chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I went to emergency room due to abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Mar2021 19:00 (lot number: PAA156051) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient went to emergency room due to abdominal pain on an unspecified date. No treatment was given for the event. Prior to vaccination, the patient had no COVID and patient was not tested for COVID post-vaccination. The patient was not pregnant at the time of report. The outcome of the event was unknown.
Large erythematous warm raised area in 2/3 of R thigh approx 6x8 inches.
Pt reacted to FluMist after it was given to him on 12/08/03. His mom said he started with runny nose and red rash all over his body. Pt came back into the office and treated with Zyrtec and Oraped.
VERY SLEEPY; FEELING IRRITABLE; SOAR ARM; FEELING TIRED AND FATIGUE; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 03-MAY-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 an unspecified date, the subject experienced very sleepy, feeling irritable, soar arm, and feeling tired and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soar arm on 03-MAY-2021, and had not recovered from feeling irritable, feeling tired and fatigue, and very sleepy. This report was non-serious.
Red Hives Circled around left arm approx. three inches below injections site.  Hives on right uppper arm. Hives on neck and chest.  Fatigue.  Abdominal pain.  Painful arm where shot given.
Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was resolved (duration 1 day).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by the patient via  interactive digital media. The patient received Shingles vaccine and only side effect was a sore arm and that was the next day. The follow-up could not be possible as no contact details were available.
After I received shot that my lips, tongue and throat started itching; After I received shot that my lips, tongue and throat started itching; After I received shot that my lips, tongue and throat started itching; This spontaneous case was reported by a consumer and describes the occurrence of LIP PRURITUS (After I received shot that my lips, tongue and throat started itching), TONGUE PRURITUS (After I received shot that my lips, tongue and throat started itching) and THROAT IRRITATION (After I received shot that my lips, tongue and throat started itching) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP PRURITUS (After I received shot that my lips, tongue and throat started itching), TONGUE PRURITUS (After I received shot that my lips, tongue and throat started itching) and THROAT IRRITATION (After I received shot that my lips, tongue and throat started itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, LIP PRURITUS (After I received shot that my lips, tongue and throat started itching), TONGUE PRURITUS (After I received shot that my lips, tongue and throat started itching) and THROAT IRRITATION (After I received shot that my lips, tongue and throat started itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.
Pt received KINRIX, MMR, Varicella on 8/17/11 at 4 year WCH appt. No hx seizures pt. or family - had all vaccines in past without adverse effect. Evening of 8/17/11 began having seizure-like activity.
Patient was administered expired MMRII.; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not provided.      On 23-OCT-2020, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, frequency, strength and route of administration were unknown; lot # was R029516 and expiration date was 14-OCT-2020; therapy type was rHA) for prophylaxis.         The outcome of the event was unknown.
oN 9-17-2019 EVENING SHE STARTED FILLING CHILLS AND BODY ACHES ALL OVER. SHE DRESSED UP WARM CLOTHES AND WENT TO BED. IN MIDDLE OF NIGHT SHE WAKE UP WITH HEAVY SWEATING AND ALL HER CLOTHES WERE WET. SOMETIME IN NITE SHE DEVELOPED RASH WITH ITCHING. IT FEELS HOT AND BY TOUCHING IS ITS HOT. AT THIS TIME MEDICAL ATTENTION NOT NECESSARY. SHE CAME TO STORE ON 9-18-2019 AROUND 530PM TO TALK TO PHARMACIST. I SUGGESTED COLD COMPRESS WILL DO THE JOB. I HAVE TAKE A PICTURE OF RASH INCASE ANY ONE INTERESTED
58 y.o. male PMH obesity, fibromyalgia, hypertension, sleep apnea on CPAP, chronic respiratory failure, dermatomyositis with interstitial lung disease on immune suppression, depression.    Today, he mentions that he noted SOB which started about 3-4d ago progressively worsening with increased O2 needs. Associated symptoms include inspiratory chest pain and notable work of breathing, no cough, reported "fever" 99.7F, chills, occasional abdominal pain, decreased appetite, increased LE edema, skin changes w/ "splotches" on his hands similar to past admissions w/ flares w/ associated pain on his fingernails. Denies recent sick contacts, n/v, diarrhea, cough, congestion, cp. No treatments tried at home including his inha lers as he does not feel they are helpful. Does not think that his recent prednisone taper has been an issue but instead that his IVIG is wearing off. Closely follows w/ both Pulm and Rheum outpt for his Dermatomyositis w/ associated ILD.   Saw Rheum yesterday in which he states that his breathing was better than it is today however, worse than his baseline. During this visit he was advised to continue his tacrolimus, continue his 10mg  Prednisone per day, restart IVIG 150g per month in 2 dived doses, continue cylophosphamide cycle 6 of6 on 2/17.   Uses 3.5L O2 at home w/ 5Lw/ activity. Uses CPAP at night. Uses a walker at home. Regular care and PCP at the VA. No smoking or regular alcohol use. Denies history of blood clots. He is not interested in talking to palliative medicine during this admission.
initially tested positive five days ago; initially tested positive five days ago; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 23Mar2021 as dose 1, single (Lot number: ER2613), in right arm at the age of 56 years, on 13Apr2021 as dose 2, single (Lot number: EW0153), in left arm at the age of 56 years, on 03Nov2021 as dose 3 (booster), single (Lot number: FF2593), in right arm at the age of 56 years and on 26Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FU9893) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "DVT", start date: 2004 (unspecified if ongoing), notes:not on blood thinners, now. The patient had no any known allergies. Concomitant medication(s) included (in 2weeks): ACYCLOVIR [ACICLOVIR], start date: 12Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03May2022, outcome "unknown" and all described as "initially tested positive five days ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I retested positive; (03May2022) Positive, notes: I initially tested positive five days ago. Therapeutic measures were taken as a result of covid-19 with Paxlovid.
Positive Covid test; Positive Covid test; This is a spontaneous report from a non-contactable consumer (patient).   A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced positive covid test via Nasal Swab, on 27Aug2021 with outcome of recovering. The patient did not receive any treatment for the event. No covid prior vaccination.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Today (Day 9 after shot) I have redness (approximately 2-3 inches all around injection site) .  It feels warm to the touch.  Does not hurt.  Until today I have had no problem.  Need advice as far as receiving 2nd shot.
ON OXYGEN 24/7; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced on oxygen 24/7. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from on oxygen 24/7. This report was non-serious. This case is a duplicate of 20221212212.
Tiredness, headache, chills, low grade fever, injection site swelling, injection site bruising, nausea, feeling unwell, arm pain
Pt received vaccine in evening; next day had fever 100 - 102 lasting for 3 days, injection site swelling and nausea.
Information has been received from a pharmacist referring to a 50 year old patient of unknown gender. On an unspecified date in August 2008 the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot 13834, no expiration date available, national drug code (NDC) 0006-4739-00, dose and route unknown). On an unspecified date in September 2009 the patient received the second dose of PNEUMOVAX 23 (lot 0468X, expiration 26-JUN-2010, NDC 0006-4943-00, dose and route unknown) in less than indicated time interval (inappropriate schedule of drug administration). No adverse effects was reported. The pharmacist stated the patient indicated for PNEUMOVAX 23 by past medical conditions including but not limited to chronic obstructive pulmonary disease (COPD). Lot number 13834 and 0468X are invalid lot numbers for PNEUMOVAX 23. Additional information has been requested.
3-14-12 Patient received immunization around 4 pm. Left center, returned around 530 on 3-14-12. Mother states as they were walking down the street. Child started sneezing and look around eyes was swelling. Given BENADRYL IM 6.25 mg IM.
Flu-like symptoms while in bed. Fever, sweating, nausea, fatigue which lasted from midnight till morning.
We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursion; Product Storage Error; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursion), PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursion), PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursion), PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursion) and PRODUCT STORAGE ERROR (Product Storage Error).    No concomitant medication was provided by the reporter  It was reported that Moderna product was stored in the fridge and experienced multiple warm excursions. Data shows the vaccine was below 36F for a total of 166 hours. The minimum temperature reached was 31.658 F. The vaccine was above 46F for a total of 67 hours. The max temperature reached was 50.234 F.  No treatment medication was provided by the reporter.
Muscle aches , Joint aches, cold sweats, chills,  Stomach Pain, Diarrhea
Patient left facility after vaccination (nurse) requested her to wait for 15 minutes- Mom reported "she was driving" and taking daughter out for breakfast"- returned to clinic one hour later-reportedly "CP, radiating to back, dizzy, and H/A- B/P 158/82 HR 96- patient denies dizziness at this time- reportedly ate a large breakfast after vaccinations, mom calling primary care provider Dr. - advised mom if CP would need to have her checked out in ER or Dr Office- patient did not faint- reports "feels better now, just has H/A".
At work(Nurse), I started feeling nervous, lightheaded, weak, sweating and my chest was pounding. I sat down and the symptoms did not subside. I stood up and stumbled to the door to get help, blacked out and fell into a wall. Was told I was unconscious for ~20 minutes, very pale/grey, very sweaty, irregular breathing, very tachycardic. A respiratory therapist put a pulse oximeter on me and my oxygen saturation was in the low to mid-80s, they applied an oxygen cannula. Taken to ED by hospital's code team, IVs placed, fluids given, CT scan, EKG, labs drawn. While recovering, I had uncontrollable shaking and shivers. Start of event to time of ED discharge ~3.5 hours.
Pain and discomfort that evening, applied ice, everyday after the pain got worse to the point I couldn't lift my arm or use it in any way without pain.
6NOV @ 1930 teaching aeorobics had abdominal cramps-severe-mild abdomen for using on rt side now & rt side sore fatigue;
pt recv vax & 1 day post vax no adverse event had occurred @ that time;16SEP97 pt exp tenderness @ the inj site;pt recovered;
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that vial was placed in refrigerator on 06-Dec-2021.  Treatment information was not provided.   This case was linked to MOD-2022-448109, MOD-2022-449524 (Patient Link).
1800 on 17FEB94, pt began screaming x 5 hrs; would not stop, fever 99; mom phoned MD no treatment & not seen by MD;
1st dose: 24 hrs after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explore; 1st dose: 24 hours after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explor; 1st dose: 24 hours after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explor; This is a spontaneous report from a contactable self-reporting other health professional.  A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686), intramuscularly on an unspecified date in Jan2021 at 13:00  (at the age of 36-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included anaphylactic reactions to penicillin and pistachios. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was administered to the patient in a hospital. The patient reported that twenty-four hours after administration she developed a searing migraine that lasted for approximately fifteen hours. She stated that "no medications could touch the pain" and it felt like her brain and eyeballs were going to explode.  The patient specified that she did not receive any treatment for the events. The clinical outcomes of migraine, sensation of pressure and eye discomfort were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
fever 102.5 for 4 days, then gradually lowered, chills, aches and pains, on 5th day extreme pain in my right side of face, cheek and especially one tooth.  Infection in tooth roots and cheek, had emergency root canal and two rounds of antibiotics for infection.  Face/cheek on right side continue to feel noticeable pain and sensitivity daily.  Dentist has suggested I have trigeminal neuralgia with no problems with this prior to the vaccine or any problems with teeth.  Will be seeing a neurologist regarding this issue.
Initially I only had pain at the injection sit but then the next evening my left arm starting hurting and it was a shooting pain down to my hand. This has continued for two days. On Wednesday I began having chest pains on the left side that intensify when I lean forward.
Headache sweaty, chills Reports headache, sweaty, chills. Affecting work day.
Extreme arm pain with diffuse swelling, redness extending from injection site to elbow.  Hot to touch with itching,  lasting 4 days.
I had both vaccines in the Pfizer series. #1 on 2/7/21 and # 2 on 2/28/21. On 3/30/21 I tested positive fir COVID.
RECEIVED PFIZER-BIONTECH MONOVALENT (NDC 592-1025-04) INSTEAD OF INTENDED BIVALENT (NDC 59267-0304-02)
Pt was 46 years old with Doctor's order. Vaccine label use for 50 years and older. No adverse event occurred other than age.
Complaints of itchy sore throat, numbness and tingling to left cheek, was taken to the ER for further assessment
3/22-3/25: extreme fatigue, pain at injection site, body aches, congestion, elevated pulse 3/30: one inch red circle emerged 8 days after vaccine. By day 10 the circle is now 3 inches in diameter. Possible ?Covid arm ?.
Patient presented to the ER at  Hospital with nausea, vomiting, and tremors that developed 12 hours after vaccination. Was treated with Zofran and released.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Received Hep A immun. 7/23/07. C/O pain left arm, can't lift arm x 2 days (48 hrs). Flu symptoms, fever, headache, tiredness, body aches x 2 days.
Pt had vaccine at 9:28 AM. Went home, went for a walk, not feeling well, had chills, fever 101 degrees, nausea, wife thought he was having heart attack, took to E.R., no high blood pressure, ran EKG pt. seems OK now. ER thought this was reaction to vaccine.
Site warm, firm erythematous mild ascending weakness to legs & arms neck pain back pain nausea HA.