chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was considered medically important. Information regarding PREVNAR vaccine was received from a physician regarding a 5-month-old female patient who experienced positive culture for Streptococcus pneumoniae-drug ineffective, fever, vomiting, congestion, and appeared to be in pain. The patient received a second dose on 29-Feb-2008. The patient also received the second dose of Hib-Titer Vaccine, the second dose of DTaP, the second dose of Polio-Vaccine (Not Specified) and the second dose of ROTATEQ (Merck & Co Inc) on 29-Feb-2008. The patient has a past history of eczema. The patient previously experienced hypersensitivity while taking Penicillin NOS. Concomitant therapy included TYLENOL and homeopathic teething tablets. The patient experienced fever, vomiting and congestion on 01-May-2008. She was brought into the office on 05-May-2008, because she still had a fever, was vomiting and appeared to be in pain. The physician collected blood cultures on 06-May-2008 and 07-May-2008 (see test results). The cultures were positive for Streptococcus pneumoniae-drug ineffective on 06-May-2008. The fever went down without any antibiotic treatment, and was afebrile on 07-May-2008. On 07-May-2008, the child received one dose of ROCEPHIN. The outcome for vomiting, congestion, pain and Streptococcal bacteremia are unknown. No further information was available at the time of this report. Full blood count (results: normal), and blood culture (results: positive for Streptococcus pneumoniae, serotype not reported) were done on 06-May-2008. Full blood count (results: normal) and blood culture (results: positive culture for Streptococcus pneumoniae, serotype not reported) were done on 07-May-2008.
2 hours and 20 minutes after receiving the Pfizer COVID-19 vaccine I started to experience difficulty swallowing and the back of my tongue started to swell.  First, I immediately drank children's liquid Benadryl from the bottle (therefore, I can not tell you the exact dose). Next, I called my healthcare provider for a EpiPen prescription in which I had filled immediately. After 30 minutes to 1 hour after taking the unknown dose of the Children's liquid Benadryl my symptoms did not progress. I did not need to use the EpiPen, however, I did take one tablet of adult Benadryl 25mg at 11am. After sleeping for several hours, I had no further symptoms.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks was reported as yes. Patient received Paxlovid treatment from 28Dec2022 to 01Jan2023 for Covid-19, other medication in 2 weeks product Levothyroxine 25 mcg, other medication in 2 weeks product: nifedipine, other medication in 2 weeks start date: 04Dec2021, other medication in 2 weeks stop date: 27Dec2022, other medication in 2 weeks product lisinopril, other medication in 2 weeks start date: 29Dec2022. Paxlovid/COVID Rebound 5 days after testing negative and symptoms had gone away. The sore throat returned. adverse event start date: 05Jan2023.
arm very red; arm tender to the touch; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of   in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 26620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.    Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No new information was provided.
Pfizer 4/5/21, 5/8/21, 11/23/21. Positive on 12/2/22
This spontaneous report was received from a registered nurse concerning to a 67 years old patient who in 2006 was vaccinated IM with a dose of PNEUMOVAX 23 (dose and lot # not provided) and on 24-AUG-2012, the patient received a second dose of PNEUMOVAX 23 (dose and lot # not provided). The nurse stated that during the vaccination on 24-AUG-2012, the hub of the needle became loose. The vaccine leaked from the hub, resulting in a partial dose of PNEUMOVAX 23 administered to the patient. No adverse effect was reported. This is one of several reports received from the same source. Additional information is not expected.
Vaccinee received first dose of Engerix-B at approx 3:30PM on 3-OCT or 4-OCT. About 2 hrs later she experienced slight headache, felt achy, had dryness in throat.  No treatment was given.  Events cleared by the following morning.
BODY PAIN; LOW BACK PAIN; CHILLS; HEADACHE; FEVER; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. 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 17-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced pain at injection site. On an unspecified date, the subject experienced body pain, low back pain, chills, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.4 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at injection site, body pain, chills, headache, low back pain and fever was not reported. This report was non-serious.
Swollen and painful arm. Patient taking TYLENOL for pain. Seen by provider 9/24/16. Patient to continue with TYLENOL and to apply cold compresses.
As soon as the injection was given the area around the injection site swelled up. Cold pack was applied immediately and the swelling went down within 1 minute.
Erythema, edema, pain at site after 24 hours (7/23).  Reported to Urgent Care, given antibiotics for Cellulitis.  7-24-08 - 14cm x 9cm area of erythema and edema with vesicular localized changes.
Red, burning eyes; presence of mucus secretion in eyes affected vision; severe headache; aches in back and shoulders, tightness and tingling and then pain in chest; slight fever.
Pt recvd 3 doses of Engerix-B & 28OCT91 it was determined that pt did not respond to the vax series;
No additional AE reported; HCP reported PROQUAD was administered after a temperature excursion to patient. Product was administered on Jun 2, 2022. No further information provided. This is patient one of two. Cross reference AE case: 02178242. No additional AE reported. No PQC; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported.  On 02-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection once (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number U039957, expiration date reported and validated as 14-JUN-2023) as prophylaxis, that experienced a temperature excursion (product storage error). No additional adverse event reported.  The vaccine experienced a temperature excursion of minus (-) 4.5 degrees Celsius (C) for 3 hours and 58 minutes. There was no previous temperature excursion.  This is one of the reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001554:
I did not have an adverse reaction to the vaccine. Two months after receiving the vaccine, I developed an itchy rash on my buttocks that moved down my thighs, then to my forearms, elbows and hands. When it is red it feels raised up and very itchy. As of today, I continue to have the breakouts. I have seen my primary care doctor and a dermatologist. I am currently under treatment.
Patient was supposed to recieve Fluzone due to age. Patient recieved Flublok. Mom was notified.
Within 3 hours of receiving vaccine, I experienced pain in my right arm, chills, fatigue, fever, muscle aches, shooting pains in my legs. This lasted 24 hours.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 at 09:15 as dose 1, single (Lot number: EP7533), in left arm and on 24Apr2021 at 09:15 as dose 2, single (Lot number: EW0170) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with paxlovid from 26Dec2022 to 28Dec2022. Patient took other medication in 2weeks. Patient did not had allergies.
PATIENT STATED THAT THEY FELT SOME ARM PAIN (4/10) WITHIN 10 MINUTES OF RECEIVING THE VACCINATION, SYMPTOMS WERE TREATED WITH ACETAMINOPHEN AND WATER, RESULTING IN PAIN OF 2/10
My throat started swelling up about 45 minutes after receiving the COVID VACCINE EN6207 injection.  Took one dose of liquid Benadryl and was fine. No other symptoms since day of injection
ACUTE NON ST ELEVATION MI 1/13/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient tested positive for COVID-19 after being vaccinated, 30 days after dose. Patient received J&J dose of COVID vaccine on 3/15/21 . Tested positive on 4/14/21. NOT hospitalized. Symptoms:  congestions, stuffiness (very mild cold)
Moderna Bivalent Booster 0.25mcg was given to patient and was to receive 0.5mcg. Wrong dose was given to patient.
The first dose of vaccine (lot number EW0176) was taken on 05/06/2021, and the second dose of vaccine (lot number EW0186) was taken on 05/27/2021. within 12 hours of second does she had gotten severe headache, she couldn't eat for severe vomiting, she said she felt like she was hit by a truck, and had the chills. she would go from really cold to really hot. She couldn't keep anything down even water. On the third day after the vaccine she was very sick and we ( the family) thought she was sleeping but when we went to try and wake her up we discovered her dead.
pt w/myelodysplasia w/chronic low WBC, RBC & platelet counts got permission from MD to take flu shot;next day called to say vaccinated arm was red & swollen shoulder to wrist;referred to MD sent to urgent care placed on ATB for staph cellus
had the same side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had the same side effects) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had the same side effects). At the time of the report, VACCINATION COMPLICATION (had the same side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The caller reported that a relative of their had the same side effects.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-403246, MOD-2021-403284 (Patient Link).
On June 18th at 7:15pm she had a febrile seizure along with a 103.4 fever.
Patient developed flu like symptoms then a rash on chest and torso 3 days later.  Completely resolved by 11/15/16.
Severe fibromyalgia type pain in muscles of both legs; became sharper/more painful upon standing, had to sit or lay down due to pain. This occurred for over one month and decreased over time.  Also for one month: had a hard time keeping food down, nausea, vomiting, daily severe headaches, night sweats, fever on and off (was not influenza)  Daily headaches continued. Started to have feeling of "fullness" in stomach regardless of how little was eaten, had elevated CRP level. This continued into the next year. After a long search for the cause, was finally diagnosed with the autoimmune disease Crohn's disease a year later.
Initial and follow up information has been received from a epidemiologist and a registered nurse concerning a 16 month old female patient who on 11/15/04, was vaccinated with a dose of MMR (lot # 646552/0961N). Subsequently, on 11/23/04, the patient developed a high fever of 104 and a seizure. Unspecified medical attention was sought. It was also reported that the patient was not hospitalized and she was feeling much better and feeling normal. The patient was considered to be recovered (date unspecified). Upon internal review, the patient's seizures were considered an other medical event (OMIC). The epidemiologist wanted to know if the high fever was related to the lot of MMR. Lot check has been requested. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. This is a consolidation of two reports concerning the same patient. It was reported that 3 other patients developed high fevers post vaccination with MMR (WAES0412USA01748, 0501USA00211, 0501USA00212). Additional information is not expected.
mom states that pt exp singe & sx of shock,became lethargic & pale,weakness approx 1 hrs p/vax;pt was taken to MD for eval;
This case was reported by physician via call center representative and described the occurrence of allergic reaction in a patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The health care professional mentioned that the patient had an allergic reaction to a previous flu vaccine. The health care professional did not provided information about the brand of flu vaccine or any patient information.
Two weeks after receiving his Varicella vaccine he developed a rash, which was seen by the doctor and confirmed as varicella
experienced swelling; arm feeling hot; arm is still sore; having difficulty moving; arm redness; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix. On 28th August 2020, less than a day after receiving Shingrix, the patient experienced swelling arm, extremities hot feeling of, pain in arm, movement disorder and erythema of extremities. On an unknown date, the outcome of the swelling arm, extremities hot feeling of and erythema of extremities were recovered/resolved and the outcome of the pain in arm was recovering/resolving and the outcome of the movement disorder was not recovered/not resolved.   The reporter considered the swelling arm, extremities hot feeling of, pain in arm, movement disorder and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her 1st dose of Shingrix that night experienced swelling and the other effects as noted in this report.  The effects lasted for 2 days. Her arm was still sore, but it was not red.  The reporter consent to follow up.
13 minutes into 15 minute observation, patient began c/o feeling nauseous. Patient offered water and began to dry heave. Patient vitals obtained BP 87/35 P48 T 97.1. Patient continued to drive heave with an emesis x 1. Patient given crackers. Patient noted very pale and sweating. Second set of vitals obtained at 9:54 patient lying on cot observed with BP 103/62 P 72 T97.1 PO 100% room air, expressing she was feeling better at this time. Father of patient present during this matter. During the time patient noted laying flat she expressed she felt better and her initial color began to return.  At 10:16 Patient seated sitting up BP 117/75 P69 T 97.5 PO 100 room air. Noted talking and laughing with dad. Patient expressed she had not had any prior reactions to any vaccines/medications and none with the first. Patient did express she had gone to the gym prior to coming to vaccine clinic and had eaten after working out at the gym. Patient standing BP 115/69 P 78 T 97.5 PO 100% Room air. Patient standing and able to ambulate without feeling light headed. No nausea expressed. Patient felt well enough to leave with her dad. Lead made aware of this matter.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Lymph Node Swelling-Mild
65 y.o. male was admitted on 9/9/2021 for shortness of breath and hypoxia.  Acute hypoxic respiratory failure from COVID pneumonia.  Treated with IV antibiotic, remdesivir, dexamethasone. Patient also had decompensated liver cirrhosis, underwent paracentesis. Bilateral leg DVT.  Thrombocytopenia.  S/p IVC filter 09/16/2021.  Even with 100% oxygen and BiPAP support, respiration and oxygen saturation gradually worsening.  Patient and family declined intubation, opted for comfort care.  Patient passed away 2203 hours on 09/17/2021.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 28Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Apr2022 as dose 4 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Negative, notes: my last negative test; (06Jun2022) Positive, notes: Tested positive on a home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Patient had no known allergies. Patient was not received other medication in 2 weeks. Anti-viral details: product=COVID 19 Treatment, brand=Paxlovid, Treatment start date= 28May2022, Treatment stop date= 01Jun2022, Indication=Treatment of COVID-19. Relapse on 06Jun2022, 5 days after stopping Paxlovid, 4 days after her last negative test. Headache and runny nose. Tested positive on a home test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine given 8/15/02 left deltoid. Arm is swollen, hot at site of vaccine measure approx 10 x 7 inches.
short fast breathing, temperature 100, small patches of rash on skin. Gave Motrin and fever reduced. Fever did come back at about 11:30 AM. Called Dr office for suggestion but no response yet
Chest pain, short of breath, axillary swelling, (L) breast swelling, erythema at injection site x 4 days.
That night, I initially felt I been hit by a truck. By the next day I had a 102 fever and chills (about 24 hours after shot) and pain in arm. Fever and intense chills persisted next few days, white blood count shot up to 19,000 by Friday and arm swelled (bright red) with extreme pain (from below elbow to shoulder). I could not move my arm. I continued to feel that I had been beaten up and had extreme pain in arm and head. Was hospitalized starting Thursday (went to emergency room then) and was released Sunday evening. They believed I might have had a blood infection and/or blood clot but later determined was severe adverse reaction to shot. Horrible experience and I still have some pain in my elbow.
Racing pulse, chest tightness, high blood pressure; 30% increase in systolic pressure 300% increase in triglycerides (500+ total); too high to get regular readings of LDL/HDL cholesterol Unusual weight gain; 25lbs in 6 month period Gout like symptoms in left ankle; intermittent every 3 months
Evening of vaccines, pt developed rash on extremities -hands, feet throat felt funny - next day rash cont - today rash is just to biceps no temp - no local reaction.
Fatigue, feeling cold, shortness of breath,  poor appetite lasting  3 days extreme soreness at injection site lasting 4-5 days
Patient reported redness and heat at site of injection and pain in the left arm (injection arm) that has persisted for 4 days. Reports feeling feverish however do not have a temperature value at this time. Reports that adverse reaction symptoms are resolved with tylenol. Reports that this started the day of injection and has persisted.
Patient stated her arm became hot and swollen and was bleeding. She also stated she got the chills and was "knocked out" for approximately 6 hours.
On 02/05/2023, I woke feeling terrible.  I had cold symptoms. I had neck spasms, neck and shoulder up to my ear. I had an appointment last week on 02/27/2023 because it is still bothering me. He examined it and suggested I use heat and gave me exercises and prescribed Flexeril.
large red and inflammed circle around injection site, red patches on face and stomach, painful skin, headache, nausea, lower back (kidney) pain, lethargy, generalized pain and discomfort