chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Period started one week after and lasted 32 days; This is a spontaneous report from a contactable consumer(patient). A 49-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number was not reported), via an unspecified route of administration on 23MAR2021,12:00 PM (at the age of 49-years-old) as DOSE 2, SINGLE into left arm for COVID-19 immunization. The patient took vaccine at hospital. The patient medical history was known allergies to penicillin and other concomitant medications were not reported. The patient took Historical Vaccine BNT162B2 (COMIRNATY, Solution for injection, Lot Number unknown), via an unspecified route of administration as DOSE 1, SINGLE for COVID-19 immunization. The patient did not received any other vaccine in four weeks but took other medication in 2 weeks. The patient was not pregnant at time of vaccination. It was reported no covid prior vaccination and Covid tested post vaccination. On 31Mar2021 the patient experienced period and lasted 32 days which resulted in doctor or other healthcare professional office/clinic visit. The patient did not received any treatment for the event. The outcome of the events was recovered with Sequel.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Information about lot/ batch number has been requested.
patient presents with ascending progressive weakness in legs and arms, 15 days after receiving the second dose of the COVID-19 vaccine Pfizer/BioNTech (R/O Guillian-Barre).
Pain, warmth, bruising swelling at site of injection. Bilateral swelling of lymph nodes in axilla and up into neck. Fever, lethargy decreased rom, diarrhea.
This spontaneous report was received from a 65 year old female patient who was reporting on herself. The patient did have pertinent medical history and had an allergy to unspecified topical product. The patient's concomitant therapies included BENICAR, calcitonin and tobia (unspecified). On 26-MAY-2016, the patient was vaccinated with a doze of ZOSTAVAX (dose, route of administration and lot # were not reported). On 20-MAY-2016 (three days after receiving ZOSTAVAX), the patient developed three "spots" on her legs and redness near the injection site. The patient sought medical attention via speaking with a specialist. The patient was placed on valacyclovir by a physician to mitigate the symptoms. There was no lab diagnostics and studies performed. The patient's outcome was reported as recovering/resolving. The relatedness between the events and the therapy with ZOSTAVAX was not provided. Additional information is not expected as there was no consent to contact a healthcare professional.
I am still somewhat sick with COVID-19 . I started with aches and fevers. Then had stuffy nose and extreme fatigue. I am still on and off with fevers. Stuffy nose has resolved and aches more or less. I had 48 hours of being really miserable. Since Sunday it's been on and off with fatigue.
Reddened area at site of injection. It is neither raised, hot to the touch nor itchy nor sore.The area is only red and patient was concerned.
pain on right arm; back of legs is itching/butt is itching; upper torso is blistering/neck is blistering (comes and goes); headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on right arm), PRURITUS (back of legs is itching/butt is itching), BLISTER (upper torso is blistering/neck is blistering (comes and goes)) and HEADACHE (headaches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     no medical history is provided and concomitant drugs are provided.  Concomitant products included METFORMIN, Generic Crestor and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain on right arm), PRURITUS (back of legs is itching/butt is itching), BLISTER (upper torso is blistering/neck is blistering (comes and goes)) and HEADACHE (headaches). At the time of the report, PAIN IN EXTREMITY (pain on right arm), PRURITUS (back of legs is itching/butt is itching), BLISTER (upper torso is blistering/neck is blistering (comes and goes)) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from an RN concerning a 91 year old Caucasian female pt with a sulfa and penicillin allergy who on 11/2/01 at 14:00, was vaccinated SC, in the right arm, with a 1st dose of pneumococcal vaccine 23 polyvalent (lot 640577/0995L). Concomitant therapy that same day, at 14:00, included the 1st dose IM in the left deltoid, of influenza virus vaccine (Fluzone) (lot U0694AA). Subsequently on 11/3/01, at 10:00, the pt developed a 5cm circular erythema about 48 hours post vax. The pt recovered from the erythema on 11/6/01. Unspecified medical attention was sought. The nurse reported 2 other cases of injection site swelling (lot number 640577/0995L) (WAES 01110500 and 011111375). Additional information has been requested.
12/23/20 0850 Stinging/burning at injection site right arm; 2000 entire arm right burning and feeling of sunburn across chest down to liver then to left flank and entire back; 12/23 2300 generalized joint pain; 12/24/20  0830 101.3, 1030p 100.6; Friday 12/25/2020 1030am 100.1; 5pm 99.3; Vomited 830p;11pm 101.3  Saturday 12/26/2020 1pm 100.0
I have been dealing with a chronic lung Disease Lupus and RA. I did not have this before the 2nd dose. After I got the dose, I went to the ER in May, June, and July. I was diagnosed, I had a biopsy through my nose to find out which lung disease I have. But it came back as inconclusive. I am now on several medications. I and taking Hydroxychloroquine and Prednisone from July 2021-Feb 2022, CellCept. They are calling it ILD. They do not know which one I have. When I walk I am having extreme shortness of breath. I have permanent damage to my lungs.
PEDIARIX vaccine given; Hepatitis B vaccine also given (Hep B is component of PEDIARIX) No reaction observed or reported to date.
Mild nausea, fever, bloating. Massive post-nasal drainage made it hard to sleep. Lethargy, loss of appetite.
low fever; felt pain in his arm; cannot lift arm without difficulty/had some concerns with how the vaccine was administered; This is a spontaneous report received from a contactable reporter (physician). The reporter is the patient. A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (lot number unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "cannot lift arm without difficulty/had some concerns with how the vaccine was administered"; PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "not recovered", described as "felt pain in his arm"; PYREXIA (non-serious) with onset Oct2023, outcome "unknown", described as "low fever". It was unknown if therapeutic measures were taken as a result of pyrexia, pain in extremity, vaccination site movement impairment.  Additional Information: The patient received the vaccine on 16Oct2023. For 24 hours he had no symptoms. On an unknown date in Oct2023, he then developed a mild reaction to vaccine such as low fever, but then felt pain in his arm which has not gone away. He now cannot lift arm without difficulty. He had some concerns with how the vaccine was administered but in his opinion as a physician, he thinks this is separate from the symptoms he communicated today. It is unknown if the patient had covid-19 prior to the vaccination and unknown if covid tested post-vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
sugar went to up to 140s; This case was reported by a physician via sales rep and described the occurrence of glucose increased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes (Sugar was running in low 100's).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced glucose increased. On an unknown date, the outcome of the glucose increased was unknown.   It was unknown if the reporter considered the glucose increased to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The week, the patient got shingrix her sugar went to up to 140s.
3 weeks post booster dose, I experienced a short menstrual cycle. This is uncommon for me as I have a Mirena IUD and have not had a menstrual cycle since late 2018. It only lasted 3 days or so and was mild
miscarried; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 28-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 22Jul2021 as dose 2, single (Lot number: EW0187) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history included: "Subclinical Hypothyroidism" (unspecified if ongoing), notes: Subclinical Hypothyroidism diagnosed during pregnancy; "Bipolar II" (unspecified if ongoing); "Generalized Anxiety Disorder" (unspecified if ongoing); "Known allergies Penicillin" (unspecified if ongoing). Date of last menstrual period: 11Jun2021. The patient was 5 weeks pregnant at the time of exposure to BNT162b2. The patient was 6 weeks pregnant at the event onset. The patient is expected to deliver one baby(s) on 18Mar2022. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose product=COVID 19, brand=Pfizer, lot number=EW0187, date=30Jun2021, DOSE 1, SINGLE), administration date: 30Jun2021, when the patient was 28-year-old, for Covid-19 Immunization. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 22Jul2021, outcome "unknown", described as "miscarried". The pregnancy resulted in spontaneous abortion. The patient underwent the following laboratory tests and procedures: Ultrasound scan: I had indeed miscarried, notes: At subsequent visits this was also true - this was done to confirm via ultrasound that I had indeed miscarried. Therapeutic measures were not taken as a result of abortion spontaneous.  Additional information: "I received my first dose of the Pfizer Covid-19 vaccine when I did not realize I was pregnant on 30Jun2021. I would then have my second dose on 22Jul2021 at exactly when my baby would have been 6 weeks old. When I went in for my first OBGYN appointment, my baby had stopped growing at 6 weeks. At subsequent visits this was also true - this was done to confirm via ultrasound that I had indeed miscarried." Patient did not had covid prior vaccination.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event miscarriage and the use of suspect product cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Swelling around the injection site, pain at injection site, redness around injection site, and itching at injection site. Lasted about 5 days.
30 minutes after the shot, patient was driving home and was disoriented and confused. He pulled his car over and said he sat there for 60 minutes. After an hour he said he felt fine and back to normal and was fine since.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no drug reactions or allergies, patient's medical history or concomitant medications reported. On an unspecified date in May 2014, the patient was vaccinated with a first dose in series of vaccinations of GARDASIL (strength, route, administration site, LOT#, expiration date were not reported). On an unspecified date in Aug 2015, patient was vaccinated with GARDASIL 9, (dose number, strength, route, administration site, LOT#, expiration date were not provided), (inappropriate schedule of drug administration and interchange of vaccine products). No adverse effects were reported and the patient did not seek medical attention. The outcome of interchange of vaccine products was unknown. The causality between interchange of vaccine products and suspect vaccines was not reported. Additional information has been requested.
was up all night urinating/starting urinating at midnight; Diarrhea; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 23Feb2021 03:00 (Lot Number: EN6200, expiration date: unknown) as unknown, single dose for covid-19 immunisation. Medical history included irritable bowel syndrome from 2011 to an unknown date, ongoing blood cholesterol abnormal , ongoing blood pressure abnormal. Concomitant medications included valsartan taken at a dose 160 mg, once a day (at night) for blood pressure from an unspecified start date and ongoing; amlodipine besilate taken for blood pressure at 2.5 mg, daily from an unspecified start date and ongoing; atorvastatin taken for blood cholesterol at 20 mg, daily from an unspecified start date and ongoing. The patient had been taking concomitant medicines for a couple of years. The patient was up all night urinating/starting urinating at midnight on 24Feb2021, diarrhea on 24Feb2021. She is concerned if she should get the second shot or not. It just didn't seem right to her. Therapeutic measures were taken as a result of diarrhea. She took Imodium AD for the diarrhea. The diarrhea has improved. The outcome of the events was recovering.
Patient didn't think she fainted. Thought she fell asleep. However,  a customer saw her phone and personal items fall. She did state she has a history of fainting from taking blood, so it's possible she fainted. She was feeling light headed and woozy and her ears were ringing just before the episode. I asked her if she wanted me to call 911 and she said no because when it had happened in the past, she had been fine. I took her blood pressure and it was 95/52. She waited in the area till 12:25 and I took her blood pressure again and it was 115/60.  She did not have any other incindent. She left with her companion. I called her at 1:27p. She had arrived home and was still doing ok.
received the first dose of Shingrix over a year ago / would like the second d; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2020, over a year ago before date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination and would like to receive the 2nd dose now. The pharmacist was unable to provide vaccine details.  The reporter did not consent to follow-up.
Dizziness, Vertigo, Nausea,  onset @ 8;45am. Lasted for 2 hours. Reoccurring intermittent milder symptoms of dizziness, vertigo and nausea over the proceeding 60 hours.
pt recvd vax & exp h/a, arthritis, aches, nausea & devel white bumps on forearms;
Redness to arm below injection site by 5am measuring 9.5 cm x 5 cm. Seen by provider, recommended BENADRYL, ice, caladryl lotion or cortisone cream if becomes itchy.
Cellulitis of left upper arm; reaction not around injection site; reaction lower than injection site; red with blisters present above and below injection site. Pt on AUGMENTIN and BENADRYL - started 11-14-14.
This spontaneous report was received from a healthcare worker and refers to a 9 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 15-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiration date 17-JAN-2016, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a registered nurse concerning a patient who on 03-JUL-2007 was vaccinated with Zostavax (Oka/Merck) instead of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (MSD).  The incident was a mistake and was not due to product confusion.  The patients did not experienced any kind of symptoms.  This is one of several reports from the same patient.  Additional information has been requested.
On 2/23/22  the patient developed right arm soreness , which got gradually worse and became severe. The arm if tender to touch. Tylenol and Ibuprofen did not help with the pain.  There is decreased range of motion.  BP 185/96 (usually 112/68.  HR 140 (usually 99).   On exam Right deltoid area is red, warm and swollen/. indurated.  Diagnosed with cellulitis of the right arm, Rxd Cephalexin 500 mg po four times a day for 7 days, Oxycodone as needed for pain.
About 15 minutes after vaccine, noted L arm "stiffness" at site, wrist with some numbness/tingling at 4 and 5th digits and wrist.  As time progressed, felt "cold" in hand as well. Denied shortness of breath, swelling, no issues swallowing.  VSS: BP 110/68, pulse 69, p ox 100%; remained stable throughout staying another 20 min. Numbness/tingling resolved; some stiffness/coldness remained/ No issues breathing. Felt better; comfortable leaving. Reviewed if symptoms worsen seek medical attention. If issue remains, follow up with MD.
Pt recvd 3 doses of Engerix-B approx AUG90 & SEP90 & JAN91 & it was determined that pt was a non-responder; reporter indicated that would probably give pt one more dose;
Pt seen 10/23/03 with chronic cough moist likely asthma tx'd wiht Zyrtec and Advair, and given flu shot. Fever and joint c/o began 10/30/03. Persisted and developed pericardial effusion and ventricular dysfxn. Dx'd with systemic JRA later. Seeing rheumatologist. Difficult to tx. The medical records state epiglottitis.
had normal fatigue after vaccination that started the following morning,  parasthesias in left side of face and left leg below knee, comes and goes, worse in am and pm and when tired
Pt experienced itchiness on chest and back approximately 5 minutes after receiving the vaccine, she also noticed a rash on her chest.  Lips started burning and tongue felt bigger about 15 minutes after inj.  Face itchiness started about 40 after inj.  Epi pen, Zyrtec, Benadryl, pepcid, dexamethasone, saline.
All the muscle aches and pains; Nausea; A spontaneous report was received from a 36-year-old female health care professional who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced all the muscle aches and pains, and nausea.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient reported having muscle aches and pains. She also reported nausea but denied experiencing vomiting, swollen lymph nodes and fever.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, all the muscle aches and pains, and nausea, were unknown.; Reporter'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
Moderna Covid-019 vaccine  was given after the expiration date.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED ( Moderna Covid-019 vaccine  was given after the expiration date.) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED ( Moderna Covid-019 vaccine  was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED ( Moderna Covid-019 vaccine  was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Number of doses/vials: 4 vials (15 dose). 44 doses Date the vial was initially stored in the refrigerator: 24Sept2021 Date(s) of administration of vaccine: 24Oct2021 - 27Oct2021 Consent given for Safety follow up/contact with caller.  No concomitant medications were administered. No treatment medications were reported.
Day 13, redness rash around vaccine site plus a red streak 3 inches long and 2 inches wide. No itching.
Shingles/just getting over it and it was horrid; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had already got one shot and was just getting over shingles and it was horrid. The patient was waiting to get their booster shot. The patient also communicated that one should not mess with shingles.
Still  ongoing bright red tash from head to toe, fever 102.7  and  simpLy cant move arpumd
stroke (brain); This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on 08Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN , SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced stroke (brain) (caused hospitalization) in Aug2021 days after vaccination with outcome of unknown.  The patient was hospitalized due to the event from Aug2021. It was reported that the stroke was a reaction due to the vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow-up.