chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started having symptoms on 01/20/2023 with mild cough, nasal congestion and shivering. I noticed when I coughed, I had pain in my abdominal area. I was having pain in my liver. I seen my provider and prescribed PAXLOVID 5 day supply. Then a week later I had rebound COVID-19. Same symptoms but worst. I did have follow up labs.
This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with all three doses of GARDASIL or GARDASIL 9. On an unknown date, the patient reported that she had unspecified health issues ever since being administered the GARDASIL series of vaccines. The outcome of the events were unknown. Additional information has been requested.
No Adverse event. On 11/03/2021 the Vaccine Refrig data logger showed a temperature excursion occurred on 10/29/2021 at 10:48 a.m. of +50.7 (F). The timeframe documented is 13 mins with n 5 min alarm notification totaling 18 min. The vaccine providers were not aware that the vaccine needed to be used within a 24 hour timeframe of the excursion prior to discussion with an authority on 11/3/2021. A clinic was scheduled for Moderna Booster doses at a High School for their employees for 11/1/2021. This clinic did occur with the Moderna Vaccine with Lot # 076C21A between the hours of 3:00-5:00 p.m. A total of 16 people received Moderna Booster shots 0.25ml.  The vaccine provider learned on 11/3/2021 in conversations with the health department that due to the excursion, the vaccine should be discarded if not used within 24 hours of the temperature excursion. With the instructional education provided via the health department, all remaining doses of Moderna with Lot# 076C21A was wasted.
At 4 am on Sunday I woke up with chills, severe body aches, a fever off and on thorough out the day, extreme fatigue. I treated with Tylenol on a strict schedule and that helped everything minus the headache. This morning I woke up fine but this afternoon my arm felt hot and looked down and noticed a bright red rash that?s 4 inches in width and about 1 inch tall on my arm. Since noticing it has not gone down in size but maintained. My arm is swollen at the injection site as well as extremely warm and somewhat painful.
A day after I got the vaccine, I got hives on my chest. Sort of an allergic reaction.
INAPPROPRIATE AGE AT VACCINE ADMINISTRATION (ADMINISTERED TO UNDER THE AGE OF 18); OFF LABEL USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: 1855191, expiry: 11-APR-2022) dose was not reported, administered on 26-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-NOV-2021, the patient experienced inappropriate age at vaccine administration (administered to under the age of 18). On 26-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration (administered to under the age of 18) and off label use was not reported. This report was non-serious.
15 mins after injection pt felt nauseated then falling to the ground struck the R frontotemporal area. Mom states-was pale and clammy and loss consciousness for 5 seconds. No tonic clonic reactions. Of note has had 3 previous vasovagal episodes and a single partial complex seizures.
Patient received dose #2 of Pfizer vaccine on 6/7/2021 vaccination services and was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Affiliated Physicians re-administered dose on 6/14/2021 as recommended. No adverse reactions identified on site.
Suddenly went into afib, shortness of breath, throat was tight for a short time, body felt cold inside, shaking inside
First night 5/4 exhaustion and headache.  Following morning 5/5 exhaustion, headache, pain/lump at injection site. All over muscle and joint pain. By late afternoon fever of 100.3. 5/6 lingering exhaustion. Temp went back to normal early morning hours. Injection site lump with redness, pain, hot to the touch growing. 5/7 Injection site pain, redness, hot to the touch have spread farther along upper arm.  Pain not muscle soreness, feels more like a deep painful bruise. All other symptoms have subsided.
Began vomiting at 1:00 am, 12 hours after vaccination. Vomited every 30 mins. Swallowing water also triggered vomiting. After 8 hours, lower back pain and headache began. Arrived at emergency room around 2:00 pm for fluids and medication. discharged after about 3 hours feeling heavily fatigued and much more hydrated. Slept 11 hours, no nausea, persistent mild lower back pain.
Information has been received from a pharmacist and a registered nurse concerning a patient who on an unspecified date was vaccinated with PNEUMOVAX (Lot# 660717/0224X) and developed injection site reaction. The pharmacist   stated that the reactions included joint pain and immobility and were "over and beyond soreness". The pharmacist reported that he was not sure if it was the first or the second dose for the patient. A lot check has been requested by the registered nurse. Follow up information was received via a telephone call from the registered nurse (R.N.) who reported that the patient did not go the the emergency room and was recovering (95% recovered)/ A standard lot check for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. Additional information ahs been requested.
History of Present Illness: This is a 63-year-old Female Patient with a history of B-cell lymphoma presents to the ED with progressive weakness and stroke like symptoms. She states that her weakness has gotten increasingly worse since she got her 1st Covid shot about 1 month ago, and progressed to R sided hemiparesis.  She has not received the 2nd shot per oncologist recommendation.  She has been worked up for right arm weakness. She states she has seen an ophthalmologist for  trouble with her vision.  She had an MRI of her brain the beginning of June which was unremarkable. She developed dysphagia and has a feeling of something stuck in her throat, she also developed facial droop so she presented for further evaluation and treatment.  Assessment:  63 Y.O female with a history of B-cell lymphoma presents with progressive weakness that worsened after her 1st covid vaccine. She has developed facial droop and R sided hemiparesis. Plan:  Acute medical Problem Generalized weakness/ stroke like symptoms Chest X-ray, CTA head and neck, and brain MRI unremarkable PT/OT/ST eval and treat Neuro checks  6/3/2021 DX : Paired Brachial veins is partially thrombosed
LEG SWELLING; This spontaneous report received from a consumer concerned a female 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced leg swelling. The action taken with covid-19 vaccine  was not applicable. The outcome of leg swelling was not reported. This report was non-serious.
3 days after vaccination abrupt appearance of non elevated plaques left ankle where several months ago, she had a non displaced fibula fracture. Mildly pruritic. No spread. No fever, No buccal mucosa involuntary.
2 inch x 2 inch hard nodule & swelling left deltoid area. 2" x 1" area of redness over nodule with yellowish bruising above the redness.  Area warm to touch.  Symptoms noticed the next morning after receiving injection, 9/29/07.  Area observed today 10/01/07.  No increase in symptoms since 9/29/07.  Ibuprofen 400 mg. given.  Told to ice area at least twice a day until swelling down.
Before shot pt expressed her fear of needle stating she wasn't going to look.. I gave her the shot place the Band Aid.. pt then slumped forward and blacked out for a few second.. she came around  we offered BENADRYL .. her dad came in gave him BENADRYL to go and informed to seek medical attention.
Severe Arm Pain and Rash at Injection Site on Left Arm.  Rash appeared morning after shot.  Over next 24 hours, rash has gradually increased and become more painful.  Rash is raised on arm.
Vaccination given by RN. Right arm upper tricep area with erythematous caused cellulitis 6 x 3 cm warm to touch.
fever of 102 for 2 days unrelieved by Tylenol, nausea, malaise
Large circular rash at site of injection which has worsened since time of injection. Shingles like rash on torso that developed in the 2 days after injection. Pt has not yet seeked treatment but will see PCP 9/11.
I've had both doses. I had shingles/suspected vaccination failure; dose 2, some soreness in the injection site/dose 1, some soreness in the injection site; had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), injection site pain and shingles. On an unknown date, the outcome of the vaccination failure, injection site pain and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, injection site pain and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 6-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both doses of Shingrix vaccine for shingles and had shingles. The patient had no side effects, some soreness in the injection site, that's it. The patient stated that you did not want them, get vaxxed. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Postural tachycardia to 130?s, resting heart rate usually 65
Diagnosed with COVID after first vaccine; Diagnosed with COVID after first vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with COVID after first vaccine and wanted to know if the patient could take the second dose afterwards. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19  and suspected LOE  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, previous drug reactions, allergies, concurrent conditions and concomitant medications was not provided. On 26-SEP-2018, the patient was vaccinated with the first dose of GARDASIL 9 injection. Lot number N020139 and expiration date 14-FEB-2020 (frequency, route and anatomical location of vaccination were unknown). On 04-MAR-2019, the patient was vaccinated with the second dose of GARDASIL 9 injection. Lot number R010596 and expiration date 11-DEC-2020 (frequency, route and anatomical location of vaccination were unknown) and on 02-APR-2019 was vaccinated with the third dose of GARDASIL 9 injection. Lot number R010596 and expiration date 11-DEC-2020 (frequency, route and anatomical location of vaccination were unknown). All for prophylaxis. No adverse effects were reported.
Anemia; doses 2 and 3 were given after the beyond use date; doses 2 and 3 were given after the beyond use date; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 10-month-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Mar2023 as dose 3 (maroon cap), single (Lot number: GK1667) at the age of 10 months intramuscular, in left thigh for covid-19 immunisation. The patient's relevant medical history included: "Patent Ductus arteriosus" (unspecified if ongoing); "Atrial septal defect" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1 (MAROON CAP), SINGLE, Anatomical site of injection: Right Thigh, Route of administration: Intramuscular, Batch/Lot number: FT9142), administration date: 22Apr2022, when the patient was 1-day-old, for COVID-19 Immunization, reaction(s): "Overdose", "Inappropriate age at vaccine administration", "GER"; BNT162b2 (DOSE 2 (MAROON CAP), SINGLE, Anatomical site of injection: Right Thigh, Route of administration: Intramuscular, Batch/Lot number: FT9142), administration date: 06Jan2023, when the patient was 8-month-old, for COVID-19 immunization, reaction(s): "1st dose: 22Apr2022; 2nd dose: 06Jan2023", "doses 2 and 3 were given after the beyond use date", "doses 2 and 3 were given after the beyond use date"; fluzone (DOSE 2, SINGLE, Manufacturer: Sanofi, Batch/Lot#: UT7716LA, Route: IM, Anatomical site of injection: Left thigh, No. of previous doses: 1), administration date: 06Jan2023, when the patient was 8-month-old, for Influenza immunisation; Fluzone (DOSE 1, SINGLE), for Influenza immunisation. The following information was reported: ANAEMIA (non-serious) with onset 03Mar2023, outcome "unknown", described as "Anemia"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 03Mar2023, outcome "unknown" and all described as "doses 2 and 3 were given after the beyond use date".  Additional Information: The patient did not experience any adverse event(s) as a consequence of the error.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300150037 same reporter, product, different patients and event;US-PFIZER INC-PV202300113800 same reporter, vaccine, patient, different dose and event;US-PFIZER INC-202300234323 same reporter, vaccine, patient, different dose and event;
Itchy arms and chest. No hives or bumps.Benadryl 25 mg, PO given.
I received my 3rd dose of Moderna on 08/24/2021. I got COVID-19 infection on 02/16/2022 in the afternoon at 4:00PM. I had a headache, congestions in my nose, upset stomach, and tickle in my throat. Throughout the night and the next day I wasn't feeling well. I knew something was wrong. so, I did a COVID-19 home test on 02/17/2022 at 4:55PM the test was positive. I called one of my primary care's office and they told me I can come over to the office. On 02/18/2022 I went to my doctor's office they COVID-19 test that day. My COVID-19 test was positive. They prescribed me with albuterol, azithromycin for 5 day only if my situation got worse. I didn't the antibiotic I only used the inhaler as per needed. I took over the counter vitamin C. On middle to end of April before my 4th dose and after getting COVID-19 infection I noticed that my heartrate started to go up. This is what caught my attention. I get my blood work done every 3 months due to my health conditions. On 06/07/2022 When I got the result of my blood test with my HIV doctor I told him that I wasn't feeling good. My red blood cell count was 3.82, Hemoglobin was 12.03, Hematocrit  was 35.09. All these 3 groups were low. I started taking IV infusion because I was feeling so bad. On 07/01/2022 I went to get my IV infusion done the nurse asked me how I was feeling so I told her I wasn't feeling well. At this time my blood vessel burst on my face, arm, hands, around my right ankle. I did a blood panel at my doctor's office my red blood cell count had come up to 4.25, white blood cell count was 17.5, Hemoglobin 12.09, Hematocrit 39.09. They haven't figure out why my blood vessels are bursting as of today. I never had this kind of problem before. I didn't even change my medications everything is the same routine not sure what is happening. This is from 07/01/2022 my neutrophils absolute was 14.1 cut off was 7, Monocytes absolute was 1.04 and the cut off was 0.9. Absolute Granulocytes was 0.2 cut off was 0.1, Irion panel was low at 29 cut off at 38 (low), Uibc 366 which was high   cut off was 343. Iron saturation was at critical low at 7% low cut off 15. Ferritin level was low at 28 reference level was 30-400. I never had this kind of problem for over 20 years. This happened all of a sudden.
Rash in his armpit; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash in his armpit) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (DECONGESTANT II) for an unknown indication.    On 12-Mar-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 RASH (rash in his armpit). The patient was treated with PREDNISONE for Allergy, at an unspecified dose and frequency. At the time of the report, RASH (rash in his armpit) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-356213 (Patient Link).
Sore arm; fatigue day 2 to 3; dizziness day 2 - current; vertigo day 5 to current; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 14:00 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included Peripheral polyneuropathy and allergies to vicodin, tuna, basil and yeast. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN) and pregabalin (MANUFACTURER UNKNOWN), both for unknown indications from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 09:00 the patient experienced sore arm, fatigue on day 2 to 3, dizziness from day 2 to current and vertigo from day 5 to current. Therapeutic measures were taken as a result of sore arm, fatigue, dizziness and vertigo and included treatment with valium meclizine. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event fatigue was resolved on 24Mar2021 (day 2 to 3) and for events pain in arm, dizziness and vertigo was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous prospective pregnancy report was received from the patient's friend regarding a pregnant female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient became pregnant. On an unknown date, the pregnant patient (gestation unspecified) was vaccinated with VARIVAX for prophylaxis (dose, route and lot# were not reported (exposure during pregnancy). The LMP (Last Menstrual Period) and EDD (Estimated date of delivery) was not known.
Temperature excursion; No Adverse event; Received these vaccines post excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) 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. 049D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2022, 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 09-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion) had not resolved and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) 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 POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion).    No concomitant medications were reported. The nurse reported that, there was temperature excursion on 01-Nov-2022 in the refrigerator. At the time of excursion, the vials were in refrigerated storage. It was individual vials and vial size was unknown.The patient received the vaccine post excursion and remaining vials were discarded.  The maximum or minimum temperatures reached at time of excursion was minimum 34.8 F (Fahrenheit) and maximum at 42.49 F for 14 Minutes duration. The vials were moved from freezer to refrigerator in less than 30 days. On visual inspection vials were in normal state. No treatment medications were reported.