chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 10:00 PM that night, I started having a fever.  I was hallucinating, slurred speech, and could not walking in a straight line.  Then within 2 hours, I started having serve pain all over my body.  My period ended on that day as well.  And I did not have a period for 2 months.  I finally got my period on June 25th, and it continued until July 21st with medications to stop my period.  I lost 5 mL an hour of blood.
Severe arm pain, heat at injection site, migraine, flu symptoms, sneezing, severe joint aches
Day 2-4 after receiving booster shot I got covid arm. (Sweeling,red and itchy at injection site).  Day 12 after receiving booster shot I broke out in hives. I began taking benadryl. Day 14 after receiving booster shot I developed gastrointestinal issues (nausea, diarrhea, stomach cramps, tight esophagus).  Day 16, I went to medical facility and was prescribed zyrtec and pepcid.  Day 17, I went to my primary care physician. She advised to continue taking zrytec and pepcid.  Day 20 (today 12/23/2021) all issues remain. Hives come and go. Zrytec helps temporarily. Gastrointestinal issues still remain and are discomforting. I'm considering to go to ER.
On 6/22/06, patient's left deltoid area became increasingly red, swollen, and warm. On 6/23/06, patient evaluated in clinic - observed left deltoid to have 6-8cmx6-8cm area of erythema, edema, warmth. DX: cellulitis. Treated with Augmentin PO BID for 10 days.
Swelling began at site of injection within hour of administration. Slowly increased by 2-13-06 was 3 cm area round with erythema, slightly raised. No discharge from site. No adjacent LAN. Notes on 2-15-06 swelling slowly going down. Is being observed/followed. 2 -20-06 swelling gone but feels hard.
Vaccine had a BUD of 1/18/2023 as it was delivered unfrozen and immediately placed in the refrigerator unit
Patient reported 4 weeks after second dose, was hospitalized for heart failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 03Mar2021, for Covid-19 Immunization. The following information was reported: CARDIAC FAILURE (hospitalization, medically significant) with onset 2021, outcome "recovered with sequelae", described as "Patient reported 4 weeks after second dose, was hospitalized for heart failure". The patient was hospitalized for cardiac failure (start date: 2021). It was unknown if therapeutic measures were taken as a result of cardiac failure.  Clinical Course: It was unknown if patient received other vaccine in four weeks. Patient reported 4 weeks after second dose, was hospitalized for heart failure. Physician would not link symptoms to COVID shot. It was reported that patient recovered with lasting effects. It was unknown if patient had covid prior vaccination, also unknown if tested for covid post vaccination.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300318717 same patient/reporter/vaccine, different dose, events;
Patient has 2nd dose of vaccine at mass vaccination event at Arena. She developed fever to 103.7F, nausea, dizziness within a few hours. 6 days later she is still having dizziness/vertigo, nausea, vomiting and reports intermittent nerve pain up and down right arm.
Started oral typhoid on 10/11/2005. Started feeling itchy on lower and upper extremities on 10/12/2005 pm, completed 3 doses of oral typhoid every other day. Rash and itch continues. Saw PCP on 10/17/2005 was prescribed Atarax and prednisone. Pt felt a lot better on 10/19/2005.
This spontaneous report as received from a medical assistant refers to patients of unknown demographics. On unknown dates in 2016 (between 30-JUN-2016 and 20-JUL-2016), the patients were vaccinated with unspecified doses of PROQUAD immunization series (lot # M006102, expiry date: 01-AUG-2017) that were improperly stored (incorrect product storage). Temperature/Time: Multiple excursions between 30-JUN-2016 and 20-JUL-2016. Freezer: maximum 30.6F, cumulative time 96 hours, 51 minutes. Refrigerator: 31.3F minimum/maximum 49.4F for cumulative out of range: 35 hours 9 minutes. Data logger was involved. No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received form the same reporter. Additional information is not expected as the reported did not wish further contact.
Nonspecific pruritic papular rash on bilateral shoulders, upper chest, upper back, neck.
Temp of 100.5, feeling achy, tired, head congestion, occasional headache
CLIENT REPORTS UNSCHEDULED MENSTRUAL BLEEDING X 2 MONTHS POST VACCINATION THAT SELF-RESOLVED
Vaccine was administered on Friday, May 4 in the evening. Patient stated that on Saturday and Sunday, she had chills and was hot and cold on and off. She also had swelling and redness in the injection area. It felt burning hot and was itchy as well. On Wednesday, May 9 she went to the doctor and was prescribed a 6 day course of prednisone or methylprednisolone (she could not remember which steroid) and a 10 day course of cephalexin. She stated that she did not like the insomnia from the steroid, so she stopped it after 3 days and is currently finishing up the cephalexin course. Per the patient, the area is still red but is gradually getting better. She is planning on talking to her doctor about getting over the counter hydrocortisone since she stopped the systemic steroid early.
Diarrhea, swelling of arm with a  5cmx3cm rash spot at injection site. Firm on palpation with pain.
Get achy/flush 24 hrs out from the 2nd dose; Get achy/flush 24 hrs out from the 2nd dose; This is a spontaneous report from a non-contactable physician (Patient)   A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient reported she was starting to get achy/flush 24 hour out her second dose. She also confirmed that she didn't have any significant effects after the 1st dose though. At the time of the reporting events outcome was unknown.   No follow-up attempts are possible: information about lot/batch number cannot be obtained.
Fever of 103 degrees, 24 hours after receiving immunizations.  Fever lasted 2 days then resolved.
Really bad pain under right arm, right breast up over right shoulder, into right shoulder blade. Burning pain under right arm-slept with pillow (shot given in right arm) under arms for four days.
when mom examined pt on 26JAN96 noted redness of lt deltoid area;temp not known-mom had given APAP;on exam 2" warm red area in deltoid w/t99.4
Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 12:19 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 12-Feb-2022 at 12:19 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported  No Treatment medication was reported
Itching; This is a spontaneous report from contactable consumer (patient) reported for herself. An 83 years old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EW0151, Expiry: 31Jul2021) injection to left arm around on 06Apr2021 09:30 at age of 83 years old at single dose for COVID-19 immunization. It has been a while since she had taken any of the medications she had allergies to. Allergies to Penicillin, Sulfa, Cipro-full name unknown; and Fosamax. Concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (Lot: EN6204, Expiry: 30Jun2021) injection to left arm on 09Mar2021 9:30 at 83 years old for COVID-19 immunisation and had no reaction. Patient stated she had no reaction to the first dose of the Pfizer-BioNTech COVID-19 vaccine and received the second dose last Tuesday. She explained she then has been experiencing itching. She asked it was reported as a side effect to the vaccine and how long it would last. Patient asked if she can take diphenhydramine hydrochloride (BENADRYL) for her itchiness, after vaccination with the Pfizer-BioNTech COVID-19 vaccine. Explained: Pfizer is unable to make treatment recommendations for individual patients. Used section "Safety: Adverse Reactions or Side Effects" of the VR-Consumer Inquiry Management (Off-Label or No Info) for referral to HCP. Added:  "In the Pfizer-BioNTech COVID-19 vaccine study, people were allowed to take antihistamines, like diphenhyrdramine." Patient asked for a website where she can retrieve a list of reported side effects for the Pfizer-BioNTech COVID-19 vaccine. This consumer is the patient who reported itching after having been administered her second dose Pfizer-BioNTech COVID-19 Vaccine. She asked if anyone else called in experiencing itching; asked how long the itching was expected to last; and if there was anything she can do in the interim for the itching. She was afraid to take anything like Benadryl and wanted to ask about if it would be ok to take Benadryl. Itching on 06Apr2021. She had no rash as of yet, just the itching which had improved, seems to be less for the past 2 days. Reporter seriousness for Itching was unspecified. Patient verified that there were no relevant concomitant products or other medical conditions to provide for this report. Additional information obtained from vaccine supplemental form medical history query documented in that field as provided. The adverse events (AE) did not require a visit to Emergency Room or Physician Office, the patient was not hospitalized. There were no vaccinations within four weeks prior to the first administration date of the suspect vaccine, other than dose 1 of 2 of the Pfizer-BioNTech COVID-19 Vaccine. Outcome was recovering.   No follow-up attempts are needed. No further information is expected.
Today I have a low grade fever; today the pain at the injection site is like I had had a Tetanus shot; flu symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of low grade fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-JUN-2023, the patient received the 1st dose of Shingles vaccine. On 15-JUN-2023, 1 days after receiving Shingles vaccine, the patient experienced low grade fever (Verbatim: Today I have a low grade fever), injection site pain (Verbatim: today the pain at the injection site is like I had had a Tetanus shot) and flu symptoms (Verbatim: flu symptoms). The outcome of the low grade fever, injection site pain and flu symptoms were not resolved.   It was unknown if the reporter considered the low grade fever, injection site pain and flu symptoms to be related to Shingles vaccine.     It was unknown if the company considered the low grade fever, injection site pain and flu symptoms to be related to Shingles vaccine.   Additional Information: GSK receipt date: 15-JUN-2023 This case was reported by a consumer via interactive digital media. The patient had first shot yesterday (from the date of reporting). Today (on the day of reporting) had a low grade fever and flu symptoms which was told was normal and to expect it.  Didn't feel the shot at all but today the pain at the injection site was like he/she had had a Tetanus shot.
fever; chills; head soreness; extreme sleepiness / falling asleep constantly; chronic fatigue syndrome; ache her my arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 11Mar2021 as 1st dose, single dose for COVID-19 immunisation. Medical history included diabetes from an unknown date. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced fever, chills, head soreness, extreme sleepiness / falling asleep constantly, chronic fatigue syndrome and ache her my arm at the injection site. Therapeutic measure was taken as a result of the event ache her my arm at the injection site included TYLENOL. It was reported that the patient was asking if the vaccine can cause a false-positive or false-negative for Cologuard. The patient was also asking if it is okay to take an antibiotic between the 2 doses of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse, referring to her daughter, an 18 year old no-pregnant female patient. The patient presented drug allergy/reaction to DENEROL, however, no information about the patient's pertinent medical history was reported. On an unknown date (when the patient was 12 year old), the patient was vaccinated with VARIVAX (strength, dose, lot number, route and anatomical location were not reported). Concomitant medications were not reported. On an unknown date, the patient had been coming down with singles episodes, she was currently 29 years old and she had 5 shingles episodes since age 18 (date unspecified) and currently was having sensation on her back around S3 vertebrae area, similar to what she experienced with each episode of shingles. The patient was suspecting that she might becoming down with possibly 6th shingles. Nurse reported that the patient's very first episode of singles was presented with right hip pain and two days later, the patient noticed legions on her back, L3 and L4 vertebrae area, along with pain. Nurse reported that the patient's all 5 episodes of shingles manifested exactly the same way, each time, with hip pain and legions on her back. The current pre-shingles sensation the patient was experiencing was around S3 area on vertebrae but patient was yet to have external symptoms of rash but patient described to the reporter that sensation was very similar to what she felt with previous cases of shingles. Nurse also reported that the patient was diagnosed with fibromyalgia in the year following first case of shingles. Nurse reported that her daughter also had polycystic ovarian syndrome and currently going through in vitro fertilization (IVF) treatment. The patient sought medical attention via an office visit and received Acyclovir for the shingles. No lab diagnostic studies were performed. At the time of reporting, the outcome of fibromyalgia, herpes zoster, polycystic ovaries and sensory disturbance was reported as not recovered/not resolved. The relatedness between the events and the vaccination with VARIVAX was not reported. No product quality complaint was involved. Additional information has been requested.
Next day after first injection noticed axillary lump waited until September 21, 2021 to have mammogram.
I had an EKG before receiving my second dose of Moderna with no indication of T-wave abnormalities but an EKG for a pre-op recently revealed a heart murmur that was not there before. (confirmation from Cardiologist- not a previous provider, had to receive clearance for surgery)
Received latest COVID immunization 22 Sep. Sore arm BUT beginning 23 Sep - 21 Sep temp 100C, joint pain, fatigue, nausea, 23 Sep - 26 Sep fine rash developed on torso (hot too!), resolved and now skin itches.
Patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 031A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NALOXONE, IBUPROFEN, HYDROCHLOROTHIAZIDE and TRAMADOL for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter states it is unknown if patient experiencing any symptoms. The Number of doses/vials: 7 Doses administered from 3 vials. The vial was initially stored in the refrigerator on 07-Dec-2021, it was taken out of freezer and kept into fridge, vial did not undergo any temperature excursions.
This spontaneous case, initially received on 12-Oct-2016, was reported by a health professional and concerns a 16-month-old patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 12-OCT-2016. Dose: 0.5 ml, Route of administration: Intramuscular, Batch number: WT56908. No additional suspect drugs. Adverse reactions/events and outcomes: On 12-Oct-2016, a 16 month old patient received AFLURIA vaccine (special circumstances: drug administration error). No adverse reaction noted after administration. The outcome was reported as unknown. Reporter comments: The healthcare professional considered all events non-serious.
Seen 2/22/21 for hives/swelling hands and feet since 2/21 PM (started the day after receiving the vaccine). No respiratory or sytemic symptoms. Treated with Benadryl as needed.
Seizures occurred after dx'd with infantile spasms by neurologist. Parents reported activity cluster similar to infantile spasms occurring about 1 week, post vax. No treatment. The pt is on chronic anticonvulsant. Followup info states developemental delay first noted 9/21/1999 and infantile spasms diagnosed 10/28/1999.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 18-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017)(dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Pediatric Pfizer COVID-19 Vaccine (COVID-19, mRNA, LNP-S, PF, 10 mcg/0.2 mL dose  CARTON, 10 MULTI-DOSE VIALS) This shot's side effects resulted in Hazem feeling dizzy and having eye sight issues. The eye sight issues included seeing objects from the opposite side (i.e. looking to the left, he would see objects that are supposed to be on his right and vice-a-versa, looking up resulted in seeing what was down and vice-a-versa) for several minutes. He also would only see in black and white for moments at a time. These side effects occurred consecutively over 4 days and then occasionally the following week. (Saturday night, Sunday morning, Monday night, then Tuesday morning) and again on Thursday.
breastfeeding currently; breastfeeding currently; Only mild-mod sore arm; This is a spontaneous report from a contactable physician. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 intramuscular, administered in Arm Left on 22Dec2020 13:00 (Batch/Lot Number: EH9899) as 1st dose, single dose for an unspecified indication. Medical history included Obese (BMI Approx 30), seasonal allergy. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. The patient's other medications in two weeks includes Prenatal Vitamins, Allegra, Probiotics. Patient don't have known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced breastfeeding currently on 22Dec2020 and only mild-mod sore arm on Dec2020.The patient underwent lab tests and procedures which included body mass index resulted in approx. 30 on unknown date. The outcome for events was unknown.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Chills, extreme fatigue, nausea, stomach pains - 48 hours; Cramps and lack of appetite 10 days
complaint of COUGH, FEVER & NAUSEA The patient describes cough ongoing for nearly eight weeks, following the confirmation of COV19 infection on 8/5/21.  In the past three days, she has had fever to 104.9F (reportedly), nausea, with NB emesis and body aches.  Cough is minimally productive of white phlegm, no hemoptysis.  No chest discomfort, dyspnea, asymmetric calf pain/swelling, orthopnea, pedal edema, neck stiffness, HA, vision or speech changes, focal numbness or weakness, diarrhea, abdominal pain, or urinary complaint.
1/27 NECK SORE (RT SIDE) 1/28 RIGHT CERVICAL LYMPH NODE SWOLLEN SUNDAY - SWOLLEN RED BUMPS DIME & QUARTER SIZED & LARGER, UPPER & LOWER LEGS - SORE, NOT ITCHY.
Spoke with mom today. Vaccine 6/17/19. woke up with rash 6/18/19. Rash spread and increased to itching, went to urgent care 6/19/19. Pt. given steroids and Benadryl. Followed up with dermatologist who increased doses of each. Pt is better but not 100%, she did leave for international trip yesterday.
mild chills; Temp 99/Temp spiked to 101 at 1500; Body aches/body aches- especially back/ hips; Slight post nasal drip; cough; This is a spontaneous report from a contactable nurse. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:5730), intramuscular in left arm on12Jan2021 19:00 at single dose for covid-19 immunization. The patient's medical history included known allergies to Penicillin (PCN). Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously took Levaquin and versed and experienced allergies. The patient received the first dose of bnt162b2 (lot:5730) on 21Dec2020 at 18:30, intramuscularly in the right arm  for covid-19 immunisation. On 12Jan2021 07:00, events started 12 hours of out with mild chills. Temp 99. Body aches. Took Tylenol 0900, symptoms improved to tolerable range. Temp spiked to 101 at 1500. Chills, body aches- especially back/ hips. Slight post nasal drip and cough. The outcome of the events was not recovered