chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 18th January 2022, the patient received the 2nd dose of Shingrix. On 18th January 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was administered with an expired dose of Shingrix on the reporting day and the reporter asked if she should be re vaccinated. The reporter consented to follow up.
The pt developed redness, swelling, mild discomfort for 24 hrs on the left deltoid. Treated with Ibuprofen.
Patient was injected with Pfizer covid 5-11 primary series vaccine on 10.03.2022 that had a manufacturer expiration date of 09.31.2022.  Spoke to site medical director who said the dose did not need to be repeated since it was within 30 days of expiration.
Fever of 101 orally, 96.9 axillary 22AUG90, swelling, redness & soreness at site of injection
Infantile seizure disorder; under the care of pediatric neurologist, taking Tegretol.
Large localized reaction 6 x 4 1/2 cm red area with a red hard core center of 3x1cm itching, edema 5/3/05 site improved red to pink extended had rec'd DT 5-6 yrs ago and prior to reaction.
1-Personality shift immediately from laughing and talking at 2pm to only crying, which was very unusual for her. Unexplained screaming fits lasted until 11/22 and first signs of talking again on 11/22. On 12/12 was the first sign of laughter again. Personality starting to come back. 2-The evening of the shot, 11/9 she developed a twitch where her head was sporadically twitching and tilting to the right side (ear to shoulder) looking like nerve damage. Lasting several days. 3-On 11/10 was a reaction at injection site. Swollen, red, hot and lump lasting until 12/5/16. 4-On 11/12 starting to throw up all day. No longer can take solids without throwing up. Believe to have triggered FPIES. Had no problem with the same food prior to shot. 5-Developed sporadic eye twitch in her right eye lasting until 12/26. Again same side as the previous head twitching. Again showing signs of damage to central nervous system and possibly brain. Could have been mild stroke.
Doses administered after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 4:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 4:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's age was reported as 47.80.  No concomitant medications were reported.  The vial was initially stored in the fridge on 05-Jan-2021, moved to clinic on 07-Jan-2021 and proposed beyond use date was 04-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
EARLY SUNDAY MORNING THE PATIENT BEGAN VOMITTING AND SHORT OF BREATH  AND CHEST AND BACK PAIN.  SHE CODED WHEN SHE GOT IN THE ER AND LATER PASSED AWAY THE MONDAY.   DIAGNOSIS WAS PNEUMONIA AND HEART FAILURE PER STEP DAUGHTER.
Patient reports feeling lightheaded and feeling like passing out, no other symptoms. Patient reports she had this feeling before, currently taking iron tablets, she reports feeling a little better. Patient was assessed by EMS and cleared. BP; 118/74,  pulse 96, Spo2 100%
About 5 hours after my shot I got a mild bitemporal headache and moderate myalgias.  I get this every time I get the covid shots, and this happened more quickly and was milder than in the past (each shot has had side effects quicker but milder over time).  Then Saturday morning after my shot I had pain in the back of my head that quickly intensified to the worst headache of my life.  Motrin, sumitriptan, excedrin migraine did not help.  Got a massage the next day, helped briefly.  Then the Monday after my shot I saw neurology who gave me occipital nerve block.   I had to miss work this day because headache so severe. Worked for the most part with mild headache bitemporal remaining that was gone by that night.  Then Tuesday my headache came back in the front/side of my head moderate/severe.  Took medrol dose pack and cyclobenzaprine and finally headache aborted and stayed.
AM p/vax hives in arm of inj;large welts, itchiness, low grade temp 100-101 resolved completely p/36hr;did not recv 2nd inj;
It is suspected that the patient received an inadequate dose at this administration. They presented and were potentially injected with an empty syringe (no air, just empty vanish-point).  The care team talked with the patient and they stated they had no signs or symptoms of a reaction and had no pain at the injection site. They stated they had some symptoms after their first dose. The patient was told that they will be rescheduled for their 2nd dose.
Only diluent was given, no active vaccine. No adverse side effects, family had to return for active vaccine.
Slightly swollen, red / inflamed, itchy rash area around vaccine injection site on left arm; about 3 inches in diameter; very sensitive to touch; lasted about 4 days. No treatment (did not disrupt normal functioning). Receded after about 4 days, no more symptoms.
Received 5 Covid Vaccines in the span of a month; Medication error; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 5 Covid Vaccines in the span of a month) and MEDICATION ERROR (Medication error) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 28-Jan-2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to at an unspecified dose. On 16-Feb-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, received fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received 5 Covid Vaccines in the span of a month) (seriousness criterion hospitalization) and MEDICATION ERROR (Medication error) (seriousness criterion hospitalization). At the time of the report, EXTRA DOSE ADMINISTERED (Received 5 Covid Vaccines in the span of a month) had resolved and MEDICATION ERROR (Medication error) outcome was unknown.        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.   The reporter states that the patient was transferred to a rehabilitation center on 19-MAY-2021 and then looks like she was in the rehabilitation center until 28-MAY-2021. Hospitalization: 19-MAY-2021 to  28-MAY-2021 rehabilitation center.  This report refers to a case of extra doses administered which resulted in a total of 5 Covid vaccines being given with an interval of approximately  1- 2 weeks apart,  who was hospitalized 3 months after receiving the vaccines. Very limited information has been provided at this time. Further information has been requested.; Sender's Comments: This report refers to a case of extra doses administered which resulted in a total of 5 Covid vaccines being given with an interval of approximately  1- 2 weeks apart,  who was hospitalized 3 months after receiving the vaccines. Very limited information has been provided at this time. Further information has been requested.
Painful right armpit (lymph node?), all- over- my-head headache,  dry cough, sweating, body aches & tightness all over, painful back of neck & low back especially.  Treatment: Tylenol & naproxen
Mom reports child started with knees itching then developed hives eight hours after vaccines given. Child was given oral Benadryl by mother. Seen by Pediatrician the next morning. Steroids prescribed then. Mom reports all symptoms resolved. Pediatrician plans to do allergy testing on child.
Got inj on 11/02/04 of TD Booster. The next day rash with raised areas with itching on chest back, neck stomach. Mother used Hydrocortisone and Benadryl. Saw on 11/16/04 Tx: Kenalog 30mg IM.
11:30PM 09-21 : headache, pain at injection site  4 hours after Vaccination  Ibuprophen 400mg 9:00 AM 09-22 : continued headache, Mild nausea 10:30 AM Fever(100.9), chills, muscle ache, headache, rersting heart rate 85bbp,Unable to proceed with daily activities  2:00 PM symptoms continue; ibuprofen 800mg 7:00PM Symptoms begin to lessen muscle aches gone 10:00PM Fever gone 400MG ibuprofen  02:00AM 09-23 Headache gone
This solicited report was received from a social media researcher regarding an article about HPV vaccine as a part of market research. The patient demographics and numbers were unknown. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates the patients received GARDASIL (dosing details not specified). On an unknown date, a lot of reactions were reported in number of patients such as epilepsy, dizziness, fatigue, weakness, headache, abdominal pain, muscle pain, and muscle weakness, joint pain, autoimmune problems, chest pain, hair loss, loss of appetite, personality changes, insomnia, trembling hands/feet, shortness of breath, heart disease, paralysis, itching, hives, swelling, muscle aches, menstrual cycle changes, fainting, swollen lymph nodes, night sweats, nausea, temporary vision loss and temporary hearing loss. Action taken with the vaccine was not applicable. The outcome of the events was not reported. Causality of the events with the study therapy was not reported. Upon internal review the events of epilepsy, stroke, autoimmune problems, paralysis, temporary hearing loss and temporary vision loss were considered as medically significant. This is one of the several reports received from the same source. Additional information is not expected as there was no consent for contact.
The employee got her first dose of Moderna COVID19 Vaccine on 18Nov2021 and 30Dec2021.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The employee got her first dose of Moderna COVID19 Vaccine on 18Nov2021 and 30Dec2021.) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The employee got her first dose of Moderna COVID19 Vaccine on 18Nov2021 and 30Dec2021.). On 30-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The employee got her first dose of Moderna COVID19 Vaccine on 18Nov2021 and 30Dec2021.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was reported.  Reporter stated that the patient has received her first dose of Moderna COVID-19 Vaccine on 18-Nov-2021 and second dose on 30-Dec-2021 and did not have any reactions.   Reporter also stated that the patient was not immunocompromised.   This case was linked to MOD-2022-460371 (Patient Link).
Approximately 24 hours after adm. of PENTACEL developed 2 x 2.5 cm erythema.  No itching.  No induration of right deltoid area.  Not painful.
Blurred and distorted vision that has progressed; Full bloom pain and spasms in left arm in muscle; Blurred and distorted vision that has progressed; Blurred and distorted vision that has progressed; Full bloom pain and spasms in left arm in muscle; This spontaneous case was reported by a consumer and describes the occurrence of METAMORPHOPSIA (Blurred and distorted vision that has progressed), MYALGIA (Full bloom pain and spasms in left arm in muscle), MUSCLE SPASMS (Full bloom pain and spasms in left arm in muscle), VISION BLURRED (Blurred and distorted vision that has progressed) and CONDITION AGGRAVATED (Blurred and distorted vision that has progressed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A2A1 and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced METAMORPHOPSIA (Blurred and distorted vision that has progressed), MYALGIA (Full bloom pain and spasms in left arm in muscle), MUSCLE SPASMS (Full bloom pain and spasms in left arm in muscle), VISION BLURRED (Blurred and distorted vision that has progressed) and CONDITION AGGRAVATED (Blurred and distorted vision that has progressed). At the time of the report, METAMORPHOPSIA (Blurred and distorted vision that has progressed), MYALGIA (Full bloom pain and spasms in left arm in muscle), MUSCLE SPASMS (Full bloom pain and spasms in left arm in muscle), VISION BLURRED (Blurred and distorted vision that has progressed) and CONDITION AGGRAVATED (Blurred and distorted vision that has progressed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment included Tylenol and Using ointments   This case was linked to MOD-2021-272155.
VACCINE WAS POSSIBLY PAST THE BUD AT VACCINATION ACCORDING TO THE VACCINE RECORD.  NURSE REPORTED ON VACCINE RECORD THAT VACCINE WAS GIVEN ON 11/1/22 BUT VIAL WAS OPENED ON 10/27/22.  UNABLE TO CONFIRM IF INDIVIDUAL WAS VACCINATED ON 10/27 OR 11/1.
large urticarial type plaques all over body, especially trunk;started to occur eve of vax;pt took DPH 6PM, again 12AM & again on next day;pt examined by MD given DPH & atarax;
Symptoms began approx 1 hours after administration vaccine. Chest pain, chest and throat tightness, nausea, vomiting, elevated B/P. Seen in ER/IV fluids Zofran.
Terrible pain in back of neck/ very bad pains back of my neck; Shoulder pain; Headache comes and goes; Little nauseous; Feeling generally unwell; Short of breath; Muscle pain; This is a spontaneous report from a contactable consumer (patient). An 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EL3249; expiry date: unknown) via an unspecified route of administration, on 14Jan2021, at a single dose, for COVID-19 immunisation (to protect from the virus). Medical history included COVID-19 and he was in the hospital for 3 or 4 days. He came out 10 days later and it was negative. Other medical history included heart disorder. Concomitant medications included carvedilol (COREG) taken for many years because it strengthens his heart, apixaban (ELIQUIS) as blood thinner, finasteride, furosemide (LASIX), sotalol, spironolactone, and ezetimibe, simvastatin (VYTORIN). The patient received his first vaccination this past Thursday and everything was fine. He woke up the following morning (15Jan2021) with terrible/ very bad pains pain in back of his neck, shoulder and headache. He was a little nauseous, just feeling generally unwell, and short of breath. The headache comes and goes which he controlled with Tylenol. He also had muscle pain on an unspecified date in Jan2021. Tylenol was also taken for events muscle pain, shoulder pain, headache, and terrible pain in back of neck/ very bad pains back of my neck. He was wondering if there is anything, he should know and do about it. Patient underwent an unspecified blood test/ lab works with unknown results. Outcome of the events headache and short of breath was recovering, for event muscle pain was unknown, while for the remaining events was not recovered.
20 days post vax the pt experienced fever and headache. The next day the pt reported 6 red vesicular lesions on her left flank and abdomen. The reporting physician "determined/recommended not to continue with second varicella vaccine assuming obvious immunity due to varicella like rash. On an unspecified date, the pt recovered. No further information is available.
an expired tenivac was given with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 17-year-old male patient to whom an expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine; HPV VACCINE VLP RL1 4V (YEAST) (Gardasil); measles vaccine, mumps vaccine, rubella vaccine (MMR) and polio vaccine (Polio) all for Prophylactic vaccination.  On 10-Feb-2023, the patient received suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult at a dose of 0.5 ml once (lot U6922AA, expiry date: 22-Jan-2023) via intramuscular route in the left deltoid for immunization.  On 10-Feb-2023, an expired tenivac was given with no reported adverse event (expired product administered, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.   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 the 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.
Lymph node under left ear swelled and remains swollen as of 5/25.; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0187) via an unspecified route of administration in the right arm on 20May2021 at 15:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse and cholesterol high. The patient had no known allergies. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN); ezetimibe (ZETIA) and apixaban (ELIQUIS) from an unknown date, for unknown indications and unknown if ongoing. 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 COVID vaccine. On 22May2021, the patient experienced lymph node under left ear swelled. The patient reported that she had lymph node under left ear swelled within 48 hours of vaccination and remained swollen as of 25May2021. No therapeutic measures were 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 lymph node under left ear swelled was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Received the 2nd dose of Moderna vaccine on 21st day, after receiving the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose of Moderna vaccine on 21st day, after receiving the 1st dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose of Moderna vaccine on 21st day, after receiving the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose of Moderna vaccine on 21st day, after receiving the 1st dose) had resolved. Not Provided      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.   No concomitant medications was reported.  No treatment details were provided.