chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given to 16 year old; A spontaneous report  was received from a pharmacist concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine given to a 16 year old.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 1 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 1 Jan 2021, vaccine was given to a 16-year-old, per the pharmacist. The patient had no reported adverse reactions. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine given to 16 year old, was considered resolved on 1 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.   There were no reported adverse events associated with this case.
Pt reports injection site reaction of pain and bruising that began immediately after injection and within a few days noticed erythema, edema, pruritis, and heat of upper left arm that lasted about 2 weeks. She took benadryl q 8 hours during those 2 weeks until symptoms resolved.
Kidney creatinine levels went up from 1.1- to 1.5.  The levels was fine in February 2021 after shot in March health went down.
Felt facial numbness (right face) after the shot, and right face was swelling. First saw neurologist to see if it was bell's palsy and doc said it was not and prescribed prednisone for 9-days. Not getting better, saw allergist and continued to take zyrtec. Still TBD on how the vaccine causes allergy. Face is still swollen and need to take allergy test at the end of the month. Both doctors are from another state.
big jump in While Blood Cells; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (big jump in While Blood Cells) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication.    Concurrent medical conditions included Chronic lymphocytic leukemia (CLL "a type of Leukemia", diagnosis goes back at least a year or two), High cholesterol and Blood pressure abnormal. Concomitant products included ZINC, VITAMIN C [ASCORBIC ACID] and ACALABRUTINIB (CALQUENCE) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient received dose of INFLUENZA VACCINE (FLU) (unknown route) 1 dosage form. In March 2022, the patient experienced WHITE BLOOD CELL COUNT INCREASED (big jump in While Blood Cells). The patient was treated with PARACETAMOL (TYNELOL) at an unspecified dose and frequency. At the time of the report, WHITE BLOOD CELL COUNT INCREASED (big jump in While Blood Cells) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, White blood cell count: high (High) big jump in While Blood Cells. On an unknown date, Heart rate: normal (normal) normal. On an unknown date, Oxygen consumption: normal (normal) normal.         Other concomitant drugs included blood pressure medicine, Glameron and high cholesterol medicine. The patient had no history of COVID. The patient had a medical history which included CLL, a type of Leukemia and started taking (Calquence) on the 07-April but had since stopped taking it until follow-up with oncologist. The patient stated Leukemia diagnosis goes back at least a year or two (but could not give specifics). The oncologist was taking blood tests up until this time (for WBC) but then there was a big jump in While Blood Cells in the middle of Mar-2022.   This case was linked to MOD-2022-546508, MOD-2022-546692 (Patient Link).
Warmth/erythema at site of Pneumovax. Low grade temp, arthralgias.
Shoulder was very sore immediately after the shot and a bruise formed. Over the course of the evening, shoulder became even more sore and was painful to move. I took naproxen before bed. By the next morning, had significant body aches, arm very sore, headache, nausea but no vomiting. Felt like the flu. I took more naproxen, which helped. The following day still had some arm pain and some fatigue, but overall felt much better. By the 3rd day, still had minor shoulder pain but mostly back to normal. My husband had the shot at the same time and had very similar symptoms.
Individual received a 1st dose of Moderna COVID vaccine in a long term care facility on 1/26/2021. We were not aware of the previous COVID vaccine. We administered a 1st dose of Pfizer COVID vaccine on 8/26/21 and a 2nd dose of Pfizer COVID vaccine on 9/17/21.
I couldn't get out of bed for two days at least and I had high temperature between 103-104 and I had terrible chills, My hands were so cold that they were hurting me. I took some advil and that helped. By Sunday I was starting to feel to better, Monday I was still tired and a low grade fever.
Reaction to PEG in moderna 1st vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to PEG in moderna 1st vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to PEG in moderna 1st vaccine). At the time of the report, VACCINATION COMPLICATION (Reaction to PEG in moderna 1st vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment was reported.
Received vaccine at 745a, at 8a patient stated "tongue felt weird", patient was offered 25mg of liquid benadryl. Patient's husband drove her home soon after. Checked on patient at 10am and she stated benadryl helped but her "throat felt uncomfortable"  a few minutes prior to the call. Called again at 4:41p and patient said she now had a headache, nausea, chills, hot but no fever.
Case number PHEH2014US025041, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 50-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 15 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
12/32 vaccination 1/1 Swollen, painful lymphnodes L side of body.  1/8 woke up with large welt at site of injection; lasted 24 hours
May 8th, I felt like I had either a bad cold or the flu. I had to take work off. I was very fatigued. I had a fever of 101. (I haven't had a fever in years.) The fever lasted the whole day, less than 24 hours, and I spent the whole day in bed. I was exhausted. The fever was 99.9 after that for awhile. I was a little achy, feverish and very fatigued. Really did not feel well. I probably had a stuffy nose, too, as I took a little bit of Benadryl. I may have taken a little taken a little Tylenol. I had a bad headache, too, which is unusual for me. These symptoms went on for a few days. Immediate, after the vaccine: I spent the day in bed not feeling well. I felt very fatigued and not very well. Two days after the vaccine, I had a terrible headache. I never get headaches. The headache lasted about 6 hours. I think I took a Tylenol and stayed in bed both of those days.
I was very tired & very sleepy all the time it felt like I was drained. I was already pre-diabetic but now I am diabetic & on meds.
Per patient report localized swelling, redness, bruising, pain for several weeks post vaccine administration.
Shooting pain radiating down back and in shoulder and arm. Complained 1 hour after injection. Stayed home from school the next day.
approx 8 hours after vaccine started having nausea, vomiting, chills, fever, muscle aches. Since vaccine having constant fatigue, dizziness, brain fog, muscle and joint pain primarily in both knees, stomach pain and lack of appetite
PATIENT STATED  SHE FELT ITCHY GENERALIZED, 20 MINUTES AFTER VACCINE WAS ADMINISTERED.  VITALS  SIGNS TAKEN.  ALL NORMAL LIMITS FOR PATIENT.  ASSESMENT WAS MADE AND FOUND NO REDNESS, NO HIVES, NO SHORTNESS OF BREATH.
Had a fever of 104 since 08/31.  Kept a fever.  Patient had for 1 week per mother.  Had a rash on 09/04/2003.  Seen in my office 09/05/2003.  Tiny red spotches all over body.
Large circular welt on upper arm where vaccinated. Red, about 6 inches in diameter, and warm to the touch.
Developed allergies to latex, avocado, and estrogens. No longer received period for the 14 years following vaccine. And took clomid to get pregnant and experienced a miscarriage at 19 weeks 4 days
I am an insulin dependant diabetic. Went into a low sugar coma at 1am following flu shot. Discharge summary states diaphoretic, combative. msv
Developed a knot at injection site, then turned red and itching then spread down my arm to elbow.  Treated with antibiotics:  Injection of Ceftriaxone (Rocephin) plus prescription of doxycycline hydrate 100 mg  twice a day for 10 days.  At this writing there is still some pain but very little redness.  Appears to be healing.  Diagnosis was cellulitis of left upper limb.
Thyroiditis; Tremor; heart palpitations; inability to regulate body temp; Extreme fatigue; weakness; This is a spontaneous report from a contactable consumer or other non hcp (patient herself).   A 54-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9581) via an unspecified route of administration in right arm on 10Feb2021 (at the age of 54 years-old) as dose 2, single for COVID-19 immunization. The patient medical history reported as none. The concomitant therapy reported as other medications in two weeks reported as prenatal vitamins. The patient was not a pregnant at the time of vaccination.The patient previously took doxycycline and experienced allergies (Known allergies: doxycycline). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration in right arm on 20Jan2021 at 01:00 PM (at the age of 53 years-old) as dose 1, single for COVID-19 immunization. Facility type vaccine reported as doctor's office/urgent care. No other vaccine in four weeks. No Covid prior vaccination and not Covid tested post vaccination. Other medications in two weeks reported as prenatal vitamins. On 18Feb2021, 8 days after vaccination the patient experienced thyroiditis, tremor, heart palpitations, inability to regulate body temp, extreme fatigue and weakness. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a medication management for the adverse events. The patient underwent lab tests and procedures which include body temperature with results inability to regulate body temp on 18Feb2021. The clinical outcome of all events was not recovered.  No follow attempts are required. No further information is expected.
Within 5 minutes of administration of Boostrix and MMR, patient felt dizzy and had to lay on the bench by the pharmacy. A customer that was shopping close by said she saw him having a seizure and his eyes were rolled back. Rph did not see that and rph saw that patient was responsive, but was sweating profusely. Patient's skin felt clamy to the touch. Patient was given water and he needed help getting to a sitting position to drink his water. Management was called over and 911 was dialed. Rph stood by patient's side with immunization cart ready to administer CPR if necessary. EMS then arrived after about 10 minutes. They ran some tests on him and asked him to stand up. Patient could not stand up and he also stated now that he is nauseous. EMS then put him on stretcher and carted him off to hospital. Patient returned back to pharmacy 3 hours later, wanting to get a third vaccine, which this pharmacy did not have. He said the nurse at the hospital, told him the diagnosis was him having anxiety and his blood pressure dropped. He said they administered a few other tests on him, one of which was a blood sugar test, and that they did not find anything else wrong. Patient said he felt fine now and he is on his way to find the third vaccine, Varivax, in which he wants to get today.
Immediate erythema surrounding injection site. Itching (mild) in area within a few minutes
Pfizer-BioNTech COVID-19 Vaccine  Fever, chills, headache, joint pain, exhaustion lasted 24 hours then the fever broke and I was very tired for the next two days.
Erythematous lesion of rt thigh 6 cm X 2 cm firm.
Information has been received for an 80 years old male patent referring to himself. The patient's concurrent condition included high blood pressure. The patient's historical condition included appendix removed on 20-NOV-2018. The patient had no drug reactions or allergies. The patient's concomitant medication included many unspecified medications. On unspecified date in 2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23 valent) (manufacturer unknown (reported as PNEMOVAX)) (dose, strength, route, lot# and expiration date unknown) for prophylaxis. On 01-MAR-2019, the patient received a "booster" of PNEUMOVAX 23 (dose, lot# and expiration date were unknown) intramuscularly for prophylaxis same day the patient experienced injection site pain and swelling. The next day the patient experienced more swelling accompanied by joint pain from shoulders to hands. 11 days later the patient was still experiencing joint pain in his wrist. All the events caused hospitalization. No treatment was given to the patient. No lab diagnostics or studies was performed recently. The outcome of the events were not recovered. The causality between the events and PNEUMOVAX 23 was not reported.
Information has been received from a 60 year old female patient with penicillin and SERZONE allergy and no other pertinent medical history who on 06-JUN-2012 was vaccinated SC with a dose of ZOSTAVAX (Merck), 0.65ml. On 07-JUN-2012 the patient mentioned that she had a red welt on her right arm at the injection site that was the size of a quarter. The patient was also questioning the fact that after she picked up the vaccine from her pharmacy, more that 30 minutes had elapsed before the shot was given to her. Her pharmacy said that it was okay to give her the vaccine up to 60 minutes after reconstitution. The product was not refrigerated the time of pickup at the pharmacy and the time of the injection at the doctor's office. There was no lab diagnostic performed. The patient had not sought medical attention and there was no treatment given to her. At the time of the report, the patient was not recovered. Follow up information has been received from the Medical Assistant (MA) concerning the 60 year old female patient with allergy to CARBOCAINE, Guaifenesin and ENTEX LA, penicillin, SERZONE and TEQUIN and no illness at time of vaccination, who on 06-JUN-2012 at 16:20 was vaccinated SQ into the right upper arm with the first dose of ZOSTAVAX (Merck) (lot number 672932/0599AE; exp. 22-JUN-2013), 0.5ml (previously reported as 0.65 ml). The M.A. reported that the patient was given ZOSTAVADX (Merck) without incident. There were no adverse reactions to vaccine or side effects reported by the patient (previously reported as red welt on her right arm at the injection site that was the size of a quarter). The M.A. also stated that the patient picked up the medication from the pharmacy at 15:45. The vaccination appointment was scheduled for 16:00. The patient was taken back at 16:08 p.m., was very argumentative, stated she was informed per pharmacy that needed to have the vaccine given within 30 min. Patient was informed she was still within the acceptable amount of time per physician. Additional information is not expected.
Patient stated she was extremely nervous prior to getting her vaccine. She grabbed her husband's arm to ensure he was close by. She was fine while the vaccine was being administered at approximately 1:00pm. A few minutes later, approximately 1:03pm, she appeared to pass out. Her husband stated this reaction is normal. He then mentioned that she has a history of passing out and tends to drift off for 15-30 minutes. She would come and go saying she was tired and that she wanted to go to sleep. I repeatedly asked her to open her eyes and tell me her name. The patient did not respond. I checked her breathing which was normal, she was not having any difficulty breathing. I looked for other symptoms of allergic reaction but couldn't find any. This continued for about 20-30 minutes and then the husband stated she has never been in this state for this long. I reached out to my store manager to ask him to call the paramedics. The patient opened her eyes for a few minutes but then would return to her unresponsive state. After the paramedics arrived, she vomited a small amount of liquid into a trash can. She ultimately was taken out of the store on a stretcher with the paramedics by her side.
Woke up and at first felt fine.  Took thyroid med and went back to sleep.   Woke up again and when I sat down with my coffee I began to shake uncontrollably with teeth chattering.   Threw up my coffee.  Went back to bed, covered up with blankets and went back to sleep.  Awoke  a few hours later and felt fine.   Did not feel like I had a fever.  Cannot read a thermometer due to vision loss.  Was not hungry and finally ate cereal for dinner as I felt like I should have something.
Tdap vaccine given 8:20 am and at 11:00 pm that same day, developed chills, fever 102.5, all over body aches, difficulty raising arm that vaccine administered in (left) she is right handed. Massive headache. Took TYLENOL resolved 9/13 630AM.
Itchy sores that popped up on his arms and torso; Spontaneous report received on 02MAY2019.   A 29 years old male patient experienced itchy sores on his arms and torso following the administration of ACAM2000( smallpox (vaccinia) vaccine live).   Two days ago (30APR2019) the subject received smallpox vaccine (lot, dose and route unknown).  Patient stated that he had smallpox vaccine 2 days ago and he was keeping the area covered. Patient reported that in the morning (02MAY2019) he developed some itchy sores that popped up on his arms and torso. He enquired if that could be from the vaccine or anything else was going on? Outcome at the time of report was unknown.  Patient's medical history and allergies was not reported.  Concurrent medical conditions and Concomitant medication was not reported.  Company Comment: The information provided is not enough to properly assess this case. The Company considers that the itchy rash is not assessable and possible autoinoculation unlikely. Normally, papule formation at the vaccination site occurs at the third day and it would have been unlikely to have contamination at the same day of vaccination. Ideally, more information is needed.
Red, itchy, burning face, tingling throughout the body, and dizziness; Took 50mg of Benadryl and symptoms resolved
Tinnitis started Dec, ongoing. Reported  to PCP in Feb; seeing audiologist this week Tue 03/22/2022. Never had before that injection; noticed in Dec; like buzzing in my head; worst at night, but always there. No history of working/living in noisy conditions or attending loud concerts, etc.
"Throat closing up". Asthma symptoms with wheezing and hives, started approx. 45 minutes, post vax. Treated with Benadryl IM and a breathing treatment.
Severe local pain, redness, swelling; WBC 9.3/ ESR 31.
Immediately after injection patient passed out and then began to seize. Seizure did not last longer than 30 seconds and then shortly after patient recovered. 911 was called, vitals were checked and patient refused to be transported to the ER. No past history of seizures.
Pt had PPSV23 on 07/21. the next morning he suddenly felt exhausted. Later, he began feeling achy all over and feverish. Pt thought it was a rxn to vaccine. That night he started coughing deeply like a chest cold. It went on for a while. The following morning (07/23), he felt fine with just a headache. 07/24 he felt fine.
Drop in blood pressure and fainting episodes. Blood pressure still not stabilized after 10 hours. Dropped 25-30 points below my average.
SOME BODY ACHES; BRAIN FOG (ESSENTIALLY FELT LIKE YOU DO WHEN YOU'RE STARTING TO COME DOWN WITH SOMETHING); FELT A LITTLE COOL/CLAMMY; LITTLE SORENESS AT INJECTION SITE (LIKE REALLY MINISCULE); This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced some body aches, brain fog (essentially felt like you do when you're starting to come down with something), felt a little cool/clammy, and little soreness at injection site (like really miniscule). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the some body aches, brain fog (essentially felt like you do when you're starting to come down with something), little soreness at injection site (like really miniscule) and felt a little cool/clammy was not reported. This report was non-serious.
At 0931 client received her second vaccine of Moderna. At 9044 client complained of feeling light headache, blurred vision, dizziness and nausea. At 0945 BP was 180/112, HR 131, RR 23, 02 sat 99% on RA. Client denies eating breakfast or anything. At 0953 BP still 180/104 HR 93, RR 20, 02 sat 98% on RA still having light headache, blurred vision, nausea and dizziness. At 1002 client denies nausea, but still having headache and dizziness. At 1004  BP was 160/90 HR 88, 02 sat 97% on RA. client verbalized having BP issues but not on any medication. All symptoms resulve in 31 min. Client left at 1011. Client will be driving self home. No further treatment needed at this time.
Information has been rec'd from a Dr's office. It was reported that 4 children who received a dose of Tripedia vaccine (Lot #U0583AA). All 4 of the pt's experienced local reactions of redness and swelling. No additional info was provided. A phone call was made to the reporter on 9/12/02, to obtain additional info on pt's. Reporter stated that she does not have any specific information to identify each pt at this time. she agreed to inform the manufacturer when the info becomes available. See cases U2002-0067, U2002-0084, U2002-00805, same reporter.
Patient was 14 years old and received booster dose approved for 16 years and older.