chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT DID NOT HAVE AN ADVERSE REACTION. PT WAS ADMINISTERED THE 1ST VACCINE ON 3/18/21 AND THE 2ND DOSE WAS ADMINISTERED ON 3/30/21. NO ADVERESE REACTION WAS NOTED DURING THE PATIENT'S OBSERVATION PERIOD AT THE FACILITY NOR DID THE PATIENT CALL OR PRESENT BACK TO THE CLINIC WITH ANY COMPLAINTS.
1 wk after DT injection pt experienced pain. No inability to fully open the jaw. Tx in progress. Benadryl, medial dos pack
8 days post vax the pt developed a fever of 102.9 with a macular papular rash on trunk and then progressing to extremities.
Patient reported he had SOB and trouble breathing while sleeping and his tongue felt "heavy" while eating.  Patient went to the ER at 1634 on 4/8/2021.  ER report- positive for swollen tongue, weakness, negative for respiratory distress, Respirations were normal with mild scattered bronchial sounds
Chills; Fatigue; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.            No Concomitant medication information was reported. No treatment medications were provided.  it was reported that  the longest duration of symptoms for them was 3 days. They did not receive any treatment, everybody expected it.
25JUN93 tonic clonic sz, 5 mins, t103 dx febrile seizure; WBC 11300; Ne 585; H 36%; M 8%; hgb; urticarial lesion;
9-30-2016: Severe R-shoulder pain (10++). 10-1-16: Very bad shoulder pain, 7pm hives appear on R-arm, R-ribcage area. I called the doctor office for advice. Advised to take ZYRTEC, and it was a 24-hour problem. Use cool or warm compress. 10-2-16 Hives were bad, more hives come up neck. 10-3-16 Things finally calm down.
Administered TDaP (Boostrix) and Meningococcal (Menactra) vaccines. Patient fainted approximately 5 minutes after vaccine administration. Hit back of head. Vital signs stable, alert and oriented. Referred to physician for evaluation. Resources provided. Left clinic in care of mother.
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age. Pertinent medical history, drug allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX lot # M033907, expiry date 20-JUL-2018 for prophylaxis at 75 F temperature and was call because of a data logger (incorrect product storage). No adverse effects were reported (no adverse event). Lot number M033907 has been verified to be a valid lot number for VARIVAX. Additional information has been requested.
pain on a hand; joint pain; body pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on a hand), ARTHRALGIA (joint pain), MYALGIA (body pain) and HEADACHE (headache) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain on a hand), ARTHRALGIA (joint pain), MYALGIA (body pain) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (pain on a hand), ARTHRALGIA (joint pain), MYALGIA (body pain) and HEADACHE (headache) outcome was unknown.            Treatment information not reported. No concomitant medications reported.
Felt out of sorts; Body chills; Fever; Soreness in arms; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Felt out of sorts), CHILLS (Body chills), PYREXIA (Fever) and MYALGIA (Soreness in arms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISORIENTATION (Felt out of sorts), CHILLS (Body chills), PYREXIA (Fever) and MYALGIA (Soreness in arms). At the time of the report, DISORIENTATION (Felt out of sorts), CHILLS (Body chills), PYREXIA (Fever) and MYALGIA (Soreness in arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included .  relevant concomitant products usage were not reported by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .  On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain).  At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown.    No treatment information was provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
6 days post vaccination, I was at work when I suddenly began feeling numbness, tingling, burning sensation, muscle pain, and nerve pain in my both legs. Previously I did not have any neurological symptoms prior to vaccination.
I was sick; I summinestred the fist dosis on april, but don`t the second; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was sick) and PRODUCT DOSE OMISSION ISSUE (I summinestred the fist dosis on april, but don`t the second) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I was sick) and PRODUCT DOSE OMISSION ISSUE (I summinestred the fist dosis on april, but don`t the second). At the time of the report, ILLNESS (I was sick) and PRODUCT DOSE OMISSION ISSUE (I summinestred the fist dosis on april, but don`t the second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.  The patient needed  to start the process of second vaccine.
Her cycle was suppose to start one week after she got her first dose of the vaccine but she didn't.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; Lot number: ER8731) via an unspecified route of administration in right arm on 18Apr2021 at 10:30 (at the age of 47-year-old) as DOSE 1, SINGLE for COVID-19 immunization and patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; Lot number: unknown) via an unspecified route of administration on 06May2021 at around 9am in right arm as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. It was mentioned that the history of all previous immunization with the Pfizer vaccine and additional vaccines administered on same date of the pfizer suspect, prior vaccinations (within 4 weeks) and events following prior vaccinations, family medical history and relevant tests were reported as none. On an unspecified date in Apr2021, it was reported that the patient's cycle was supposed to start one week after she got her first dose of the vaccine but she did not. No therapeutic measures were taken. The patient did not require emergency room and physician office visit. Caller wanted to know what information was available regarding menstrual changes and if this had been reported or is a know side effect. They responded that the authorized  Prescribing Information for the Pfizer-BioNTech COVID-19 Vaccine did not list menstrual changes as adverse reaction from clinical studies and post authorization experience. We might not have the list of all the possible side effects related to the vaccine. The event outcome was unknown.   Follow-up attempts were needed. Further information was expected.
approx 15 mins p/vax pt vomited once & then became very lethargic; w/in mins tone was ashen-gray & peripheral perfusion was poor in the ofc; BP however & VS remained stable;
Information has been received from a physician concerning their niece who was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). The physician reported that their niece subsequently developed diarrhea. Unspecified medical attention was sought. After three days the diarrhea resolved. No further information is available.
No adverse event; Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent).    No concomitant medications were reported.  It was unknown if patient experienced any AE.  Total 7 patients received 0.25 mL doses instead of 0.50 mL of Moderna COVID-19 Vaccine Bivalent vaccine.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-663474, US-MODERNATX, INC.-MOD-2022-663502, US-MODERNATX, INC.-MOD-2022-663552, US-MODERNATX, INC.-MOD-2022-663563, US-MODERNATX, INC.-MOD-2022-663577, US-MODERNATX, INC.-MOD-2022-663578 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663474:same reporter US-MODERNATX, INC.-MOD-2022-663502:same reporter US-MODERNATX, INC.-MOD-2022-663552:same reporter US-MODERNATX, INC.-MOD-2022-663563:same reporter US-MODERNATX, INC.-MOD-2022-663577:same reporter US-MODERNATX, INC.-MOD-2022-663578:same reporter
Injection site very swollen and hot to the touch. Couldn't use left arm for 3 days, Extreme joint and muscle soreness. Light headed. Blurred Vision. Very Dizzy. No depth of field. Severe muscle cramps all over legs, arms and torso including neck. Headaches. Insomnia. Chronic Diarrhea. Nausea. Vomited. Severe hot and cold sweats. Not steady when I walk. It'll be a week tomorrow and I'm still in bed trying to recoup. I really don't want to get the second follow up shot in 2-6 months, I can't do this again.
Only slight soreness at injection site for a day, but then I noticed 10 days later a red rash 3 inches wide and about 5 inches long extending from the injection site down my arm.  Very slightly itchy.  No fever, no chills, no systemic symptoms, no pain.  Today, on day 12, only 20% of the rash remains, and it is fading (now only slightly pink).  In other words, it is disappearing.  I noticed it on day 10, but don't know when it started-- probably a couple of days before that.  It wasn't there on day 2.
3rd HPV vaccine was given when it was not medically indicated. Patient received 2 HPV vaccines prior to the age of 15 years.
Patient may have received empty syringe based on inventory count of doses from vial. Patient getting titers for confirmation and further follow-up.
Hospitalization for COVID on dates 7/7/2022-7/12/2022. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Guillain Barre Syndrome; Chronic Inflammatory Demyelinating Polyneuropathy; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 25-JUN-2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist in a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by unspecified providers for Guillain Barre Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy. The outcome of Guillain Barre Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy was unknown and the causal relationship between the events and zoster vaccine live (ZOSTAVAX) was considered related.   Upon internal review, the events Guillain Barre Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy were considered medically significant.
As I was administering the vaccine, the needle unscrewed from the syringe, resulting in about half the dose squirting on the floor.  The patient had only received about 0.25 mL of the dose. I consulted with Dr. and she advised that I give the patient another 0.25 mL dose to make up for it. Patient tolerated both injections well
Discharge Provider: MD Primary Care Provider: FNP Admission Date: 9/1/2022 Discharge Date: Sep 3, 2022  PRESENTING PROBLEM: Shock   HOSPITAL COURSE: Patient is a 36-year-old man with past medical history of bipolar disorder, untreated hepatitis-C, IV drug use, recent admission due to MSSA bacteremia complicated by epidural abscesses status post decompression and fusion with hardware and multilevel spinal osteomyelitis was concerns for septic pulmonary emboli treated with IV nafcillin for 4 weeks during that hospitalization followed by 2 doses of Bactrim and now currently undergoing dalbavancin  infusions as outpatient on a weekly basis for the last 2 weeks presented to facility leading to hospital from his outpatient infusion clinic due to abnormal labs concerning for acute kidney injury and worsening leukocytosis.  In the emergency department patient was tachycardic and hypotensive requiring 4 L of IV fluids and subsequently requiring pressor support.  He was later transferred to medical intensive care unit for further management.  Patient was found to be in septic shock related to hypovolemia and eventually Levophed was weaned off.  His echocardiogram showed preserved itchy ejection fraction and no vegetations.  Blood cultures remained negative and WBC started down trending after receiving IV fluids.  Infectious Disease was consulted who recommended discontinuing broad-spectrum antibiotics which include cefepime with recommendations to observe patient off antibiotics.  His acute kidney injury improved significantly.  Incidentally during this admission patient was also found to be COVID positive.  He was transferred out of the Medical intensive care unit once he no longer required pressor support.  Patient did really well hence was discharged in a stable condition with prescription for doxycycline 100 mg twice daily which he should be taking lifelong to prevent infections.
After eating her left side of face swells up and then goes down; After the second shot that day it didn't make anything that day but on Sunday I hardly could get; Fatigue after second dose; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (After eating her left side of face swells up and then goes down), FATIGUE (After the second shot that day it didn't make anything that day but on Sunday I hardly could get) and FATIGUE (Fatigue after second dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included LEVOTHYROXINE for Thyroid therapy.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced FATIGUE (After the second shot that day it didn't make anything that day but on Sunday I hardly could get) and FATIGUE (Fatigue after second dose). On 31-Mar-2021, the patient experienced SWELLING FACE (After eating her left side of face swells up and then goes down). On 28-Mar-2021, FATIGUE (After the second shot that day it didn't make anything that day but on Sunday I hardly could get) and FATIGUE (Fatigue after second dose) had resolved. At the time of the report, SWELLING FACE (After eating her left side of face swells up and then goes down) outcome was unknown.            No treatment information were reported.
RIGHT DELTOID SWOLLEN AND MOVING TO LOWER ARM JUST ABOVE ELBOW. DR STARTED PATIENT ON KEFLEX WITH SOME IMPROVEMENT. SIZE 70MMX50MM CELLULITIS.
POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a 62 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality drug administered was not reported. This report was non-serious.
fevers (up to 102.4F) / defervesces in about 2-3 days; myalgias; arthralgias; chills; and night sweats every 3-4 weeks; Labs drawn / show elevated acute inflammatory markers; transiently low white blood cell counts; This case was reported by a physician and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received in October 2019. please refer the case US2020AMR197667).   In January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, myalgia, arthralgia, chills, night sweat, inflammatory marker increased and white blood cell count low. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, myalgia, arthralgia, chills, night sweat, inflammatory marker increased and white blood cell count low were unknown.   It was unknown if the reporter considered the fever, myalgia, arthralgia, chills, night sweat, inflammatory marker increased and white blood cell count low to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The second vaccination in January 2020. Since then, she's had fevers (up to 102.4F), myalgias, arthralgias, chills, and night sweats every 3 to 4 weeks.  Labs drawn during the fevers show elevated acute inflammatory markers which are normal when she's asymptomatic as well as transiently low white blood cell counts. She defervesces in about 2 to 3 days and feels fine in between. So far, extensive heme/onc, infectious disease, and rheumatologic evaluations have been negative although some labs were pending. She had no personal or family history of periodic fever syndromes.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197667:same patient (2nd dose)
Day 4 after injection developed severe gastrointestinal symptoms, including diarrhea, vomiting, decreased appetite lasting 5+ days
Immunizations were given approx 11:30AM; mom now reports that about 2:30PM baby was sleeping on the floor (a folded blanket under him)- on his back and propped up a little on a pillow; as she passed by she noticed that he seemed unusually still; she is not sure about his color may have been pale but def not blue or ashy; also not sure about his respiration she did not wait or take specific note of whether he was breathing or not; she immediately picked him up and shook him gently and spoke his name several times; but he was totally unresponsive, his body habitus was a little on the limp side, def no rigidity; she then began to shake him a little more vigorously and slap his face lightly; after an unknown number of seconds he aroused and began to cry; after the baby quickly returned to his normal state of alertness tone and activity, and has been acting and looking quite normal since; has not felt febrile at anytime.
bad heel pain; Around June, they both got plantar fasciitis on the left foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (bad heel pain) and PLANTAR FASCIITIS (Around June, they both got plantar fasciitis on the left foot) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced PAIN IN EXTREMITY (bad heel pain) and PLANTAR FASCIITIS (Around June, they both got plantar fasciitis on the left foot). At the time of the report, PAIN IN EXTREMITY (bad heel pain) and PLANTAR FASCIITIS (Around June, they both got plantar fasciitis on the left foot) outcome was unknown.            No concomitant medication information provided. On 28-Nov-2021, the patient received booster dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form (batch number- 034F21A) and the patient was fine. No treatment medication information provided.   This case was linked to MOD-2021-408563 (Patient Link).
12 hours later woke up with chills, shakes, chattering teeth, felt very cold. Entire body ached. Took Tylenol every 4 hours which barely helped the symptoms at all. No headache, no nausea. Clearly had fever but I did  not take my temp.  By 6pm  that night (approx 17 hrs later) symptoms started to ease. Within another 2 hrs they were all gone and I felt perfectly well that late evening and next day.