chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a parent via a company representative through social media concerned a 40 year old male of an unspecified race and ethnicity. Initial information was processed along with the additional information received on 28-JUN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received two doses of covid-19 vaccine from an unspecified manufacturer (dose number in series 1) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered for prophylactic vaccination. It was unknown whether patient had any adverse events following two doses of covid-19 vaccine from an unspecified manufacturer (dose number in series 1). On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (third dose) (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered 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 patient experienced covid (suspected covid-19 infection) and was down for a week and had suspected clinical vaccination failure (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000237655. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220654990-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Got ZOSTAVAX on 12/28 and around 1/17 had a really bad headache until 1/20 felt a bump on my eyelid that was really sore, 2 days later another bump popped up on the side of my eye and about 2 days later 2 or 3 more popped up in my eye brow above that eye and one on my forehead. So on 1/27the I went to my dermatologist and they had started coming to a head and the one on my eyelid looked like an ulcer.  She said it looked like an insect bite or shingles which I really believe it is shingle because now my eye and face on that side are swollen and all the bumps have scabbed over and are really red around them.  When I looked up the ZOSTAVAX drug insert I read about post vaccination Zoster rashes that occurred up to 42 days after vaccine.
Felt odd sensation in arm and into 4th & 5th fingers lasting over night.  10/09/2014 AM continues with "odd" numbness in R) 5th finger.
G47.33 OBSTRUCTIVE SLEEP APNEA 4/28/2023 OBSTRUCTIVE SLEEP APNEA
rashes turning into hives spreading all over , lip swelling, facial swelling,throat tightness, dizziness or light headed, severe pain on joint area, lower area both leg to feet area, weakness, tingling, numbness, unable to walk normally, blood preasure 160 to 180, tightness or numbness on facial area. body itchy later hot .
4-5 hours after receiving the vaccine I began to feel dizzy, nauseated, I had chills and body aches. Through the night I had a fever of 100°F and severe neck stiffness and headache that didn't get better with acetaminophen. The next morning the headache, neck pain, and nausea/dizziness were worse and I had 3 episodes of vomiting. All symptoms eventually subsided with rest and fluids about 24 hours after receiving the vaccine
MILD MUSCULAR PAIN IN CHEST AND BACK AREA AFTER 3 OR 4 DAYS.  ACUTE MUSCULAR PAIN THROUGH DAY 10 WHEN CERTAIN MOVEMENTS ARE MADE.  I CANNOT ATTRIBUTE PAIN TO ANY ACTIVITY.  NO HEADACHE OR ARM PAIN.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 66 year old male.  Initial information was processed along with additional information on 01-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: lung cancer (missing1/4 of lung for years). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: unknown) dose was not reported, 1 total administered on right arm on 09-MAR-2021 for prophylactic vaccination. Patient did not receive the booster shot. Age at time of vaccination 65 years old. No concomitant medications were reported.  Since 21-JUN-2022, the patient was feeling sick, had bad cough and headache. On 26-JUN-2022, he tested positive for Covid-19 (unspecified test) (confirmed covid-19 infection) which led to confirmed clinical vaccination failure. The headache was recovering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220702322. This report was associated with product quality complaint: 90000240649.; Sender's Comments: V0: 20220702424-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Following HIB and SYNAGIS injection, patient crying and diaphoretic and then suddenly went pale approximately 1 min later. No sign of breathholding or reflux. Patient became quite pale and then dusky/blue, seemed to stop breathing for a second. Was stimulated with sternal rub and began breathing. Was not really crying but just whimpering and pale for about 2-3 minutes after the event. First HR about 1-2 minutes after the event was noted to be 50-60, so possibly some sort of vagal episode. Sent to ED for further evaluation, expect called.
Within 48 hours there were changes in my heart rate and rhythm that felt like fluttering. I used a smartwatch to take an EKG that recommended I contacted a doctor. It was not a normal rhythm, contact a doctor. That kind of came and went for several hours. It was more anxiety inducing than anything else. I contacted my GP the next morning, and he immediately directed me a cardiologist. Saw him within the next week. He did an EKG and recommended a full work up with a stress echocardiogram. All of that came back normal. He also had me wear a heart monitor for 2 weeks 24/7. The monitor registered a pretty regular intervals, PVCs. He told me it wasn't dangerous, and it was then my husband's cardiologist to not worry about it and that it would pass in 5-6 weeks. He said it was due to the vaccine, but it was gone in 5-6 weeks. It got less and less each week and finally gone in the middle of the 6th week. Same symptoms happened for the 2nd and 3rd vaccinations - but less severe compared. Fewer incidents within the same time frame of 5-6 weeks.
Patient called and stated she developed a bruise about 3" round and has red lines developing below bruise, two days after FLUZONE administration.
After the vaccination i developed a fever and got sick on the job and was sent home.  I was off work for about 3 days before the fever began to break.  Headache, joint pain and fever was associated throughout those few days and finally the symptoms subsided with tylenol.
Reported itchy face covered with hives and one over eyelids very swollen. She was prescribed prednisone and symptoms resolved.  Provided pictures in the email. She said her doctor advise not to take 2nd dose.
pt recvd vax & had localized redness; swelling at site of vax lasting several days;
pneumonia; upper respiratory infection; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection). At the time of the report, PNEUMONIA (pneumonia) and UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection) outcome was unknown.            Treatment medication used as Steroids and Antibiotics. Concomitant medication information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Developed angio edema of face, large wheal @ inj site of MMR @ 10 minutes.  Uricaria over truck & limbs by 20 minutes & some drooling -> im epinephrine given
Had a mildly sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient experienced mild sore arm. The patient said that there was not a big deal at all. Follow-up would not possible, as no contact details were available.
Patient with c/o significant bilateral hip pain. Has been doing some stretching and using  machine at PT on her hips that makes it feel a  lot better when she is there. Is trying to do the exercises at home, but pain is the worst when she gets up in the morning and after sitting at night watching TV. IT Bands present as tight on exam bilaterally.
No additional AE; Pharmacist calling to report an adverse event involving a 25 year old patient who was inadvertently administered an expired dose of MMR II.  Pharmacist stated that the MMR II dose had a labeled expiration date of 7/15/2023, and was administered today; This spontaneous report was received from a pharmacist and refers to a 25-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-NOV-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) injection, therapy type: rHA, two dose series, lot #U022316, expiration date: 15-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). Pharmacist confirmed no report of symptoms or medical concerns at this time from patient involved (No adverse event). Pharmacist stated they were unaware if the dose administered was the first dose the patient has received.  No additional information provided regarding this adverse event.
This case was reported by a consumer via call center representative and described the occurrence of tonic clonic movements in a female patient who received BOOSTRIX. In August 2017, the patient received BOOSTRIX. In September 2017, less than a year after receiving BOOSTRIX, the patient experienced tonic clonic movements (serious criteria GSK medically significant), syncope, paresthesia and visual disturbance. On an unknown date, the outcome of the tonic clonic movements, syncope, paresthesia and visual disturbance were not recovered/not resolved. The reporter considered the tonic clonic movements, syncope, paresthesia and visual disturbance to be possibly related to BOOSTRIX. Additional details were provided as follows: The patient's parent reported this case. The age at vaccination was not reported. The patient's adverse events were noted in the first week of September 2017. The neurologist was conducting additional tests. The reporter did not want to provide more information.
Anaphylactic reaction; her hands were itchy; developed hives on her hands; her throat was closing.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent.  A 18 year-old female patient received bnt162b2 (COMIRNATY), administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset Sep2021, outcome "unknown", described as "Anaphylactic reaction"; PRURITUS (non-serious) with onset Sep2021, outcome "unknown", described as "her hands were itchy"; URTICARIA (non-serious) with onset Sep2021, outcome "unknown", described as "developed hives on her hands"; THROAT TIGHTNESS (non-serious) with onset Sep2021, outcome "unknown", described as "her throat was closing". The events "anaphylactic reaction", "her hands were itchy", "developed hives on her hands" and "her throat was closing." were evaluated at the emergency room visit.The reporter asked whether the patient should not get the COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine if patient had a severe allergic reaction after a previous dose of this vaccine or if patient had a severe allergic reaction to any ingredient of this vaccine.Reporter reports that her 18 year old daughter who is also a college athlete received her first dose of the Pfizer Biontech covid 19 vaccine back in Sep2021 from which she experienced an anaphylactic reaction. It started about two and a half to 3 hours after dose, her hands were itchy, developed hives on her hands and by 4 hours her throat was closing. She had an epi pen and was rushed to the ER for treatment. On 14Dec2021 she received allergy testing that resulted she was not allergic to PEG and polysorbate therefore her allergist said it was ok to get a second dose of the vaccine. Following the second dose within 35-40 min after they left the facility and got home her throat begin to close and again required an epi pen and went to the ER for treatment to open her throat. Reporter reports no residual side effects. Reporter also reports patient has history of asthma and allergies. Reporter seeking information as to why she is having these reactions, is it the mRNA spike proteins that are initially irritating her? Her allergist thinks maybe it is a combination of PEG and polysorbate together.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient stated her arm was numb about an hour after the shot.  She has been taking Ibuprofen alternating with Tylenol 3 times daily.  She said she also had body ache and fever like she did with the first shot.
Patient received vaccine and walked around the store with her husband while waiting for observation after the vaccine. She returned about 10-15 minutes later saying she didn't feel well. Her face was very red, she said she felt a little light headed and was asked to sit down. A single hydroxyzine 25 mg tablet was administered with a full bottle of water to mitigate symptoms and she was observed for another 15 minutes. She felt fine afterwards and was referred to her physician.
Headaches, itching then progressive eruption of shingles within 3 to 4 days. Positive Dx of shingles by family dr.
Information has been received from a consumer concerning her granddaughter who is in college now. When the patient was in junior high was vaccinated with a 0.5 ml dose of VARIVAX (Merck). "Last week", on approximately 06-APR-2010, the patient developed shingles like rash on her lower back and nerve pain. The patient had not been diagnosed. At the time of the report the patient had not recovered. The patient did not seek medical attention. No further information is available.
abd cramping approx 15-30min p/vax;flu like sx x 1wk, next wk tired, lethargic feelings;local stiff, swell, sore-heavy feeling;bilat arm;
Patient reported redness and induration of about 4 inches on right arm post administration of Spikevax from a week prior. She states pain started right after injection but has subsided. She only feels pain upon application of pressure and is improving with time. She was advised to seek medical attention if pain does not go away completely within the next couple of days.
This spontaneous report as received from a registered nurse refers to a population of unspecified elderly patients. On an unknown date the patients were vaccinated with a second dose of ZOSTAVAX (0.65 ml) (lot number and expiration date not reported) subcutaneous. There was no concomitant medication reported. The registered nurse stated that she had no administer ZOSTAVAX as 2 separate doses on unspecified dates because the elderly patients did not serologically convert after the first dose of ZOSTAVAX on unspecified dates. The outcome of the event was unknown. Additional information is not expected.
PAIN IMMEDIATELY AT VACCINATION SITE, THEN INTERMITTENTLY POSTERIOR RIGHT SHOULDER PAIN WITH ACTIVE MOTION. PAIN MAINLY IN ACTUAL JOINT, BUT SLIGHTLY TENDER POINT OVER POSTERIOR SUPERIOR SHOULDER.
Blood sugar spiked; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On an unspecified date, blood sugar spiked after getting the vaccine. The patient was brought to the emergency room (ER) to stabilize blood sugar level and went home after. The adverse event resulted in emergency room/department or urgent care. The outcome of the event was unknown (as reported).  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
missed the second dose in the vaccine series of GARD ASIL 9; the patient was 45 years old when the GARDASIL 9 vaccine series was started and turned 46 years old prior to receiving the second GARDASIL 9 shot; the patient was 45 years old when the GARDASIL 9 vaccine series was started and turned 46 years old prior to receiving the second GARDASIL 9 shot; No additional AE reported; This spontaneous report was received from a pharmacist referring to a 46-year-old patient of unknown agender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On an unknown date in October 2021 (also reported as the date was not certain), at age of 45-year-old, the patient was vaccinated with the first daose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. The patient turned 46 years old prior to receiving the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (circumstance or information capable of leading to medication error, product administered to patient of inappropriate age). On an unknown date, the patient missed the second dose in the vaccine series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product dose omission issue). The patient still had not received the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). At the time of reporting, the patient was 46-year-old. No additional adverse event (AE) or product quality complaint (PQC) was reported.
This spontaneous report as received from a nurse refers to a 1 years old patient. The patient was intended to receive VARIVAX (Merck), was inadvertently administered ZOSTAVAX (single dose, Subcutaneous, lot # not reported) on 31-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
h/a & BP elevated to 150 systolic; now is being treated for BP; did not want to give MD name;
Patient called pharmacy to report that she woke up in the early morning of 11/11 with the arm she got pneumovax in having swollen to twice its normal size and being red and warm to the touch.  She took acetaminophen for it, which had little effect.  She debated calling in sick to work but chose to go in anyway.  Patient called the pharmacy in the afternoon on 11/11 to report this reaction and say that while it hasn't yet gone down, it hasn't gotten any worse either.  Advised patient to try benadryl and topical hydrocortisone over the counter and monitor; if worsens to visit urgent care.
DTAP GIVEN ON RIGHT DELTOID. HER ARM WAS RED, HOT TO TOUCH, SWOLLEN FROM HER SHOULDER TO THE ELBOW.  SHE WAS GIVEN ICE PACKS, TOLD TO TAKE HER TO THE MD FOR CHECK UP IF IT WORSENS.
Proquad was given to a patient older than the age range. No adverse event or treatment neccesary.
1 hour after getting vaccine felt hot, developed vertigo and threw up.  Lateral gaze nystagmus demonstrated.  3 days later symptoms had cleared.
I did not have a reaction to the vaccine. Around Christmas time, I noticed vision changes in my right eye. I noticed more floaters moving in my right eye, it was not floaters but a hemorrhage. The nerve was very inflamed. I did see my primary care doctor and my eye doctor. They stated they are seeing cases like this more often. I was put on steroids which helped but I continue to have blind spot(s). I have been told that in time these symptoms will improve.
PATIENT STATED DID NOT FEEL WELL THE DAY FOLLOWING HER VACCINE ADMINISTRATION.  BY DINNER TIME SHE CAME DOWN WITH CHILLS, ACHES, HEADACHE, UNCONTROLLABLE SHAKING (THAT LASTED 2 HOURS) AND SHE HAD TROUBLE WALKING     THIS LASTED FOR 48 HOURS AND THEN SHE FELT BETTER
Shot given on right thigh (swollen and warm to touch). Started on Keflex 125 mg per 5 ml 1 tsp three times a days 10 days.
Patient received incorrect dose for #2 in series.  After CDC guidelines discontinued monovalent, was given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug.  Should have received Moderna Bivalent blue cap/gray label 0.25ml/25ug.