chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer booster; I had a rash starting all over my body and its still here; it itches, its a crazy, crazy itch; my neck, side of my face, my back, my stomach, my arms and my legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Dec2021 17:45 (Lot number: 32030BD) at the age of 58 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 17:45, outcome "unknown", described as "Pfizer booster"; RASH (non-serious) with onset Dec2021, outcome "not recovered", described as "I had a rash starting all over my body and its still here"; PRURITUS (non-serious) with onset Dec2021, outcome "unknown", described as "it itches, its a crazy, crazy itch; my neck, side of my face, my back, my stomach, my arms and my legs". Therapeutic measures were taken as a result of rash, pruritus.  Additional Information: It was reported that I am gonna call my doctor now because I have to I thought it would go away you know I have been putting lotion on and taking a Zyrtec (Treatment) everyday but this is now that's the fourth day and so I don't know I mean I hope it goes away I just need something for the itching so I am gonna call my doctor but I wanted you guys to know because that's really the only thing that happen with can be attributed to it.". Prior vaccinations (Within 4 weeks) was reported as none. Treatment: Consumer stated, "Yes I took Zyrtec, I have been taking a Zyrtec everyday and just I am putting cream Cetaphil moisturizer, Cetaphil moisturizing cream." And then so I am gonna call my doctor just to see if she can give something to stop the itching and then I will just tell her, I had already reported this so she doesn't have to do it again right?"  Follow-up attempts are completed. No further information is expected.
UNABLE TO USE LEFT ARM.   CAN NOT RAISE ARM, HARD TO GET DRESSED AND UNDRESSED BECAUSE OF SEVERE STIFFNESS.  HAD TINGLING AT INJECTION SITE SOON AFTER INJECTION WAS DONE.
Pt (R) arm has been throbbing, he is unable to move his Right arm with out using his Left arm to assist. He complains of throbbing in injection site area. Patient has treated with Tylenol with little relief.
Developed severe abdominal pain/cramping, diarrhea,  and vomiting with chills. I went to the ER where they did bloodwork,  CT scan and administered pain and nausea meds. I was told I had inflammation in my small bowel consistant with a Crohn's flare up and my WBC count was very high.
Two weeks after receiving my smallpox vaccination, I started showing symptoms of viral meningitis and self inoculated (blisters) around the vaccine site. The blisters were in a 3 inch circle around the site. The viral meningitis was verified in the ER.
Erythema, itching and slight induration at injection site measuring ~2 inches in diameter that persists 11 days post-injection.
Redness, soreness, swelling reported 10/6/14 - applied ice - as day progressed extreme swelling down to elbow area and lump in arm by 9 pm 10/16/14. Went to ER for steroid/antibiotic treatment.
Stiff neck pain, could not move; headache; describes the occurrence of NECK PAIN (Stiff neck pain, could not move) and HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031/20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Stiff neck pain, could not move) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, NECK PAIN (Stiff neck pain, could not move) and HEADACHE (headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were reported.
had both shots/ have the shingles\ suspected vaccination failure; have the shingles; very horrible pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated, he/she received both Shingles vaccine on firsthand and had shingles. The patient stated, he/she had shingles going on 2 weeks, very horrible pain, could not imagine if the pain would have been worse with no shingles shots. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation were not provided.
She stated that she received the H1N1 vaccine around 1430 on Monday, 11/09/09, and that night started having severe headaches, nausea, vomiting which lasted all of Tuesday and subsided on early Wednesday morning (after midnight).  She stated that the headaches were worse when she stood up and around bright light so she stayed in bed in a dark room.  She denied any more headaches since it subsided Wednesday morning.
This spontaneous report as received from a physician refers to a 16 month old patient. On 29-AUG-2017, the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 29-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Five Hive like welts, spread over both feet, top and side . Tremendously  Itchy constantly, cannot sleep, As bad or worse 48 hours later.  Remedies:  Oral: diphenhydramine 25mg every 6 hours,  Topical: lidocaine, hydrocortisone 2.5% cream, gel ice pack Red welts and somewhat swollen.  Possible bites?
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 26-MAR-2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Symptoms began a few hours after immunizations. Elevated temp 99.6, chills, aches, c/o joints hurting. Sore muscles, hands & knuckles hurt. Weakness. No treatment given. Observation.
Approximately 2 days post vax, the pt became more fussy, and eating decreased. This persisted for at least one week. She was seen in the office on 5/26/01 and 5/31/01. There was not fever. She gained 10 ounces in that time period.
Japanese enceph vacc SA14-14-2, inactivated Yellow Fever unclear in our records if YF-Vax vs. Stamaril. Manufacturer is Sanofi pasteur.  Pt received Japanese Encephalitis, typhoid, and yellow fever vaccines during mass vaccination on 13DEC22 @ approx. 1354. Approx 45 minutes later, pt noticed nausea w/o vomiting, sensation of tongue swelling, and SOB. Pt took OTC Benadryl shortly thereafter. Pt presented to ED 13DEC22 @ 1649 with SOB. Administered STAT diphenhydramine 50mg @ 1700. Per ED provider note, patient may have had a mild allergic reaction to 1 of the 3 vaccines he received at the mass vaccination event this afternoon. ADR investigation ? unpreventable ADR, Level 3 moderate requiring treatment. Pt treated w/ diphenhydramine 50mg in ED and discharged home with rest, fluids, repeated diphenhydramine if needed, w/ ED return instructions should he develop delayed symptoms of anaphylaxis or serum sickness. No since ED visits. PCM visit 22DEC22 for flight physical, however did not mention reaction. Notified PCM and added to allergies.
Patient received Flumist on 07Sep12 and on 08Sep12 developed nausea, vomitting and diarrhea which persisted throughout the day. She subsequently went to the local emergency room on 09Sep12. She was admitted to the intensive care unit after a discovery of a platelet count of 7000 per cubic millimeter. She reported no other unusual labs. She was seen by a hematologist-oncologist who diagnosed acute Idiopathic Thrombocytopenic Purpura (ITP)and initiated steroid therapy. She was released from the hospital on 11Sep12 and was asymptomatic at he time of release and is currently taking prednisone 80mg twice daily. She did not require any platelet transfusion or IV immunoglobulin.
Bumps and itching behind ear and scalp.  Loratadine 10mg 1 x daily and observation.
Initial information was received from another manufacturer health care professional on 23 September 2008.  The initial reporter to this manufacturer had been a health care professional.  A female patient with no reported past medical history developed an anaphylactic reaction after receiving an influenza vaccine "sometime in the past" (lot number, manufacturer, date, route and site of vaccination was not reported).  No further information was provided.
FROM MD NOTES 3/22/2021: - Acute hypoxemic Respiratory failure due to COVID-19 pneumonia. Decadron iv, empiric abx, maraviroc, remdisivir,proning and IS. Bumex and HD for volume mgmt. HFNC, NRB,. ID consulted.  - ESRD on HD. Nephrologist consulted, cont HD with fluid removal  - HTN. stable on meds.  - Normocytic Anemia. Due to ESRD. stable. Monitor  - Dark stools. R/o GIB, hold asa/plavix/hep, monitor CBC. PPI bid.appreciate GI follow up, pt clinically not stable for gi procedure, will cont to monitor, further GI work up when stable  - Renal hyperparathyroidism. Due to ESRD. monitor phos and calcium per renal.  - DM with PAD and aortic atherosclerosis and renal manifestation. Stable sugars, monitor on insulin. s/p R tibial arterectomy with angioplasty, L femoral arteriotomy in 2019, monitor on ASA/plavix if GIB ruled out.  - Sec hypercoag state. Due to Covid-19, holding hep and ASA due to possible GIB.  - Malnutrition, mild. Due to acute illness and low po intake, monitor diet.  - Immunodeficiency due to other medical conditions. Due to malnutrition, educated on immunosuppression during flu season.
Returned to store after third round of clinic at the facility and found record of having already received 2 doses. Contacted facility to verify that patient had not refused shot on first two clinics. Facility was unable to locate records from  previous clinics to reference any notes on registration documents. Patient was registered for clinic for 1st dose on 01/13/21 under a different first name (patient goes by middle name) and 02/10/21 then registered for 2nd dose on 03/10/21. Confirmed patient did receive 3rd dose; however, no adverse reactions have been noted at this time.
Feeling a bit nauseous; Vaccine which is already expired; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Feeling a bit nauseous) and EXPIRED PRODUCT ADMINISTERED (Vaccine which is already expired) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2021 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced NAUSEA (Feeling a bit nauseous) and EXPIRED PRODUCT ADMINISTERED (Vaccine which is already expired). On 28-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine which is already expired) had resolved. At the time of the report, NAUSEA (Feeling a bit nauseous) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.
Once I pulled the needle out I noticed immediate swelling and redness. Patient also complaint of pain, cool compress applied, 600 mg ibuprofen given PO within 10 min swelling & redness decreased. Topical anesthetic applied to site per MD orders (mc cream).
Confirmed Positive Covid case July 21 with temperature of 103 for several days. Period began July 25, heavy flow using ultra size changing every hour with clots the size of a palm of the hand. Have continued to bleed from July 25-September 27 (today). Flow fluctuates but continuously bleeding enough to need super tampons at minimum.
Injection site itchiness; She was very powerless and tried yesterday stayed on bed; fever temperature of 102F, Fever; Injection site swelling,  injection site swollen as a size of a lemon; Injection site swollen as a size of a lemon which is very red; Low blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Low blood pressure), VACCINATION SITE SWELLING (Injection site swelling,  injection site swollen as a size of a lemon), VACCINATION SITE ERYTHEMA (Injection site swollen as a size of a lemon which is very red), VACCINATION SITE PRURITUS (Injection site itchiness) and FATIGUE (She was very powerless and tried yesterday stayed on bed) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced HYPOTENSION (Low blood pressure) and VACCINATION SITE ERYTHEMA (Injection site swollen as a size of a lemon which is very red). On 16-Nov-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swelling,  injection site swollen as a size of a lemon). On 17-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (Injection site itchiness), FATIGUE (She was very powerless and tried yesterday stayed on bed) and PYREXIA (fever temperature of 102F, Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 17-Nov-2021, PYREXIA (fever temperature of 102F, Fever) had resolved. At the time of the report, HYPOTENSION (Low blood pressure), VACCINATION SITE SWELLING (Injection site swelling,  injection site swollen as a size of a lemon), VACCINATION SITE ERYTHEMA (Injection site swollen as a size of a lemon which is very red), VACCINATION SITE PRURITUS (Injection site itchiness) and FATIGUE (She was very powerless and tried yesterday stayed on bed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Blood pressure measurement: 25 (Low) low blood pressure 25beets/1min. On 17-Nov-2021, Body temperature: 102 (High) fever temperature of 102F.         No concomitant medication were provided.
left armpit and left breast discomfort received no treatment still have discomfort had mammogram 6/1/20...nothing found to alarm had left neck lymph enlarge to quarter size had CT, saw Dr., after 8 weeks left
Sensation in tongue/ Sensation on lip; Generalized itching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of SENSORY DISTURBANCE (Sensation in tongue/ Sensation on lip) and PRURITUS (Generalized itching) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SENSORY DISTURBANCE (Sensation in tongue/ Sensation on lip) and PRURITUS (Generalized itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of 1 UNK. At the time of the report, SENSORY DISTURBANCE (Sensation in tongue/ Sensation on lip) and PRURITUS (Generalized itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Follow-Up information received on 05-Apr-2021 contains No Significant information.
Pfizer / BioNTech: Dose Number: 1, Dose Number: 2, Dose Number: 3; Paxlovid: COVID 19 Treatment; Pfizer / BioNTech: Dose Number: 1, Dose Number: 2, Dose Number: 3; Paxlovid: COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1 , single (Lot number: EL9267), in right arm, on 10Oct2021 as dose 2 , single (Lot number: EN6207), in right arm and on 20Feb2022 as dose 3 (booster) , single (Lot number: FF2590) at the age of 66 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, latency 7 months 3 days after the suspect product(s) administration, outcome "recovering" and all described as "Pfizer / BioNTech: Dose Number: 1, Dose Number: 2, Dose Number: 3; Paxlovid: COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. No known allergies. Covid symptoms returned 4 days after my last dose of Paxlovid. Stuffy head, headache and fatigue. All symptoms were worse than I had prior to taking Paxlovid.
his neck which is still in pain; he was experiencing with his legs; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (his neck which is still in pain) and LIMB DISCOMFORT (he was experiencing with his legs) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (his neck which is still in pain) and LIMB DISCOMFORT (he was experiencing with his legs). At the time of the report, NECK PAIN (his neck which is still in pain) and LIMB DISCOMFORT (he was experiencing with his legs) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that patient went to the pain doctor because of his neck which was in pain, he told the PA what he was experiencing with his legs after the Moderna vaccine. The PA then told him that a lot of her patients have complained about the exact same thing as him. He was told that there's nothing that can be done.   No treatment medication were reported.   Reporter did not allow further contact
445 PM - STARTED FEELING  NAUSEA, HOT FLASH, NERVOUS, POSSIBLY DIZZY.. PATIENT SAID IT WAS PROBABLY A PANIC ATTACK/ANXIETY.  PUT WET PAPER TOWEL ON BACK OF NECK AND WRISTS. ADVISED PATIENT TO LAY DOWN WITH FEET ELEVATED BUT SHE DID NOT WANT TO; SHE SAID SHE WAS FEELING BETTER. SHE SAID HER THROUGHT WAS NOT BOTHERING HER. HER BLOOD PRESSURE WAS 124/80 AND REGULAR HEART RATE. AT 520 PM PATIENT SAID SHE FELT FINE, BLOOD PRESSURE WAS 134/68, REGULAR HEART RATE. SHE SAID SHE WAS JUST A LITTLE NERVOUS ABOUT WHAT HAPPENED.  OFFERED TO CALL 911 TO HAVE HER CHECKED OUT, PATIENT REFUSED. SUGGESTED FOR PATIENT TO CALL SOMEONE FOR A RIDE HOME, PATIENT REFUSED. 542PM - CHECKED IN WITH PATIENT. SHE IS STILL SHOPPING IN STORE AND SHE FEELS PERFECTLY FINE FEELS COMFORTABLE TO HEAD HOME.
developed systemic pruritus about 2 weeks after covid vaccine booster which has persisted since that time. Her sibling also got the Moderna booster and also developed the same itching symptoms after the booster. No issues with initial vaccines (also Moderna).
Numbness on left side of this body/numbness on left arm and leg/numbness on left side of face; lost feeling on left side of body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (lost feeling on left side of body) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII in 2003.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced FEELING ABNORMAL (lost feeling on left side of body). On 25-Feb-2021, FEELING ABNORMAL (lost feeling on left side of body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 11-APR-2011, the patient was vaccinated with a dose of VAQTA (lot#, dose and route were not reported) by an unspecified physician. Then another dose of VAQTA was administered on 19-SEP-2011 by an unspecified physician (Inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.