chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEVELOPED BLOOD CLOTS; This spontaneous report received from a patient 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 ad26.cov2.s (suspension for injection, route of admin was not reported, and batch number: Unknown, expiry: Unknown ) dose was not reported, 1 in total, administered on 16-SEP-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 16-SEP-2021, the patient took the covid shot and developed blood clots and now patient had to take Xarelto. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of developed blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210933744-COVID-19 VACCINE AD26.COV2.S.- Developed blood clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jul2022 as dose 4 (booster), single (Lot number: FH2908) at the age of 51 years, 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 was not reported. Concomitant medication(s) included: IBUPROFEN; ZYRTEC ALLERGY; FLONASE [FLUTICASONE PROPIONATE]; MUCINEX; ROBITUSSIN DX. Past drug history included: Known allergies: cipro, reaction(s): "Drug allergy"; Known allergies: zithromax, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown"; COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Paxlovid treatment start date was 01Aug2022 and stop date was 06Aug2022.  No follow-up attempts are possible. No further information is expected.
Well patient, in for well child care. Pt held breath then had syncopal episode shortly after vaccines had been given. Recovered quickly, normal exam.
Feet skin dry and my head dry also; Rash on my chest, back, arms, legs and hands; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 55-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0171) via an unspecified route of administration in left arm on 24Apr2021 at 09:00 AM as 2nd dose, single for COVID-19 immunization. Patient previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP7533) via an unspecified route of administration in left arm on 04Apr2021 at 08:00 AM as 1st dose, single for COVID-19 immunization. Medical history included blood cholesterol and COVID 19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. On 29Apr2021 at 04:00 PM, patient experienced small red rashes only back after a week my hole chest, my back, legs, my arms get a really bad rash and my hands are very dry and my feet also and my head dry also. Can you contact me and let me know what can I do please. I been like this 30 days. Patient treated with Medroll 16 mg 2 a day. Since the vaccination, patient had not been tested for COVID-19. The outcome of the events was not recovered.    Information on Lot/Batch number was available. Additional information has been requested
Heavy menstrual bleeding, quarter sized clots, loss of appetite, high fever, headache, tingling in left arm and both legs, tiredness, confusion, random bruising. Most symptoms lasted for a week and a half. Still having issues with menstruation.
PATIENT RECEIVED BOOSTER VACCINE DOSE EARLY. 2ND DOSE (MODERNA) WAS GIVEN ON 9-16-21. NO ADVERSE EFFECTS WERE REPORTED TO HAVE OCCURRED. PATIENT WAS SPOKE TO ON 1-12-22 WHEN THE ERROR WAS IDENTIFIED.
Vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 17-Apr-2023; No adverse event; Bivalent Moderna vaccines that expired on 15-Apr-2023 and was given to one patient on the 17-Apr-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccines that expired on 15-Apr-2023 and was given to one patient on the 17-Apr-2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 17-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) on 12-Feb-2021, Moderna COVID-19 Vaccine (Dose 2) on 13-Mar-2021 and Moderna COVID-19 Vaccine (Dose 3) on 19-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 17-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccines that expired on 15-Apr-2023 and was given to one patient on the 17-Apr-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 17-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccines that expired on 15-Apr-2023 and was given to one patient on the 17-Apr-2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 17-Apr-2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccines that expired on 15-Apr-2023 and was given to one patient on the 17-Apr-2023) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 17-Apr-2023).    No concomitant medications were reported. Vial was initially stored in the refrigerator on 16-Mar-2023. Vial did not undergo any temperature excursions. Patient had not reported any adverse reactions to the vaccine. No treatment information was provided.
sore arm with insomnia Narrative:  sore arm with insomnia  Other Relevant History:
Received MMR vaccine on 4/23/10 in back of LEFT upper arm; approx. 5 days later noticed small rash on LEFT forearm (not vaccine admin. site); rash progressed over 2 wk. period to become a raised itchy, blistering lesion approx. 2 in. in diameter; healed to leave a dark pigmentation, treated with Bactrim ointment, and oral antibiotics, later KOH slide taken and treated with antifungal cream.  Part II of vaccine administered on 5/21/10 in back of upper RIGHT arm, similar 1 inch lesion appeared 10 days later on RIGHT forearm, treated with antifungal cream. Twelve days after part II of vaccine, administered, another lesion appear on the border of the healed lesion on LEFT forearm. UNSURE IF RELATED TO VACCINE BUT EXPERIENCE OCCURRED AFTER ADMINISTRATION OF VACCINE IN BOTH ARMS.
pt recv vax 27NOV95 & 5JAN98 pt exp chickenpox & was seen by MD;it was reported that pt had approx 25 lesions when seen in office;
"sore shoulder" (injection site) after 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA ("sore shoulder" (injection site) after 1st vaccine) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified (Patient had two Open Heart surgeries) and Lupus syndrome. Concomitant products included LOSARTAN, METOPROLOL, HYDROXYCHLOROQUINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), FUROSEMIDE and IRON for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ARTHRALGIA ("sore shoulder" (injection site) after 1st vaccine). The patient was treated with HYDROCODONE for Pain relief, at a dose of 1 dosage form and IBUPROFEN for Pain relief, at a dose of 800 mg, 2 tabs every four hours. At the time of the report, ARTHRALGIA ("sore shoulder" (injection site) after 1st vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Arthritis: elevated (High) elevated inflammation - arthritis test extremely high. On an unknown date, Blood test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-110157 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: No new information added; Sender'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. Further information has been requested.
MY smart watch told me that my heart rate was 158; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (MY smart watch told me that my heart rate was 158) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (MY smart watch told me that my heart rate was 158). At the time of the report, HEART RATE INCREASED (MY smart watch told me that my heart rate was 158) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Erythema, softball size swelling, warmth. Treatment: Diphenhydramine MG, methylprednisolone.
The day after vaccination, the patient started having numbness in the opposite arm as the shot. He did not report anything at that time because he didn't think it was a result of the vaccination since it was not in the arm that he got the vaccine. He just had a nerve conduction study done and there is nerve damage in that opposite arm where he once had a rotator cuff injury. The doctor told him that he thinks the vaccine aggravated his old injury somehow even though it was in the other arm. The doctor told the patient he has seen the vaccine even aggravate old leg injuries. The doctor said it will heal with time.
Left arm started feeling numb and ticklish, both legs below knees; Left leg felt prickly; Weakness in my left leg; Dizzy; Numbness in my lip and face, jaw; Something in my throat; Fatigue; Past the 42 day range, not received the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), HYPOAESTHESIA (Numbness in my lip and face, jaw), OROPHARYNGEAL DISCOMFORT (Something in my throat), HYPOAESTHESIA (Left arm started feeling numb and ticklish, both legs below knees) and PARAESTHESIA (Left leg felt prickly) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the 42 day range, not received the 2nd dose). On 25-Mar-2021, the patient experienced DIZZINESS (Dizzy), HYPOAESTHESIA (Numbness in my lip and face, jaw), OROPHARYNGEAL DISCOMFORT (Something in my throat) and FATIGUE (Fatigue). On an unknown date, the patient experienced HYPOAESTHESIA (Left arm started feeling numb and ticklish, both legs below knees), PARAESTHESIA (Left leg felt prickly) and ASTHENIA (Weakness in my left leg). At the time of the report, DIZZINESS (Dizzy), HYPOAESTHESIA (Numbness in my lip and face, jaw), OROPHARYNGEAL DISCOMFORT (Something in my throat), HYPOAESTHESIA (Left arm started feeling numb and ticklish, both legs below knees), PARAESTHESIA (Left leg felt prickly), ASTHENIA (Weakness in my left leg), PRODUCT DOSE OMISSION ISSUE (Past the 42 day range, not received the 2nd dose) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information or concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Followup received on 29-June-2021 and contains significant information
Dry mouth, sore throat, piercing headache, spinal pain, chills, cold symptoms; start 1/2 hour after injection with duration of one week. General weakness following day.
chills; shaking; joint aching; soreness; her left arm is extremely sore and hurts; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     NO medical history information was reported.     On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts). At the time of the report, CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     NO medical history information was reported.     On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts). At the time of the report, CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  No treatment details were reported.
3 days rash, blotchy face, upper chest, upper arms, fever, highest t102, & chills; skin feels warm, sl cough w/watery red eyes & photophobia, joint discomfort & large lymph nodes; Seen in ER;
Diarrhea, rash, inconsolable crying, 10 days after MMR. Note: Had 2 pt with similar symptoms, same lot#. Treatment: Supportive care.
Approximately 24 hours after receiving the vaccine, the child complained to his mother of severe pain and swelling to which she monitored and thought nothing of it. The very next day, June 16, 2021 her son lifted his shirt to show her the area he felt was swollen to which she saw excessive swelling on his axila, arm and breast area on the side of the injection site. She took him to see his primary physician who prescribed ibuprofen, a Medrol dose pak and an epipen. Her son is at home being monitored. He was started on the ibuprofen to some relief. She is waiting to begin the dose pak until tomorrow morning 06/16/21.
Swollen shoulder & arm down into armpit Redness around arm at shoulder  Trouble lifting arm, cannot lay on it Headache and fuzzy headed
When here for 12-15 mo shots states that last time here in Nov, pt had 103 fever and that has had after each set of shots. Had not told nurse prior to this.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 16-NOV-2015 at time- 17:10, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.1 and 2.3 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Received an expired dose of the Moderna booster, after 30 day Use By Date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna booster, after 30 day Use By Date) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna booster, after 30 day Use By Date). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna booster, after 30 day Use By Date) had resolved.            No concomitant medications were reported.  No treatment information was provided. It was reported that the pharmacy, they said it may be a typo or someone put the manufacturing date instead.
patient states that immunization was not given in the muscle and was given higher in the shoulder. accoring to her pcp patient states that it hit a nerve and she does not have full range of motion in her arm since
Upon checking in to our vaccinatin clinic on 8/12/21 with parent, this 17 year old was looked up in the database to discover that a Moderna Vaccine was entered in by pharmacy with an administration date of 1/29/2021.  Parent and patient denied receiving this Moderna vaccine and presented to our clinic to receive a Pfizer vaccine.  Clinic staff took the work of the parent that the child did not receive the Moderna vaccine and there must have been an entry error, so Pfizer dose 1 was administered.  On 8/13/21 writer called pharmacist and confirmed the patient did receive a Moderna vaccine on 1/29/2021 at their pharmacy.
Information was received from a physician concerning an 18 month old female who on 15-MAR-2007 (also reported as April 2007) was vaccinated with a dose of Proquad (Oka/Merck upgrade process), lot number 656445/1482F. Concomitant therapy included amoxicillin which was to treat an upper respiratory infection which was present at the time of vaccination. It was reported that "on 01-MAY-2007 the patient developed a varicella like rash that was spreading fast, all over her body that look like bug bites". The doctor requested VZV analysis. Unspecified medical attention was sought. The patient's medical status was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
worse headache, neck pain, bodyache, chills, sweats, jaw pain, nausea, upper body rash, dizziness, lightheaded, insomnia,
dx henoch-schonlein purpura secondary to vax;pt recvd vax 23AUG95 & 25AUG95 devel severe urticaria, tx w/DPH & Ibuprofen @ home;26AUG95 sever swelling of hands & feet, t100.5;27AUG95 10AM fever, spiked to 104.6 & later 105;pt hospitalized;