; Swelling from armpit to occipital bone with lymph node swelling; Fatigue and headache took three days to go away; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in right arm 8 inch by 5 inch patch around bicep), LYMPHADENOPATHY (Swelling from armpit to occipital bone with lymph node swelling), FATIGUE (Fatigue and headache took three days to go away) and HEADACHE (Headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swelling in right arm 8 inch by 5 inch patch around bicep), LYMPHADENOPATHY (Swelling from armpit to occipital bone with lymph node swelling), FATIGUE (Fatigue and headache took three days to go away) and HEADACHE (Headache). In August 2021, FATIGUE (Fatigue and headache took three days to go away) and HEADACHE (Headache) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling in right arm 8 inch by 5 inch patch around bicep) and LYMPHADENOPATHY (Swelling from armpit to occipital bone with lymph node swelling) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.   This case was linked to MOD-2021-309088 (Patient Link).
4/15/03: Rash around left thigh where shot was given - Augmentin ES, Benadryl. 4/17/03: Recheck for shot reactin - Dx with reaction to DTAP - Pt to finish Augmentin.
pt devel hives, rt arm swollen, hot, tender at vax site w/lymphadenopathy axilla;MD exam & rx for DPH & keflex;
PATIENT COMPLAINED OF TINGLING FEELING ALL OVER HIS BACK. HE SAID IT FELT LIKE SOMEONE WAS STICKING HIM WITH LITTLE NEEDLES WHICH LASTED A FEW WEEKS