chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the shot, my irregular heartbeat that have been under control with medication were getting out of control. I went to the doctor and he prescribed me metoprolol succinate 50 mg, and order an EKG. I have been referred to another cardiologist for further testing and evaluation due to medication not working for irregular heart beats, which was previously under control prior to vaccine.
I started getting itchy hives all over my body whenever anything contacts my skin.  I was prescribed antihistamines to be taken twice a day.  While on antihistamines, I still get red marks but the itchiness mostly goes away.  When I stop taking antihistamines, itchy hives return in about 12 hours after last antihistamine.
Report 201018310-1 described seizure in a 7 month old female who received Infanrix. Allergies, medical history, and concomitant conditions were not specified. On 06/28/2001, the vaccinee received her first dose of Infanrix. On 06/28/2001 17:50, according to the father, the vaccinee experienced a 'full-body seizure and turned blue." The mother of the vaccinee performed cardiopulmonary resuscitation. The seizure reportedly ended and was replaced by a "half-body seizure." It was unknown whether the pt was treated at the ER or by a physician. Seizure is considered to be medically serious. As of 07/26/2001, the outcome of the event was unknown.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Aug2022 at 14:30 as dose 4 (booster), single (Lot number: Fn2908), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). There were no concomitant medications. Past drug history included: No. Vaccination history included: Moderna (DOSE 3, ;Lot No: Os4e4a; Anatomical location: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 24Nov2021, for Covid-19 Immunization; Covid 19 (Initial immunization completed: MANUFRACTURER UNKNOWN ), for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 03Aug2022 at 06:00, outcome "recovering", described as "Sore throat". Therapeutic measures were not taken as a result of oropharyngeal pain. No follow-up attempts are possible. No further information is expected.
Had been given Sanofi vaccine in clinic for ages 3 and up. Recently changed to Novartis H1N1 and didn't realize it was for ages 4 and up. No adverse effects for patient. If age ranges were consistent with all manufacturers it wouldn't be as confusing.
sinus infection has accelerated after receiving vaccine. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sinus infection" (unspecified if ongoing), notes: Caller has been fighting sinus infection prior to recieving her first Vaccine. The patient's concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "sinus infection has accelerated after receiving vaccine.  Additional information: Patient has been fighting sinus infection prior to recieving her first Vaccine dose on 10Mar. She was wondering if ok to have an anti-biotic like a Z-pack since she's now had her 1st dose. Relayed number and transferred to PMI. (name) took call. Faxing to Pfizer DSU for concerns sinus infection has accelerated after receiving vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
her first dose was invalid because it had not been properly stored; her first dose was invalid because it had not been properly stored; she slept for 12 hours after the vaccine; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received a call saying that her first dose was invalid because it had not been properly stored, there was a quality assurance measure that was done and the cold chain temperure had been broken. She believes she got some immunity from the first vaccine though because her arm hurt and she slept for 12 hours after the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Moderate chest pain that began early the morning after the COVID-19 Moderna booster. The chest pain was located on the left pectoral with chest pain, shortness of breath, and fatigue symptoms. Patient went to the ER at 7am on 12/21/2021 and received an ECG which showed normal vitals. Patient was diagnosed with 'chest wall pain' and sent home. Patient continued to monitor symptoms throughout the week, which persisted at around the same pain level. Patient alternated doses of Tylenol and Aleve for pain and notes that the pain persisted. Patient notes that the pain is centered around the sternum, and feels like a tight/burning sensation that is uncomfortable and creates difficulty breathing. On 12/26/2021 the patient returned to the ER with the same chest pain symptoms as earlier in the week. Patient had blood tests performed, which returned negative for anything heart related, and was diagnosed with Nonspecific Chest Pain. Patient was prescribed methocarbamol and directed to a cardiologist for a follow up appointment.
significant arthritic pain in both hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 10Feb2021 13:00 (Lot number: EN6201) at the age of 66 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "significant arthritic pain in both hands". Therapeutic measures were taken as a result of arthralgia.  Additional information: The patient did not take any Prior Vaccinations to covid-19 vaccination. No relevant tests were none. Patient needed steady Intake of Advil or Tylenol.   No follow-up attempts are possible. No further information is expected.
Arm is itchy; Red rash; Burning; soreness in left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2019, the patient received the 1st dose of Shingrix. On 29th December 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 3rd January 2020, the patient experienced itchy upper limbs, red rash and burning sensation. On an unknown date, the outcome of the pain in arm, itchy upper limbs, red rash and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, itchy upper limbs, red rash and burning sensation to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had soreness in her left arm for a few days which was resolving.   The patient got up and her arm was itchy and she still has a red rash that was burning. The reporter consented to follow up.
After The Vaccination, patient experienced soreness at site. The following day, patient experienced chills, and an intense headache. Since the vaccination, patient has experienced daily migraines, and random episodes of high blood pressure.
A nurse reported that a 54 year old female received an injection of Pnu-Imune 23 and Flu Shield (2001-2002 formula) on 10/30/01. The following day, she developed an injection site reaction characterized by redness and swelling extending to the elbow on the left arm. The pt was treated with ibuprofen, elevation of the extremity and application of heat to the area. The specific sites of vaccine administration were not reported.
Extreme tiredness, extreme pain in left wrist, cannot sleep, headache, nausea,  irritability,   THESE HAVE BEEN GOING ON FOR A WEEK. I've had to call into work
flu like symptoms; body aches and pains; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-year-old male patient of received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EL9267 and expiration date was not reported), dose 1 intramuscular, administered in left arm on 12Feb2021 at 07:30 AM (Age at vaccination was 73 years) as dose 1, single for covid-19 immunisation. Medical history included arthritis also stated that, which was pretty normal for his age, cancer caller states he does have a compromised immune system from previous cancer treatment from an unknown date and unknown if ongoing. Concomitant medication(s) included paracetamol (TYLENOL)  taken for arthritis, start and stop date were not reported. On an unspecified date in Feb2021 the patient experienced body aches and pains and on an unspecified date patient also experienced flu like symptoms. It was also explained that patient says, body aches and pains, flu-like symptoms and things like that, which he know are all normal. Patient was asking if he can take Tylenol to treat symptoms because he read you should not take it before the vaccine. Patient was asking if he needs to stop taking Tylenol before the next dose. Patient stated he was still getting body and aches and pains. Patient wanted to know is it pretty much normal to still be experiencing this. The patient stated he started to get body aches and pains a couple of days after the shot. The relevant test was none. The outcome of event body aches and pains was not recovered and outcome of flu like symptoms was unknown.  No follow-up attempts are possible; No further information is expected.
Less than 24 hours after receiving flu vaccine, pt reports nausea, muscle aches, itchy eyes, fatigue.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with no drug reaction/allergies. On 21-JUL-2014 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot #, expiration date unspecified), subcutaneous. No concomitant medication included. The patient stated that she was not supported to receive injections in her left arm, because she had her lymph nodes removed as a treatment for breast cancer. The pharmacist stated that the patient returned to the pharmacy on 25-JUL-2014 because she had a small "line" of lesions about an inch below the injection site which "look like they have a head of them". He also reported that the patient had redness at the injection site. He stated that the patient was scheduled to see her physician concerning these side effects. The events outcome was reported as not recovered/not resolved. The patient had sought medical attention. No treatment was given. No lab diagnostics studies performed. Additional information has been requested.
SHORTNESS OF BREATH; NAUSEA; WOOZINESS/DIZZINESS; SICK TO HER STOMACH WITH GAS; FEVER; TIREDNESS; 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 concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tiredness. On 11-MAR-2021 12:00, the subject experienced wooziness/dizziness. On 11-MAR-2021 12:00, the subject experienced sick to her stomach with gas. On 11-MAR-2021 12:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99 F. On 12-MAR-2021 12:00, the subject experienced shortness of breath. On 12-MAR-2021 12:00, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from wooziness/dizziness, sick to her stomach with gas, shortness of breath, and fever, and had not recovered from nausea, and tiredness. This report was non-serious.
Pain and swelling in left armpit. I've been applying warm compresses to area off and on for a couple of hours per day at home.
pt called 6hr p/vax & c/o arm swollen, warm & sl tender @ inj site;pt came in allerg rxn to shot;given med to localize;pt called 9SEP97 to say still sore but not as swollen;
A serious report of hearing loss/deafness has been received from a study investigator concerning a four-year-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 08-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for hearing loss/deafness on 05-Dec-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the events was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
I now have lymphomatic colitus which can have a stealth approach to starting. It was unstoppable by July 2022 and confirmed by a recent biopsy in Sep 2022, but could have been there earlier. I read in a study that although it is a possibly inherited autoimmune disease that the vaccine has set some cases off so wanted to report my case so you know. I'm not expecting any further action. Just figured you might like the data. The acute onset was closer to dose 4 but there were subtler signs throughout 2022 and 2021 that could have been the actual onset so it could have started after dose 3 or even dose 2. There's no real way of proving that. Dose 5 was AFTER this started.
?Pfizer-BioNTech COVID-19 Vaccine EUA blurry vision next day and headache, but had slightly abnormal eye exam by eye doctor so could be primary ophthalmologic issue. also seen by neurology and normal CT scan of head
Patient presented with localized rash on the arm around the injection site. rash approximately 6 inches in diameter and slowly spreading  downward and across and getting worse as reported by patient. She is going to the primary care doctor today to get it looked at.
Pt. states her urine appeared to be dark and reddish in color 2 days after vaccination. Pt is also starting on PRILOSEC and has an appointment today with MD.
On 01/03/2001 the patient complained of myalgia and joint pain for 2 weeks. The patient was treated with ibuprofen and told to return in 2 weeks if symptoms persisted. The patient did not return until 06/21/2001 with symptoms ongoing.
I had headache, chills, sore throat, shortness of breath, fatigue, anxiety & couldn't sleep well for 2 nights.  the next day I was mostly better, but on day 3 on got sick again with sore throat & fatigue.  I am very concerned about taking the next dose.
The patient states the evening on the day (5/28) of receiving the SHINGRIX vaccine her left arm became very sore, swollen and hot to touch. She says the next day, 5/29, she could not move her arm and stayed laid down that day taking Ibuprofen 200mg in the morning and (2) 500mg Tylenol that evening. She reported the situation to the pharmacy on 5/30 at 9:30am saying that she could now move her arm over her head but said she had a painless red rash under both breasts and on the left side of her neck. I spoke to her later at 2:30pm in which she stated she felt better and the rash was clearing up.
Tingling (pins and needles sensation--no pain) in left forearm and left hand intermittently still on 5/25/2010.  Encouraged to MD if symptom continues
Information has been received from a registered nurse referring to an 11 year old patient of unknown gender. On 16-JUL-2015 the patient was vaccinated with GARDASIL (lot # K008931, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
High temp, 3 seizures, crying, appetite loss 2 days, during early arm after immunization, previous afternoon Motrin and Tylenol alternating dose per Dr instructions. Saw MD in ER the next day.
p/vax pt devel T104.1, 3 days; given ibuprofen; observation; not other neuro symptoms
Information has been received concerning an 8 year old female who was vaccinated with a dose of Varivax. On 10-MAY-2006 the patient developed "less than 50". The patient's outcome was unknown. Additional information has been requested.
Abscess left arm with warm, erythema and drainage, needed wound drainage and packing of wound for more than 1 week.
Chills and fever from 9 am to 5:30 pm on 3/18/21 - fever was at 101 degrees for 2 hours before breaking in the late afternoon. A headache was felt all day, becoming increasingly painful as the day continued.  It was sharp, intense pain in temples, across the forehead that pounded.  Intense pain behind the eyes for 2 hours before the fever broke. I had not taken any pain or fever reliever all day - wanting to let the vaccine run it's course, however at 3:30 I took one acetaminophen tablet.  I could not take the headache anymore.  By 4:30 the headache had eased up and the fever was at 100.  By 5:30 the headache was gone, temperature was at 98. I then slept for the entire night.  The next day - no fever or pains/aches, just tired.  I felt like myself by the end of the day.
Fever that started about 6 hours after injection and lasted for about 9 days, even with Tylenol and Motrin the fever would not break.  Body aches/ chills lasted for a bout a week, severe Bone pain on and off.  sharp pain that traveled from my chest down to my left arm and hand, this happened for about 3 days on an off. Rash that appeared once I woke up after the injection. The rash was on my chest and abdomen it lasted for about 6 days. Sore throat, cough and short of breath, used inhaler for this and it helped. I did not feel better for about 9 days, After 9 days I was able to get up and move around, but could not work yet. Heavy menstrual bleeding with large clots the month after the injection and still occurring now.
In general she feels week; pain in the arm; dizziness; chills; blood pressure measured and it was very low; This is a spontaneous report from a contactable consumer or other non HCP. A female patient of an unspecified age received bnt162b2 (bnt162b2), dose 1 via an unspecified route of administration on 31mar2021 (batch/lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 20Apr2021 18:09:46 patient experienced in general she feels week, pain in the arm, dizziness, chills, blood pressure measured, and it was very low. Outcome of events was unknown.  Revised on 06 April 2021, no reports of dizziness, the other side effects reported by caller where previously reported on the clinical trials of the vaccine. No specific contraindication for patients with asthma.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse refers to a unspecified number of patients (unknown age and gender). In unknown date in 2014 the patients were vaccinated with RECOMBIVAX HB dose, route of administration and lot# were not reported. On 23-MAY-2014 doses of RECOMBIVAX HB was exposed to -1C for 2 hours. Reporter stated that there other excursions that were below 2C, and she did not have that information organized presently in order to report it. Reporter would "run a report" of the patients who received these improperly stored doses and she would provide the full details of the excursions. There were no adverse experience to report at the time of the report. This case is linked with MARRS # 1406USA008824 (Same Reporter Link(. Additional information has been requested.
2-9-07 Mother noticed an indentation on Right leg.  Denies any redness, or warm skin to touch.  No difficulty of walking noted.  3-26-07 Mother brought child to clinic with complaint of quarter size indentation on right upper outer quadrant of thigh.  Denies any difficulty walking or redness or tenderness at site. States she notices this after she received her last set of shots.   Encouraged her to keep child walking and to report any changes in site or condition of child.
Sever pain in both shoulders and knees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUAD QUAD), in Nov2023 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "avascular necrois" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (3rd dose, MANUFACTURER UNKOWN ), for COVID-19 immunisation; Covid-19 vaccine (2nd dose, MANUFACTURER UNKOWN ), for COVID-19 immunisation; Covid-19 vaccine (1st dose, MANUFACTURER UNKOWN ), for COVID-19 immunisation. The following information was reported: ARTHRALGIA (non-serious) with onset 18Nov2023 at 12:00, outcome "not recovered", described as "Sever pain in both shoulders and knees". Therapeutic measures were taken as a result of arthralgia. Additional information: treatment received VOLTAREN
Rash that began not quite 24 hours after injection; rash began on torso, chest and spread to back and later legs.  Rash still present on day 5 post injection.  Dr. suggested Benadryl and have been keeping up with Benadryl at least 2-3 x/day.  Rash may be easing up now.
This spontaneous report was received from a 60 year old male patient who is also a pharmacist. Patient current condition included arthritis. No medical history was reported. Approximately on 15-OCT-2012(reported as middle of October 2012), the patient was vaccinated with a one time dose of ZOSTAVAX (lot#, expiry not reported), 0.65 ml, subcutaneously. No concomitant medications were reported. On 15-OCT-2012 (reported as middle of October 2012), the patient experienced exacerbation of arthritis after receiving ZOSTAVAX. Patient is taking ADVIL(unspecified manufacturer) as treatment. Patient sought medical attention(patient is the pharmacist). Laboratory diagnostics studies performed was none. The outcome of exacerbation of arthritis was unknown. Additional information has been requested.
The evening after immunization, patient reports to have redness, pain, and itching at site of injection. Patient had a fever that lasted for approximately 2 days.  Patient also reports that the swelling on her arm is approximately the size of her palm. Patient went to urgent care on 10-4-2021 at which time she was diagnosed with cellulitis and given an antibiotic.