chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effects; two patients, received improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age.  Concomitant therapy included sterile diluent lot number S007963 expiration date 02-AUG-2021 (dosage schedule, route, anatomical location, lot number and expiration date were not reported).  The patient's historical condition and drug reactions or allergies were not reported.      On 28-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number R030800 and expiration date 22-APR-2019, for prophylaxis(dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of the vaccine experienced a temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit. Total frame from 15-MAY-2019 to 31-MAY-2019 (16 days, 384 hours).  No previous temperature excursion. It was not recorded by a data logger.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA000935:
Sunday night, my heart started pounding really hard. I went to ER - Medical Center. They did an EKG and took my vitals. I had a fever (slight) and chills and was nauseous. Put  ONDANSETRON -4 mg. The nausea didn't go away and I couldn't eat or drink without vomiting until today. I couldn't eat or drink or was very tired and groggy and miserable. Today I  had another trip to the ER Medical, I got on an antibiotic and anti-nausea medication (GETHALEXIN - 500 mg for the GI) (METOCLOPRAMIGE HCL - 5 mg-  for nausea) from the hospital and I had a shot that went into my immune system. They also found a UTI today.
PLEURTIC CHEST PAIN, TINNITUS, PERIPHERAL DYSESTHESIA OF ARMS AND LEGS.  CLINICAL DIAGNOSIS OF PLEURITIS AND SMALL FIBER NEUROPATHY CAUSED BY MRNA VACCINATION
Leg swelling onset evening of shot. 48 hrs later, upper and lower leg signif. swelling. Ultrasound negative for DVT. Treated with antibiotics for presumed cellulitis.
MUCLE & JOINT PAIN THEN 13 DAYS AFTER CHEST PRESSURE
It has been 10 days and I am still suffering from aching pain mostly in my calves, but the rest of my body less severely. This happened after my first dose, perhaps more severely, but for only about 24 hours. This time it has not gone away.
About 2 weeks after receiving his booster shot he had horrible migraines that were happening 2-3 times a week and had shortness of breath! He had a CT of his head that confirmed he was in fact having migraines and we recently addressed the shortness of breath because it is getting worse and his EKG showed inflammation of the heart and he recently had a Echo
Within hours patient began studdering, slurring and became unable to form a sentence. She had difficulty doing regular tasks such as drive a car., she was tired and went to bed early. The next morning she complained of a headache, pain in her right arm at the insertion site, and could not walk without holding on to walls, speaking was difficult the same as above.  She went to the ER by 1 pm where they found that she was having a double brain bleed. With a cat scan with contrast. They send her to  a near by hospital with a Neurosurgeon on staff, Medical Center. They administer Vitamin K and Platelets and monitored her. At the first Hospital.  She is presently being admitted to a Rehabilitation unit. She continued with difficulty with speaking, difficulty with simple tasks such as using the phone and the nurse reported that she is weaker today than yesterday.
Localized reaction 2cm with 48 hours. Rx: warm compress Tylenol, benadryl as needed.
Within 7 min of injection, pt developed urticaria at injection site and scattered on hand and extremities. Wheezing-mild. Rx Zyrtec, Orapred and albuterol.
Big red rush around the area where the shot was given and it is very itchy still. At first it was swollen, red, itchy, tender and it was about the size of a quarter but it keeps getting bigger even though is not swollen any more.
Sore left arm persisting after INFLUENZA vaccine administrating to left deltoid 11/11/11.
Cramps; Concentrated urine; I got super sick with the first dose; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps), URINE OSMOLARITY INCREASED (Concentrated urine), ILLNESS (I got super sick with the first dose), HEADACHE (Headache) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Cramps), URINE OSMOLARITY INCREASED (Concentrated urine), ILLNESS (I got super sick with the first dose), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Cramps), URINE OSMOLARITY INCREASED (Concentrated urine), ILLNESS (I got super sick with the first dose), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug information was reported.   This case was linked to MOD-2021-071342 (Linked Report).; Sender's Comments:  MOD-2021-071342:same patient (second dose events)
Pt had a sore and had restricted movement with a low grade fever and states she had to stay in bed all day.
Pulmonary embolism diagnosed 1-2 weeks after vaccine, now on Eliquis. No right heart strain on echo.  Uncertain if vaccine is cause. PE being treated as unprovoked.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No any concomitant medications were reported. No any treatment medications were reported.  It was reported that expired vaccine were given as booster shot to patient. The vaccines were stored in freezer and took out one to two vial and placed in fridge each day as needed.
Systemic: temporary paralysis-Severe, Additional Details: Abdel went to bed at 11:00 PM that night after receiving vaccine at 11:01 AM that day. He woke up 4 hours later at 3:00 AM and could not move. He eventually went back to sleep and when he woke up several hours later he had enough movement to roll himself off of the bed. He eventually regained full mobility. Says he feels normal now.
seizures 28Feb-seen in ER @ 1130 pm, life flighted to Hosp-CT scan showed "cereberal bleeding"
Aches; Chills; Tired for two and a half days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), CHILLS (Chills) and FATIGUE (Tired for two and a half days) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported.). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN),High blood pressure medications for an unknown indication.    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 PAIN (Aches), CHILLS (Chills) and FATIGUE (Tired for two and a half days). At the time of the report, PAIN (Aches), CHILLS (Chills) and FATIGUE (Tired for two and a half days) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: changed outcome of event from unknown to recovering/resolving
Went to the ER with severe pain in my upper right shoulder/chest area and shortness of breath. Was sent home with pain medication. Returned to the ER because of severe pain and shortness of breath. Was diagnosed with multiple pulmonary embolisms and admitted to hospital. Was put on antibiotics, blood thinners, pain medication and oxygen therapy. Was discharged 2 days later with antibiotics, pain medication, oxygen and Eliquis. Still have slight pain in right shoulder area and shortness of breath. I now have scar tissue in my lung from the blood clot.
Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
slight cough; severe nasal congestion; headache; diagnosed with COVID in mid JUL2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (diagnosed with COVID in mid JUL2022), COUGH (slight cough), NASAL CONGESTION (severe nasal congestion) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced COVID-19 (diagnosed with COVID in mid JUL2022). On an unknown date, the patient experienced COUGH (slight cough), NASAL CONGESTION (severe nasal congestion) and HEADACHE (headache). At the time of the report, COVID-19 (diagnosed with COVID in mid JUL2022) outcome was unknown and COUGH (slight cough), NASAL CONGESTION (severe nasal congestion) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         The patient was a senior citizen, in the 62-75 age group. No concomitant drug was reported. The patient had received the Moderna COVID-19 vaccine primary series as well as one booster shot.  No treatment drug was reported. it was reported that headache and cough lasted for 5 days but the nasal congestion lasted beyond 2 weeks.  Company comment: This is a spontaneous case regarding a female patient of an unknown age who received 3 doses of mRNA-1273 vaccine and experienced non serious event of COVID-19 (AESI). Vaccination dates were not provided, latency cannot be assessed. She had a headache, slight cough, and severe nasal congestion. The headache and cough lasted for 5 days but the nasal congestion lasted beyond 2 weeks. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case regarding a female patient of an unknown age who received 3 doses of mRNA-1273 vaccine and experienced non serious event of COVID-19 (AESI). Vaccination dates were not provided, latency cannot be assessed. She had a headache, slight cough, and severe nasal congestion. The headache and cough lasted for 5 days but the nasal congestion lasted beyond 2 weeks. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient received 4 vaccines on 10/24/07. Within 3-5 minutes of administration both child legs swelled up with red, blotchy, warm skin. Physician watched and observed for approximately 20 minutes and swelling diminished. Child has no other symptoms to date. Mother reported fever of 100 degrees on 10/25/07.
pityriasis rosea; 5 of 6 rpts from same provider; 9DEC93 No response to f/u request;
2nd dose administered 23 days after initial dose.  (initial dose administered on 2/ 03/2021.
Pt received varicella vaccination subQ in the back of her right arm; the next morning, the injection site was red and swollen, with a small knot. Pt states it continued to get worse throughout the day and extended around entire arm. Pt also became dizzy and lightheaded.
April 1: I received my second Moderna COVID vaccine on April 1st in the morning around 9:40am. I did not experience any major side-effects within the 24 hours, no chills, no fever, I slept well and woke up fine the next day.  April 2: I got very tired on the following day around 2pm and had a headache of April 2nd, I took an Advil and after a long nap I woke up and felt fine.  April 3: On April 3rd in the evening around 8pm I noticed that my arm was feeling hot around the injection site. I went to check and it was a little swelled up on the injection site I had a rash that went from the injection site around for about 4 inches down towards my elbow. It was a itchy so I applied some cortisone cream and it went away after 2 days.
Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in the refrigerator on 18 Oct 2021. Vial did not undergone any temperature excursion. No adverse event was reported.  No treatment medications were reported.
Vaccine given at 3:30pm Left Arm; At 3:45 she reported that her right arm felt like she had the injection in it.  It felt "heavy".  She went upstairs to work and felt immediately her LEFT leg felt like it was "falling asleep"  pins and needles up calf and back felt heavy.; 3:45 examined, no SOB, lips and mouth okay, right arm non remarkable.   4pm  BP 236/80   HR 96  POX 98; 4:15   No change, had her have some water, go for a walk. 4:30 feels the same, pins and needle in leg, but otherwise fine.  Working with nurses for next few hours.  Told her to report any issues  to nurses.
seizures; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history was reported as none (never having any clinical history in the past). The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced seizures on an unspecified date. The outcome of the event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Croup symptom/bronchitic productive cough x 1 wk; Croup symptom/bronchitic productive cough x 1 wk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): RA-2022M1120651 (RA).  This serious spontaneous report originated was received by Viatris on 26-Oct-2022. This initial case, received from consumer, non health professional, involved a 64-years-old female patient who reportedly experienced croup infectious, productive cough while receiving Celebrex (celecoxib). Medical history and concomitant medications were not reported. Current condition included arthritis. Non-company suspect medication included pfizer biontech covid-19 vaccine (tozinameran). Unknown date: The patient initiated celecoxib capsule at a dose of 100 milligram bid via unknown route for arthritis/for arthritis left thumb and the patient experienced croup symptom/bronchitic productive cough x 1 wk. The event Croup infectious was considered as medically significant. 13-Oct-2022: The patient initiated tozinameran injection at an unknown dose, unit, frequency via unknown route (batch/lot number 22581 and expiration date was 28-Feb-2023) for unknown indication. Action taken with celecoxib and tozinameran were not reported. At the time of reporting patient was recovering from the events croup infectious and productive cough.  Celebrex is under agreement with Viatris.  Causality Assessment: Drug: Celebrex for events Productive cough, Croup, Per Reporter /Company (Viatris) was Possible. Sender's Comments: Viatris Comment: Serious: Croup infectious and productive cough (non-serious) are listed events as per company of celecoxib. Causality of the reported events croup infectious and productive cough has been assessed as possible as the contributory role of suspect drug cannot be completely excluded with known safety profile of the drug.
pt devel glandular swelling, low grade fever, gen malaise post MMR vax-cont to have probable w/diff sx-saliva glands no longer function etc;dx w/Sjogren's disease;
Patient reported that he had such extreme pain that it triggered an anxiety attack that more than one day in which he could not sleep.
pt recv vax & devel classic varicella w/greater than 100 varicella like lesions & a fever;
Diffuse rash over upper region of body and treated with OTC BENADRYL.
I suffer acute appendicitis 07/10/2021. I had surgery on 07/11/2021 to have my appendix removed. 07/02/2021 I experienced a extremely heavy period that lasted 21 days.
patient get a second bivalent dose.  have one in 10/10/2022 and a second dose today 12/07/2022
Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 9:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 9:17 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 60.42 during 14-Feb-2021 administration and 60.52 during 21-Mar-2021 administration. No concomitant medication was reported by reporter. Vials were in cooler storage and were not in frozen storage during high-pace COVID-19 vaccination at around 2021.  It was reported that each time a vials were 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. Vials were moved to fridge on 09-Feb-2021 (Lot: 031L20A), 16-Mar-2021 (Lot: 003B21A) and moved to clinic on 13-Jan-2021 (Lot: 031L20A), 21-Mar-2021 (Lot: 003B21A). Vials were punctured right before administration. Vials best before use date were 10-Mar-2021 (Lot: 031L20A) and 15-Apr-2021 (Lot: 003B21A). Vials were undergone temperature excursion at 09:00 AM with 32 degree Fahrenheit (Lot: 031L20A) and 09:00 AM  with 34 degree Fahrenheit (Lot: 003B21A). After administration, the vials were returned to the freezer/refrigerator, or maintained at room temperature.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Patient stated she felt fine the day she received the new Comirnaty (Pfizer) vaccine, but started experiencing palpitations during the evening. Patient went to urgent care the following day and stated that her heart was not beating as fast anymore, and urgent care sent her home with Tylenol for her headaches. The 2nd day after receiving the vaccine (today), patient reported experiencing runny nose and coughing. Denied any fever, body pains, fatigue.
No adverse event. The vaccine administered on 3/30/22 expired in 3/17/22. Moderna tested the stability of the same lot number and determined that the dose given was still protective against the COVID-19 virus.
Large red rash at injection site. Very sore. Hard lump at injection site. Very itchy on the red part at injection site. Lasted 4 days and is finally going away but still a hard bruise at injection site.