chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose outside the 30 day window, 4 days after 24-Jun-2021; Patients received doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received doses from an expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose outside the 30 day window, 4 days after 24-Jun-2021) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021 at 3:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021 at 11:03 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received doses from an expired vial). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose outside the 30 day window, 4 days after 24-Jun-2021). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patients received doses from an expired vial) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose outside the 30 day window, 4 days after 24-Jun-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. Treatment medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Significant followup received included time of second dose vaccination details were updated and additional event of inappropriate schedule of vaccine administered
Client came into clinic and registered saying she was here for a booster. Her covid-19 record card was not looked at until after the vaccine was administered, and she had received a booster dose already on 12/21/21. She is not immunocompromised and did not qualify for another dose at this time. Client was observed for standard 15 minute wait time after and experienced no adverse events.
Chills, fever, nausea, headache, plugged ears, sore/stiff neck and back.
Patient is past the 42 day window; Blisters could be a bug bites; Bubble blisters on the arm of the injection one inch in diameter; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE VESICLES (Bubble blisters on the arm of the injection one inch in diameter), PRODUCT DOSE OMISSION ISSUE (Patient is past the 42 day window) and ARTHROPOD BITE (Blisters could be a bug bites) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE VESICLES (Bubble blisters on the arm of the injection one inch in diameter) and ARTHROPOD BITE (Blisters could be a bug bites). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is past the 42 day window). At the time of the report, VACCINATION SITE VESICLES (Bubble blisters on the arm of the injection one inch in diameter) and ARTHROPOD BITE (Blisters could be a bug bites) had not resolved and PRODUCT DOSE OMISSION ISSUE (Patient is past the 42 day window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that the patient has not received the second dose as she is waiting for blisters to heal and is past the 42-day window.   No treatment medications were reported.
Following Pfizer vaccination (during the 15 minute wait), parents of child brought her to nurse stating that she "started slurring her words, passed out, and had some seizure like movements."  Patient was pale in color.  Feet elevated at that time, cool cloth applied to forehead, and apple juice given.  Patient reported feeling sick to her stomach.  Drank about 2 ounces of apple juice.  Provider, PAC was consulted and performed a full evaluation.  Patient had vitals taken throughout the time of observation.  Per PAC, exam was within normal limits prior and post vaccination.  Instructions were provided to parents to follow up with PCP (MD) in 1 week for evaluation and to provide guidance on further vaccination.  This was patient's first immunization.
Slight headache, flashed/red on the left side of my face, tenderness on my right arm, nauseous and every now an then a chill. Also my right arm is a little bit swollen and on my right side of my torso by my hip area it has been itching since I woke up.
pain, tenderness, swelling, hardness, redness and sore under arm pit in lymph nodes. fatigue, body aches, chills, nausea and slight fever. I almost passed out while driving.
After injection I received the normal side effects you would expect. My abnormal short term symptoms about (5 days) were shortness of breath, and weird heart palpitations. My long term effects are chronic fatigue and weakness. Now I?m experiencing sharp chest pain on left side that comes and goes.
(L) upper arm 2" x 5" area of erythema, area is warm & swollen. No induration, no tenderness, no d/c from injection site.
Patient suffered Severe back pain, Tingling of lower extremities, Loss of sensation, Band like feeling around torsoe, Unable to stand, resulted in permanent paralysis, Bladder disfunction, Bowel disfunction, Loss of balance, Motor Skills and has since been diagnosed with breast cancer and diabetes. Final discharge diagnosis as Transverse Myelitis at the T-4 - T-6 level. Treatment included Prednisone, full course IVIG.  2/2/09 MR received for DOS 12/19-30/2005 with D/C DX:  Transverse Myelitis.  Mild depression.  Anxiety.  Hx of breast cyst.  Hx of removal of L facial cyst.  DM Type II.  Pt presented to ER with c/o decreasing sensation in the lower extremities with inability to walk. Neuro exam (+) for decreased sensation from the waist down, decreased strength-0/5 in both legs, decreased reflexes and (+) Babinski.  Unable to move legs  due to ascending motor paralysis. Tx with IVIG.  Transferred to rehab.
Drastically decreased breastmilk supply on AM following vaccination, required supplementation.  Improved prior to second vaccine and then worsened again.  3rd child, 2 previous children with no issues nursing and over production of milk.
Pain and soreness in shoulder; Vaccine was administered in shoulder joint; This is a spontaneous case, initially received from pharmacist on 02-Nov-2018, concerning a female patient of unspecified age.  On an unspecified date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: shoulder joint as reported (explicitly coded as vaccine administered at inappropriate site), batch number and expiry date: not reported] for an influenza prophylaxis.  On an unspecified date, after vaccination, the patient experienced pain and soreness in the shoulder. The patient was doing physical therapy.  The outcome of the events was not reported.  The reporter assessed the case as non-serious.  Significant case amendment (02-Nov-2018): The 'treatment received' of the event musculoskeletal pain was changed from 'UNK' to 'Yes' in the event tab. No changes were made in the narrative.; Reporter's Comments: A female patient of unspecified age administered the Afluria Quadrivalent vaccine in the shoulder joint (vaccine administered at inappropriate site) and developed shoulder pain on an unspecified period of time after vaccination. The company assessed the causality of the event (shoulder pain) as related to suspect vaccine, considering the anatomical site specific reaction and the causality of the event (vaccine administered at inappropriate site) as not related to the suspect vaccine due to accidental nature of the event (medication error).
Child is 8 mo old, was not supposed to receive 3rd dose d/t child's age.   No symptoms or problems.
Headache; high blood pressure, 139; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure, 139) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced HYPERTENSION (high blood pressure, 139). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HYPERTENSION (high blood pressure, 139) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Blood pressure measurement: 139 (High) High.         Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Non significant follow up received on 12-MAY-2021, no new information
Narrative:  He relates having developed nausea, diarrhea and cold sweats the day after the initial vaccination - which lasted for about 10 days afterwards. Towards the end of the 10 days, he also experienced mild dizziness and the nausea occasionally persists. He took OTC pepto-bismol, which did not provide ver much relief. During the He spoke with his provider, who informed him that "She thinks I may have been exposed to COVID in the past causing the symptoms from the first dose." Last COVID testing done in June/July was negative and he has no new medications (OTC or rx) or known exposure.
24 hours after shot, started with headache, then chills and low grade temp (99.9)  for two days. Tired
mom reported high fever that evening and a rash about 1 inch from injection sites on left thigh the following day on 12/1/09. Treated with Benadryl, but had swelling on the mouth on 12/2/09
20OCT pt vaxed 9AM & @ 6PM same day temp up to 105 pt given APAP; given advil ER to which was taken 10PM; 21OCT t102 all noc even w/advil;
Information has been received from a registered nurse, for the pregnancy registry for GARDASIL concerning a 21 year old female with a history of laparoscopic cholecystectomy (27-JUL-2007) and cesarean section who on 16-JAN-2008 was vaccinated intramuscularly in the right deltoid with a dose of GARDASIL (lot#659439/1267U). There was no concomitant medication. The patient sought unspecified medical attention during an office visit on 16-JAN-2008 and 04-FEB-2008. The nurse reported that the patient was pregnant. Last menstrual period was 23-DEC-2007 and estimated date of delivery is 28-SEP-2008. The patient had a negative urine pregnancy test on 16-JAN-2008 and a positive pregnancy test on 04-FEB-2008. No symptoms have been reported. Follow up information received on 04-MAY-2009 from the registered nurse stated that the patient transferred her prenatal care to another physician. The reporter said that she does know that the patient did deliver her baby and had no complications. Follow information received from a physician indicated that the patient gave birth to a normal live born female, who weighted 6 lbs and 6 ounces on 13-SEP-2008 at 37 weeks and 3 days from LMP. The baby's length was 19" and her apgar score was 9/9. There were no congenital abnormalities. It was also reported that the baby experienced decreased fetal movements and decreased heart beat to beat variability. There were no complications during pregnancy and during labor. The patient had routine prenatal blood work within normal limits. No further information is available.
Pt had flu like symptoms the day after the injection. Two days after the injection she broke out in hives. Hives are controlled by Benadryl. Currently still needs benadryl.
Back of neck expanded with enormous amounts of fluid needed palpation to swallow excess fluid. The right larger than left. Pain and tenderness in both ears, sound sensitivity, overall aches in head. This continued for over a month adding difficulty going over mountains or high elevation experiencing immense pressure and pain. The fluid turned to crepitus and was crunchy all the way to shoulder traps. Had walk in care at work check me out at work immediately after I couldn't handle pressure. My ears had blood in them and I coul blow air through my right ear. Had to wait months for ENT which worked as well. She claimed it was TMJ despite me explaining this all happened because of the flu shot. I was suspended without return of job on Dec 12 2018 because I refused the flu shot for medical reasons.
Report A0370081A describes a 46 year old male who did not respond to two injections of Twinrix. This report was received from the vaccinee and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. The vaccinee reported that he received injections of Twinrix in October 2001 and November 2001; exact dates of immunization and lot numbers of vaccine were not known. The vaccinee donated blood in May 2002. At that time, he was told that he did not "have protection from hepatitis B." His spouse and child, who also received two injections of Twinrix "had protection."
swelling of right arm; blisters below the injection site; This case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 44N5L, expiry date unknown) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced swelling arm and blister. On an unknown date, the outcome of the swelling arm and blister were unknown.   It was unknown if the reporter considered the swelling arm and blister to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix and developed swelling of the right arm, a raised area described as a large mosquito bite, and a couple of blisters below the injection site. It was unknown if the event was ongoing.  The patient would like to receive the 2nd dose and it had been more than 6 months since the initial dose. The follow up consent was granted. The reported batch number was updated from 44NSLto 44N5L, as per sales data sheet.
Rheumatoid arthritis; little stiffness in her arm; she was not feeling very"/just felt little off; little pain in her left arm where the vaccination was given; pain in her elbow; seems like her left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (lot number: EN6202 and expiration date: 30Jun2021) as 0.3 mL, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Vaccine last Friday (05Mar2021) and on an unknown date, she had little stiffness in her arm and she was "not feeling very" (incomplete sentence), you know she was just felt little off but other than that, not too bad. The patient also had a little pain in her left arm where the vaccination was given and some stiffness on unknown date. Since then, she had pain in her elbow on left arm and today (10Mar2021), the pain was pretty persistent and seems like her left arm was swollen. The patient also stated "I guess I should say, I have rheumatoid arthritis" (pending clarification)". The patient received treatment for the events, stated "The only thing I took in this morning is Tylenol." Outcome of the events was unknown.
Redness and swelling and tenderness on the upper 1/2 of the (R) upper arm after Tdap (IM) injection. Advised warm compress/Motrin 100/5 1 tsp q 6 hr. Return to clinic in 48 hours.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 17th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th February 2019, less than a day after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX on left arm. The patient planned to follow up with her physician on an unknown date. Consented to follow up was provided.
urticaria; body turns red; Initial information was received on 12-Aug-2020 regarding an unsolicited valid non-serious case from the physician.  This case involves a female patient of unknown age who experienced urticaria and her body turns red (erythema), while she received vaccine TETANUS TOXOID.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer for prophylactic vaccination (batch number and other dosing details were not reported).  On an unknown date, the patient developed non-serious urticaria (urticaria) and her body turns red (erythema), (unknown latency) following the administration of TETANUS TOXOID.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
Moderna COVID-19 Vaccine EUA Upon reconciliation of the patient records in ICARE, it was brought to the attention of Dr. that this patient, is only 17 years old, and was inadvertantly administered the Moderna vaccine.  Upon review, per the CDC website: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html if a minor is inadvertantly administered the vaccine, a second dose may be administered if the benefits outweight the risk.  Called patient today, spoke wtih mother Svetlana, to inform her of the inadvertant vaccine administration to her son such that he is 17 years old, which does not meet the EUA approved age of 18 years and older for Moderna.  Mother stated that son tolerated first dose well, and has no underlying health conditions.  Discussed the current lack of evidence/data for those less than 18 years old on the efficacy of the Moderna vaccine, but that trials are currently underway.  At this time discussed risk/benefts, and clinically at this time there is minimal risk to her son receiving the second dose if the parent/son agree.  Informed her that a parent/gaurdian must be present with her son at time of vaccination.  Mother verbalized and agreed to all above information. Mother stated that she will have her son get second dose, and to keep appt on 4/23.
No adverse event reported. Pt may have received expired vaccine and this is why the Pharmacy has me reporting this as a VAERS.
Upset stomach; Gas; Cramps in stomach; Difficulty getting to the bathroom; Headache; Tired; Nausea; Got diarrhea again; Intermittent bouts of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Intermittent bouts of diarrhea), ABDOMINAL DISCOMFORT (uUset stomach), FLATULENCE (Gas), ABDOMINAL PAIN UPPER (Cramps in stomach) and ASTHENIA (Difficulty getting to the bathroom) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TRAZODONE, ROSUVASTATIN CALCIUM (CRESTOR) and GABAPENTIN for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced DIARRHOEA (Got diarrhea again). On an unknown date, the patient experienced DIARRHOEA (Intermittent bouts of diarrhea), ABDOMINAL DISCOMFORT (uUset stomach), FLATULENCE (Gas), ABDOMINAL PAIN UPPER (Cramps in stomach), ASTHENIA (Difficulty getting to the bathroom), HEADACHE (Headache), FATIGUE (Tired) and NAUSEA (Nausea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Adverse event NOS, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Intermittent bouts of diarrhea) had resolved and ABDOMINAL DISCOMFORT (uUset stomach), FLATULENCE (Gas), ABDOMINAL PAIN UPPER (Cramps in stomach), ASTHENIA (Difficulty getting to the bathroom), DIARRHOEA (Got diarrhea again), HEADACHE (Headache), FATIGUE (Tired) and NAUSEA (Nausea) outcome was unknown.            This case was linked to MOD-2021-034265 (Patient Link).
This spontaneous report as received from a healthcare worker refers to a 54 year old female patient with no pertinent medical history. In 1998 the patient ws vaccinated with a dose of VAQTA (dose, route, indication, lot# not reported). On 25-JUN-2014, the patient had unspecified labs drawn on because the patient was going to be having an unspecified surgery on an unspecified date and the lab results showed that the patient was positive for Hepatitis A. There was no treatment given for the event. The patient did not seek medical attention. The outcome of the event was unknown. Additional information has been requested.
MMR given 06/21/02 pt reports knot appeared right site of neck (even at ear lobe to hair line). Size of walnut-swollen/tender. Passed out 07/04/02 while shopping c/o nausea-vomiting, fever and taken to ER. Told by ER doctor lymph nodes, placed on clindamycin and nuaprox. Knot still present and not tender as of 07/09/02. Decreased swelling, slightly still with nausea/fever as of 07/08/02. Tetanus vaccne (U0375AA) IM right arm on 06/26/02.
Patient after receiving the vaccine was waiting in the observation area when she told us that she was dizzy.  Soon after that she briefly passed out on the chair she was sitting on.  Patient was passed out for about 5-10 seconds and came out soon after.
Erythema and blistering of skin around injection site. Application of OTC topical steroid