chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4487007-00.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 20Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis", start date: 2007 (unspecified if ongoing); "Tobacco User", start date: 1994 (unspecified if ongoing); "abstains from alcohol" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LEFLUNOMIDE taken for rheumatoid arthritis; ATENOLOL taken for blood pressure abnormal; BENAZEPRIL taken for blood pressure abnormal; ATORVASTATIN taken for blood cholesterol abnormal; AMLODIPINE taken for blood pressure abnormal. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Positive, notes: positive covid-19; (11Aug2022) Negative, notes: Covid-19 swab test of nasal and throat negative result for Covid-19; (22Jul2022) Positive, notes: Positive Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Reported eye swelling on 11/1/16. Noted fluid pockets above and below both eyes. No relief with Zyrtec. On 11/8/16, temp was 99.1 with c/o diarrhea. On 11/29/16, she had a fall, and was noted to have confusion and weakness. This progressed into bilateral weakness with some bladder and bowel incontinence. Was unable to walk or transfer by herself. Confusion and weakness continued. Was seen in 2 emergency depts., and by primary MD. Symptoms started to resolve on 12/22. MD office called on 12/26 to report flu vaccine is listed as allergy now d/t weakness and cognitive decline.
Pt. received 2 Moderna vaccinations as ordered, ended up with covid + requiring monoclonoATB IV
Moderna EUA Pt started having left leg pain, discoloration (blue-purple) and swelling on 3/9/2021. Pt went to the hospital and was later called to come back to the hospital because she had a blood clot. Pt was sent to clinic and had a procedure by to remove clots. Pt states that the clot was "2/3 size of thigh." Pt states that she is scheduled to have a second procedure in May to remove blockages from iliacs.
HiB Pedvax HIB given early at 6 mo mark versus 15 month mark.  No adverse reactions noted.  No treatments given.
Pain, and swelling of lft. arm, and hand. Some numbness, and tingling sensation in both lft. and rt. hands. Lingering numbness, tingling, and pain in lft hand. On day of 04/29/21. Level of pain scale 1-10. An eight (8). Some body stiffness the morning of 04/29/21.  All events happened day(s) after vaccinated. Took day of work next day 04/28/21.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: she said she had mild scratchiness, slight swelling of tongue previously w the 2nd covid vaccine, which went away w benadryl without further issues. same happened again this morning, pt was not concerned and wanted Moderna. after 5 minutes, slight swelling of tongue, gave her 2 tablets of 25mg Benadryl, feeling better right away, totally fine after the 30 min wait time. called her again in the evening and she said she is perfectly fine.
First day I became very shaky and feeling off not right. Second day I woke up to the worst ever headache, neck pain , upper back and lower back pain, left wrist and ankles in pain, and i became extremely drowsy not able to stay awake. Third day, Lower back pain was bad, and ankle swelling some and painful. Fourth day painful in the kidney or lower lung made me feel like i could not breathe when breathing in. I have right wrist pain. This so far as it is still going on. Sorry the part about the breathing happened on the second and third day.
Patient received second herpes zoster vaccine, reported signs of herpes simplex on right shoulder. No issues. Patient gets this reaction outbreaks occasionally since 18 years of age.
Patient was schedule for vaccines on 2/27/20 and was briefed/screen and sent for urine HCG testing which came back negative and so patient was given 4 vaccines - Anthrax, Typhoid, Japanese Encephalitis and Smallpox. Few days after the vaccines were given the patient performed a home pregnancy test which was positive and so the patient went to medical center  on 3/11/20 for follow-up appointment where she was sent for a HCG Quant blood test which result as 1007.86 mIU/ml (H). Pt was seen in Health Clinic at 0900am 3/12/20 and was schedule to see the OB intake nurse at Health Clinic at 10am 3/12/20 where she will be referred and given an appointment to be evaluated and tracked at the OB health Clinic.
Pt noted onset of dizziness 5/28/04, 1 day after receiving Hep A #2, Hep B #1, rabies PCEV #1, Which gradually abated over the following 1-3 weeks. Rabies PCEV #2 was given 6/3/04 without exacerbation of Sx. 6/29/04 received hep B #2 and rabies #3, felt worse afterwards with complaints of nausea, lightheadedness.
arm pain; Body ache; joint pain; Fever; Chills; muscle pain; headache; nausea; A spontaneous report was received from a medical assistant who is a 43 year old, female patient who experienced fever, body ache, chills, muscle pain, joint pain, arm pain, headache, and nausea.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On 02 Jan 2021, approximately 15 and a half hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 037K20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   The patient reported that she received the vaccine on 02 Jan 2021 at  08:30 AM, at midnight, she experienced fever, body ache, chills, muscle pain, joint pain, arm pain, headache, and nausea. Symptoms were still present when reported the next day. Treatment for the event included paracetamol (2, 500mg) on 03 Jan 2021.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.   The outcome of the events, fever, body ache, chills, muscle pain, joint pain, arm pain, headache, and nausea was not known/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
she thought she had an ear infection; patient looking at lot number, stated that her eyes are bad; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 52-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in the left arm high up in the muscle, at age 52 years, on 04Mar2021 18:00 (Batch/Lot Number: EN6205; Expiration Date: 30Jun2021) as 1ST DOSE, SINGLE for COVID-19 immunisation as she did not want to get COVID. Medical history included hypothyroidism and chemical allergies from unspecified dates so she was  nervous to get the COVID shot. There were no concomitant medications. There were no additional vaccines administered on same date of the Pfizer suspect. Prior vaccinations within 4 weeks was none. Patient reported that she received the first dose of the Pfizer COVID-19 vaccine on 04Mar2021 at 18:00, she got the shot in her left arm, high up in the muscle. Then, stated that last Sunday (14Mar2021) she started feeling symptoms and then tested positive last Tuesday on 16Mar2021 for COVID. Symptoms started with stomach, diarrhea thing and it was like wow what is going on, the symptoms are mild as far as COVID goes. She had a fever for a day and a half from an unspecified date. Patient stated she used paracetamol (TYLENOL 500mg) the night she got the vaccine and the morning after (total of 1000 mg) by mouth. The AEs did not require emergency room or physician office visit. Patient stated she made it a year and got the vaccine and then got COVID. Patient stated thank goodness nothing really happened. Patient really didn't think the symptoms, like from watching commercials it lists you can have all this and think you would have everything and she thought she had an ear infection on an unspecified date. When patient was looking at the lot number, she stated her eyes are bad from an unspecified date. She also stated that she can't be the only person that has gone through this, she knows she isn't. Patient stated her friends got the MODERNA vaccine and they didn't say anything and just went and got their 2nd dose and she was just trying to do the right thing here and is not holding for much longer. She wanted to know if she should go back for her second dose scheduled on Thursday (25Mar2021). The outcome of the events was unknown.
muscle pain with both doses; This is a spontaneous report from a contactable consumer or other non hcp.    A 56-years-old male patient received first and second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that her 56-year-old husband (patient) had complaints of muscle pain with both doses of the Pfizer Covid-19 vaccine on an unspecified date. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Significant swelling in left arm down to elbow and slightly into chest. At vaccination site pt described as the size of a lemon. Also experienced chills and fever last night. No report of hives or difficulty breathing.
15 minutes after Jansen COVID vaccine, patient complaining of being hot and began wheezing. SPO2 of 91 when wheezing. Unable to get a BP read. Patient taken to ED via wheelchair.
Moderna 3/3/21, 3/31/21, 12/16/21, 8/3/22. Positive on 12/14/22
Chills, exhaustion, whole body achiness, headache, upset stomach, redness at injection site, pain at injection site.
pt recv vax 4NOV95 & exp a large local rxn of redness & swelling @ inj site, body aches, & a h/a;pt has recovered;
pt recv 2 doses of vax & lab eval revealed a positive core & positive surface antibody;lab eval prior to vax revealed a neg core;no further details were provided;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 4:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 4:06 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 28.25.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 20-Mar-2021, At excursion time 09:00 AM, temp was 34, at 10AM temp was 37, total doses given for the day was 184, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were moved to clinic. Vaccine date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 PM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Red bright spots all over body; Itchy; red bright spots coming all over and bumpy on the skin line; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red bright spots all over body), PRURITUS (Itchy) and SWELLING (red bright spots coming all over and bumpy on the skin line) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced RASH MACULAR (Red bright spots all over body), PRURITUS (Itchy) and SWELLING (red bright spots coming all over and bumpy on the skin line). At the time of the report, RASH MACULAR (Red bright spots all over body), PRURITUS (Itchy) and SWELLING (red bright spots coming all over and bumpy on the skin line) outcome was unknown.
ADMINISTRATION OF EXPIRED VACCINE WHOSE VIAL WAS PUNCTURED AT 8:30 AM STORED IN THE REFRIGERATOR AND THEN ADMINISTERED APPROXIMATELY AT 3:20 PM (7 HOURS AFTER PUNCTURE, 50 MINUTES PAST EXPIRATION); This spontaneous report received from a health care professional concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 14-SEP-2021 15:20 for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021, the patient experienced administration of expired vaccine whose vial was punctured at 8:30 am stored in the refrigerator and then administered approximately at 3:20 pm (7 hours after puncture, 50 minutes past expiration). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine whose vial was punctured at 8:30 am stored in the refrigerator and then administered approximately at 3:20 pm (7 hours after puncture, 50 minutes past expiration) was not reported. This report was non-serious.
brick in her stomach; headache; very sore arm; severe stomach cramps; vomited; diarrhea; stomach ache; A spontaneous report was received from a concerning female patient of 68 years old, who was administered with Moderna's COVID-19 vaccine for prophylaxis of COVID-19 infection.  On 22-FEB-2021, the patient was administered with a first dose of mRNA-1273 vaccine. The patient's medical history was allergies as provided.  Concomitant medications were not provided.  The adverse events such as headache, very sore arm, stomach pain and vomiting were experienced on 19-FEB-2021.On 20-FEB-2021, patient felt diarrhea all day and was recovered on the same day.  The treatment for the adverse event were: For the symptoms: Kaopectate for the stomach symptoms and Advil for the headache. Other: Vascepa, Prozac, Synthroid, Trazodone, Seroquel, baby Aspirin and Effient, provided by the patient.  Action taken with the dose of mRNA-1273 vaccine was not reported. Consent to follow up from safety was provided by the patient.
Started with stomach pain that continued to increase. Went to E.R. After variouse test found a blood clot near stomach in vein.
I received the shot as one requirement of becoming a volunteer with Hospital.  I also received the TDAP shot at the same time, in the same arm (right).  Since that time I have had persistent pain in my right deltoid muscle, during activities that engage that muscle.  I have seen my personal physician who has prescribed physical therapy.  I've had 4 massages which have not helped.  The pain affects daily tasks that require lifting or pushing actions with my right arm. I have fairly good range of motion still in that arm, but when downward weight is applied to my arm the pain is evident.  It's been almost 6 months since the shot, and the muscle pain has not abated.  I would like to know if there is a strategy or treatment that will relieve the pain.  I cannot afford to have an MRI.
chills, muscle aches, joint pain, fatigue, dizziness, lightheadedness, irritability, injection site pain Administered Tylenol 1000mg and Tramadol 100mg Fell Asleep
Injection site is really warm; Large red spot; Almost like an allergic reaction; A little bit of dizziness; Injection site is itching really bad; Injection site is a little bit swollen; Injection site was really red; A knot at the injection site that was kind of hard; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (A knot at the injection site that was kind of hard), VACCINATION SITE WARMTH (Injection site is really warm), ERYTHEMA (Large red spot), HYPERSENSITIVITY (Almost like an allergic reaction) and DIZZINESS (A little bit of dizziness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy and Gastritis. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, BIOTIN for Vitamin supplementation, AMLODIPINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced VACCINATION SITE MASS (A knot at the injection site that was kind of hard) and MYALGIA (Soreness). On 03-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is really warm), ERYTHEMA (Large red spot), HYPERSENSITIVITY (Almost like an allergic reaction), DIZZINESS (A little bit of dizziness), VACCINATION SITE PRURITUS (Injection site is itching really bad), VACCINATION SITE SWELLING (Injection site is a little bit swollen) and VACCINATION SITE ERYTHEMA (Injection site was really red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Itching, at an unspecified dose and frequency. On 27-May-2021, VACCINATION SITE MASS (A knot at the injection site that was kind of hard) and MYALGIA (Soreness) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site is really warm), ERYTHEMA (Large red spot), HYPERSENSITIVITY (Almost like an allergic reaction), DIZZINESS (A little bit of dizziness), VACCINATION SITE PRURITUS (Injection site is itching really bad), VACCINATION SITE SWELLING (Injection site is a little bit swollen) and VACCINATION SITE ERYTHEMA (Injection site was really red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products also included centrum silver.  Patient said that after using Benadryl cream, it kind of went away but she currently has an ice pack on it with some gauze.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30-Jun-2021, included fax number was updated and no new information was recorded
After 10 hours after receiving Influezea vaccine, patient complained of confusion and Temp of 103. Treated in ER with Tylenol and observation. Regained coherence and normal temp within 3 hours.
A very small amount of vaccine appeared to dribble out of patient's arm post-vaccination. The patient received more than 1/2 the dose, so patient was not revaccinated per previous manufacturer guidance.
Headache; metallic taste when drinking; diabetic/blood glucose at 875 and A1C greater than 15; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2, administered in arm left, administration date 08Apr2021 14:30 (Lot number: EN6955) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "R/Arthritis" (unspecified if ongoing); "Ankyloding spondylitis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Nitro, reaction(s): "allergies". Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: EN6240; Arm Left; 02:45 PM), administration date: 08Mar2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: HEADACHE (prolonged hospitalization, life threatening) with onset 16Apr2021 12:15, outcome "not recovered", described as "Headache"; DYSGEUSIA (prolonged hospitalization, life threatening) with onset 16Apr2021 12:15, outcome "not recovered", described as "metallic taste when drinking"; DIABETES MELLITUS (prolonged hospitalization, life threatening) with onset 16Apr2021 12:15, outcome "not recovered", described as "diabetic/blood glucose at 875 and A1C greater than 15". The events "headache", "metallic taste when drinking" and "diabetic/blood glucose at 875 and a1c greater than 15" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood glucose: (16Apr2021) 875; glycosylated haemoglobin: (16Apr2021) greater than 15. Therapeutic measures were taken as a result of diabetes mellitus. Clinical course: Headache, metallic taste when drinking with led to him in the ER with blood glucose at 875 and A1C greater than 15. He was not a diabetic before this and now he is. Now he has to take insulin. Vaccine received during existing hospitalization.