chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 26-MAY-2022; Dose of the Moderna COVID-19 vaccine was administered after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna COVID-19 vaccine was administered after the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 26-MAY-2022) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2022 at 1:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 26-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna COVID-19 vaccine was administered after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 26-MAY-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna COVID-19 vaccine was administered after the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 26-MAY-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    The vial did not undergo any temperature excursions.  No treatment information was reported.   This case was linked to MOD-2022-583132 (Patient Link).
After 1 hour developed heaviness in left deltoid, left shoulder running down my clavicle. Pain at injection site. Neck tiredness. Shoulder heaviness. Fatigue. Tiredness. Exhausted. Neck soreness.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female with depression, gestation for 14 weeks and 5 days and no drug allergies who on 09-OCT-2010, 17-OCT-2011 were vaccinated with the first and second dose of GARDASIL, respectively. Concomitant therapy included prenatal vitamins (unspecified). On an unspecified date, routine lab blood work was performed with unspecified results. The patient contacted physician to seek medical attention. No treatment was given for the adverse event. The last menstrual period was on 07-JUL-2011, and estimated delivery date was on 12-APR-2012. At the time of the report, the patient's outcome was unknown. Follow up information has been received from an outreach specialist who reported that the patient gave birth on 19-APR-2012 at 40 weeks, to a healthy baby boy via vaginal delivery. The infant weighted 8 lb 5 oz. There were no complications with delivery or infant congenital anomalies reported. Follow-up information has been received from a physician concerning a patient with obesity and depression and a history of two previous pregnancies and two elective abortions. Concomitant medication was reported as "prenatal vitamins". It was reported that the patient gave birth on 19-APR-2012 at 41 weeks (previously reported 40), to a male infant without congenital anomalies; it was also reported that the baby was not normal. Apgar scare 8/9. Diagnostic tests included ultrasound scan (Date:unknown, result: normal). There is no complication and infections or illness during pregnancy. No further information is available.
After shot 1 - violent diarrhea, ill, confused after shot 2 - worse diarrhea, sick + weak, much congnitive impairment AFTER BOOSTER  ER Violent diarrhea, weakness, collapse afibrillation could not be controlled required pacemaker went into congestive heart failure - rapid decline-> died in hospice  Following pacemaker installation, patient went into rapid decline, was in and out of the ER and stayed in cardiac ICU repeatedly until she died in hospice on September 23, 2022 She had been strong and active, entirely independent, residing in an independent  living residence for active seniors. She went to the gym took exercise classes, had only intermittent afibrillation. Her 2nd Covid shot impacted her cognition. She did not recover. Very intelligent professional woman. Fully competent.. Following her booster shot the afib became uncontrollable in the heart hospital. She became disoriented and very sick. After the surgery she returned to normal cognition progressed well through her rehab but began to experience all the symptoms of congestive heart failure from which she died.
Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient was vaccinated with an improperly stored dose of PROQUAD 0.5 ml (unspecified dose) with lot number L031603 (expiration date 18-FEB-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
This spontaneous report was received from a registered nurse refers to a currently 4 year old patient of unknown gender. On an unknown date, the vaccine PROQUAD was improperly stored. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (dose, route and lot # were not reported). No adverse effects reported. At the time of the report the action taken was not reported. This is one of several reports from the same source. Additional information has been requested.
Arms were swollen to the elbow, severe pain, arms hot and had a metallic taste in my mouth. Lost time from work, post vax. Confined to bed rest for approx. 18 hours straight. Arms were red in color, had headaches and fevers. These symptoms occurred after each vaccination and lasted for months.  Follow up on 12/20/2000 : "The patient fully recovered from adverse event.  Patient did receive further shots, events were" Itching, swelling, pain, soreness and redness in arm.  There was also a bump in arm that took about 2 months to disappear.  Fevers and headaches."
No other adverse events reported; an expired dose of VAQTA was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 31-MAR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA)1 dosage form, lot #T040581, expiration date: 28-MAR-2022, administered intramuscularly for prophylaxis (strength was not provided). No additional events were reported.
This case involves an adult patient who experienced patient was allergic to that flu vaccine (allergy to vaccine), while the patient received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious patient was allergic to that flu vaccine (allergy to vaccine) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Details of laboratory data was not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the event outcome is unknown. There will be no information on batch number for this case.
Opposite arm pain.  Then chills and pain in all joints and muscles.  It lasted all night following injection. The next few days I felt tired and easily out of breath.
This spontaneous case reported by a patient, describes the occurrence of administration site discomfort (the doctor believes this dose might have hit the bone) and vaccination site pain (experiencing pain) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# not known) for COVID-19 immunization. No medical history reported. On Apr 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced administration site discomfort (the doctor believes this dose might have hit the bone) and vaccination site pain (experiencing pain). At the time of the report, administration site discomfort (the doctor believes this dose might have hit the bone) and vaccination site pain (experiencing pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported/provided.
Knot there in my arm area; Spot on her left temple like a pimple or a blister; Lethargic; Fever shot up; Fatigued; Arm swelled up; Sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever shot up), FATIGUE (Fatigued), PERIPHERAL SWELLING (Arm swelled up), PAIN IN EXTREMITY (Sore) and MASS (Knot there in my arm area) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 and Allergy (Aspirin salts.) since an unknown date.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PYREXIA (Fever shot up), FATIGUE (Fatigued), PERIPHERAL SWELLING (Arm swelled up), PAIN IN EXTREMITY (Sore) and LETHARGY (Lethargic). On an unknown date, the patient experienced MASS (Knot there in my arm area) and BLISTER (Spot on her left temple like a pimple or a blister). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Blister, at an unspecified dose and frequency. On 24-Jan-2021, PYREXIA (Fever shot up), FATIGUE (Fatigued) and LETHARGY (Lethargic) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm swelled up), PAIN IN EXTREMITY (Sore), MASS (Knot there in my arm area) and BLISTER (Spot on her left temple like a pimple or a blister) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication provided patient called for her eye doctor and who gave her eyedrops which she using.
Fatigue and headache day after vaccination, next morning I passed out. Nausea, dizziness.
Swollen and painful lymph; Very swollen and painful lymph in the armpit; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 15Apr2021 at 15:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included Meniere's disease and seasonal allergy.  The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (ADVIL) from an unknown date and unknown if ongoing for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 15:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 16:00, the patient reported that she had very swollen and painful lymph in the armpit on the same arm as the second injection. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events very swollen and painful lymph in the armpit was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient developed near immediate pain and swelling at the injection site. This progressed over several hours and was accompanied by a fever to 102 degrees. The involved arm was difficult to raise. The patient also had a headache. 48 hours later, the pain is less and the fever is 101 degrees. There is now induration and erythema at the injection site that is 10 x 12 cm.  The patient was treated with benadryl and vicoden. Keflex was also added.  The patient carries the diagnosis of ITP and is being prepared for a splenectomy.
Approx 10-15 mins after I experienced a cloudy vision  for a few seconds, after rapid blinking 10-15 times vision returned at the same time I felt a tightening of muscle or spasm sensation starting from behind my right ear moving around the base of my head to the middle this tightening sensation was very alarming and after getting stronger I alerted the nurse who monitored my condition and had me to stay longer than the 30 mins required. I felt not myself after reaching the lobby and sat a little while there. Once home took tylenol and rested for while woke with horrible headache including the next day.
Hyperthyroid issues; A Spontaneous  report was received from a consumer concerning a female  patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hyperthyroidism/hyperthyroid issues.  The patient's medical history was  provided as sinus infection and tooth extraction before vaccine administration. The concomitant medications were reported as unknown antibiotics.   On 18 Feb  2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route in an unknown location for prophylaxis of COVID-19 infection.  On an unknown day after vaccination patient experienced hyperthyroidism.   No treatment medication was reported.   The event hyperthyroidism was considered as medically significant.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, hyperthyroidism  was considered as recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
On 9/28/00, pt had a sore arm. ON 9/29/00, pt had scratchy throat, nausea, headache, muscle soreness, fever up to 102F and dizziness. On 10/03/00 and 10/04/00, pt had vomiting.
Redness, swelling, and increased pain occurred anteriorly and inferiorly to the injection site, and these symptoms started about 1 day after the shot.  They worsened over next 24 hours, and I was able to observe this by comparing picture from yesterday to his arm today in clinic. I diagnosed him with cellulitis.
The second one gave me eczema; This case was reported by a consumer via interactive digital media and described the occurrence of eczema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix vaccine with an associated reaction of illness (1st dose was received on unknown date. Kindly refer this case - US2023AMR018247).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced eczema. On an unknown date, the outcome of the eczema was unknown.   The reporter considered the eczema to be possibly related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR018247   Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's comments: This case was reported by the patient via interactive digital media. She had stated that she got the shingles vaccine.  The first one made her sick. The second one gave him/her eczema.  The reporter had asked others to skip the shot.  Additional supportive information: Follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR018247:Same reporter.
Cold and flu like symptoms for 2 days after initial vaccine and 1 day after second dose, including fever, chills, lethargy and overall tiredness. Have not had my period since administration of second vaccine
Child became febrile, cyanotic on feet and white hands (per parent). Seen in ER and released.
Felt a huge pain on left calf; Swollen and extremely painful injection site; Swollen and extremely painful injection site; Muscle pains all over the back and legs; Muscle pains all over the back and legs; Headaches; Joint pain; Swollen fingers; Brain fog; Pain started on the right leg and thigh; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient 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 31Aug2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and polycystic ovarian syndrome (PCOS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL); both from unknown dates for unknown indications and unknown if ongoing. On 01Sep2021, the patient experienced swollen and extremely painful injection site for about 4 days. The patient had muscle pains all over the back and legs that had not gone away even after 2 weeks and it was getting worse. The patient had headaches, joint pain/ swollen fingers, and also experienced brain fog. On 02Sep2021 (Day 2), the patient felt a huge pain on the left calf that got better after 2 weeks. Then, on an unknown date in Sep2021, the pain started on the right leg and thigh. It was reported that the events were all after the first dose only. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen and extremely painful injection site was resolved on 05Sep2021, after the duration of 4 days. The clinical outcome of the event felt a huge pain on left calf was resolving. The clinical outcome of the events pain started on the right leg and thigh, muscle pains all over the back and legs, headaches, joint pain, swollen fingers and brain fog were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Had usual nasal rinse for allergies, per mom, approximately seven hours after receiving flu mist on 10/7/08.  Also uses Astelin nasal spray.  Blister noticed 10/11/08, getting worse.
1/17/01 8:35am mother called stating child rec'd vaccine yesterday and presently was complaining of swelling of both legs and L foot, unable to put shoe on L foot, states child has been very fussy since leaving clinic yesterday pm and has been up most of the night crying. No complaint of SOB or respiratory discomfort. Referred to Dr for evaluation
blood clots in both legs were detected on 5/11/2021, 18 days after receiving the 2nd dose of Moderna vaccine.
body aches, lethargy/drowsy, loss of appetite, nausea, dizziness
Pt developed 3 quarter size hives, hot to the touch the evening after receiving the varicella vaccine in the LA. Area very itchy.
pancreatic insufficiency; diarrhea; gas; This case was reported by a consumer via call center representative and described the occurrence of pancreatic insufficiency in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included carica papaya (Papaya Tablets) tablet for product used for unknown indication.   Concurrent medical conditions included pre-diabetes.   On 23rd October 2019, the patient received the 1st dose of Shingrix. In October 2019, the patient started Papaya Tablets at an unknown dose and frequency. In October 2019, less than a week after receiving Shingrix, the patient experienced pancreatic insufficiency (serious criteria GSK medically significant), diarrhea and gas. The patient was treated with pancreatin (Creon). The action taken with Papaya Tablets was unknown. On an unknown date, the outcome of the pancreatic insufficiency and gas were unknown and the outcome of the diarrhea was recovering/resolving.   It was unknown if the reporter considered the pancreatic insufficiency, diarrhea and gas to be related to Shingrix.  Additional details were reported as follows: The patient was pre diabetic before getting the Shingrix shot and she was taking papaya pills at night before getting the shingrix shot.      The patient developed diarrhea within a week after receiving shingrix vaccine. She tried eating eggs and cheese to resolve the issue. The patient went to the doctor who ran blood tests and did stool sample and nothing was found. She was referred to a Gastroenterologist who determined she had pancreatic insufficiency.  She was prescribed to take creon enzyme tablets and those tablets helped with the diarrhea but patient stated that she was being told her pancreas may not improve. The patient had a computerised tomogram scan and there was no growth on pancreas and no cancer was detected. The reporter consented to follow up.      Lab Comments: On an unknown dates, the lab tests were performed
Patient got really flushed and hot and came back to the pharmacy about a half hour after the shot. She then started saying that she was itchy and continued monitoring. Patient said no issues breathing but I gave her 50mg of benedryl. Patient declined going with ems as she was feeling better after the benedryl.
About 4-5 hrs after shot, arm began to get sore and had some body aches that night.  The following  day  muscle aches got worse and that evening got really bad chills with a migraine.  Woke up the next day and was back to normal.
Fever, body aches, edematous lymph nodes, malaise, fatigue , edema and fever a injection site
This spontaneous report as received from a nurse refers to a 16 year old patient of an unknown gender. On 26-JAN-2015, the patient was vaccinated with improperly stored GARDASIL (lot # H012643 and expiry date: 30-MAR-2015). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Pt came to office with red widespread papular rash, MD thought consistent with post MMR vaccine rash. No fever.