chrisvoncsefalvay/vaers-outcomes huggingface dataset:
did not receive the second dose as scheduled; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive the second dose as scheduled) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M22A) for COVID-19 vaccination.     The patient's past medical history included Dialysis (3 times a week) since an unknown date.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive the second dose as scheduled). On 16-Mar-2021, PRODUCT DOSE OMISSION ISSUE (did not receive the second dose as scheduled) 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.   Concomitant medications were not reported.
A few days after shot felt slightly nauseous, slight tingling and swelling of lips and Irritable Bowel Syndrome was triggered with diarrhea.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with improperly stored M-M-R II injection (lot number, dose, frequency and route of administration was not reported). No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. No further information was provided. Additional information has been requested.
ADMINISTRATION OF EXPIRED VACCINE; TEMPERATURE EXCURSION; This spontaneous report received from a pharmacist concerned a 19 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the patient experienced administration of expired vaccine. On 24-MAY-2021, the patient experienced temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210913164, 20210916129, 20210916498, 20210916465, 20210916415, 20210916401, 20210916697, 20210915646, 20210915719, 20210916715, 20210915661, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210915623, 20210915731, 20210915748, 20210915852, 20210916228, 20210916300, 20210916312, 20210916455, 20210916520, 20210916584, 20210916658, 20210916808, 20210916811, 20210916849, 20210916910, 20210916959, 20210916965, 20210917074, 20210917160, 20210917500 and 20210917603.
On the evening August 4th, I started to have numbness on left side of face. I went to the PCP. The doctor ordered an MRI of brain and upon those results they found 14 lesions on my brain so I was referred to a neurologist. I went to neurologist who ordered spinal tap, bloodwork, and two MRIS of my spine. After MD reviewed the results I have been diagnosed with MS ( Multiple sclerosis ) as of September 10th 2021. I started a treatment on Sunday 9/26/21 with injectable medicine. I will be giving myself the shots weekly and monthly for treatment.
Significant hearing loss in right ear; some hearing loss in left ear. Right ear has persistent pulsatile tinnitus (pulsating heartbeat sound). Some hearing has been restored since the onset, but a great degree of hearing loss remains, especially in the right ear. Pulsatile tinnitus persists.
2nd dose was received 4/25. Early morning of 4/26, I experienced mild flu-like symptoms (weakness, body aches) which subsided by 4/27. By afternoon of 4/27, I started to experience vertigo. I'm still experiencing vertigo and have not taken any medication for my symptoms.
pt recv vax 16AUG96 & 2MAY97 pt exp chickenpox that consisted of 100 spots or more as well as redness & swelling @ inj site;
Swelling and slight pain on collar bone on left side of neck (possibly a lymph node), 6 days after first vaccine dose, no treatment yet
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant use were reported No Treatment were reported
This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A female patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection; batch/lot# and expiration date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient previously vaccinated with flu shot for influenza immunization on an unspecified date. With the COVID-19 vaccine, patient experienced muscle spasms and soreness in her arm on an unspecified date. Reportedly, it felt like when she gets a flu shot. The outcome of the events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021206222 Same reporter and product, similar event; different patient.
pt devel severe flu-like sx w/confusion & had many lab abnormalities to include inc LFT's, inc creatinine & subclinical DIC, pt recovered w/in 24 hrs; T101.6; BP lowest 90/50
Information has been received from a liscensed practical nurse (LPN) concerning a 28 year old female with no past medical history who on 06/12/01 was vaccinated with varicella virus vaccine live (dosages, dose series and lot number not provided). There was no concomitant medications. On 06/26/01, the pt developed red spots w/blisters present and a fever of 99.5 degrees F. At that time, she sought medical attention. Not treatment or medication was prescribed. Additional information has been requested
Felt sick after first shot; Arm hurt  after first shot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick after first shot) and PAIN IN EXTREMITY (Arm hurt  after first shot) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced MALAISE (Felt sick after first shot) and PAIN IN EXTREMITY (Arm hurt  after first shot). On 09-Feb-2021, MALAISE (Felt sick after first shot) and PAIN IN EXTREMITY (Arm hurt  after first shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided. No treatment information was provided.   This case was linked to MOD-2022-489191, MOD-2022-489192 (Patient Link).
Broke out in a rash on chest, neck, face, and eyes. sharp Mid back pain. Continues to break out in a rash and mid back pain a few times a week.
I was so dizzy I almost had to pull over; pain in right arm; pain in right jaw down to her right side of her neck; general pain similar to the flu; general pain similar to the flu; Pain in my neck; vertigo; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I was so dizzy I almost had to pull over), PAIN IN EXTREMITY (pain in right arm), PAIN IN JAW (pain in right jaw down to her right side of her neck), PAIN (general pain similar to the flu) and INFLUENZA LIKE ILLNESS (general pain similar to the flu) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-May-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I was so dizzy I almost had to pull over), PAIN IN EXTREMITY (pain in right arm), PAIN IN JAW (pain in right jaw down to her right side of her neck), PAIN (general pain similar to the flu), INFLUENZA LIKE ILLNESS (general pain similar to the flu), NECK PAIN (Pain in my neck), VERTIGO (vertigo) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, DIZZINESS (I was so dizzy I almost had to pull over) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt c/o dizziness and "head heaviness".  BP 109/69, HR 62, RR 18 -- > 101/58, 68, 18.  Pt given water.  Pt stable and released from the vaccination site.
**************COVID BREAKTHROUGH CASES*************** I felt a little stuffy on May 16 and I had a sore throat. Then on the May 17 it got worst and I developed a cough. The May 18th I took an at home COVID test and it was positive. Later that day I took a PCR test the following day they told me it was positive as well. On the May 19th, I contacts my PCP and my Cardiologist. I felt it was critical to contact my heart doctor because I am on a 30 day monitor. Both doctor decussated Paxlovid but they both decide that the Monoclonal antibodies would be better. I went to the hospital on the 21 of May to start the infusions and by Monday I started to feel much better.
This spontaneous report was received from a medical assistant and refers to a 66-year-old female patient. Her concurrent conditions included elevated blood pressure, hypothyroid, allergy to ragweed, mold and pollen. Her medical history was not reported. The patient's concomitant therapies included unspecified medications for blood pressure and thyroid. On 07-FEB-2019, the patient was vaccinated with a dose of PNEUMOVAX 23 lot #R002084, expiry date 26-OCT-2019 (exact dose, route and site of administration were not reported) for prophylaxis. Patient was due for vaccination because she received last dose in 2012. On 07-FEB-2019, the patient experienced muscle pain at injection site. On 08-FEB-2019, the patient experienced nausea. No treatment was given for the event. No lab tests were performed. The patient sought medical attention in doctor's office. The outcome of the events was reported as not recovered. The causality assessment was not reported.
eye (very weak lt) motor skill weak; pt holds breath until turns purple & faint;not vax rxn per MD;mom does not want pt to recv immun for religious reason;
9JUN93 elevated temp (was not taken), dec appetite, c/o aching was seen by MD 11JUN93, t102 @ clinic; pt's mom states MD said it was a reaction to pertussis & pt should not have anymore; pt felt well 12JUN93;
Information has been received from a physician referring to a approximately 52 year old female patient (also reported as "he"). Concurrent condition and medical history of the patient were not reported. On an unknown date in February 2016, the patient was vaccinated with her first dose of VARIVAX (lot#, expiration date, dose and route unspecified). On an unknown date in 2016, the physician stated the patient recently completed serologic testing and the result shown negative titer for varicella (Antibody test negative). Physician stated patient had no other adverse effects. Treatment was given for the event "negative titer for varicella". The patient was "doing fine" at the reporting time. Additional information is not expected as we are not permitted to contact the physician.
4 patients received the pediatric formulation of 0.5 mL as their booster doses (Lot #064A22A, Expiration date: 25SEP2022), instead of the Moderna COVID-19 vaccine, bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (4 patients received the pediatric formulation of 0.5 mL as their booster doses (Lot #064A22A, Expiration date: 25SEP2022), instead of the Moderna COVID-19 vaccine, bivalent) and NO ADVERSE EVENT (No adverse event) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (4 patients received the pediatric formulation of 0.5 mL as their booster doses (Lot #064A22A, Expiration date: 25SEP2022), instead of the Moderna COVID-19 vaccine, bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (4 patients received the pediatric formulation of 0.5 mL as their booster doses (Lot #064A22A, Expiration date: 25SEP2022), instead of the Moderna COVID-19 vaccine, bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (4 patients received the pediatric formulation of 0.5 mL as their booster doses (Lot #064A22A, Expiration date: 25SEP2022), instead of the Moderna COVID-19 vaccine, bivalent).    No concomitant information provided. Patients have not reported any adverse reactions at this time. HCP  was  looking for recommendations/guidance for these patients. No treatment information provided   This case was linked to US-MODERNATX, INC.-MOD-2022-644023, US-MODERNATX, INC.-MOD-2022-644018 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644023:same reporter US-MODERNATX, INC.-MOD-2022-644018:(same reporter)
10cm x 11cm area of redness and induration on (L) ant. thigh with cellulitis.
Left arm redness, warm to the touch, slightly swollen when woke up on 7/8/22. Afebrile. Used ice for site.
AFTER ABOUT 20MINS - THROAT & TONGUE SWELLED    ON FRIDAY - STRAIGHT FROM SHOT TO EMERGENCY ROOM    HEART NOT BEATING RIGHT - DIZZY - SHORT OF BREATH - WENT BACK TO EMERGENCY ROOM SUNDAY WITH  137 PULSE.......HAD WEEK AND A HALF OF HEART PAPULTATIONS/DIZZY/WEAK/COULDNT EAT / THEN WEEK OF LOW BLOW PRESSURE / THEN WEEK OF CHEST PAINS/THEN / A WEEK OF FEELING LIKE I WAS BEING STRANGELED-PRESSURE ON THROAT...   STREP THROAT / COLD / BRONCHITIS / NOW TRYING TO GET 2ND COLD         ISSUES STILL COMING SINCE SHOT   I HAVEN'T HAD SO MUCH AS A COLD IN A YEAR OR TWO
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 15-FEB-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9(strength and route were unknown) (lot# N021475 and expiration date 03-JAN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
Swelling, redness, bruising,itching and pain for 8 days. Fever 101... chills and shivering for 2 days after vaccine.... persistent tiredness for a week..
This spontaneous report as received from a registered nurse (patient's grandmother) refers to a 4 month old patient of unknown gender. On 01-SEP-2016 the patient was vaccinated with two doses of PEDVAXHIB. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Patient claims she got swollen lymph nodes, tender/swollen arm, body aches-hips, fever at 101 degrees F, and dark urine after getting the vaccinations.
feel achy; arm started to hurt and was bothering him; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm started to hurt and was bothering him) and PAIN (feel achy) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm started to hurt and was bothering him). On 18-Mar-2021, the patient experienced PAIN (feel achy). At the time of the report, PAIN IN EXTREMITY (arm started to hurt and was bothering him) and PAIN (feel achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.   No treatment information was provided.
No other AE/PQC reported at the time of this call.; Nurse calls to report an expired dose of MMR II was given to a patient.; This spontaneous report was received from a registered nurse, referring to a 9-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 24-FEB-2021, the patient was vaccinated with an expired measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection (lot number S004118 which has been verified to be valid, expiration date reported and validated as 11-FEB-2021) (dose, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported) as prophylaxis (expired product administered). No other adverse events were reported in the patient.
Speech difficulty, nervous/anxious 3 to 4 hrs after vaccine was given. Admitted to hospital for neuro eval.
Pt. fainted shortly (a few seconds) right after receiving flu shot due to nervousness. Pt. recovered quickly, asked for some water, rested for 15 min then left the pharmacy.
Arm pain started shortly after flu shot was administered in his left arm, it was injected high in muscle.  Pain with lifting arm up.  Minimal pain with moving back and forth.  Has knots in his deltoid muscle.. Has not been able to work well with this. Not able to sleep more then an hour or two at most.  Large joint/bursa injection was done on 10/26/2020.  Patient developed symptoms of steroid flare about 3 hours after the procedure, PCP added Norco, since tramadol offered no relief.
Cellulitis- softball size, continues to grow, hard, warm (hot) to the touch.  Started with sore arm Friday night, but Saturday night is was described as above. Marked it and took ibuprofen. It continued growing outside of marks and I was seen at the ED.  Given IM shot of antibiotics and oral as well.
Dizziness; Naseua; Vomiting; She experienced a really bad headache; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced a really bad headache, nausea, vomiting and dizziness.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 30-Dec-2020 intramuscularly in the left shoulder for prophylaxis of COVID-19 infection.    Patient received their Moderna vaccine on 30-Dec-2020 at the Health Department in the left shoulder.  One day later, on 31-Dec-2020, she reported a bad headache which was resolved by the next day, 01-Jan-2021.  She continued to feel normal on 01-Jan-2021, however, on 02-Jan-2021, she again reported experiencing a bad headache as well as nausea and vomiting, all of which were resolved by 03-Jan-2021.  She stated that she was fine for the remainder of that day.  Finally, on 04-Jan-2021, she reported that experienced nausea and dizziness.    Treatment for the event included paracetamol for symptom management.   Action taken with mRNA-1273 in response to the events  was not provided.  The outcomes of the events, a really bad headache and vomiting, were considered recovered/resolved.  The outcomes of the events, nausea and dizziness, were considered unknown.; Reporter'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. Further information has been requested
This spontaneous report was received from an unspecified source, concerning unknown female patients (also reported as girls) from unmentioned ages, posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore it was reported, that since unspecified dates, dozen of girls were suffering from acute physical effects after vaccination. The relatedness between events and vaccination with GARDASIL was not provided. This is one of several reports received from the same source. Additional information is not expected as no contact details were given.; Sender's Comments:  US-009507513-1705USA002407: US-009507513-1705USA002409: US-009507513-1705USA002408: US-009507513-1705USA002410: US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002414: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: ZA-009507513-1507ZAF012830: US-009507513-1705USA003214:
Arthralgia, Diarrhea, INJECT SITE PAIN X 2 DAYS Narrative:
Addendum: (Jan 31 2023 3:13PM) Finalized: (Jan 31 2023 3:13PM) Patient had a reaction after the vaccine were given, on the way out patient passed out, code was activated, on my arrival patient was found to be pale, diaphoretic however he was alert and awake. his initial vitals were significant for borderline low blood pressure 106/68, heart rate at 70s, saturation 99%, blood sugar was at 100s, after patient drink and apple juice.  After few minutes patient started feeling better, however he passed out for the second time, was becoming extremely pale, diaphoretic, reported chest tightness and or being unable to breathe at, with a normal saturation.  He was given a shot of EpiPen, with improvement of symptoms.  And normal vital signs emergency services was called after patient passed out for the second time.  Patient was taken to emergency room for further work-up and monitoring.