chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Constant coughing, brain fog, light headed, dizziness, fevers usually between 99-101F, headaches, weakness, always tired, sore throat, feeling of swollen throat at bottom, i have to lift my head up to clear it. Usually take Tylenol for fevers. Sometimes it breaks the fever, sometimes it doesn't. Coughing is a dry cough. Was told by doctor to take Mucinex DM. Did not help. All these symptoms have been since February 2022. New symptom since June 28, 2022- Ear ache.
rash started on face then 2 days later appeared on stomach.  by day 4 stomach was puffy, red, and hurt, by day 8 blisters began to form and it continued to spread on stomach.  By day 8 face rash had disappeared
patient presented to office within 24 hours stating her arm was red, hot, swollen, unable to move arm. Pt diagnosed with cellulitis and given Doxycycline P.O.
Approximately 48 hrs after administration intradermal FLUZONE developed red, hot, swollen area at vaccine site.
Narrative: Pt with malignant neoplasm of breast, secondary malignant neoplasms of bone, and lymph nodes. Also hx of depression, gi reflux, vit b6 def, hypocalcemia, CKD stage 3, hypothyroidism, paresthesia, carpal tunnel syndrome, osteopenia, anxiety disorder had received covid vaccines on 3/23/21 & 4/20/21. Pt died on 5/19/2021 likely of cancer diagnosis & death not related to covid vaccines, however no notes regarding details of patient's death
Hives on hands and leg in morning that went away and again started at 5pm Swollen lips around 9.30pm Took Benedrayl at 11.30pm
Headache; Tiredness; Fever; stomach pain; muscle aches; This is a spontaneous report received from a contactable consumer or other non hcp. A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration in Arm Right on 12Apr2021 10:30 as SINGLE DOSE for COVID-19 immunization. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing , colitis microscopic from an unknown date and unknown if ongoing , alopecia from an unknown date and unknown if ongoing ,and had history of covid-19 before vaccine. No medication was taken prior to covid-19 vaccine. Historical vaccine taken was BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: E L3247) via an unspecified route of administration, in Arm Right on 22Mar2021 11:00 as SINGLE DOSE for covid-19 immunisation. Concomitant medications included tofacitinib citrate (XELJANZ) taken for an unspecified indication, start and stop date were not reported (two weeks prior to vaccination). On 13Apr2021 12:00, the patient experienced headache, tiredness, fever, stomach pain and muscle aches. Outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
dad c/o pt crying from last noc 11PM-3AM then again same x 2hr;given APAP;
Both arms painful and disabled. Chills, vomiting, fever (101 degrees), aches. Symptoms subsided 11/12/03. Follow up on 12/03/03: "Received follow up letter has no additional information to add to report (re: lot and manufacturer name)."
Patient falsified DOB when registering for vaccination. Guardian consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB made the vaccine a contraindication.  No known adverse reactions noted.
Event: Arm around injection site developed a reaction/rash that was warm to the touch, red and raised. Area starred small then grew to cover entire shoulder Treatment: benadryl and rest
Patients arm became red and swollen at injection site. She was given an injection of dexamethasone and betamethasone.
Extensive bruising but pain has diminished. Advised patient to take ALEVE BID and apply ice BID. Give it a few more days and if no improvement visit w/MD.
Initial and follow up information has been received from a medical assistant, via a company rep, concerning an 80 yr old white retired male, with glucose intolerance, hyperlipidemia, herpes zoster virus, and a history of abdominal aortic aneurysm, AAA, who on 01Aug05, was vaccinated SC with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). Initially the nurse reported that, on an unspecified date, the pt developed cellulitis of the arm after having been vaccinated with pneumococcal 23v polysaccharide vaccine. Follow up information from the nurse further described that on 02Aug05, the pt developed erythema, warmth, and tenderness at the site. On an unspecified date the pt recovered. No product quality complaint was involved. It was reported that there was no illness at the time of vaccination. Clearance for dental procedure was noted. The reporter considered the pt's experience to be an other important medical event (OMIC). Additional information is not expected.
Developed Baker's cyst in left knee; Baker's cyst leaking fluid; Leg swelling; Sharp pains in left knee and calf; Sharp pains in left knee and calf; Knee clicking; Could not walk normally or put pressure on left leg; MRI also showed evidence of arthritis behind knee which there was no prior history or issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: ER8732) at the age of 54 years as dose 1, single and administered in arm left, administration date 20Apr2021 (Lot number: EW0170) as dose 2, single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing). Concomitant medication(s) included: ESOMEPRAZOLE. The following information was reported: SYNOVIAL CYST (non-serious) with onset Apr2021, outcome "not recovered", described as "Developed Baker's cyst in left knee"; SYNOVIAL RUPTURE (non-serious) with onset Apr2021, outcome "not recovered", described as "Baker's cyst leaking fluid"; PERIPHERAL SWELLING (non-serious) with onset Apr2021, outcome "not recovered", described as "Leg swelling"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "Sharp pains in left knee and calf"; JOINT NOISE (non-serious) with onset Apr2021, outcome "not recovered", described as "Knee clicking"; GAIT DISTURBANCE (non-serious) with onset Apr2021, outcome "not recovered", described as "Could not walk normally or put pressure on left leg"; ARTHRITIS (non-serious) with onset Apr2021, outcome "not recovered", described as "MRI also showed evidence of arthritis behind knee which there was no prior history or issues". The events "developed baker's cyst in left knee", "baker's cyst leaking fluid", "leg swelling", "sharp pains in left knee and calf", "sharp pains in left knee and calf", "knee clicking", "could not walk normally or put pressure on left leg" and "mri also showed evidence of arthritis behind knee which there was no prior history or issues" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of synovial cyst, synovial rupture, peripheral swelling, arthralgia, pain in extremity, joint noise, gait disturbance, arthritis.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Treatment taken as as a result of synovial cyst, synovial rupture, peripheral swelling, arthralgia, pain in extremity, joint noise, gait disturbance and arthritis included aspiration of Baker's cyst, Cortisone, Orthovisc.  No follow-up attempts are possible. No further information is expected.
Was around someone who tested positive for COVID. I took a home test and it was positive. Talked to Dr. on the phone and was given PAXLOVID. I tested positive for 1 week.
Initial and follow-up information has been received from a physician and a nurse concerning a 10 month old male who had a history of being born premature 35 weeks, and had hyperbilirubinemia 1 week of age.  The child had a history of a fever and redness at the injection site with prior vaccination (unspecified).  His siblings (2) also experienced a fever and redness at the injection site with prior vaccination (unspecified).  On an unspecified date, the patient was vaccinated with the first dose of PEDVAXHIB.  At the time of being vaccinated with the second dose, the child had no illness.  On 27-NOV-2007, the child was vaccinated with a second dose of PEDVAXHIB (lot # 656519/0259U) IM in the left vastus laterlis (LVL) at 11 AM.  Concomitant therapy given also on 27-NOV-2007 included PEDIARIX (lot # AC21B125BB) IM in the right vastus lateralis (RVL); PREVNAR (lot # B70143C) IM in the right vastus lateralis (RVL); and DTAP.  On 27-NOV-2007, in the PM, the patient experienced a fever up to 102.5 degrees.  On 28-NOV-2007, the second day, the fever was 100 and on 29-NOV-2007, the 3rd day post injection was afebrile.  The patient also experienced redness of both legs, swelling at the injection site, and swelling of one of his legs which took about 2 weeks to resolve.  It was reported that the patient also received DTAP on the same day in one leg and PEDVAXHIB in the other.  The mother of the patient did not remember which leg was injected with what vaccine.  No treatment was given.  Medical attention was not sought.  No diagnostic tests were performed.  Follow-up information was received from a nurse.  On 21-DEC-2007 at 3 PM, the mother called the clinic and reported that her child has a bad viral cold since receiving the vaccine and has not gotten better.  The mother had received a letter about PEDVAXHIB vaccine bad lot.  The child now had a cold, and is congested.  Coughing is bad at night time.  No fever.  The child is teething so the child has been given TYLENOL and MOTRIN.  The mother was told to bring the child to the clinic on 21-DEC-2007.  The outcome of the viral cold, cough, and congestion was not reported.  No additional information is expected.
Blood in urine, no other symptoms - 12/05/2021 11:30PM, Patient Office Visit, no symptoms - 02/06/2021 2:20PM, no treatment necessary at this time, Outcome - tests revealed no blood in urine and all factors are within normal range, no symptoms experienced before or since actual event. Patient will self-monitor and contact office if event occurs again.  There are no indications to conclude that this event was in anyway related to the patient's COVID-19 booster shot.
Right Arm swelling developed the next day after vaccination. The day after that he developed a hive on his left foot. The third day after vaccination he developed hives on left arm and left upper trunk. The fourth day after vaccination, he started to have swelling of his lower lip and his right cheek.
pt c/o lightheadedness, dizzy, upset stomach;pt looked pale nurse gave whiff of ammonia amp then gave juice to drink;BP 98/68, P64;pt realized in chair w/nurse @ side;drank juice 15min p/tx felt better;
BILATERAL LEG BODY ACHE; LEFT JAW PAIN; INJECTION SITE PAIN; 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, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: 21-MAY-2021) dose was not reported, administered on 03-MAR-2021 at 11:30  hours to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 03-MAR-2021 at 16:00 hours, patient experienced left jaw pain and also experienced injection site pain (unspecified time). The patient was treated with Tylenol and Advil and with no effect. On 04-MAR-2021, she also developed bilateral leg muscle pain (coded as bilateral leg body ache) upon waking up in morning.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left jaw pain, bilateral leg body ache, and injection site pain. The reporter assessed the events as related to covid-19 vaccine ad26.cov2.s. This report was non-serious.
Hurts a lot, secondary symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28-APR-2023, the patient received Shingles vaccine. In APR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Hurts a lot, secondary symptoms). The outcome of the pain was not resolved.   The reporter considered the pain to be related to Shingles vaccine.     The company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 29-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that, the vaccine hurts a lot, he/she received it yesterday and it gave her/him all the secondary symptoms. The patient hope he/she get better soon. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 02-NOV-2012 at 12:26, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
With the first vaccine dose I had a headache, body aches, and a very sore arm (where I received the vaccine) for a couple of days.  Side effects I expected.   But with the second dose I initially had a fever of 101 and body aches. As the night/early morning went on my fever increased to just over 103 (with Tylenol) and I had heart palpitations off and on for a couple of hours.  Once my fever started to go down the palpitations stopped.  I was nauseated, unable to even drink water, and had a headache with chills and body aches for about 36 hours.  I am still unusually tired, I have joint swelling on my left side (new for me), and arm pain where I received the vaccine.
feeling tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DUPIXENT. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "feeling tiredness".  Additional information: Covid vaccine taken on 21Mar2021 last shot on 11Apr2021 Pfizer  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Interchange of vaccine products; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) and in Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Inverted Papilloma" (unspecified if ongoing), notes: Inverted Papilloma; "Pre Diabetes" (unspecified if ongoing), notes: Pre Diabetes; "Chronic Inflammation" (unspecified if ongoing), notes: Chronic Inflammation; "Known allergies: Penicillins" (unspecified if ongoing), notes: Known allergies: Penicillins. The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "Known allergies: levaquin", notes: levaquin; Demerol, reaction(s): "Known allergies: demerol", notes: Known allergies: demerol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 27Sep2022 to 02Oct2022 as treatment for Covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Localized cellulitis. Pt went to urgent care 12/24/16 prescribed SEPTRA DS #20 1 bid for swelling warm compression three times daily.
#1  Hot flashes/ lightheaded, nauseous within the first 5 min. after the shot. , Heat /burning and inflammation in gut/ descending colon, pain/itching/heat/ burning inflammation in back, neck, hands that have arthritis / osteoarthritis.  within the next hour increasing throughout the day and into the next several day.  It reduced but did not completely resolve by the 2nd shot.  I followed a very basic diet to reduce distress on the gut.  Drank a lot of water and walked more each day to keep joints from getting sore and stiff.   I was moved to where I could be monitored by blood pressure.  #2  I had shooting pain up my left collar bone into my left lower jaw and left side of my face within 5 min of the shot while I was still being monitored.  The heat and pain in my gut, back, neck, hands flared again.  The neck and back wore worse in intensity and duration with the 2nd shot.  The left side of my face was numb and puffy for several days.  I did go to the Dr. who was unable to provide an explanation.   I still have occasional irritation on the left side of my jaw and face.     I again followed a basic diet to reduce any inflammation, increased water intake, and walked to keep from getting more sore and stiff.   * I would like to note that the areas affecting me are all areas that have an active form of arthritis, inflammation including a left jaw injury in 1978.
This spontaneous report as received from a nurse refers to a 2 years 5 months old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) Liquid ROTATEQ, injection, lot # K016313, exp. date: 31-MAY-2016 and lot K011663, exp. date: 20-MAY-2016 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contaca6t details were provided.
This spontaneous report was received from a physician via company representatives and from a support services director concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 24-JUN-2014, the patient was vaccinated with an improperly stored of GARDASIL "PFS 6x1.5mg/0.5ml w/o Sfty Syr" lot # J009098, expiration date 04-DEC-2015 (route and dose were not provided). This vaccine had a temperature excursion of 4164 hours. The highest temperature recorded was 59.9 degrees Fahrenheit (15.5 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient developed a lower extremity DVT approximately 2 weeks after receiving the J&J COVID-19 Vaccine. Patient was treated and discharged from our facility on apixaban.
This spontaneous report was received from a registered nurse and refers to a 12 month old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 18-JAN-2017. On 13-FEB-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M038860 with expiration date of 13-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 27 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.