chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by an other healthcare professional, describes the occurrence of SARS-CoV-2 positive test (patient tested positive for COVID after 1st dose of Moderna vaccine) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for an unknown indication. The patient's past medical history included no adverse event. On Dec 28, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Dec 30, 2020, patient had a SARS-CoV-2 positive test (patient tested positive for COVID after 1st dose of Moderna vaccine). At the time of the report, SARS-CoV-2 positive test (patient tested positive for COVID after 1st dose of Moderna vaccine) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, treatment information or concomitant medication.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 29-Mar-2022 at 12:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Mar-2022 at 12:01 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient Ethnicity provided as private.  It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event.  It was unknown if other vaccines were given on the same day as Moderna COVID-19 Vaccine to the patient.  It was unknown if patient received other vaccines within one month prior to any dose of Moderna COVID-19 Vaccine.  On 29-Mar-2022 at 12:01:42, the patient received a booster dose (Lot: 066H21A and expiry date 04-APR-2022) of Moderna vaccine.  Reported that patient received Vaccine past its 30-day expiry date, vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021.  No treatment drug information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
Mother reports to clinic on Friday 9-9-11, reports redness & swelling at the Rt arm. Large mildly erythematous 4" x 3", warm to touch, no swelling noted. Mother reports has not gotten any worse in last two days. She only used an ice pack, no TYLENOL given. Child also has a rash under his neck x several weeks. Saw MD. Most likely contact dermatitis tx with TAC 0.1% cream.
Agitation mood: anxiety, appetite loss, cold, flu-like symptoms, sleep: insomnia, menstrual abnormalities, neurological: depression mood: angry, irritable, nervousness, blood in urine, headache, nasal: allergies constipation, ache: joints, bones, cyst: uterus, sleep problems: shifting patterns, pain: lower back, feet (like electrical shocks), numbness: and tingling sinusitis, skin: sensitivity (hematomas easily), numbness and tingling fingers.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-OCT-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Almost immediately got a very bad headache and nausea.  About 30 minutes later I got foggy in the head.  Within an hour, I felt exhausted. I went to sleep until about 7pm and when I woke up I felt really nauseous and still very tired. I had a little broth and went back to sleep. on 02/19/2021 at 1am I woke up feeling really hot and had horrible body aches. Even my joints hurt. I took my temperature and it was only 99.2 but my temperature usually runs 97.4 or 97.6.  I woke up  on 02/20/2021 and my left eye was crusted over just like the first vaccine.  My body aches and nausea lasted until 02/20/2021. In the evening of 02/20/2021 I noticed about 10 little red bumps in various places on my body. (2 on left arm, one on back neck in hairline, two on upper back,  one on chest, two on left leg, one on lower back and one on left buttock.  Today is 02/22/2021 and I am still feeling fatigued. It's not as bad as it was over the weekend but I am still tired.  My arm was much sorer with this injection.
This spontaneous report as received from a patient's parent, refers to a approximately 18 years old female patient. The patient's concurrent conditions included "little allergy problems, she was allergic to dust". No information on the patient's concomitant medications, pertinent medical history and drug reactions was reported. On an unknown date in early 2015, the patient was vaccinated with the first dose of RECOMBIVAX HB injection, (dose, route of administration, lot number and expiration date were not reported). At the time of vaccination, the patient was a 17 years old female. In fall 2015, the blood test was performed as a routine, because the patient was entering a college as a student in fall of 2015. The blood test confirmed that the first dose was ineffective. The physician stated that the patient did not have any antibodies present to fight off the disease and decided to repeat the dose of RECOMBIVAX HB. On an unknown date in January 2016, the patient was vaccinated with the second dose of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not reported) (Inappropriate schedule of vaccine administered). On an unknown date in July 2016, the second blood test was performed, which revealed that there were still "no antibodies present". There was no treatment given for the event. The patient did not seek medical attention. The outcome of vaccination failure was considered as not recovered/not resolved. The relatedness between the event and the RECOMBIVAX HB was not reported. Additional information has been requested.
Arm swollen, tender, and red. Claims that he feels "real bad". Doctor told him that he received a "bad batch" and prescribed antibiotics.
Employee was given vaccine in early morning and shortly after developed erythema and tingling around her left arm. Employee also experienced "itchiness" and a dry throat.
inadvertently administered an expired Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old male patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 21-JUN-2023, the patient received Havrix. On 21-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired Havrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 30-Oct-2023 The registered nurse called to inquired that it was still good or they should revaccinate. The reporter did not consent to follow-up. The patient received an expired dose of Havrix, which led to expired vaccine used.
My child had inconsolable high pitched screaming and crying for 4-5 hours. She NEVER acted like this before. I know she must have been in severe pain as her eyes were begging me to do something to help her and I had no way of doing so. NOTHING i did would help calm her. It was heart wrenching and I almost passed out due to her being so upset.
Within first week, post vax, had minor itching all over my body with no rash. As of 2/15/2000, rash appeared all over body with severe itching, including injection site.  Follow up on 05/17/2000: "Patient recovered from adverse event."
had baby on 02Dec2021; knees locked when her water broke (was leaning over bed) and legs cramped (such as thigh); knees locked when her water broke (was leaning over bed) and legs cramped (such as thigh); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 30's (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "TBI from car accident in 20s" (unspecified if ongoing), notes: TBI from car accident in 20s; "Knee surgery" (unspecified if ongoing), notes: Knee surgery; "Drug allergy" (unspecified if ongoing), notes: Reaction: Allergy, Drug: Unsure. The patient took concomitant medications. The following information was reported: EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "had baby on 02Dec2021"; MUSCLE SPASMS (non-serious), JOINT LOCK (non-serious), outcome "unknown" and all described as "knees locked when her water broke (was leaning over bed) and legs cramped (such as thigh)".  Additional information: Patient had baby said was a whirlwind delivery but haven't gotten other details. List of any other medications the patient received within 2 weeks of vaccination: likely blood thinner shots but unsure if that was during vaccination period. Baby went to pediatrics appointment today and reporter described baby as totally perfect, which means he is healthy. Unsure of medical history of both parents. Patient had TBI in 20s and is on blood thinners (has continued to use following pregnancy). Patient is relatively healthy. Other ailments unknown. Baby came two days before set induction date. He originally was not growing as quickly, but started feeding more, and now he is wearing 23-month-old colthes. Had around a pound of water weight that he lost after initial birth. They feed him breastmilk. Patient told me birth story, and I don't think there were any AEs but two things stuck out. Contractions started the day before or estimated 12 hours before labor. Patient knees locked when her water broke (was leaning over bed) and legs cramped (such as thigh) to where doctors had to roll her onto the bed. Patient is estimated 36 years old. She definitely has received first shot of vaccine, but cannot remember whether got second. Her husband, early to mid 40s is also vaccinated and may have been vaccinated 2 dose during pregnancy or conception, unsure timeline (separate AE submitted for this previously). Cannot confirm, but spouses may have gotten Moderna. Patient was in mid-30s. Dad was in 40s, if pertinent. Reporter believe mother and baby are doing well.  Follow-up attempts completed. Information about lot/batch number cannot be obtained. No further information is expected.
Completely unsure if related at all to the vaccine, but 3 days after my third dose of Pfizer I had very very severe menstrual bleeding. Turns out a miscarriage from Aug 5, 2021 was not 100% "complete" and this was my first period since pre-pregnancy.  The bleeding was so sudden and SO severe (massive blood clots) that I went to the ER.  The bleeding slowed down after 2-3 hours, but I had to have a D&C later that day.  The only reason I'm reporting it is because it had been 2 full months since the miscarriage and my body did not have a reaction to the incomplete miscarriage -- but was there something about getting the vaccine that triggered this kind of severe bleeding/response to the remnants of the pregnancy?
Fever, body aches, headache lethargy, and sniffles. I got it with flu so cannot be sure which one is which.
Approximately 12 hours after administration of pneumovax into left deltoid, client's arm swelled significantly, requiring an ER visit. Client put on cephalexin p.o..
Vasculitis. Rash on face, trunk, extremities. Palpable papules with some petechiae on face 8 days after MMR.
5 days after vaccine, feet/ankles sore, 2.5 weeks after vaccine swelling in feet/ankles and aching in joints of extremities
FVER,DIARRHEA, VOMITING,CHEST PAIN,ELEVATED CARDIAC ENZYMES
Severe pain in arm immediately, and continuing into day 3. Fever of 100.0 for 8 hours the night following the shot. Chills for 2 hours during the night following the shot.
This spontaneous report as received from a nurse refers to a multiple patients of unknown ages and genders. On an unspecified dates in 2017 (reported as since 12-JUL-2017), the patient were vaccinated with improperly stored doses of VAQTA lot # M042322 expiration date 21-FEB-2018, lot # N002913 expiration date 23-FEB-2019 for prophylaxis. The temperature excursion lasted 15 minutes. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1708USA010530: US-009507513-1708USA010529: US-009507513-1708USA010515: US-009507513-1708USA010531.
severe/immobilizing back and neck pain (lasted for 2 days); still having severe neck pain intermittently; within 24 hours, severe shoulder pain; Severe pain in arm several minutes after receiving vaccine;; severe/immobilizing back and neck pain (lasted for 2 days); still having severe neck pain intermittently; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO176) via an unspecified route of administration in the left arm on 19May2021 at 19:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and gallbladder disease. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN), lamotrigine (LAMICTAL) and gabapentin (MANUFACTURER UNKNOWN);all from unknown dates for unknown indication, unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19May2021 at 19:15, the patient experienced severe pain in arm several minutes after receiving vaccine, within 24 hours, severe shoulder pain, within 48 hours severe/immobilizing back and neck pain (lasted for 2 days), was still having severe neck pain intermittently. No therapeutic measures were taken as a result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe pain in arm, severe shoulder pain neck pain and back pain was recovered with sequelae on an unknown date in May2021.
Ana received  first dose of Pfizer on 1/7/21 and 2nd dose of Moderna on 1/28/21
The patient received the Moderna vaccine instead of the Pfizer vaccine which was prescribed for him.  The Moderna vaccine is not yet approved in individuals under the age of 18.  The patient was provided the vsafe information to continue to report any side effects of the vaccine, which to date the patient has not experienced.  This is considered an off label prescribing and is being reported as such.  The patient is scheduled to receive his second dose May 28th 2021, as recommended by the CDC.
His thigh, where injection site, and knee swelled to about twice it's normal size. The knee cap was not recognizable. There was a blotchy rash. Both lasted about 48 hours. The doctor was unconcerned.
This spontaneous report was received from a physician refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unspecified dates, from 12-NOV-2015 thru 30-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L016428 and expiration date 30-JUN-2017, (dose, route of administration and anatomical location were not provided). There were no concomitant medications provided. No adverse effects were reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
Numbness in the fingers; Pain from the elbow to shoulder; Joint pain on the left side; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in the fingers), PAIN (Pain from the elbow to shoulder) and ARTHRALGIA (Joint pain on the left side) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 037821A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced HYPOAESTHESIA (Numbness in the fingers), PAIN (Pain from the elbow to shoulder) and ARTHRALGIA (Joint pain on the left side). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness in the fingers), PAIN (Pain from the elbow to shoulder) and ARTHRALGIA (Joint pain on the left side) had not resolved.            No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Constant crying; started approx 90 min. after vaccines given. Did not respond to TYLENOL. Seen in office at 1500 - quiet, consolable; cries if not being held.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 15-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5 ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced two temperature excursions of 48 hours each. For one excursion the lowest recorded temperature was 34 F (1.111111111 Celsius) and for the other excursion the lowest recorded temperature was 32 F. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Swollen; red; itching; warm; tender; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Oct2021 12:00 (Lot number: FF2587) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing). Concomitant medication(s) included: NIFEDIPINE; METOPROLOL; GABAPENTIN; OLMESARTAN/HYDROCHLOROTHIAZIDE. Past drug history included: Ees, reaction(s): "known allergies: EES"; Pcn, reaction(s): "known allergies: PCN". Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose lot number=ER8730,, prev dose dose number=2), administration date: 01Apr2021, when the patient was 63 years old, for COVID-19 Immunization; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer,, prev dose lot number=EN6199,, prev dose dose number=1), administration date: 11Mar2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: SWELLING (non-serious) with onset 08Oct2021 16:00, outcome "not recovered", described as "Swollen"; ERYTHEMA (non-serious) with onset 08Oct2021 16:00, outcome "not recovered", described as "red"; PRURITUS (non-serious) with onset 08Oct2021 16:00, outcome "not recovered", described as "itching"; FEELING HOT (non-serious) with onset 08Oct2021 16:00, outcome "not recovered", described as "warm"; TENDERNESS (non-serious) with onset 08Oct2021 16:00, outcome "not recovered", described as "tender". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling, erythema, pruritus, feeling hot, tenderness.  Additional information: Patient stated events Swollen, red, warm and tender area approximately 2.5 inches x 1.5 inches with itching. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
The pt experienced swelling and complained of pain in the left deltoid. Treated with ice pack.
Abdominal pain; Difficulty of breathing; Muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included VITAMIN B12 NOS for an unknown indication.   On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Jan-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Jan-2021, ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-026685 (Patient Link).
16FEB96 very tired PM, vomited;17FEB96 flu-like sx, chills, sore stomach;18FEB96 lethargic, no appetite;19FEB96 shooting pains through hips & legs 3-4 days (irritable);20FEB96 shock like pains in chest;dizziness, itching to rash & arm pain