chrisvoncsefalvay/vaers-outcomes huggingface dataset:
02/11 pt developed rash - fine red non-raised, on legs, arm, back, trunk and faintly on face (off school 02/14 & 02/15). Rash reported to nurse on 02/14. Denies fever, sore throat, or difficulty breathing. Physician prescribed Pediatric Prednisone, decreasing dose. Returned to school 02/16 - lace like rash on trunk, back, arms and faintly on legs, and face. Pt reports possible fever 02/15.
pt recv vax & approx 1wk post vax pt devel numbness & paralysis in lower legs, which traveled up the lt side of body to lt arm w/in 2wk;seen in clinic but no tx;dx GBS;pt stated has nerve damage in lt hip & numbness in heels of feet;abn CBC
Magnets stick to her vaccination site; Fever exceeding 102; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE DYSAESTHESIA (Magnets stick to her vaccination site) and PYREXIA (Fever exceeding 102) 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.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. 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 VACCINATION SITE DYSAESTHESIA (Magnets stick to her vaccination site) and PYREXIA (Fever exceeding 102). At the time of the report, VACCINATION SITE DYSAESTHESIA (Magnets stick to her vaccination site) and PYREXIA (Fever exceeding 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (Inconclusive) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
raise inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "raise inflammation".  Additional information: The patient had no issue receiving vaccines that contained dead virus. mRNA vaccines were another and they raised inflammation and caused me serious side effects and the patient had no intention of repeating. The patient had long lasting issues from the vaccine so did not opt for boosters. Aside from that, the only people who got COVID more than once are those who got many boosters.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot # M042599) for prophylaxis. The PNEUMOVAX 23)was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
U/A found EMS with 56 yo F seated in stationary vehicle, CAO x 4, c/o N/V and dizziness approx 10 mins after receiving her Covid vaccine (Johnson & Johnson). Paramedic advised that pt had initial BP of 90 mmHG systolic, 12 lead showed sinus rhythm w/o ectopy, and that he attempted ODT zofran w/o success due to pt's vomiting, all prior to EMS arrival. Pt. denied CP, abd pain, diarrhea, fever, cough, HA, syncope, neck or back pain. Pt. stated she felt SOB immediately after vomiting. All assessments/interventions as noted in rest of ePCR. GCS= 15, skin pink, warm, diaphoretic. No obvious signs of trauma. Pt. assisted from vehicle to stretcher, secured w/ straps. VS taken, WNL. Abd. soft, non-tender to palpation. Cardiac monitor showed sinus rhythm, rate of 60 bpm. Pt. actively vomited x 3 while IV access attempted and established. Pt. given 4 mg zofran IV w/ improvement in N/V. Pt requested transport for further evaluation. During transport, pt's VS remained WNL, and pt stated she was feeling better, that dizziness and nausea had stopped. Noted occasional unifocal PVC on 4 lead as well as increase of HR to 124 bpm for approx. 3 seconds during transport, then returning to baseline of sinus rhythm or sinus brady. Pt. stated she normally had a low HR and BP, and had felt palpitations in the past, but no episodes of palpitations today, including during transport. Pt. transported COLD traffic to where pt care, 12 lead, and report were transferred to RN in triage w/o incident.
GOT PERIOD OR SPOTTING A LOT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was skipping placebo of birth control so had never get period for years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced got period or spotting a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got period or spotting a lot was not reported. This report was non-serious.
the patient having gotten a pneumonia vaccine and contracting pneumonia at a later time; the patient having gotten a pneumonia vaccine and contracting pneumonia at a later time; This is a spontaneous report from a contactable consumer reporting for her husband.  A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacture unknown), via an unspecified route of administration on an unspecified date at single dose for immunization.  The patient's medical history and concomitant medications were not reported. it was reported the patient having gotten a pneumonia vaccine and contracting pneumonia at a later time. The reporter felt like the vaccine did not help prevent pneumonia for her husband. The outcome of the event was recovered on unknown date. Lot/batch number has been requested.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein)  in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein)  has submitted the same report to the regulatory authorities.
G47.33 OBSTRUCTIVE SLEEP APNEA 11/15/2022 HYPOTENSION I26.99 ACUTE PULMONARY EMBOLISM 1/12/2023 HYPOTENSION I95.9 HYPOTENSION 1/12/2023 HYPOTENSION J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/12/2023 HYPOTENSION G47.33 OBSTRUCTIVE SLEEP APNEA 11/15/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION I26.99 ACUTE PULMONARY EMBOLISM 1/12/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION I95.9 HYPOTENSION 1/12/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/12/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION G47.33 OBSTRUCTIVE SLEEP APNEA 11/15/2022 ANEMIA I26.99 ACUTE PULMONARY EMBOLISM 1/12/2023 ANEMIA I95.9 HYPOTENSION 1/12/2023 ANEMIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/12/2023 ANEMIA
10/16 swelling started in his right axilla and got worse on 10/17.  Narrative: 10/16 swelling started in his right axilla and got worse on 10/17. 10/18 swelling is about the same. No pain or redness. Feels soft. Also feels fatigue, muscle aches. Denies F/C. Has taken some motrin for it. Hasn't seen a doctor for it. 10/19 - reports swelling has improved in his right axilla and he no longer has fatigue and muscle aches. He has returned to work.
About 24 hour immunization developed erythema with fever, left lateral thigh which increased within over 24 hours to 8cm diameter when seen in over 11/9/06 TX Keflex.
On 4/23/21 patient received second dose of Moderna COVID-19 vaccine. Dose administerd 0945. In the observation lot, patient complained of nausea. Vitals: BP 111/48, HR 48. Patient was evaluated by Dr. Patient given water and food. Observed for 30 min. BP unchanged 118/56, HR 91. Patient felt better and was deemed ok for discharge home.
I received the Moderna Bivalent booster for COVID-19 on 9/6/2022, On the night of 11/2/2022, I woke up with head congestion, stuffy nose, and scratchy throat. When I woke up on the morning of 11/3/2022, I still had the same symptoms and felt pretty run-down, so I took a home antigen test twice, and both times I received a positive result. On 11/4/2022, I had a virtual visit with a NP at the hospital with which my cardiologist is affiliated. I was prescribed PAXLOVID, and he also recommended that I use OTC medicines like TYLENOL and MUCINEX to treat the symptoms. The NP also suggested that I stop taking rosuvastatin for 8 days on account of contraindications with PAXLOVID. I took the full course of PAXLOVID for 5 days. My symptoms resolved pretty quickly after the first 5 days or so, and I finally tested negative on both 11/11/2022 and 11/13/2022. However, on 11/14/2022, I began to get a scratchy throat again, along with mild head congestion and mild fatigue. I tested myself again twice that day, and I got a positive result both times. I had a rebound. Whenever I felt any discomfort, I just treated it with OTC medicine. I also periodically tested myself, and it wasn't until 11/24/2022 that I finally tested negative again. Ever since then, I have been symptom-free and am doing fine.
Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a Other Health care professional (pharmacy intern). This case involves patient who had vaccine for which syringe was placed back into the fridge, and the dose was then given 2 days later, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route. It was also a case of actual medication error due to incorrect product storage. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    Concomitant medication was not reported. The vial was initially thawed on 10-Jun-2023.  Treatment medication was not reported.  This case is for 21st patient out of 30 patients reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received contains Vaccine administration date.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Began screaming inconsolably about 5 hrs after vaccines.  Wouldn't breast feed.  Mom states she acts like her belly hurts.  Suggest Tylenol, warm bath & comf measures.
Received first dose back in January/received second dose today 22Apr2021; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose back in January/received second dose today 22Apr2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose back in January/received second dose today 22Apr2021). On 22-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose back in January/received second dose today 22Apr2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details not reported by the reporter.
I experienced insidous onset of rapid heart rate with palpitations after approximately 2-3 minutes of inoculation.  This episode lasted about 1-2 minutes.  I was not expecting this having no prior history of adverse response to vaccines.  I also felt a flushing sensation in my head.   My breathing felt slightly more difficult.  No sweating, throat closure or itching.   I did not measure pulse and instead tried to breathe/meditate to bring it down.  I estimate it was about 140 bpm .  Breathing/meditation brought it down but it was still elevated when the nurse checked me after 20 minutes.  I remained onsite an additional 15 minutes until I felt well enough to leave but my heart rate was still somewhat elevated, about 20 bpm higher than my usual.   My heart rate seemed to fluctuate throughout the evening and my sleep was subsequently very poor.  I feel much better this morning, just the usual arm soreness after a vaccination.  I have reached out to my primary doctor concerning whether she feels this event would warrant my not getting the second dose or perhaps having a prescribed epipen on my person.  Having no personal history but a family history of severe heart disease (father had first MI at age 42, second at 44 followed by triple bypass and CHF) this incident with my heart rate certainly raised some anxiety.  I had a routine EKG done in June which was normal, I am a physical therapist and in good health.  I am hoping to have the next vaccine in a proper medical facility.   I have read CDC recommendations to not have the second shot if certain adverse responses are experienced and I am not certain whether this would qualify.   I have no history of adverse reactions to vaccines.    Considering the role of anxiety versus the insidious and nearly immediate onset of rapid heart rate with palpitations and persistent elevated heart rate for more than 12 hours, I feel this event was primarily driven by the vaccine.
Began with chills during the night. Woke the next morning and, upon rising, felt lightheaded and broke out in a cold sweat. Had to lay down to keep from fainting. This passed within a few minutes. About four hours later had a fever of 101 that lasted about an hour. Then my temperature remained between 99 and 100 the rest of the day. (Usual temperature is 97.9.) Was fatigued for two days.
This spontaneous report was received from a registered pharmacist refers to a patient of unknown age who on 10-SEP-2012, was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (route not reported) (lot number 669579/0595AA) that was expired. The vaccine expired on 30-AUG-2012. No adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested.
Flu vaccine was administered on 11/23/16. Employee came to clinic for 1st time on (12/14/16). Patient stated that he experienced flu like symptoms (cough, increased phlegm, congestion red eyes as well a initial low grade temp. No rash, no SOB. Symptoms lasted 6 days. The symptoms began day after vaccine.
Received vaccine 12/28. Woke up on 12/29 with fever 101, malaise, a red warm tender (L) arm @ injection site.
This spontaneous report was received from a Registered Nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history and historical drugs were not reported. The patient's concomitant medication included sterile diluent. On 17-APR-2017, the patient was administered the first dose of M-M-R-II lot number M037096, expiration date 23-AUG-2018, and on 08-MAY-2017, the patient received the second dose of M-M-R-II lot number M044350, expiration date 04-NOV-2018 (dose and route were not reported) both for prophylaxis. Additional information has been requested.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 2:04 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021 at 2:04 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient allergic to medications, food and other product was unknown at the time of reporting. It was unknown that the patient had ever been diagnosed or tested positive for COVID-19. The vaccine was stored in an ultra cold freezer at minus 82 degrees Farenheight. Excursion duration was reported as 1 month and on 19 Nov 2021 vials went from the super cold freezer to the refrigerator. At the time of reporting, 70 vials were still in ultra cold freezer and 8 vials were stored in refrigerator. No vaccine state changes were noticed and the vaccine was never refrozen. Number of vials/doses 78 vials were impacted. No previous temperature excursions were noticed.  No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
pt recvd pedvaxhib on 24DEC91 & following inject pt bled from the inject site for more than 10 minutes; knot formed @ inject site that persisted for over 2 months; @ the time of the report the knot had dec in size & the pt had recovered;
Moderate to severe joint pain, particularly in hands, but also hips, elbows; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 12:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included triglycerides high. The patient did not have any allergies to medications, food, or other products Concomitant medications included omega-3-acid ethyl ester (LOVAZA), BCP (UNKNOWN MANUFACTURER), Ipatroprium NS (UNKNOWN MANUFACTURER), mefenamic acid (ADVIL), curcuma longa (TURMERIC), colecalciferol, retinol (VITA) all from unknown dates and for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 11Mar2021 at 12:00 (at the age of 56-year-old), as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 the patient experienced moderate to severe joint pain, particularly in hands, but also hips, elbows. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event severe joint pain, particularly in hands, but also hips, elbows was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PT NOTICED SWELLING START TO OCCURE AT 0950.  HAD VACCINE AT 0930.  EMPLOYEE THEN MENTIONED WITH FIRST DOSE TONGUE/THROAT ITCHED FOR 2 WEEKS.  PT. HAD SORE TOUNGE (BLISTERED), SWELLING OF THROAT/TOUNGE, DIZZINESS, HEADACHE, AND FAST HEARTBEAT.  PT. SENT TO THE EMERGENCY ROOM.
Arthus reaction, classic type started before 24 hours after shot and by 48 hrs was above shoulder joint and to elbow on shoulder (L). No fever, mildly tender, very hard, indurated, red.