chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a male who in 2000 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). No second dose of varicella virus vaccine live (Oka/Merck) was administered. The mother of the patient told the nurse that in September 2006 the patient developed a bad case of shingles on the face (duration unspecified). In March 2007, the patient also developed a breakthrough of chickenpox over the whole body that was described as moderate to severe. At the time of this report, the present status of the patient was unclear. No other information was reported at this time. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Information has been received from a healthcare worker concerning a 59 year old female patient with allergies to DEMEROL and adhesive tape who on 23-MAR-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot# 665707/1407Y). Concomitant therapy included LIPITOR, lisinopril and HCTZ. Subsequently, the patient developed a fever of 102.2 degrees F. and swelling of her arm at the injection site after receiving the PNEUMOVAX 23. The reporter did not know if the patient had ever received PNEUMOVAX 23 in past. The patient sought medical attention via phone call. At the time of the report, the patient was recovering from these events. Additional information has been requested.
Heart rate elevated to 150 and above, shortness of breath. Went to emergency room. Admitted with blood clot in lung. Previously had COVID in 2020, and we are unsure if this is related to previous illness.
vaccine expiration date. it appears that vaccine was given 3-5 days after expiration date; No adverse reaction after vaccination
Nausea; Cold; soreness at injection; itching at injection site; woke with a sweaty neck; Dizziness; He experienced weakness 1-2 hours after he received the first dose.; Drowsiness; Fever; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9269) via an unspecified route of administration, administered in Right arm on 11Feb2021 (at the age of 60 year) as dose 1, single for COVID-19 immunisation.  Medical history included itching and soreness from allergy shot from 29Jan2021 to 01Feb2021.He gets an allergy shot every 2 weeks. His last allergy shot was on 29Jan2021. He didn't take it for 14 days prior to getting the Covid-19 vaccine. He doesn't know the name of the medication that he gets with the allergy shot. There were no concomitant medications. On 11Feb2021, 1-2 hours after he received the first dose, the patient experienced weakness. He also was drowsy. The dizziness lasted about three hours. When he went to bed he had a fever and nausea. He was cold for a few hours. He felt like he wanted to throw up. He got under the covers and a hour to two later it subsided. He started drinking water to help with the nausea. The fever lasted about two hours. He woke with a sweaty neck. He was cold for 35-40 minutes. No relevant tests were done. The outcome of the events was Drowsiness, pyrexia, nausea, cold was recovered; dizziness was recovered with sequel; sweating was unknown and of other events was recovering.  No follow up attempts are possible. No further information is expected.
Information has been received from a physician and a certified medical assistant concerning a 69 year old female who on 18-OCT-2006 was vaccinated with a dose of Pneumovax 23.  Concomitant therapy included SYNTHROID, NASONEX and PREMPRO.  The physician reported that the "patient had a reaction to Pneumovax 23" (date not provided).  A certified medical assistant in the office further indicated that on 13-NOV-2006 the patient returned to the office complaining of muscle and joint pain since the vaccination.  On 13-NOV-2006, an antinuclear antibody test, sedimentation rate, C-reactive protein, complete blood count and uric acid test were all normal.  The patient was reported to be afebrile with normal blood pressure.  The patient was given a MEDROL dose pack on 13-NOV-2006.  On 20-NOV-2006 and 27-NOV-2006, the patient returned to the office still complaining of muscle pain and joint pain.  The patient was referred to a rheumatologist.  An MRI of the c-spine was normal.  MRI results of the brain were not yet reported.  The patient was diagnosed with myopathy and polyarthralgia.  The physician felt that the patient's reaction was related to therapy with Pneumovax 23.  Additional information has been requested.
pt recvd vax; aches, myalgias, malaise; myopathy dx 13nov95;hosp & hydrated Nov 3-7, no apparent perm sequelae, musc bx=nonspec myopathy w/o toxic postviral metabolic myopathies.
This spontaneous report was received from a medical assistant and refers to a 13-month-old patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On 12-APR-2017, the patient was vaccinated with an expired dose of M-M-R II injection (albumin status: recombinant human albumin rHA), lot # L012479 with an expiry date 10-APR-2017, subcutaneously, together with non-expired sterile diluent (DILUENT MRK). No adverse experience had been reported. Additional information has been requested.
It was itching so bad; Swelling on my where I got the shot, redness; It was itching so bad; Swelling on my where I got the shot, redness; It was itching so bad; Swelling on my where I got the shot, redness; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included high blood pressure and autism. Concomitant medication included atenolol. On an unspecified date, the patient experienced that it was itching so bad; swelling on where she got the shot, redness. The patient underwent lab tests and procedures which included investigation: unknown results on 06Jan2021. Clinical outcome of the events was unknown.  Information about batch/lot number has been requested.
Then the fever started and lasted 24 hours/It was 102.1 at its worst point on Tuesday afternoon/ Tuesday night around 9 my fever came back down to 99; hard time driving; EXTREME chills like never before in my life; So bad my body tensed up for hours; my body hurt so bad; couldn't walk; Vertigo; my ears and head feel like they are underwater; This is a spontaneous report from a contactable healthcare professional, the patient. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot El8982) solution for injection intramuscular in the left arm on 18Jan2021 (at the age of 32-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure. Concomitant medication included metoprolol. The patient had no known allergies. Historical vaccine included BNT162B2 COVID 19, brand=Pfizer, lot number=Ej1686, 28Dec2020, intramuscular in left arm, dose 1, for COVID-19 vaccination and experienced extreme fatigue and headache. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 18Jan2021 at 20:00, the patient experienced hard time driving, extreme chills like never before in my life so bad my body tensed up for hours, my body hurt so bad, couldn't walk, vertigo and my ears and head feel like they are underwater. Then the fever started and lasted 24 hours/it was 102.1 at its worst point on 19Jan2021, Tuesday afternoon/Tuesday night around 9 my fever came back down to 99. No treatment was provided for the events hard time driving, chills, tensed up, fever, body hurt, couldn't walk, vertigo and my ears and head feel like they are underwater. The outcome of the events hard time driving, chills, tensed up, fever, body hurt, couldn't walk, vertigo and my ears and head feel like they are underwater was recovered with sequel in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
Devel 104 R temp 3-4 hrs p/adm; Seen by MD on 19APR; Dx HBCV rxn; Mom treated w/APAP or Panadol; temp remained >103 for four days;
Left whole upper arm was swollen hugely and erythematous, slightly tender, heavy and itchy. Double size of arm. Got better in four days with Benadryl
Approx 48 hrs p/HIB/MMR vax pt devel 4x6 cm area of erythema, warmth, & induration lateral to inject site; area minimally tender; responded rapidly to ATB;
A nurse  reported that a pt received a vaccine on 2/23/00 and within 24 hrs developed flu like symptoms and an injection site reaction the size of an orange, characterized by a red swollen arm.
30 minutes after the vaccine was administered, as I was walking in the parking lot, I all of a sudden felt weak, lightheaded, trembly, with chest tightness and a need to lay down. The biggest problem was that my eyes became strangely affected, like there were shutters being opened and closed in rhythmic waves inside my eyes. They were also very photosensitive and blurry. My whole head felt wrong. drove me home, (I could not have driven).  This lasted several hours. I had chills and stayed laying down with my eyes closed. By the end of the day I felt mostly recovered.  This series of events recurred 6 days later,  on Jan. 20th. This time it also lasted most of the day, but I continued feeling moderately unwell the next day, and today it continues. I feel weak and unsteady. My eyes are better but  not entirely. They ache and feel insecure. I am not currently feeling up to any activities besides resting.
1.5-2 inch wide circle around injection site; Warm if you touch it; Like a rash; Has a bump; Body aches; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (1.5-2 inch wide circle around injection site), VACCINATION SITE WARMTH (Warm if you touch it), VACCINATION SITE RASH (Like a rash), VACCINATION SITE SWELLING (Has a bump) and MYALGIA (Body aches) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Low grade fever). On 01-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (1.5-2 inch wide circle around injection site), VACCINATION SITE WARMTH (Warm if you touch it), VACCINATION SITE RASH (Like a rash) and VACCINATION SITE SWELLING (Has a bump). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at an unspecified dose and frequency. On 28-Feb-2021, MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (1.5-2 inch wide circle around injection site), VACCINATION SITE WARMTH (Warm if you touch it), VACCINATION SITE RASH (Like a rash) and VACCINATION SITE SWELLING (Has a bump) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
no adverse reaction, vaccine was given to pt after age of 45 and was given to early for interval of 2nd and 3rd dose
Sore arm with raised lump for 4 days, severe tension headache for 5 days, fatigue for 4 days
Pt had TD shot on 12/6. On 12/13, noted itching, soreness, redness & discomfort of R/deltoid. On 12/6, had headache, neck pain, earaches at 8:00 pm, but now states had these sx's 3 wks ago. Dx: Cellulitis due to scratching arm x 7 days.
Patient presented to the ED on 4/4/21 and 4/7/21. Patient presented to the ED on 4/10/21 with NSTEMI and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.
Uncontrollable muscle twitches followed by grand mal seizure.  (First in patient's life)
ARM SORENESS; This spontaneous report received from a patient 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm soreness was not reported. This report was non-serious.
Patient was given expired vaccine (31 days stored in refrigeration) and vaccine repeated on 5/24/2021
Information has been received from a health professional concerning a 4 year old male who on 3/14/02 was vaccinated with a 2nd dose of MMRII (lot 636663/0020L). The 1st dose was given on 9/11/98 and no problems were experienced. On 3/25/02, in the evening, the pt's mother contacted the physician's office and reported that the pt was complaining of increased urination, abdominal pain and nausea. She was instructed to take the pt to the ER and the physician saw the pt. Lab tests were done and he had an accucheck of 220 and glucose in his urine. The pt was dehydrated and had an elevated WBC and an increased eosinophil value. The pt had IV fluids administered and recurrent accuchecks and serum samples were done. The pt's blood sugar returned to normal and he was released from the ER the same evening on 3/25/02. The physician ruled out Diabetes and felt that this event could have been a reaction to the MMRII due to the eosinophila. The week of 4/3/02, the pt's mother had telephone follow-up with the physician's office and it was reported that the pt has not experienced any further problems. The plan was for the pt to have lab work done at the end of 4/02 and was scheduled for a doctor's visit on 4/26/02. It was reported that another child (WAES0203USA02975), in the pt's nursery school, had a similar experience following exposure to MMRII. Additional info has been requested.
Had knee issues after taking the vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer stated that her friend had knee issues on an unspecified date after taking the vaccine. She also had knee replacement done. Outcome of event was unknown.  Information on the lot/batch number has been requested.
Pt felt euphoric, intermittently (several hours at a time) over a 3-4 day period. Welt on his left arm, lasted over 30 days.  Follow up 06/05/2000: "Patient recovered from adverse event."
On January 21, 2021 at the Clinic, a PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator (a RN). The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the RN inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The RN then alerted the lead APRN, who escalated the situation to the operations manager. The operations manager then contacted the Quality Officer.  The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine, 0.4mL.  After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them.  Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a near miss event and is being reported out of an abundance of caution.
I felt very cold, so I took a hot shower and got into bed and covered myself with blankets, but that made me too hot. I had intense stomach aches and then vomited a few times and had diarrhea. During that time the stomach aches reached a very painful level, the hot flashes were intense and I didn't feel better until a little while after getting everything out.
Had chills and could not get warm all night.  Lasted for about 6-8 hours.  Got headache in the morning at 7 a.m..  Went back to bed, woke up around 4 p.m.  feeling much better.
No additional AEs were reported, no further information provided.; The medical assistant reported that on 7/7/2022, a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.; This spontaneous report has been received from a medical assistant concerning a patient of unknown gender and age. The patient's concomitant therapies, pertinent medical history, and drug reactions/allergies were not reported.  On 07-JUL-2022, the patient received improperly stored Haemophilus B conjugate vaccine (Meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 1 dose (lot number U014483, expiration date reported as 15-SEP-2023; strength and route of administration were not provided) for prophylaxis (product storage error). The temperature excursion was of 32.9 Fahrenheit for 44 minutes. It was reported that there was no previous temperature exclusion. No additional adverse event was reported.
Patient received 2 injections in right arm on 07-10/08 at her doctors office. Came to urgent care with pain and swelling in right upper arm (7-8 cm induration) given Keflex 500 mg qid for 5 days.
Patient experienced 6 days of high fever (up to 103.4), vomiting x 2, night terrors for 2 weeks, and behavioral changes (very hyperactive with oppositional behavior).
had a urinary tract infection after each dose; This is a spontaneous report from a contactable consumer. This 63-years-old female consumer reported that, a Male patient of an unspecified age received first dose of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN5318), via an unspecified route of administration in the left arm on 26Jan2021 at 12:30 PM as a 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications taken within two weeks included Atorvastatin 20 mg daily in evening; Algae Cal Plus (ALGAE CALCIUM), all were received for an unknown indication from an unspecified date and unknown if ongoing. The patient did not receive any vaccine within 4 weeks prior to the suspect vaccine. he did not have Covid prior vaccination. Patient received 2 doses of the Pfizer covid vaccine, and on 26Jan2021 at 06:00 PM he had a urinary tract infection. He never had a UTI in his life until he received this vaccine. This was just too coincidental. Events resulted in the Doctor or other healthcare professional office/clinic visit. Patient received treatment with antibiotic (unspecified) for the events. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9267), dose 2 via an unspecified route of administration in the left arm on 16FEB2021 at 12:30 as a 2ND DOSE, SINGLE DOSE for COVID-19 immunization. He had not been tested for covid post vaccination. Outcome of the event were Resolved on unspecified date.  No follow up attempts are possible. No further information is expected.
rash on body, no doctor was seen as of today, I used over the counter gold bond cream, still does not help.
PATIENT WAS COMING IN FOR HER FIRST COVID PEDIATRIC VACCINE. WE WENT TO DRAW UP THE DOSE BUT HAD FORGOTTEN TO DILUTE THE VIAL. PATIENT ENDED UP RECEIVED 0.2 ML OF UNDILUTED PEDIATRIC COVID VACCINE WHICH IS A HIGHER CONCENTRATION THAN RECOMMENDED. PATIENT'S PARENT CLAIM TO NOT HAVE ANY ADVERSE EVENTS OR SYMPTOMS.
Redness around where the shot was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around where the shot was given) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around where the shot was given). At the time of the report, VACCINATION SITE ERYTHEMA (Redness around where the shot was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 29-Jan-202, redness looked more like a pentagon. It went up 5 inches and the square part was about 4 inches. It was getting bigger in an unusual way. It was no hotter than the rest of her body. It did not itch. It was not a rash. Concomitant medications were not provided. Treatment information was not reported.
RAPID HEART RATE; EXTREME DIZZINESS; SLIGHT COUGH; JITTERINESS; TIGHTNESS IN THROAT; INJECTION SITE PAIN; ON AND OFF HEADACHES; FEVER; DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced tightness in throat. On APR-2021, the subject experienced injection site pain. On APR-2021, the subject experienced on and off headaches. On APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced rapid heart rate. On 08-APR-2021, the subject experienced extreme dizziness. On 08-APR-2021, the subject experienced slight cough. On 08-APR-2021, the subject experienced jitteriness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and fever on APR-2021, and was recovering from difficulty breathing, rapid heart rate, extreme dizziness, slight cough, jitteriness, on and off headaches, and tightness in throat. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious
FLUZONE HIGH DOSE given at 4:30 pm and chills started at 6:30 pm that night. Fever lasted until the next night about 24 hours later. She had a sore arm (shoulder to finger tips) and aches for 3 days. Patient states that she takes HYDREA 500 mg and doesn't know if this is the first HIGH DOSE flu shot she has had, but hasn't had this issue in the past.
This case was reported by a healthcare professional and described the occurrence of extra dose administered in a child subject of unspecified gender who was vaccinated with PEDIARIX, (GlaxoSmithKline). On an unspecified date, the subject received 4th extra dose of PEDIARIX (unknown route, injection site and batch number). No further information was available. The case was closed.