chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature was 102 F; Lips turned blue; Wheezing; Heart rate was elevated to 105-112 bpm; A spontaneous report was received from a dentist, a 37-year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced heart rate was elevated to 105-112 bpm, wheezing, lips turned blue, and temperature was 102 F.   The patient's medical history, as provided by the reporter, included monk fruit allergy and high blood pressure. Concomitant medications reported included hydrochlorothiazide.  On an unknown date, the patient received their first of two planned doses of mRNA-1273.   On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, following vaccination, the patient experienced an elevated heart rate of 105-112 beats per minute (bpm). The patient stated that 80 bpm was normal for her. At 7:30 pm, she began wheezing and her lips turned blue, both of which resolved within 2 hours. The patient took ibuprofen, naproxen, and diphenhydramine and sat in a warm tub for an hour and felt better after she covered up in bed.  On 29 Jan 2021, the patient's temperature was 102 degrees Fahrenheit (F) at midnight and 99 degrees F at 5:00 am.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The events, wheezing and lips turned blue, were considered resolved on 28 Jan 2021. The outcome of the events, heart rate was elevated to 105-112 bpm and temperature was 102, was unknown.; Reporter's Comments: This case concerns a 37-year-old, female patient, with medical history of high blood pressure and allergies to monk fruit, who experienced serious unexpected event of cyanosis, non-serious unexpected event of wheezing, heart rate increased, and non-serious expected event of pyrexia. The event of cyanosis, wheezing, heart rate increased occurred 1 day (same day) and fever occurred 2 days after mRNA-1273 (Lot# 030L20A). Treatment included Ibuprofen, Benadryl and Naprosyn. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Left arm felt like someone punched it". It is very sore; Feverish; Chills throughout body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm felt like someone punched it". It is very sore), PYREXIA (Feverish) and CHILLS (Chills throughout body) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Sleep apnea, Diabetes and High cholesterol. Concomitant products included METFORMIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left arm felt like someone punched it". It is very sore), PYREXIA (Feverish) and CHILLS (Chills throughout body). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Left arm felt like someone punched it". It is very sore), PYREXIA (Feverish) and CHILLS (Chills throughout body) outcome was unknown.            Past medical history includes prostate issue.
pt recvd vax & exp rash; high pitch cry for days; fever;d;v & measles/mouth had oral sores; rash,fever,cry w/ each following shot;
100 degree fever on second day.  tired and achy for one week.  Increase in blood pressure. SYS.mmHg from 125 to 150.  Still at 150 after two weeks.  Weight gain 10 pounds.  Do not sleep well.
Patient arrived to the local ER on 11-27-22 with complaints of SOB that started on 11-25-22.  Patient was diagnosed with a Pulmonary Embolism and was admitted to the general ward on 11-28-22 for treatment.
looked like cellulitis; rash at 7 days at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE CELLULITIS (looked like cellulitis) and VACCINATION SITE RASH (rash at 7 days at the injection site) in a 22-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (looked like cellulitis) and VACCINATION SITE RASH (rash at 7 days at the injection site). At the time of the report, VACCINATION SITE CELLULITIS (looked like cellulitis) and VACCINATION SITE RASH (rash at 7 days at the injection site) had resolved.        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 were reported.   Treatment for the events included oral prednisone for 5 days.  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.; Sender'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.
experienced  hives starting 12 hours after injection; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown demographics patient who experienced hives starting 12 hours after injection (urticaria), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history included Mast cell activation syndrome.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE injection lot number not reported for prophylactic vaccination.  On an unknown date, the patient experienced hives starting 12 hours after injection of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (urticaria).  Other relevant tests included no lab data.  Final diagnosis was urticaria.  It was not reported if the patient received a corrective treatment.  The patient was recovered from the event.  There will be no information available on the batch number for this case.
GI bleeding resulting in anemia with Hgb down to 9 and had clean based ulcer found on EGD and H pylori negative, she had the Covid vaxbooster 11/15. Just 10 days prior to the PUD.
on Mar. 22, my arm was sore, I took a look and there was a bump and around it was red.  The swelling has gone, but it is still red and still al bit sore.  I put Isopropyl alcohol on a cotton pad and dabbed it on immediately.  Not sure if that is why the swelling went down, and I can actually see where the prick of the needle was.  I could not see that before.  The person who gave me my shot did not place a bandaid on as she said it wasn't bleeding so I didn't need one.  My husband also received a shot and he is fine.  So, I guess the bottom line is. is what 's happening  to me common ?  And why 8 days later did this occur.
Client arrived at health dept on 10-4-07 to report: Had Pneumococcal Polysaccharide vaccination on 8-31-07 and that evening had congestion, coughed up blood, vomited up blood, rectal bleeding; he also reported he has Hepatitis C. He reported he did not see a M.D. on 8-01-07 Nor has he since seen M.D.; nor called M.D.
vaccine-induced autoimmunity (autoimmune illness); Information has been received regarding a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS number US-009507513-1806USA003582) from a lawyer who provided plaintiff fact sheet concerning a elderly female patient(pt) of unknown age. The pt was a non-smoker. Pt reported that she had chicken pox in 1947 when she was 7 years old. The pt never received the chickenpox vaccine. On 02-DEC-2018, the pt was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (reported as "phenomena", manufacturer unknown) (dose, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the pt experienced vaccine-induced autoimmunity (autoimmune illness). The outcome of autoimmune disorder was unknown. The reporter considered autoimmune disorder to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  Upon internal review, autoimmune disorder was determined to be medically significant.; Sender's Comments:  US-009507513-1806USA003582:
a full body rash; got itchy all over; This is a spontaneous report from a contactable Other Health Professional (patient). A 54-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FL1283) via an unspecified route of administration at left arm on 14Jan2021 17:00 (54-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included allergies to Sulfa. Concomitant medications in two weeks included estrogen NOS/progesterone patch. The patient previously received amoxicillin and experienced allergies, received nitrofurantoin (MACRODANTIN) and experienced allergies. There was no other vaccine in four weeks. Seven days after the first dose of vaccine (event start date was also reported as 14Jan2021), patient got itchy all over and by the next day, she had a full body rash. She continued to get worse. On day 6 of rash, she went to my doctor and was prescribed steroids. It took 6 days of steroids for the rash to fade. She still have rash, but it is very faded. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient had no COVID-19 prior vaccination. Patient did not test for COVID-19 post vaccination. Therapeutic measures were taken as a result of the events and included steroids. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Patient was given expired Pentacel on 9/18/23. The expiration date of the Pentacel was 9/16/23. No adverse reaction has occurred.
1. Given DTaP instead of Tdap. 8/2/12. 2. Given Tdap 8/12/12.
Swelling , redness, induration and tenderness L thigh and 5.0" in diameter rx with cold compress, Benadryl, Augmentin
The pt experienced vomiting approximately 6 hours post vax. The next morning further vomiting followed by a partial seizure. The pt was hospitalized for 24 hours. The pt was referred to a neurologist.
pt recvd vax & devel rash, swelling & whelps on face; itching; difficulty breathing & was taken to ER; t 102; devel swelling like mumps;pt devel muscle stiffness & joint pain;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021 at 1:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 1:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 71.22  for dose administered on 27-Mar-2021  Concomitant products were not provided.  On 27-Mar-2021, excursion time was 10 AM  and temperature was 35 respectively, total doses given for the day was 150, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vial was moved to clinic on 27-Mar-2021. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient states that the day she received the vaccine she felt like she was hit with the "flu"...when asked to elaborate, she stated that she has pain all over her body and red circular welts on the arm where she received the vaccine that has not gone away.
soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 immunisation.     No past medical history provided.  Concomitant products included ASENAPINE MALEATE (SAPHRIS), ZOLPIDEM TARTRATE (AMBIEN), CARBAMAZEPINE (TEGRETOL), DISULFIRAM (ANTABUSE), VALBENAZINE TOSILATE (INGREZZA), TRAZODONE, CLONIDINE, ACETYLSALICYLIC ACID (ASPRIN) and CHLORPROMAZINE for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at injection site). At the time of the report, VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-122436 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Non-Significant follow up appended
We recently moved and needed to find a new doctor for our 3 children. We chose these associates because they have many locations and convenient hours. Prior to our initial visit, we had their previous Doctor's office fax all of their records to the new Doctor and confirmed with the new office that they received them when making an appointment. We had our first visit on Thursday, July 5, 2018. My youngest was 3 weeks away from turning 3. The doctor and the nurse said she was due to receive the HepA vaccine, nurse administered it. The next day (Friday, July 6, 2018), my child was very quiet and sleepy (not like her at  all). Then as the day went on, she was burning up and very lethargic. We took her temperature and it was 102.6. She also had a very light rash around her face. I looked at the paper they gave with her height/weight stats to see if it mentioned what she got and if this was a normal reaction, because I only remember hearing from her previous doctor that low grade fevers could occur. It only showed milestones for age 2 and what to expect at a 2 ½ year visit (which made me wonder why she had another 2 year visit instead of 2 ½ or 3 yr or just new patient. So then I logged on to their site to see exactly what she received (it in fact was HepA). Then I checked her vaccine record that I had from previous doctor and what the new doctor had on her online record for her. They both matched, and showed that she already previously received both of her HepA vaccines. I then began to really worry, so I called into the new doctor's office to let them know that she received a third dose of HepA and was having a fever and wanted to know if this was normal or if I should bring her in. She said she would have a nurse call me back. We waited and waited. No one ever called. The next day (Saturday, July 7, 2018), no one still called us, so we drove in to the doctors office to try and get some answers. At this point, the rash around her face was worse, but thankfully the fever was down. A different doctor came out and sat with us to talk over our concerns, but she was newer to the practice, so she had a receptionist sit in with us. They somehow did not pay any attention to her records, and treated her as a 2 year old (instead of a 2 ½ or 3 year old) and instead of verifying her vaccines, they assumed that she needed another does of Hep A just because she is still 2 years old for 3 more weeks, when she in fact had already received both doses, and their records clearly showed that. Today, July 12, 2018, the rash is still slightly present around the mouth, fever is gone.
Mild to medium migraine after first dose, April 22nd Severe migraine after second dose, May 20th  Had a migraine every single day since the first dose.
5AM: TEMP 101.7, HEADACHE, CHILLS, LOWER BACK PAIN, LETHARGY. SYMPTOMS PROGRESSED THROUGOUT THE DAY. SYMPTOMS STARTED ABATING 1/8 TIME 2100. 5AM TOOK 2 EXTRA STRENGTH TYLENOL. 8AM- 2 EXCEDRIN. 1300 - 2 ADVIL; 1600- EXTRA STRENGTH TYLENOL. 01/0 0700 - 2 EXTRA STRENGTH TYLENOL FOR HEADACHE.
On the third day I got a nasty smell  in my urine. I went to the Doctor and they told me  I started to get an UTI, she gave me medicine. She told me the smell, I would have to drink a lot of water. She told me the smell may have been from t he vaccine but she couldn't tell me for sure.
Cutaneous swelling, warmth, redness and pain upon palpation surrounding the injection site. The affected area was at least 4 inches in diameter also with small, white bumps near the center of the affected region. The patient noticed this reaction the morning after vaccination.
Pt received his 5th dose of DTaP and second dose of MMR. Within one hour he developed head to toe urticaria and extreme pruritus. The DTaP vaccine site was red and edematous. Benadryl given - hives resolved within 3 hrs.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patients medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N019822, expiration date 13-JUL-2019  for prophylaxis. Concomitant therapies included MRK STERILE DILUENT. The doses of Oka/Merck VARIVAX)were exposed to a temperature excursion of 6°Fahrenheit  (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA002453: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
Information has been received from a physician concerning an approximately 7 year old female patient who on 8/18/98 was vaccinated with a dose of varicella virus vaccine live. On 7/22/04, the patient developed a breakthrough case of skin chicken pox. The physician reported that the patient had a mild case of about 50 lesions with no other symptoms. She was not given any medication to treat the outbreak. No further information was available. The patient is recovering. There was no product quality complaint reported. No additional information is expected.
PATIENT CAME BACK TO THE PHARMACY WITH HER HUSBAND INFORMING THE PHARMACIST THAT SHE HAD DIFFICULTY SWALLOWING AND DID NT FEEL WELL IN GENERAL. PHARMACIST ADVISED HER TO GO TO URGENT CARE TO BE EXAMINED BY A PHYSICIAN AND GET A PROPER CARE IN CASE HER SYMPTOMS WERE GOING TO WORSEN BY TIME.
It is now two days after my second dose of the COVID vaccine, and I have developed a red welt at the injection site measuring 4.9x8.7 cm. The welt is firm and hot to the touch, but not raised. It does not itch, but it is very sore, and aches when pressure is applied.  The color is a very dark pink.
pt had temp of 105 x 48 hrs unresponsive to APAP taken to MD;
Very weak; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very weak) and PYREXIA (Fever) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ASTHENIA (Very weak) and PYREXIA (Fever). At the time of the report, ASTHENIA (Very weak) and PYREXIA (Fever) had not 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.   The patient experienced side effect few hour after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine).  The patient took Ibuprofen 400mg and Tylenol 800 mg as the treatment medications.  The patients symptoms persisted and the patient was planning to call emergency number and visit emergency room since she was scared.
This spontaneous report was received from a pharmacist and refers to a currently 60 year old non-pregnant female patient. On an unknown date in 2014 (also reported as "a couple of weeks ago") the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial (dose, route were not reported; lot # J016257, expiry date 20-FEB-2014) for the prevention of shingles. The concomitant medication reported was "generic PLAQUENIL". It was reported that after receiving ZOSTAVAX on an unknown date in 2014 (also reported as "a couple of weeks ago") the patient experienced the arm soreness and the rash. Patient sought a medical attention and she saw a pharmacist. No treatment was given for the event. VZV packed was offered. The outcome of the event (arm soreness and rash) was reported as recovered/resolved on approximately 29-JUL-2014 (also reported as "3 weeks ago"). The relationship between the ZOSTAVAX and the event was not reported. This is one of several reports from the same reporter (reported as "This was the 2nd or 3rd reported by the pharmacist"). Additional information has been requested.
PT FELT DIZZY AND LOST CONSCIOUSNESS FOR 1-2 SECONDS AFTER RECEIVING FIRST DOSE OF PFIZER VACCINE, ABOUT 5 MINUTES POST ADMINISTRATION. PT STATES HAS HAD VASOVAGAL REACTION IN THE PAST WITH BLOOD DRAW. PT RECOVERED AFTER LAYING DOWN WITH LEGS UP AND DRINKING SOME WATER AND ORANGE JUICE.