chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a female with no medical history and with penicillin allergy who on 26-AUG-2008 was vaccinated intramuscularly with 0.5 ml of GARDASIL (Lot # 0152X). There was no concomitant medication. Later that night, on 26-AUG-2008 the patient developed hives all over her body including in her throat. She took OTC BENADRYL and the symptoms resolved on 27-AUG-2008. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
During the night following the vaccination, I had chills, muscle aches and a headaceh. I got up to go the batheroom and on the way back to bed I fainted and hit head on the floor.
Patient received 5th dose of Anthrax.  Patient experienced flu like sx (fever, malaise, muscle ache) and large local reaction (from left upper arm to hand) starting 24-36 hours after vaccination, slowly improving until resolution 14 days later.  See in ER several times for observation/make sure did not worsen. Recieved typhoid same day, but no reaction on subsequent typoid in Feb 2002
Expired vaccine administered to 155 patients; Product expired on 01-APR-22, refrigerated on 04-APR-22 and administered on 15-04-22; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Product expired on 01-APR-22, refrigerated on 04-APR-22 and administered on 15-04-22) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). In April 2022, the patient experienced PRODUCT STORAGE ERROR (Product expired on 01-APR-22, refrigerated on 04-APR-22 and administered on 15-04-22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Product expired on 01-APR-22, refrigerated on 04-APR-22 and administered on 15-04-22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, however the vaccine expired on 01-Apr-2022.  It was confirmed that the vial didn't undergo temperature excursion issue.  Vaccine was placed in refrigerator on 04-Apr-2022.  No treatment medication were reported.
REDNESS AND TENDERNESS TO RT DELTOID WHERE VARIVAX WAS ADMINISTERED. DR. NOTIFIED.
23DEC92 930AM pt recvd vax & 11AM chilling-teeth chattering, nausea & vomiting; fever but not measured, anorexia; 25DEC92 ER-macular rash, t98.1 ax, gaggy & dec appetite accordng to mom; dx poss drug rash;
NOT FEELING WELL (JUST NOT QUITE RIGHT); VERY VERY HIGH BLOOD PRESSURE; RAPID HEARTBEATS; NAUSEA; DIZZINESS (LIGHTHEADEDNESS); HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no prior medical history or chronic conditions. 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 28-SEP-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 29-SEP-2021, the patient experienced dizziness (lightheadedness). On 29-SEP-2021, the patient experienced headaches. On 30-SEP-2021, the patient experienced very very high blood pressure. On 30-SEP-2021, the patient experienced rapid heartbeats. On 30-SEP-2021, the patient experienced nausea. Laboratory data included: Blood pressure (NR: not provided) Very very high, and Heart rate (NR: not provided) Rapid. On 05-OCT-2021, the patient experienced not feeling well (just not quite right). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very very high blood pressure, and rapid heartbeats on 05-OCT-2021, and nausea on 30-SEP-2021, and was recovering from dizziness (lightheadedness), headaches, and not feeling well (just not quite right). This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Pt recvd MMR vax on 18OCT91 & 2 wks following vax pt devel a pencil-shaped rash on rt thigh; It was noted that some of these shapes were larger than others; also fever & pruritus;
Confusion, Dizziness, Headache, Arthralgia, chills, L arm pain, Narrative:  Other Relevant History:
Pt had onset of hand swelling, which progressed to whole body swelling within a few minutes.  Mom became very concerned, gave him liquid Benadryl, then drove him to the ER.  Pt was having altered consciousness by triage in the ER and was unable to see or hear, then slumped in his chair.  Pt was given steroids, and was sent home with a course of Prednisone for 14 days.
He sat for 15min in pharmacy when we got out to the car, he started talking and was really nasally and he sounded different. Got home 2 min away and he walked in pale white and you knew he had a headache, told him to lay down, Then he tells me he feels out of breathe, elevated his feet, ready to call 911. Then that passed, still had headache . Then he got up , went to the bathroom and came out yelling and said he felt really awnry. Told him to lay down. All this within a 1/2 hour of getting vaccine, one right after the other. Then 45 min after all this he ate and showered . I gave him a Tylenol and he later went to bed at 9 , I checked on him all night and he woke up super tired and said he?s a weird tired to this day. The doctor told me he may have had slight swelling of the brain and it?s up to me about the 2nd dose but we are very nervous as to what could happen. The doc did say he at least as a bit of protection from the first one . He does attend a large high school so definitely a concern.
Left arm red and warm to touch from elbow to shoulder. Redness extends 3/4 way around arm. Pt states no pain and minimal itching. Still a little red 12/17.
Mouth is swollen; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed but manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021, outcome "unknown", described as "booster dose"; MOUTH SWELLING (non-serious), outcome "unknown", described as "Mouth is swollen".  Additional information:This consumer is also the patient who got the Pfizer Covid Vaccine on 30Dec2021. She called to figure out what to do because her mouth is swollen, which is not too bad, just swollen a little. She was trying to figure out how long will this event last; it's not her whole face, just her mouth that is a little swollen. She wanted to know if she can smoke a cigarette, can she drink, she needed to know how long this event will last   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to an approximately 16 years old female patient. The patient was vaccinated with 0.5 ml GARDASIL (lot# unspecified) in approximately September 2012. No other co-suspects were reported. Concomitant medication included an unspecified meningococcal vaccine. On approximately September 2012 ("approximately 2 months ago"), within 2-3 days of the vaccination the patient experienced a headache and heavy bleeding. No treatment information was reported. The outcome of heavy bleeding and headache was unknown. The patient had sought unspecified medical attention. No lab test was performed. Additional information has been requested.
pt lost consciousness immed p/needle removed from lt deltoid (had just administered vax); p/about 10 seconds pt regained consciousness no injuries sustained; p/this episode pt VS were p60, resp 16, BP went from 76/50 to 90/60;
pt stated having pain in the are of the injection site, chills, and headache.  pt wanted to notate that he had been tested in November 2020 for covid anti bodies and was found to still have them in his system.
6 hours after injection, patient noticed sore arm by 21:00.  Arm painful to touch and swollen, edematous 1 hour later, took Tylenol, edematous and tender shoulder to elbow, soreness, swelling and aching all over for 3 days.
Post vaccination patient developed itching, hives, runny nose, eye redness and wheezing- treated with Epi, Albuterol, and Benadryl- transposted to local hospital
Cough, fatigue and dyspnea on 3/22/21 ER visit on 4/1/21 diagnosed with COVID pneumonia Pain and swelling in right leg Positive for DVT in lower extremity Hospitalized and diagnosed with PE
Soreness in upper arm 1 hour post injection, increasing suddenly at 9:30 pm on day of injection (9 hours post injection) and worsening overnight. Eased partially with ibuprofen. Redness at injection site on the day after injection. Continued soreness of upper arm. Headache and overall body aches expanded to  arm/neck/back starting at 7:30pm on day after injection (31 hours after injection).  Minor chills starting at 8:30pm day after injection, lasting roughly an hour.
Moderna COVID-19 Vaccine EUA.  The vaccine activated a latent Chronic Myelo Monocyte Leukemia (CMML)   The evening of the vaccine I became very fatigued and was freezing.  (A topcoat was donned and I went to bed early. ) By day three the freezing dissipated; however, the fatigue di not.  After three weeks of fatigue my physician ordered several blood analyses.  High monocytes counts (4.0) and low Platelet counts (105) were revealed.   I was referred to a hematologist who ordered a bone marrow biopsy.  It revealed CMML 1.  A A review of 18 years of monocyte and platelet showed the monocyte counts were hovering at the maximum and platelet counts hovering at the minimum until 03/29/2021 when they escalated to the counts reported above.
Shortness of breath, chest compression, headache, exterme fatigue, muscle aches, cough - 3 weeks after vaccination am better, but not back to normal yet
Muscle weakness bilateral from waist down, numbness and tingling bilateral, bilateral pain. Inability to walk without holding on to someone or something. Bilateral loss of sensation.
Severe vertigo 4 days after shot (never had vertigo previously) - unable to walk unassisted. Went to emergency room.  Received IV fluids and meclizine.  Blood and urine labs run (results unknown, but nothing of note).  Discharged 3 hours later with some improvement.  Another bout of veritgo felt two days later, but not as severe.
Patient was administered and undiluted dose of the Pfizer 5-11 COVID vaccine.
Red, raised, warm spot at injection site, lungs clear, vitals stable. Parents to observe rxn. 10 ml BENADRYL given at time of rxn.
Information has been received from a physician concerning a female patient who on 05-FEB-2010 was vaccinated with  0.5 ml a first dose of GARDASIL (route and lot number not reported). On 05-FEB-2010 the patient experienced rash around the injection site that traveled down to crease of elbow after receiving the first dose of GARDASIL. The physician administered steroid and after approximately 5 minutes, the rash diminished. It was reported that the physician was checking for latex and yeast allergies. Subsequently, the patient recovered from rash on 08-FEB-2009. The patient did not seek medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Patient came to pharmacy complaining of itchy red swollen arm in the arm that rec'd PNEUMOVAX 23. Patient showed me his arm and it was bright red around the vaccination and around to the back side of the arm. Felt warm to the touch, red. Pt stated it was not getting worse.
got a terrible case/suspected vaccination failure; shingles/got a terrible; Residual pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In FEB-2023, an unknown time after receiving Shingrix and Shingrix, the patient experienced residual pain (Verbatim: Residual pain). On an unknown date, the patient experienced vaccination failure (Verbatim: got a terrible case/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/got a terrible). The outcome of the vaccination failure, shingles and residual pain were unknown.   The reporter considered the vaccination failure, shingles and residual pain to be possibly related to Shingrix and Shingrix.   The company considered the vaccination failure, shingles and residual pain to be possibly related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 15-JUL-2023 This case was reported by a patient via interactive digital media. The patient had all the shots of shingles and got a terrible case of shingles. The patient had residual pain since February. The reporter stated that shots were no help at all. The reporter thought that the event might had been related to drug. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Approximately  10 minutes after the patient was vaccinated she vomited. The RN took her vitals signs: BP 100/70, HR 130, RR 22. Patient denied feeling dizzy. Skin warm and dry. Patient reported she felt better after vomiting.
Left eye: redness,, tearing,, discharge, blurry and  markedly diminished vision. Seen by both optometrist and ophthalmologist on 1/26/2021. Diagnosis: Keratitis . Treatment: Tobramycin-Dexamethasone Ophthalmic Suspension and Bepreve eye drops. To return to Ophthalmologist's  office in 1 week..
reduced immunity; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Feb2021 (Batch/Lot number: unknown) at the age of 81 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single; lot number: unknown; Manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNODEFICIENCY (medically significant) with onset Feb2021, outcome "unknown", described as "reduced immunity".  Clinical course: No adverse reaction to booster shot (3Innoculation).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sharp pain in her stomach; feeling a really tightening in the top of her stomach, like a knot per say; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 15Nov2021 11:30 (Lot number: 330268D) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lupus" (ongoing), notes: diagnosed like 30 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:01, Lot: 320308D), administration date: 25Oct2021, when the patient was 49 years old, for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 15Nov2021, outcome "not recovered", described as "sharp pain in her stomach"; ABDOMINAL DISCOMFORT (non-serious) with onset 15Nov2021, outcome "not recovered", described as "feeling a really tightening in the top of her stomach, like a knot per say".  Additional information: Is report related to a study or programme- No. No follow-up attempts are possible. No further information is expected.
Case number PHEH2013US001217 is an initial spontaneous report received from a consumer on 11 Jan 2013, and with a follow up received from physician on 16 Apr 2013: This report refers to a 40-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 30 Nov 2012. Three hours after vaccination, she experienced anaphylaxis. The outcome of the event was reported as subsided at the date of reporting. The seriousness and causality of the events were not reported. When the physician was contacted for follow up, he mentioned that he did not administer the vaccine and asked to contact the correct physician. No other information was provided. Follow up report received from a physician on 16 Apr 2013. When the physician was contacted for follow up, he mentioned that he did not administer the vaccine and asked to contact the correct physician.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 at 14:30 as dose 4 (booster), single (Lot number: FK9895) at the age of 70 years, in right 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 was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Tested (slightly) positive several days after treatment ended; Negative, notes: Tested negative on day 8; positive, notes: Tested positive on day 10 with symptoms (cough, nasal discharge). Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient received other medication (vitamins and supplements) in 2 weeks. Patient received treatment with Paxlovid from 11May2022 to 15May2022 for the treatment of COVID-19.
Acute Bronchitis; A spontaneous report  was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events acute bronchitis.  The patient's medical history included thyroid and cholesterol. Concomitant medications reported were Thyroid medication, Cholesterol medication, Prednisone for drug use for unknown indication.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 013M20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) acute bronchitis.  Treatment details included Prednisone.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), acute bronchitis was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Mutiple pts (total number around 40) were vaxed w/Engerix-B & Heptavax since 1984 & were recently discovered to be non responders; some shots were given in the hip; pt will recvd boosters or will restart vax series;
This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event). On 01-Nov-2022, EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day use by date) outcome was unknown. At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022).    No concomitant medications were reported. It was reported that total 6 patients of age 6 Months to 5 years of age were administered with the expired dose of vaccine, One patient on 31-Oct-2022 and 5 patients on 01-Nov-2022. There were 2 vials of size 2.5 mL of Monovalent doses. The vial was initially stored in the refrigerator on 29-Sep-2022. The vial did not undergo any temperature excursions. No treatment details were reported.  No Adverse events were reported.
Client experienced loss of consciousness for approximately 20 seconds. Reported feeling weakness, light-headed. Client had loss of color to face, increased pulse followed by reduced pulse, that normalized on its own. After approximately 25-30 minutes client was feeling better, pulse normalized, color returned to face and he reported improvement in his symptoms.
I had kaleidoscope vision for about 20 minutes that afternoon. That evening my facial paralysis went away. I suffered from partial facial paralysis for two years from a sever episode of Bell?s palsy.  The paralysis complete went away two days after got the vaccine.
pt w/a hx of thimerosal sensitivity had an unspecified adverse exp p/vax;
Patient was very anxious about receiving the injection and reported her skin "was crawling and itching" when I followed up with her 15 min after administration.  She didn't know if it was "nerves" or a reaction to the injection. I gave her 20mg of cetirizine (she stated benedryl allergy)and she took 150mg of ranitidine she had just purchased. The patient reported the symptoms had mostly resolved 15 min after taking the two histamine blocking medications.  When I followed-up an hour later the symptoms had completely resolved.