chrisvoncsefalvay/vaers-outcomes huggingface dataset:
26 doses of COVID-19 vaccines of moderna were administered past expiration date; 5 vials that where stored in the fridge for more than 30 days.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 doses of COVID-19 vaccines of moderna were administered past expiration date) and PRODUCT STORAGE ERROR (5 vials that where stored in the fridge for more than 30 days.) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (patient was under treatment for this illness.).    On 31-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 doses of COVID-19 vaccines of moderna were administered past expiration date) and PRODUCT STORAGE ERROR (5 vials that where stored in the fridge for more than 30 days.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 doses of COVID-19 vaccines of moderna were administered past expiration date) and PRODUCT STORAGE ERROR (5 vials that where stored in the fridge for more than 30 days.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had no known allergies. No concomitant medication was provided.  It was reported by Health care professional that they administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that were stored in the fridge for more than 30 days. Vial did not undergo any temperature excursions. Reporter did not know if patient experienced any symptoms after vaccination or any treatment was given to patient.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 13-SEP-2017, the patient was vaccinated with an expired dose of GARDASIL (lot # J009243 and expiration date: 17-APR-2017) for prophylaxis. There were no adverse effects.
Within one or two months of vaccine, I developed Tardive Dyskinesia (TD) symptoms.  There is some uncertainty as to whether or not I actually have TD, but I have symptoms that are like it.  They have not gone away yet.
Patient tested positive for COVID-19 after completing the full Moderna vaccine series, 46 days after 2nd dose.   Patient received 2nd dose of COVID vaccine on 2/4/21 .   Tested positive on 3/22/21.   NOT hospitalized. "First COVID test.   Had a negative test on 3/7/2021"
Headache, Myalgia, Fever, cough, rhinorrhea, fatigue, chills Narrative:
administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received Men CYW liquid conjugate portion only of Menveo vaccine and the vaccine was not reconstituted with the lyophilized Men A portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional did not have patient details or vaccine lot number and expiration date. The reporter consented to follow up. This case was 1 of 8 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169160:Same reporter US-GLAXOSMITHKLINE-US2021AMR170397:Same reporter US-GLAXOSMITHKLINE-US2021AMR170398:Same reporter US-GLAXOSMITHKLINE-US2021AMR170399:Same reporter US-GLAXOSMITHKLINE-US2021AMR170403:Same reporter US-GLAXOSMITHKLINE-US2021AMR170401:Same reporter US-GLAXOSMITHKLINE-US2021AMR170402:Same reporter
fever; chills; scleroderma; This spontaneous report was received from a currently 66-year-old female patient referring to a herself via Pfizer. Her historical vaccine included Moderna Covid-19 vaccine. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided.  On 10-MAY-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis.  On approximately 20-MAY-2021 (reported as 1.5 weeks or 10 days after the vaccination), she had a delayed reaction of fever and chills to the vaccine. On an unknown date in 2021, the patient experienced scleroderma. The outcome of fever and chills was reported as recovered on an unknown date in 2021. The outcome of scleroderma was not provided, however the patient stated, she was supposed to be starting an immunosuppressant therapy called mycophenolate mofetil (CELLCEPT) soon.  The reporter considered fever and chills to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). The relatedness between scleroderma and the suspect vaccine was not provided.  Upon internal review, the event of scleroderma was considered to be medically significant.
Pt developed fevers as high as 101 degrees F intermittently which started 24 hours after immunizations were administered. Five days after vaccines, pt developed increased sleepiness and what was reported as a febrile seizure. Pt was observed in hospital and evaluated for sepsis for 48 hours. All studies, including Head CT, EEG, CSF, Urine culture and blood cultures, were all normal.
Rheumatoid arthritis or poli rheumatoid poli maquia; Was diagnosed whit anemia; Amost could not walk; Loss appetite; Upset stomach; Lost weight; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis or poli rheumatoid poli maquia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On 09-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis or poli rheumatoid poli maquia) (seriousness criterion medically significant), ANAEMIA (Was diagnosed whit anemia), GAIT INABILITY (Amost could not walk), DECREASED APPETITE (Loss appetite), ABDOMINAL DISCOMFORT (Upset stomach) and WEIGHT DECREASED (Lost weight). The patient was treated with IRON for Anaemia, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis or poli rheumatoid poli maquia), ANAEMIA (Was diagnosed whit anemia), GAIT INABILITY (Amost could not walk), DECREASED APPETITE (Loss appetite), ABDOMINAL DISCOMFORT (Upset stomach) and WEIGHT DECREASED (Lost weight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight: decreased (Low) Decreased. In 2021, White blood cell count: increased (High) Risen in recent studies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment -This case concerns a 75-year-old, female patient with no relevant medical history, who experienced the serious unexpected event of Rheumatoid arthritis, unexpected non-serious events anaemia, gait instability, decreased appetite, abdominal discomfort and weight decreased. The events occurred on an unknown date after the second dose of Spikevax. The rechallenge was not applicable since only information about one dose was disclosed. The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns a 75-year-old, female patient with no relevant medical history, who experienced the serious unexpected event of Rheumatoid arthritis, unexpected non-serious events anaemia, gait instability, decreased appetite, abdominal discomfort and weight decreased. The events occurred on an unknown date after the second dose of Spikevax. The rechallenge was not applicable since only information about one dose was disclosed. The benefit-risk relationship of Spikevax in not affected by this report.
Patient reported soreness at injection site hours after receiving vaccine. The next day there was swelling and redness in the left arm and patient also began to experience fever and chills over whole body.
10/24 pain and warmth developed in right arm. 10/25 rash appears on right hip and leg. 10/26 rash spreads to left hip and leg resolving on right side some what. 10/30 wife calls to inform of rash. 11/1 rash resolved arm still tender.
1hr p/vax pt began crying high pitched cry last until 28SEP95 8AM;rash began 28SEP95 AM on back, shoulder, chest;
redness all over body ( allergic reaction), Difficulty breathing, Body aches, I?ll keep town food and will throw up whatever is eaten, Fever and chills
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received FLUARIX QUADRIVALENT (2018-2019 season) (batch number 59H3J, expiry date 30th June 2019) for prophylaxis. On 1st November 2008, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 2nd November 2008, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The pharmacy intern stated that the patient received the FLUARIX QUADRIVALENT vaccine in left arm. Next day the patient experienced severe soreness at the injection site. On 28th November 2018, the patient came by the pharmacy and she was still experiencing soreness. No further details were provided.
My period was supposed to start on 04/09 the day I got the vaccine. It was delayed until 04/13 when it began to bleed BLACK clotty sticky sludge. It had the appearance and consistency of vegemite or molasses. Black sludge. At first it was extremely heavy with very large black clots. Then it became tiny little black clots suspended in a brown sludge. This continued for 6 days until 04/18. Then on 04/19 my menstruation turned bright red with no clots, but has not abated at all for another 4 days. I am currently today on Thurday 04/22 still bleeding almost 2 weeks after taking the J&J shot. I cannot believe I am still bleeding after 10 full days!!! Never in 30 years of menstruating have I had a 10 day period. I am very scared and upset.
severe pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (pharmacy intern) reported similar events for 2 patients. This is 1st of 2 reports.   A patient of unspecified age and gender received bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced severe pain (not specified) on an unspecified date. The action outcome of event was unknown.  Information on lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021057811 same reporter, different patient
I developed shingles. I started taking Valacyclovir and still have the rash one week later.
Have developed a 1 1/2" width x 2 1/4" length red, patchy rash at the injection site that is tender upon palpation, warm to the touch, and itchy beginning on 1/21/2021. Today (1/22/2021) the area is red throughout and is larger measuring 2" width x 2.5" length.  It continues to be tender upon palpation and warm to the touch.  I am no longer experiencing itchiness of the reddened area. I have not treated the reddened area.  I will continue to monitor it daily.
Patient experienced fatigue and headache about 5 minutes after receiving vaccine, which subsided later that afternoon. Same day evening, patient noticed hives all over chest which were warm to touch and itchy. Next day, she noticed soreness at site of injection and stiffness in the ipsilateral hand of injection. Left hand is still stiff and hives have reduced but not gone away.
Patient received injection and within 3 minutes had large (6 inch) redness and swelling over injection site. Very itchy. No throat swell. No difficulty breathing. Watched patient for any worsening - over 15 minute period swelling went down. Patient advised to take Loratadine 10 mg. Still no hives, no tongue swell, no difficulty breathing.
On 2/7/2021 approx 8 PM noticed some tightness of the right arm at the injection site. On 2/8/2021 in the afternoon some swelling and continued "tight skin" of the right bicep was noted. On 2/8/2021 approx 9:30 PM noticed some "flu-like" symptoms and "poor dexterity" of right arm. Flu-like symptoms lasted until 2/9/2021 but "poor dexterity" and pain of right arm continued through 2/10/2021. On 2/9/2021 noticed swelling of the lymph nodes in the right armpit area, described by individual as "golf ball" size. Swelling increased on 2/10/2021 to include right side of chest. Pain was noted in the pectoralis and right side of back. Individual self-treated with motrin and ice for a few days. Individual did not seek medical care. Individual did not require hospitalization or doctor visit. Individual denied that swelling/pain interfered greatly with quality of life or activities of daily living. Individual did not report symptoms to Medical Clinic until >10 days after symptoms began. At the time of report individual states that flu like symptoms and pain have completely resolved. However, individual still reports some mild swelling (reports improvement of 80-90%).
arm was pounding; pouring headache/pouring headache; sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (on an unknown date received first dose of Shingrix, refer US2023AMR084833).   On 12-JUN-2023, the patient received the 2nd dose of Shingles vaccine. On 13-JUN-2023, 1 days after receiving Shingles vaccine, the patient experienced arm discomfort (Verbatim: arm was pounding), headache (Verbatim: pouring headache/pouring headache) and pain in arm (Verbatim: sore arm). The outcome of the arm discomfort and headache were resolving and the outcome of the pain in arm was resolved.   It was unknown if the reporter considered the arm discomfort, headache and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the arm discomfort, headache and pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR084833   Additional Information: GSK Receipt Date: 14-JUN-2023 The case was received from the patient via interactive digital media. On Monday patient got her second dose of Shingles vaccine and experienced pounding arm, her arm was hurting a lot more and had pouring headache.  She was just feeling better till date. The sore arm lasted a week.  However, she said it was better than getting shingles  Her husband had shingles and did know it right away. It was awful pain and itching bad. Her husband should get the shots as she had heard shingles could hit again. Her husband was in his early fifties and now he was in his 60s Her arm hurt some after the first shot and no others affect.; Sender's Comments:  US-GSK-US2023AMR084833:Same patient/First shingles shot
I have had a cough, sore throat, and some chest pain for almost 2 months. This all started a few days after my second shot of the Moderna COVID-19 vaccine on May 5, 2021. I went to an UrgentCare on May 24th, and the nurse told me "this is happening to everyone... it's just something going around... it will go away". A week later, I went somewhere else and got Amoxicillin. I took Amoxicillin for 7 days and it did not resolve my cough. My primary doctor is currently not seeing any patients for "respiratory-related illnesses".
Information has been received from a health professional concerning a 77 year old white female with hyperlipideamia, morphine allergy, hypertension and asthma who on 10/14/2004 was vaccinated intramuscularly in the left deltoid with a third dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included HCTZ/triamterene (Maxzide) and an unspecified asthma inhaler.  During the evening of 10/14/2004, the patient presented to the emergency room complaining of left should pain.  It was noted that the left arm pain was a possible reaction to the vaccination received that day at the physician's office.  The patient stated, I can't lift my left arm, it feels like it is broken.  The patient's skin was pink, warm, and dry.  Her respirations were easy.  The patient was given diphenhydramine HCL 50 mg to take at home that night.  The patient was also to apply ice to her shoulder.  On 10/18/2004, the patient reported that her arm felt better.  Additional information is not expected.
A few hours after shot my left arm became very sore and my lower back and thighs became very sore.  When I woke up the next morning, my ears were completely clogged, and everyone's voice sounded as if they were in a tunnel.  I had a headache, stuffy head and nose, sore arm, low back and thighs still hurting, and a general feeling of being unwell.  The clogged ears, headache, stuffy head and nose resolved in 24 hours, but my lower back and thighs still aching.  I normally have low back pain, but it has been much worse since receiving 1st covid shot.  I am hesitant now to get the 2nd shot.
Depression; This spontaneous case was reported by a patient and describes the occurrence of DEPRESSION (Depression) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEPRESSION (Depression). At the time of the report, DEPRESSION (Depression) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported. The patient's treatment medication was not reported.
Vaccinator went to our 2nd vaccine table to check-in patient.  She went through all the correct check-in procedures and took a vaccine from the brown bag on the table & administered from 1 of 2 vaccine syringes.  The gentleman began his 15-min wait time and she came right over & reported that she was certain she gave a dose from a bag left on the table dated for yesterday.  I immediately contacted my lead and in turn made contact.  We advised what had occurred, realizing someone left the 2 syringes in the bag yesterday (11-11-21).  During all the notifications, the patient had left the clinic, appearing to have no reaction of any kind.
Right lower extremity DVT; Bilateral PE; Severe fatigue; This is a spontaneous report from a contactable physician. A 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9269) via an unspecified route of administration on 25Feb2021 at a single dose for COVID-19 immunization. Medical history included Allergies: adhesive, CT scan dye & flu shot. Concomitant medication included rosuvastatin. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient also previously took Demerol, guaifenesin;phenylephrine hydrochloride (ENTEX), epinephrine, amoxicillin;clavulanic acid (AUGMENTIN) and experienced allergies. On 03Mar2021 17:15 the patient experienced severe fatigue, right lower extremity DVT, Bilateral PE. Events were considered serious, due to hospitalization for 1 day and life threatening. Treatment was received for the adverse event which included apixaban (ELIQUIS). The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19 with unknown result on an unknown date. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. Outcome of the events was recovering.   Follow up attempts needed. Further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Onset of event approximately 12:30 pm on 3/4/2021 with duration through approximately 4:pm on 3/5/2021.  Patient described extreme fatigue and weakness, disorientation/lethargy, vomiting x 1.
Loss of consciousness for under 30 seconds EMS was called and patient was awake and alert upon their arrival. Patient was light headed and dizzy so EMS encouraged patient to be further evaluated at the ER.
Got poked twice with needle when second dose was injected, didn?t feel any effects until 11pm that day.  4 am woke up with fever and extreme chills and body aches that I could not sleep. Small red rash appeared by the injected site on March. 12th 1:00pm.  Rash is not itchy yet but it hurts. Arm is bruised by needle too. More chills and body aches in the evening. March 13th 12pm the small red rash is bigger, and is now itchy. Arm aches still.
Lft. arm swelled up, got very hot, red, and itching. Continued to swell overnight.
Fever, body aches, headache, chills, 2 days weak, tired,  now hives on arms, and chest 4th day still have symptons
swelling and pain R arm injection site; headache has resolved  Recommend to caller to use cold compresses to injection site 10min on/10min off; Claritin or Zyrtec for itching; monitor site