chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; felt achy; fever of 101.7; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-May-2021 and was forwarded to Moderna on 05-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (felt achy) and PYREXIA (fever of 101.7) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043821A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced CHILLS (chills), MYALGIA (felt achy) and PYREXIA (fever of 101.7). At the time of the report, CHILLS (chills), MYALGIA (felt achy) and PYREXIA (fever of 101.7) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Vaccine given at 9:30 am on 3/26/21. Patient reports she developed  fever of 100.3 chills and body aches at 8:30 pm. She states she woke on Saturday am and had  mouth  irritation  and  what  felt like blisters under the skin inside her bottom  lip. She stated  the  whole inside of her mouth felt tender until Sunday evening on 3/28/21. She states her symptoms have improved today but still has some mouth tenderness and feels like her mouth is "dry". She is afebrile today and  feels  well other than the mouth symptoms.
I received my first Moderna vaccine on August 26, 2021 with no problems.  I then got my second shot at the same location on September 24, 2021.  On September 28, 2021 I started to notice eggs were smelling like rotten meat.  Within days this quickly progressed to cooked hamburger meat, onions, cheese, chocolate and legumes.  All smelling and tasting like rotten meat.  I also developed an odd sensation of someone blowing cigarette smoke in my face.  So strong that it burns my eyes.  I find it very difficult to find foods to eat.
Extremely short of breath O2 was in low 90s and pulse was 130+ . Labs drawn and D-dimer was elevated . No active clot was found by the time I got to ER and seen . Due date June 11th 2021
Booster dose of Pfizer vaccine.  Significant itching, irritation of eyes / tear ducts / under eye discoloration starting about 24 hrs after receiving injection. More severe adverse event lasted 2-3 days disrupting sleep then gradually tapered off over a period of a week. Minor eye irritation and discoloration under eyes persists.  Initially received Janssen vaccine 11/26/21.
Break through Covid case. I started feeling symptoms May 5th and tested positive on Monday May 9th. I developed a head cold and I treated with ibuprofen and later on with Mucinex cough syrup. As of today the only symptoms I have are residuals from head cold.
Sore left arm, felt heavy, and when she lifted it, "super sore; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Left Arm on 24Feb2021 13:45 (Batch/Lot Number: EL9262, expiry date: unknown) (at 41-years age) as dose 1, single for COVID-19 immunisation at the hospital. Medical history included thyroid cancer, and covid-19. Concomitant medication(s) that within 2 weeks prior to the vaccination includes included levothyroxine sodium (SYNTHROID); topiramate (TOPAMAX); rizatriptan (RIZATRIPTAN) taken for migraine. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 24Feb2021 09:00PM the patient experienced sore left arm, felt heavy, and when she lifted it, super sore. Sore left arm started around 9pm (after 1:40pm vaccination that day) felt heavy, and when she lifted it, super sore. She said milder as of following morning. The patient had not received treatment for all the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving.  No follow-up attempts are needed. No further information is expected
Patient had Moderna for the first dose of COVID 19 vaccine but was inadvertently given Pfizer for the second dose. Patient notified and had no adverse symptoms noted.
Patient began having throat swelling and shortness of breath, administered EpiPen, Solumedrol 125mg IV push, DuoNeb breathing treatment, 2L of O2 via nasal cannula. Patient taken by ambulance to ER.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4505546-00 (Company).  A 37-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), on 27Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1164364) at unk, citrate free, subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 10Aug2022, outcome "not recovered" and all described as "COVID-19". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Causality for Humira (adalimumab): The reporter's causality for the event(s) of COVID with Humira (adalimumab) was a reasonable possibility.  Drug: Humira (solution for injection in pre-filled pen) (adalimumab): Causality: COVID-19 (COVID-19): Action(s) taken with drug : Unknown; Causality as per reporter (Drug/Vaccine): Probable.  Drug: Pfizer Biontech COVID-19 vaccine (tozinameran): COVID-19 (COVID-19): Causality as per reporter (Drug/Vaccine): Possible.  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Suspected Covid-19 and the suspect drug cannot be excluded and Related to the suspected drug. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
body ache; Fever; Cough; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis.   Previously administered products included Covid-19 vaccine (received 2 doses of Covid-19 vaccine on an unknown date). Concurrent medical conditions included cancer.   On an unknown date, the patient received the 1st dose of Shingrix. On 28th September 2021, the patient received COVID-19 VACCINE. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced general body pain, fever and cough. On an unknown date, the outcome of the general body pain and fever were recovered/resolved and the outcome of the cough was unknown.   It was unknown if the reporter considered the general body pain, fever and cough to be related to Shingrix.  Additional details were provided are as follows: The patient self-reported this case. The patient received a dose of Shingrix in October or November 2021 (exact date was unknown) and less than 3 months after vaccination, had body ache and fever. The patient received a booster of Covid19 vaccine, less than 3 months after vaccination, but she had a cough and was not sure if it was due to Shingrix or if it was COVID related. It was unknown if the reporter considered the general body pain, cough and fever to be related to COVID-19 VACCINE. The reporter consented to contact healthcare professional. The reporter consented to follow-up. For tolerance of 2nd dose, refer case US2021257814, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021257814:same reporter
severe pain on the bottom base of the thumb; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 01Apr2021 at 15:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not receive any medication within two weeks of vaccination. The patient has no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG203) via an unspecified route of administration in the left arm on 11Mar2021 at 15:00 (at the age of 38-years-old)  as a single dose for COVID-19 immunisation. Prior to the 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. On 03Apr2021, the patient experienced severe pain on the bottom base of the thumb, it was so painful that the patient cannot close her hand and it hurts when tried to grip anything. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event severe pain on the bottom base of the thumb was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
FEVER OF 103 F ALL DAY; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-AUG-2021, the patient experienced fever of 103 f all day. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever of 103 f all day. This report was non-serious.
Severe chills, fever of 102.4, tingling/severe muscle pain, chest pain, diarrhea. 1000mg acetaminophen every 4 hours ibuprofen 800mg every 6 hours alternating.   18 hours after my first vaccination and 20 hours after my second vaccination i developed a splotchy burning rash on my arms. I treated it with benadryl cream and benadryl 50mg orally
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient ws vaccinated with improperly stored dose of ROTSTEQ (which had the lot # M019706, expiry date: 24-OCT-2017)(route, dose and anatomical place of vaccination were not provided). No adverse effects were reported. The vaccine was exposed to temperature of 34.2 Fahrenheit 24 hours and 34.5 Fahrenheit 12 hours. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. No product quality complaint (PQC) involved and no further information provided. Additional information has been requested.
Headache, joint pain, tooth pain, metal taste in mouth, soreness at injection site.
Pts mother called 5-7-10 stating that pt had swelling in (R) arm and under (R) armpit and throat irritation.
Chills, fever 100.9, headache,body aches, sore arm, and  fatigue on 2/27 in early AM at 4AM lasting about 24 hours On 2/28 and 2/29  left arm swelling along with sore arm Also watery eyes both of those days and headache continued. Sore arm for about 5 days
Sore arm, fever,  chills, shivering shortly after vaccination. Took some motrin to relieve the pain.
Patient received vaccination and left without any symptoms. Two days later, husband called and said patient's arm was sore. I advised her to massage gently. Patient has been out of town and when I called today, husband said arm was still hurting and she had been to the doctor's office to have it checked. Doctor had no explanation - said vaccine may have been given too high on arm.
severe whole body vascular appearing rash ( or thrombocytopenia.. platelets pending) started ~7-10days after 1st dose and worsening over subsequent 3 weeks. work up / labs in process
Rash; This case was reported by a health professional and described the occurrence of rash in a 45-year-old female patient who hepatitis B vaccine recombinant (Engerix-B). Medical history is notable for a possible allergy to thimerosal. On unspecified dates in November 2003 and December 2003, the patient received the first and second doses of Engerix-B.  On  26 May 2004, the patient received the third dose of Engerix-B (lot ENG5582B6). At an unknown time following the third administration of Engerix-B, on an unspecified date in 2004, the patient experienced a rash. The patient was seen at a physician's office. The health professional reported that she did not know if the rash was at the injection site or a systemic reaction. The outcome of the event is unknown.
Totally coincidental information, not yet clearly related to vaccine: Unexplained rapid heart rate; diagnosed as Supra Ventricular Tachycardia Severe or extreme breathing difficulty that occurs unrelated to exercise or exertion; however, it seems to be related to position such as putting on shoes.
This non serious case was extracted from the VAERS database via QScan on 24 February 2009 (reference number 333186). A 34-year-old female patient had received a first dose injection of FLUZONE SV 2008-2009 (route not reported), lot number U2739AA on 16 November 2008, and an unspecified amount of time later (reported as "at about 1:00pm), the patient developed a scratchy throat and red, watery, itchy eyes that felt like a film was covering her eyes. the patient had additional complaints of chest tightness and random "palpations" with her pulse faster than normal. She developed a cough due to a constant tickle in her throat, a dull constant headache (like pressure), aching in her entire body and she had no energy. These symptoms continued into the night and the patient was unable to sleep because of the headache and chest pressure (could not catch her breath). At 9:00 pm her temperature was measured at 99.7 degrees Fahrenheit. On the morning of 19 November 2008, the patient took 400 mg IBUPROFEN. She had no temperature (98.8), her chest was still tight, throat was hoarse, and her eyes were still runny, bloodshot and sore. These symptoms continued throughout the entire day with heart "palpations." At 2:00, the patient took another 400 mg of IBUPROFEN. On 20 November 2008, the patient woke up to normal white eyes, energy level was low, but more energy than previous days (11/18/ and 11/19). Heart "palpation" gone and throat was normal. The patient recovered from the even and felt no effects to date.
I developed continuous tinnitus from the 3rd/booster dose of covid vaccine. I've had continuous tinnitus for over a month now. I've been covid free this entire pandemic. The Moderna lot was 067F21A and was administered on 12/08/2021.
it is a weird bloat/stomach is hanging.; flu like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included laparoscopy (had a laparoscopic procedure and could always see the small incision scars).   On 11th May 2020, the patient received the 1st dose of Shingrix. On 13th May 2020, 2 days after receiving Shingrix, the patient experienced abdominal bloating. In May 2020, the patient experienced influenza-like symptoms. On 16th May 2020, the outcome of the abdominal bloating was recovering/resolving. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and abdominal bloating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had flu like symptoms for about a day and a half which was told could happen. The patient when getting dressed after gardening noticed the stomach looked funny and only way could describe it was a weird bloat and the lower part of my stomach was hanging. The patient had a laparoscopic procedure and could always see the small incision scars. But now patient cant see them. The reporter stated it's a little better but could you tell what's going on.
Sweating, chills, low grade fever, redness on skin especially sides and legs (very sensitive to touch), dry cough, stuffy nose, sore throat, achy all over body, eyes very sensitive, and dry mouth.
6 hours after I got the vaccine I had High fever 102.5 for about 3 days, vomiting and diarrhea as well for 4 days.  That went away the. developed Headache and leg pain and abdominal pain for about 4 days. Injection site still hurts
Change in menstrual cycle; Intense mood swings; Heavy bleeding; Spotting; Jitters; Anxiety; Depression; Facial pain; Tingling; Ongoing treatment to treat hormones; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Jun2021 (Lot number: EW0191) at the age of 36 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Gastroparesis" (unspecified if ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EW0177; Route of administration: Unspecified), administration date: 21May2021, when the patient was 36 years old, for COVID-19 immunisation.  The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Change in menstrual cycle"; MOOD SWINGS (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Intense mood swings"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Heavy bleeding"; INTERMENSTRUAL BLEEDING (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Spotting"; FEELING JITTERY (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Jitters"; ANXIETY (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Anxiety"; DEPRESSION (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Depression"; FACIAL PAIN (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Facial pain"; PARAESTHESIA (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Tingling"; ENDOCRINE DISORDER (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Ongoing treatment to treat hormones". The events "Change in menstrual cycle", "Intense mood swings", "Heavy bleeding", "Spotting", "Jitters", "Anxiety", "Depression", "Facial pain", "Tingling" and "Ongoing treatment to treat hormones" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anxiety and endocrine disorder.  Additional Information: Therapeutic measures included ongoing treatment to treat hormones and anxiety. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
chest pain; No sleep whole night.; pain; Feeling severe head ache; This is a spontaneous report from a contactable consumer (patient) reported for himself.  A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 24Oct2021 12:00 (Lot Number: FF2590) (age at vaccination 30-year-old) as dose 2, single for covid-19 immunisation at Pharmacy or Drug Store. The patient had no allergies. The patient relevant medical history and concurrent conditions was reported as no. There were no concomitant medications. The patient received historical vaccine (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (age at vaccination 30-year-old) dose 1 via an unspecified route of administration, administered in arm left on 30Sep2021 at 06:00 pm (Lot Number: 301308A) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received any other medications the patient received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies. The patient experienced chest pain, no sleep whole night, pain and feeling severe headache on 24Oct2021 at 14:00. It was reported that feeling severe headache and chest pain. No sleep whole night. Took tylenol but no use. Not slept whole night and still pain is continuing. He don't know what to do. Seriousness criteria were reported as no. The patient did not received treatment for events. Therapeutic measures were taken as a result of chest pain and feeling severe headache. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient experienced chills and flushing minutes after vaccine administration. Vital Signs stable. Spontaneous improvement. No medications offered.
6-22-11 - 1200 noon. Mom reported that 2 hours after vaccination was received, pt was inconsolably crying, (L) leg swelling & non wt bearing to (L) leg. Gave Ibuprofen & returned to our office at 1800 no swelling to leg noted; mildly favoring the (L) leg no fever, no crying. Recommended to continue Ibuprofen TID x 2d & F/U PRN.
2/14/21-Immediately after 1st covid vaccine experienced pressure sensation in chest and breast.  Great on the right side, went up to the back to neck.  The shock sensation went over the top of the head onto face with tingling bilateral.  Resolved on 3/3/21. 3/3/21- Severe vertigo-hospitalized for 3 days.  On day 1 of vertigo sudden hearing loss.