chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was initially stored in the refrigerator on 06-Oct-2022 and was administered on 07-Nov-2022; No adverse event; Expired dose was given after the 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 06-Oct-2022 and was administered on 07-Nov-2022), EXPIRED PRODUCT ADMINISTERED (Expired dose was given after the 30 days) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     It was unknown if the patient ever had been diagnosed with or tested positive for COVID-19. It was unknown if the patient had acute illness at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.  Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) for an unknown indication.    On 07-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose was given after the 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 06-Oct-2022 and was administered on 07-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 06-Oct-2022 and was administered on 07-Nov-2022), EXPIRED PRODUCT ADMINISTERED (Expired dose was given after the 30 days) 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 EXPIRED PRODUCT ADMINISTERED (Expired dose was given after the 30 days) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 06-Oct-2022 and was administered on 07-Nov-2022).    Prescriptions, over-the-counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of adverse event was reported as unknown.  On 26-Feb-2021, patient received dose 1 (0.5mL), batch no.- 010A21A.  On 26-Mar-2021, patient received dose 2 (0.5mL), batch no.- 016B21A.  On 18-Nov-2021, patient received dose 3 (0.25mL), batch no.- 076C21A on left arm.  On 09-May-2022, patient received dose 4 (0.25mL), batch no.- 056M21A on left arm.  On 07-Nov-2022, patient was administered a Bivalent Moderna vaccine from a vial of size 2.5mL with a fridge BUD of 05-Nov-2022 (removed from freezer and put in fridge on 06-Oct-2022). The vaccine was punctured and used.  The vial was in fridge for 32 days.  Patient had reported no issues and was just waiting to hear back about re-vaccinating.  The vial was individual vial and had not undergone any temperature excursions.
A pt (age not reported) rec'd an injection of Acel-Imune on an unspecified date. Following vaccination, the pt developed a small reddened area at the injection site.
This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (Blood work showed low platelets) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (Blood work showed low platelets). At the time of the report, PLATELET COUNT DECREASED (Blood work showed low platelets) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) On an unknown date, Platelet count: Low and normal. Prior vaccination the patient went for physical exam and his blood work showed low platelets and he never had low platelets before. Doctor told patient to come back with in one month for a recheck and on unknown date  blood work showed normal platelet levels. No treatment medication provided by reporter. No concomitant medication provided by reporter.
Patient is a 59 year old caucasian female with a PMHx of HTN, MI in 2008 and chronic heartburn that presented approx. 30 minutes post-vaccination with constant midline chest "tightness" without radiation. Patient describes the discomfort as 7/10 in severity. Patient denies shortness of breath, palpitations, nausea, diaphoresis, heartburn, abdominal pain, numbness or tingling, lightheadedness or dizziness and recent illness or fever. On evaluation, patient was visibly anxious and crying with heart rate of 108. States she has a cardiac history to include myocardial infarction in 2008 with 20% blockage. Reports prior history of similar chest pain following an influenza vaccination over 20 years ago and has not had another immunization since then. Patient reports no change in chest pain over course of evaluation and no improvement or worsening with position.   Vitals: BP (initial): 152/86mmHg seated BP (follow-up): 150/82mmHg seated HR (initial): 108bpm HR (follow-up): 93bpm RR: 18 SO2: 99% on room air  Patient was hooked up to cardiac monitor and found to be in sinus rhythm with a heart rate range of 93-108.   On exam, patient was A&Ox3 with appropriate affect in no acute distress and no signs of obvious injury.  Patient flushed without diaphoresis.  Tachycardic to 108bpm with normal sinus rhythm. No JVP appreciated.  Radial and posterior tibial pulses intact, strong and equal bilaterally. Normal respiratory effort without obvious distress.  Lungs clear to auscultation bilaterally without wheezing, rales, rhonchi. No stridor appreciated.
rash that looked like "pin point freckles on chest stomach and arms" that is "not itchy"; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient had no concurrent condition, concomitant medication or medical history. Drug reactions / allergies  were unknown.     On 28-MAY-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, lot# and expiration date were unknown) via subcutaneous for prophylaxis. On an unknown date, the patient experienced a rash that looked like pin point freckles on chest stomach and arms that was not itchy. On 13-JUN-2019, the patient came to pharmacist presenting the event. Treatment was given for the event. The outcome of the event was reported as not recovered/not resolved. The reporter considered the event to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II). Medical attention was sought.
didn't feel so well; woke up feeling clammy; fever; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201, Expiry date: unknown, at the age of 70-year-old), dose 1 via an unspecified route of administration, administered in Arm Left on 17Feb2021 13:30 as dose 1, single for covid-19 immunization. Medical history and concomitant medications reported as none. No additional vaccines administered on same date of the Pfizer suspect. It was reported as none for prior vaccinations (within 4 weeks), AE(s) following prior vaccinations, patient's medical history, family medical history relevant to AE and relevant tests. The patient experienced fever on Feb2021. Caller says 5 days after, I woke up clammy. not sure if I had a fever or not. I take over the counter pain med for various reasons. Yesterday I had a fever low grade. I took Advil for fever. no fever this morning, but after 16 hours later, a fever again. Caller asking if this could be related to the vaccine. The patient experienced didn't feel so well and woke up feeling clammy on an unspecified date. The caller was calling about the Covid vaccine, Pfizer. The caller got it 12 days ago. The caller had a fever yesterday, she woke up and didn't feel so well, she popped some Advil, she takes a lot of over the counter medications like Advil and Tylenol when she needs it, not every day, but she does take it regularly. She took the Advil and felt fine. The caller felt a little funny, she had a temperature of 99.5, which is strange for her, her temperature never was over 99. The caller took Advil at 6:00 last night, went to sleep, woke up this morning and she didn't have a fever, was awake, then the fever came back. Is there any way that this shot could cause low grade fevers. The patient takes a lot over the counter pills so its possible she has had this fever and did not know. Its only been 11 days. It could be that 5 days after the shot she got a new bed, she slept on it and woke up feeling clammy, like maybe she had a temperature. The patient is not going through mesopause so it was not that. The patient may have taken her temperature, she was not sure. May be she took Tylenol or Advil, she does not know. May be she was having low grade fevers, she does not know. The patient's fever was resolved last night and now its back again. Time the Vaccination Was Given: 1:30 in the afternoon. Patient did not visited to any Emergency room or Physician's office. Therapeutic measures were taken as a result of fever, didn't feel so well. The patient underwent lab tests and procedures which included body temperature: 99.5. The clinical outcome of event fever was not recovered and other events was unknown.  No follow-up attempts are possible. No further information is expected.
For 24 hours had fatigue, fever, nausea, diarrhea, lost of appetite, soreness in shot arm, and dizziness
Left upper arm red, swollen, painful, itches. Started the evening of receiving the shot and was still red and swollen when patient came into office on 5-26-10.
p/vax pt exp mild varicella w/ten pox on the trunk of body & 7 on the back;MD visit required;
Extremely sore arm, muscle aches, headache, slight nausea, fatigue.  Onset 12 hours after administration.  Effects lasted for 3 days despite round the clock Tylenol dosing.
Pneumonia viral; Vomiting mucus; Cough; Vomiting; Chills; Body aches; High fever of 101°F; Fatigue; A spontaneous report was received from a consumer concerning a 64 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, body aches, high fever, fatigue, cough, vomiting mucus, vomiting, and pneumonia.  The patient's medical history was not provided. The patient had allergic to ciprofloxacin, shellfish, soy, and levofloxacin. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: Batch number not provided) on 18 Feb 2021, prior to the onset of the symptoms via an unknown route in the left arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021 evening patient experienced chills, body aches, & a high fever of 101°F and fatigue. On 19 Feb 2021 patient had a cough, vomiting and was vomiting mucus. On 20 Feb 2021 patient took a Covid-19 test, which was negative.  On 21 Feb 2021 patient was treated with azithromycin. On 21 Feb 2021, patient was diagnosed with viral pneumonia.  On 24 Feb 2021 chest X-Ray was performed.  Action taken with the drug in response to the events were not reported.  The outcome of the events chills, body aches, high fever, fatigue, cough, vomiting mucus, vomiting, and pneumonia were unknown.; Reporter's Comments: This case concerns a 64 Y/O F with a serious unexpected event of pneumonia viral, and nonserious unexpected secretion discharge, cough, and expected vomiting, pyrexia, chills, fatigue, myalgia.  Event onset the same day as first dose mRNA-1273. Treated with azithromycin. Event outcomes unknown. Based on 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.
Began swelling at injection site right arm 24 hr post injection red approximately 12 x 12 cm subsequent vesiculobullous eruption consistent with local herpes type reaction (foster).
Bleeding at injection sight.  Pain began the next day and increased with each subsequent day.  Pain makes arm hard to raise and move especially at work and during getting dressed and undressed.  Also having muscle twitching in legs.  Pain and coldness in arm caused me to seek medical advise from my physician on 10/28.   His diagnosis was Hematoma.  If pain does not abate will seek second opinion.
2 days following the vaccination I started scratching all over my body  Then my, eyes were itching so much I removed my make up  That number gut felt hot and itchy Next day still itching so informed GP I noticed now that my skin is blotchy and pink/  red on my  arms and chest  Eyes sore and worn / tired looking  Feel hot but no one emperature Temperature was 37.1 now 36.9 BP 125/75 p 67  Thank you
COVID R arm; Sore R arm; Itchy R arm; Redness R arm; Rash over R arm; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (COVID R arm), PAIN IN EXTREMITY (Sore R arm), PRURITUS (Itchy R arm), VACCINATION SITE ERYTHEMA (Redness R arm) and RASH (Rash over R arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to atropine). Concomitant products included ATENOLOL, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and AMPICILLIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DERMATITIS ALLERGIC (COVID R arm), PAIN IN EXTREMITY (Sore R arm), PRURITUS (Itchy R arm), VACCINATION SITE ERYTHEMA (Redness R arm) and RASH (Rash over R arm). At the time of the report, DERMATITIS ALLERGIC (COVID R arm), PAIN IN EXTREMITY (Sore R arm), PRURITUS (Itchy R arm), VACCINATION SITE ERYTHEMA (Redness R arm) and RASH (Rash over R arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Information has been received from a registered nurse concerning an 18 year old female with a history of cardiac murmur who on 07-APR-2009 was vaccinated with the first dose of GARDASIL (lot # 661952/1129X), IM, 0.5ml.  There was no concomitant medication.  On 09-APR-2009 the patient experienced a rash that appeared and disappeared all over her body after receiving GARDASIL.  The nurse described the rash as similar to mosquito bites in appearance but not raised or pruritic.  The nurse stated that after reporting this incident she received lab results  for the patient that were drawn on 07-APR-2009 and the patient was positive for syphilis.  She stated that the physician assistant believed the rash was from the syphilis and not the GARDASIL injection.  At time of the report the patient was recovering.  The patient sought medical attention by office visit.  Follow up information has been received from the physician assistant who stated that the rash was not raised or red.  The patient's RPR (rapid plasma regain) screening test for syphilis was positive.  The TPPA (Treponema pallidum particle agglutination assay) confirmatory test was positive with an assigned titer level of 1:64, which was considered high.  The patient was placed on V-CILLIN K, one dose weekly for three weeks.  Additional information has been requested.
MMRV and Varicella were given at the same time. PA, Health Dept. and Mom were all notified. Mom was told to call if child displays any unusual symptoms.
like he is getting sick almost; This is a spontaneous report from a contactable consumer (patient's grandchild). A 90-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 10Jan2021 (Batch/Lot Number: EJ1686) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included calcitriol; carvedilol; clopidogrel; empagliflozin; ezetimibe; fluticasone propionate (FLONASE); and vitamin D3, all taken for an unspecified indication, start and stop date were not reported; it was also reported that the patient takes twenty other unspecified medications. The reporter stated that the patient got his first vaccine. He was doing good. He is supposed to get the second one. On 29Jan2021, he has all kind of side effects. He has a medical condition, but this was like he is getting sick almost on 29Jan2021. The patient took some medicines. One was a pain relief, kind of like of Aleve. Another one he took was Robitussin. The reporter was calling to see if the patient should get the second one or not. The outcome of the event was not resolved.
Patient reports feeling  "sides" of tongue numbness for 2nd dose; tongue felt numb in front of tongue for 1st dose.  C/o dizziness. Checked and monitored by EMT until no further symptoms.
This spontaneous report as received from a nurse practitioner via a company representative refers to a patient of unknown age. On an unknown date, the patient vaccinated with a single dose of PNEUMOVAX23, intramuscularly or Subcutaneously (start date, strength not provided). While at medical forum nurse practitioner stated their practice had a patient with pain and swelling at injection site after receiving PNEUMOVAX23. The outcome of the events were unknown. Additional information has been requested.
Redness at site of vaccine on left thigh the evening post vaccination (4/28/03). Redness enlarged over next 48 hours. Seen at office on 05/01/03. Area of redness coveres 17 x 15cm with minimal tenderness.
2 days after vaccine I woke up and my lips were severely swollen. I believe this is related to the Juviderm lip filler I got about 21 days before the vaccine.  I was first advised to try benadryl.  - it had no effect Then I was advised to try Zyrtec - it had no effect Then I was prescribed methyl prednisilone (6 days) - it had only a very minor effect Then I was prescribed lisinopril (10mg / 10 days) - it also only had a very minor effect. It has now been 31 days and I still have some swelling, in addition to that in a couple of places the Juviderm is now 'hard' like a ball.
This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with an incorrectly stored dose of PROQUAD injection, lot # R017799 with expiration on 13-DEC-2019 (dose, and route of administration were not reported) for prophylaxis, reconstituted with sterile diluent (MERCK STERILE DILUENT) injection (strength, dose, frequency, route of administration, lot number, expiration date and indication were not reported). On unknown dates, the vaccine underwent a temperature excursion of -14 to -10 degrees Celsius over the period of 19 minutes. Digital Data logger was not involved in the recording of the excursion.
Still breaking out with psorias; This is a spontaneous report from a contactable consumer, the patient and nurse. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 52-year-old) as 2nd dose, single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ, Manufacturer: PFIZER LABS; Formulation: oral solution), oral from an unspecified date (Batch/Lot number was not reported; Expiration Date: 30Jun2023) to an unspecified date, at 5 mg, twice a day for arthropathic psoriasis. The patient's medical history and concomitant medications were not reported. The patient previously took morphine and experienced morphine (0.5mg/ml P-F) and had drug allergies. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unspecified date for covid-19 immunisation. The patient stated she's has been fully vaccine for COVID 19, and still breaking out with psoriasis, meds haven't cleared it up yet. MD aware. The outcome of the event was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Itching at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at site of injection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching at site of injection). At the time of the report, VACCINATION SITE PRURITUS (Itching at site of injection) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Company Comment  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. Further information has been requested
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left 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: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: ENBREL, start date: 01Feb2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19; negative, notes: negative antigen test; Positive, notes: positive antigen test. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: Return of Covid symptoms and positive antigen test after completing Paxlovid and having negative antigen test. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient received pfizer vaccine that was stored for 72/70 days in refrigerator. no adverse effects reported.
Child suddenly jerked away his arm as needle penetrated left deltoid muscle. Some vaccine sprayed out of the needle into the air.  Upon visual inspection by RN, approximately 95% of the vaccine appeared to remain in the syringe.  RN unsure of how much was sprayed out of the syringe and into the air. Guardian requested new vaccine administration in right deltoid. New vaccine with exact same lot number and expiration date  drawn up and administered in right deltoid, per guardian request.