chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eczema; Dry skin; Bleeding skin when scratching; Hiccups; Hives, Hives in hands and hair; Itchiness all over the body; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives, Hives in hands and hair), PRURITUS (Itchiness all over the body), ECZEMA (Eczema), HICCUPS (Hiccups) and DRY SKIN (Dry skin) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21A, 008C21A and 030B2A1) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). On 09-Dec-2021, the patient experienced URTICARIA (Hives, Hives in hands and hair) and PRURITUS (Itchiness all over the body). On 26-Feb-2022, the patient experienced HICCUPS (Hiccups). On an unknown date, the patient experienced ECZEMA (Eczema), DRY SKIN (Dry skin) and SKIN HAEMORRHAGE (Bleeding skin when scratching). At the time of the report, URTICARIA (Hives, Hives in hands and hair), PRURITUS (Itchiness all over the body), HICCUPS (Hiccups), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved and ECZEMA (Eczema), DRY SKIN (Dry skin) and SKIN HAEMORRHAGE (Bleeding skin when scratching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: 2 biopsies of his skin 2 biopsies of his skin.         Treatment was Steroids and creams for the hives. Patient experienced headache and nausea since 02Dec2021 Patient reported that he has not been able to drive, go to the supermarket or eat in restaurants and developed this symptoms he has spent over 1000 dollars on medication and medical services. Dermatologist told him that these symptoms are most likely vaccine related and that he should not get another booster dose. No Concomitant use were reported
At 2AM on 24Apr I began experiencing fever, chills, nausea, headache and vomiting. I took 4mg zofran and was able to  keep fluid down. I ate some toast with a dose of motrin. Once the zofran and motrin were both on board, I began feeling increasingly better and was able to hydrate and rest.
There is a big red swollen area at the injection site. Patient is taking ADVIL for pain and will see MD on Monday.
CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patiennt concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:30am in left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, chills and nausea was not reported. This report was non-serious.
I experienced acute onset of dizziness with chest pain, shaking chills, muscle spasms in my legs, headaches and nausea. I went to hospital where they did lab work, 1280 EKG, gave me fluids, and gave me Zofran medication. They also gave me a prescription for meclizine. They also did a Covid test which was negative. I saw my PCP on 04-11-2021 who ordered a chest x-ray and lab work. I also saw my PCP 05-11-2021, because I had a TIA on Sunday 05-09-2021.  I still being worked up on lab work, TIA and an MRI has been ordered for next Monday 05-17-2021.
Rash and painful swelling at the injection site one week after the 1st vaccination.  The affected area was about 5 inches by 3 inches on upper arm. Lasted for about 36 hours.
Itchy, painful, burning red rash all over body. Swollen, stiff joints
Patient informed pharmacy a few days after her shot (FLUARIX) that her lips swelled after the shot. She took BENADRYL and was better.
This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Patient developed Shingles eruptions under arms, under breasts and over the back) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, ISOSORBIDE, OMEPRAZOLE, ATORVASTATIN, ZOLPIDEM TARTRATE, DULOXETINE, METOPROLOL, BUSPIRONE, CHLORPROPAMIDE, VITAMIN D3 and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced HERPES ZOSTER (Patient developed Shingles eruptions under arms, under breasts and over the back). At the time of the report, HERPES ZOSTER (Patient developed Shingles eruptions under arms, under breasts and over the back) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient visited ER on Friday, 23 Apr2021, who confirmed it as shingles eruption and gave prescription for pain medications and discharged the patient back home. Gave consent for safety team and HCP for follow up and the preferred method of contact is by email.
Localized swelling and redness to immunization site. Patient reports some swelling of the face on 4/26/10.
Information has been received from a consumer who was told by her friend, who was told by her physician, that a patient who was vaccinated with Zostavax experienced a stroke the day after receiving Zostavax. It was noted that the physician was no longer administering Zostavax to any of his patients. No product quality complaint was involved. No other information was provided. Upon internal review, stroke was considered to be an other important medical event. Additional information has been requested.
Patient received injection at right deltoid. Endorses right deltoid pain x5 months beginning at time of injection. Tenderness upon palpation upon examination, and limited ROJM right shoulder and elbow that the patient reports began at the time of injection and remains present today.
Large (2"x3") red splotch at region of injection. Tender and warm to touch.
tested positive for COVID; Headache; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose last 29Apr2021 and scheduled to have the second dose on 20May2021. The patient had symptoms last 04May2021 and tested positive for COVID on 06MAY2021. The patient wants to cancel her second dose schedule since the doctor advised that she should wait for 60-90 days and she should start all over again. She already tested negative for the COVID-19 on an unspecified date and reporter wanted to know how to handle this concern. Patient also experience headache on 04May2021. On Tuesday night, (04May2021,) they thought she was having allergies. On Wednesday 05May2021, she found out she had contact with someone who tested positive for covid-19. She tested on Wednesday and received positive result on Thursday (06May2021). They believe she had contact on the same day as the vaccine on the 29th of APR 2021. She had a negative rapid test on Monday and Tuesday (unknown dates). Outcome of the events was unknown.
Approx. 12 hours, post vax, pt experienced numbness and muscle spasms down length of right arm, across chest and right shoulder blade.
Threw up arms (like a startle response), unresponsive for 30seconds then fine. 18OCT 2 more similar episodes. No fever, that night another, taken to ER had another episode.
Normal 2mo exam 10 days ago then had HIB/DTP/TOPV t 99.9- prior to hospitalization, poor feeding, spitting up, irritable, & fussy; In AM of 26MAY91 t102;
Second dose was missed 2 mos ago/ Son missed second Moderna dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose was missed 2 mos ago/ Son missed second Moderna dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose was missed 2 mos ago/ Son missed second Moderna dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose was missed 2 mos ago/ Son missed second Moderna dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported by reporter. No concomitant medications were reported by reporter.  The patient's parent asked if the patient need to start the second dose regimen again.
Lightheaded; metallic taste in mouth. BP 132/88. Patient stable and returned to work.
Redness, fever in right arm at injection site, soreness in arm. Applied cold pack helped some but still having symptoms
22 hours after injection, woke up with generalized moderate to severe weakness, mild confusion and temperature elevation with sweats.
pt recv vax; pt was crying in her sleep, irritable, sudden fears & inconsolable;
pain / the reaction she had was like "charley horse pain" felt like nerve pain in the front of the leg(s)./nerve pain like a charley horse; pain / the reaction she had was like "charley horse pain" felt like nerve pain in the front of the leg(s)./nerve pain to the front of her leg; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 67-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EN6208) via an unspecified route of administration on 21Mar2021 (at the age of 67-year-old) as dose 2, single and bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EN6205) via an unspecified route of administration, administered in arm on 28Feb2021 as dose 1, single for covid-19 immunization. Medical history included diabetes, diagnosed over ten years ago; and the only thing she does have are essential tremors, which she is on medication for, and she is on a medication for diabetes and cancer, she was immunocompromised due to her cancer from an unknown date and unknown if ongoing. There were no concomitant medications. Caller stated she received her booster shot, 6 months later from the first 2 shots but said she does not know if it was a booster for an actual booster or for immunocompromised patients. Caller did not remember if it was after dose one or dose two. She stated that her third dose booster was given on 01Nov2021 of LOT: 30155, and she did't know, but there was a space then BA. On an unspecified date in 2021 the patient experienced pain / the reaction she had was like "charley horse pain" felt like nerve pain in the front of the leg(s)./nerve pain like a charley horse. She didn't took medicine or anything, she just kind of massaged it, and then finally it stopped. She says she couldn't walk on it so she would do a little bit of pulling her leg up and down and straighten it, then after pain stopped. She says she would try to massage it a minute or two, she couldn't walk on it until the pain subsided. She says it lasted maybe a couple minutes then it went away each time after she did those things. She says it may have come back a little again and then it would go away again. She says it probably happened once again after the first, then again for a couple times after the second, and maybe between, where it was tightened. She says she believes it was just the right leg that had the nerve pain to the front of the leg. The patient underwent lab tests and procedures which included computerised tomogram (reported as CT scan): blood clot in her legs, She says she had a scan for blood clots and they said it was fine on an unspecified date in 2021. No treatment received for the events. Outcome of the events were unknown.  No follow-up attempts are needed. No further information is expected.
W/in 24 hrs of receiving vaccines, PT became very irritable, jittery, febrile (temp 102) and viral intake.
General fatigue, almost constant headache, upset stomach started hours after shot and still occurring 6 days later. I don't do the things I normally do because of the fatigue. These symptoms are exactly like the symptoms I had after my first shot and continued for months.
Dizziness, extreme body aches, rash to face, malaise and severe pain at injection site. Lump with no redness or heat.
severe neurological adverse reactions; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a company representative.  This case involves female patient (age not reported) who experienced severe neurological adverse reactions, while she received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and MENINGOCOCCAL VACCINE B.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date (1 year ago), the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and MENINGOCOCCAL VACCINE B (not produced by Sanofi Pasteur) lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed severe neurological adverse reactions (nervous system disorder) unknown latency, following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and MENINGOCOCCAL VACCINE B.  Other relevant tests not reported.   Final diagnosis was severe neurological adverse reactions.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for severe neurological adverse reactions.  Information on the batch number was requested.  List of documents held by sender: none.
I immediately started getting extreme muscle cramps in my arm unlike any other flu shot reaction that I had ever had. By the next morning, I had shooting pain from my upper arm to my fingertips that exceeded pain that I've had for major back surgery and a broken jaw. The pain has been intolerable and not affected by ADVIL. I was unable to work most of the next two days. The pain has migrated around the muscle groups in my shoulder and arm, and on Day 6, I still have muscle twitching and such numbness and pain that I cannot drive or write with my right (dominant) hand.
24FEB92 approx 2 hrs p/vax pt began to vomit; cont 2 days, diarrhea began Friday, lasting 4 days; seen by MD approx 20FEB or 21FEB; pt was having colicky type pain; dx lactose def & Prosoybee x 2 wks; rash-blotches-ecchymatic area on DTP;
Left arm - red, hot to the touch, swelling from the shoulder to elbow around entire arm.
Moderna COVID-19 Vaccine EUA. Rash and itching around injection site (left arm) - went to ED and was diagnosed with cellulitis. She was given a course of antibiotics (IV cefazolin 1 gm x 1 followed by a script for cephalexin 500 mg po QID x 7 days)
Patient was administered an expired Gardasil.  Upon speaking with Father after administration, She didn't show any signs of adverse reactions.
mild numbness of jaw (left side) radiating to lower left side of face beginning 4 hours after injection, no tx, resolved within 12 hours
We had a friend come into town and he brought his girlfriend with him. His girlfriend was not vaccinated. We hung out with them for a couple of hours. On Wednesday my friend called me and said his girlfriend tested positive for Covid. My fiancé was having flu like symptoms so I told him to go to the clinic to get tested. I was perfectly fine. I just had a little bit of congestion but I have allergies so I thought that was it. The clinic diagnosed me as asymptomatic. My fiancé tested positive so I went to get tested on 08/13/2021 and my rapid test came back negative, but my PCR came back positive. They gave me Augmentin to get rid of the sinus thing I had going on.
PHARMACY LEFT PFIZER VALS IN THE FREEZER FOR LONGER THAN 2 WEEKS AT THE TEMPERATURE (-25 AND -15 DEGREES C). WE GAVE OUT DOSES FROM THE VIALS, RENDERING THEM POSSIBLY LESS EFFECTIVE.
This spontaneous report as received from a pharmacist refers to a 63 year old male patient who on 07-JUN-2013, was vaccinated with a dose of ZOSTAVAX, subcutaneously, (lot # J000435, expiration date 10-APR-2014). The pharmacist reported that on 08-JUN-2013, the patient developed hive and rash type wheal at the site of ZOSTAVAX injection. The patient complained of itchiness and scratched the site. The redness spread down to the elbow and patient went to an urgent care facility and got treated with an antibiotic. The outcome of itchiness and scratched the site, hive and rash type wheal at the site of ZOSTAVAX injection and redness spread down to the elbow was reported as recovering/resolving. Additional information has been requested.
KINREX given L deltoid on 1050 10-11-2017. Given to left arm per mother's request at 8:10. On 10-13-2017 mother phoned in stating that very large reddened area with blister. Which was getting worse at time she called. She was advised to consult physician as soon as possible.
Headache; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25120A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:26 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:26 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 29.22 for dose administered on 15-Apr-2021. No concomitant medications were reported.  Batch number 044B21A administered on 15-Apr-2021 underwent temperature excursion with temperature of 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Patient came to ED with complaints of syncopal episode.  passed out, hit her head, felt mildly short of breath with ambulation.
Headache, Myalgia, NauseaVomiting, Pain at the injection site Narrative:  Other Relevant History:
Patient was given 0.5mL of Janssen vaccine IM into her right deltoid muscle.  Post vaccine patient, fainted during the 15 minute wait period.  She was promptly attended to, and did not exhibit signs of anaphylaxis.  EMS came to assess patient even though she felt "completely normal" after she fainted.
dizziness, chills, sweating, headache, nausea, restlessness, tachycardia
pt had previous hospital admission within past 2 wks to treat COVID and STEMI; presents back to hospital with c/o confusion, headache, back pain; worsening respiratory failure; while in ED pt became hypotensive requiring vasopressors; UTI; chest xray shows infiltrates consistent with COVID pneumonia; BiPAP; during hospitalization, respiratory status declined; family and pt opted for comfort care; pt passed away in the hospital
Pt states he started to feel fatigue, lightheaded, mild headache on 10/13/2021.  Pt reports symptoms are improving.
Patient went for preadmission testing for orthopedic surgery (spinal stenosis) and tested positive for HIV through routine testing. This was false positive test. Patient takes no medication and has no relevant history. Test done on IM HIV Ag_Ab Combo. History done with physicians resulted in highly unlikely HIV positive. Patient was not COVID positive at the time. According to the lab, test was repeatedly reactive but weak from 1.374 to 1.424. Differentiation assay was negative on PCR. T cell and viral load negative.
This spontaneous report was received from a nurse via Pfizer, Inc. and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of pneumococcal vaccine (reported as PNEUMOVAX) (lot #, expiration date, dose and route of administration were not reported). Administered doses of vaccines experienced the highest temperature of 9.1 degrees Celsius and "out of range for five days, was at 8 degrees Celsius". It was not specified if a digital data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA011907: US-009507513-1703USA011908: US-009507513-1703USA011909: US-009507513-1703USA010426.