chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine was initially refrigerator on 11-May-2022; Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022) and PRODUCT STORAGE ERROR (Expired vaccine was initially refrigerator on 11-May-2022) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     No Medical History information was reported.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was initially refrigerator on 11-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022) and PRODUCT STORAGE ERROR (Expired vaccine was initially refrigerator on 11-May-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial did not undergo any temperature excursions.  No treatment medication information was provided.
White blood cell count decreased; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LEUKOPENIA (White blood cell count decreased) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Patient has been cancer free since 04-Apr-2008.) from 2006 to 04-Apr-2008. Concurrent medical conditions included Scoliosis and Anxiety. Concomitant products included DIAZEPAM for Anxiety, MAGNESIUM, ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN, VITAMIN D NOS and LEVOTHYROXINE SODIUM (SYNTHYROID) for an unknown indication.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced LEUKOPENIA (White blood cell count decreased) (seriousness criterion medically significant). At the time of the report, LEUKOPENIA (White blood cell count decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, White blood cell count: 3.0 to 3.1k (Low) 3.0 to 3.1k. On 23-Jul-2021, White blood cell count: 3.4k (Low) 3.4k.         No treatment information was provided.  Patients white blood cell count has been around 4100 since her cancer treatments were completed.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of breast cancer and use of concomitant medication are contributory factors to the event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of breast cancer and use of concomitant medication are contributory factors to the event.
Dramatic increase in sinusitis symptoms.  Coughing and some sore throat.  Started within 24 hours of receiving the 2nd dose.  1st dose 4 weeks earlier had no symptoms afterwards.  Symptoms worse than usual when having episodes of sinusitis.  Symptoms continue with no relief after 4 days.
I just don't have as much energy; Tiredness since 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I just don't have as much energy) and FATIGUE (Tiredness since 2nd dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included THYROID and VITAMINS NOS for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced ASTHENIA (I just don't have as much energy) and FATIGUE (Tiredness since 2nd dose). At the time of the report, ASTHENIA (I just don't have as much energy) and FATIGUE (Tiredness since 2nd dose) outcome was unknown.            No Treatment was reported by the reporter.   This case was linked to MOD-2021-227761 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up received on 18-jun-2021 had Non significant follow up appended
Injection given on 9/17/07; on 9/18/07 - pt developed redness, swelling and tenderness to touch (size of 1 1/1 silver dollar) on area where shot was given. On 9/19/07, area had enlarged (baseball sized) with golf ball size induration in center. Warm and tender. Pt also developed fever.
Received J&J on 4/8/21 and 11/17/21. hospitalized for bacteremia and complicated UTI, was discharged to the nursing home with 7 day course of Rocephin .Apparently she has been having shortness of breath.  On 1/20/21 she tested positive to COVID 19.  On 1/21/22 she was brought to the ED due to worsening shortness of breath. In the ED patient was noted to be hypoxic placed on BiPAP currently on 40% FiO2. There is some concern about COVID-19 pneumonia patient was started on a remdesivir and Decadron.  Also started on empiric antibiotic.  Lasix was used due to concern about slightly elevated BNP and diastolic congestive heart failure Patient was started on Decadron which lead to significant elevation in blood sugar, despite increasing her doses of insulin.  Since patient was off oxygen for last 3 days, Decadron was discontinued due to serious side effect. Patient's back to baseline.  She is advised to go on a CPAP every night.  Discussed with husband.  Husband was going to drop the CPAP machine at nursing home. I return multiple information the chart to make sure that PCP follows the blood sugar closely in case patient developed problem with the hypoglycemia. Appropriate detail instructions return in the discharge. Discharged on 1/28/22.
Patient was administered the Pfizer COVID-19 vaccine on 4/17/21 at the Health Department according to VIIS; previously the patient received the Moderna COVID-19 vaccine on 3/27/21 at the Clinic. Patient received 2 different products of COVID-19 vaccine.
Approximately 30-45 minutes after vaccine, became tachycardic, tachypneic, and experienced generalized uticaria. Hives/welts noted on neck, chest, and stomach.  Felt short of breath with a rapid heart rate and lightheaded.  Went to nearest Urgent Care for evaluation.  Vital signs monitored. Received decadron and Benadryl IM, along with PO Pepcid.  Remained at Urgent Care until stable. Discharged home with Rx for predisone to take as needed if rebound symptoms occurred.
On March 29th I had a heart attach without any blockage and they believe it was a heart spasm.
itchy skin, pink spots in a circle, and then after a few days it was a red blotch and itchy went t o the Dr he prescribed an ointment and allergy medication
Left deltoid red, swollen, warm to touch. Had hematoma palpable @ injection site. Patient already on antibiotics. Rx spider bite
Began vomiting, fever 102; Seen by MD, advised to continue APAP, clear liquids for 1 day;
Pt complained of malaise and swollen red gums at time of visit. Pt states fever got up to 104 degrees but at time of visit on 04/19 temp 96.4 degrees F. Pt also experienced slight itching - treated with Benadryl. Also given xylocaine mixed with water to gargle for gum pain.
My foot left foot swelled up, I am taking water pills to reduce the swelling.  Had an ultrasound for blood clots in my leg which came back negative.
armpit swelling and pain.; armpit swelling and pain.; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AXILLARY PAIN (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "armpit swelling and pain."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diarrhea; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is 3rd of 3 reports. A female patient of unspecified age received first dose of BNT162B2 (COMIRNATY, Solution for injection) via unspecified route of administration as single dose for COVID-19 immunization. The patient's medical history and concomitants were not reported. On an unspecified date the patient experienced diarrhoea. The outcome for the events was unknown.  No follow up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130627 similar report from same reporter
Around the site of injection, patient had developed chickenpox like skin rash with blisters and reddening of the skin. RPh recommended patient to contact her primary MD ASAP.
Possible delayed injection-site reaction appeared 7 days after receiving first dose of Moderna COVID-19 vaccine (IM injection received 1/05/2021, reaction occurred 1/12/2021-1/14/2021). No unusual symptoms noted in the first 6 days following the first dose, aside from minor pain normally associated with vaccine injections. On day 7 (1/12),  I noticed a red, slightly inflamed circle expanding out from the injection site to about 2 inches diameter.  The site was was slightly painful and hot to the touch (almost like a moderate sunburn), and grew about a half-inch over day 8 (1/13) before starting to dissipate on 1/14/2021. No other associated symptoms.
2 WEEKS POST ADMINISTRATION OF SMALL POX IMMUNIZATION, PT DELEVOPED BLISTERING RASH ON HANDS, ELBOWS, INSIDE ARMS, ANKLES, AND TORSO.
Immediately after injection (within 5 minutes) I was shaky and short of breath.  I recovered within few minutes.  Minor Anaphylaxis?
Mom noticed a swelling of the area, it increased in size & redness. Next morning whole are was swollen.
8/20/2007 Patient presented in office with hive type rash to lt anterior lateral thigh, warm to touch. Mother reports that it is spreeding. Refered to PCP who gave Depomedrol 40 mg IM to follow with Benadryl. Mother presented in office 8/23/2007 reports that patient is better.
Patient stated his arm was very sore and weak Wednesday evening after receiving the vaccine; he went to workout and could barely lift anything. Patient also stated his arm was red at the injection site and that the red area consistently kept getting larger. Patient came to pharmacy Friday to let pharmacist working know; red area on arm was ~3"x3" - 4"x4". Pharmacist working called a nurse practitioner in town to consult and to see if she would see the patient since Dr. was out of office. Patient declined seeing the nurse practitioner stating he would be fine. Pharmacist working suggested topical lidocaine or an antihistamine which patient refused; pharmacist then suggested ice over the injection area where it was red as well as some ibuprofen. Patient said he would do ice and ibuprofen; as of Saturday, have not heard back from patient regarding treatment outcomes.
Purple dots on left upper arm near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Purple dots on left upper arm near injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Purple dots on left upper arm near injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Purple dots on left upper arm near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications were provided
I experienced pain in my left side. Tenderness in both arms and left leg. Redness and pain of the skin on my chest and on top of both feet. If I stay in hot for more then 10 minutes my whole body hurts.
Information has been received from a nurse practitioner, who was told by one of her own patients, concerning a 15 year old female patient who is not a patient in her office, in late June 2008 was vaccinated with the first dose of GARDASIL at a pediatrician office. In mid July 2008, the patient experienced severe headaches, muscle weakness, neurological disorders and autoimmune issues. The reporter stated that the patient had out patient neurological tests done and she was currently experienced seizures. The HPV vaccine was discontinued. As of 23-FEB-2008, the patient had not recovered. The patient sought medical attention with a physician. Upon internal review seizures was considered to be an other important medical event. Additional information has been requested.
Patient received an unauthorized 2nd bivalent booster as she was under 65 and did not have any immunocompromising conditions.  She has not had any adverse reactions since the date of administration.
approx 16 hrs p/vax-fever 104 going through noc despite adequate APAP;
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown demographics. On an unknown date an unspecified number of patients may have received PEDVAXHIB. The PEDVAXHIB was exposed to 47 F for 4 hours. No adverse effects were reported. No PQC was filed. The case is linked to 1405USA011939, 1405USA011937 abd 1405USA009508 (same reporter link). Additional information has been requested.
Narrative:  COVID infection following COVID vaccine series 04/12 Janssen, dose #1 08/08 pt cc: chills, fatigue, fever, headache, myalgias, rhinorrhea, diarrhea exposure: unknown 08/09 COVID swab, result: detected 08/10- 08/12 pt symptoms continue
SORENESS AND REDNESS (APPROX 5 IN DIAMETER AROUND INJECTION SITE) CONTINUING AFTER 3 1/2 DAYS SINCE ADMINISTRATION.
Fever 99.9f, arm soreness, malaise; Fever 99.9f, arm soreness, malaise; Fever 99.9f, arm soreness, malaise; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), Intramuscularly on 21Dec2020 11:45 AM in left arm at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at hospital. Medical history included COVID prior vaccination. Concomitant medication in two weeks included minerals nos, vitamins nos (PRENATAL VITAMINS), probiotics, levothyroxine. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever 99.9f, arm soreness, malaise on 22Dec2020 04:00 AM. The patient received paracetamol (TYLENOL) as treatment. The outcome of events was unknown.
High fever over 100F that continually clears somewhat during the day and comes back every evening and night.
Arthritis; crohn's disease; Unexpected therapeutic benefit; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, subcutaneous for crohn's disease. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 04Dec2019, outcome "unknown", described as "Unexpected therapeutic benefit"; CROHN'S DISEASE (medically significant) with onset 04Dec2019, outcome "unknown"; ARTHRITIS (non-serious), outcome "unknown". It was reported that patient had unexpected benefit, where Humira helped Arthritis a freckle and Crohn's symptoms. The action taken for adalimumab was dosage permanently withdrawn.  The reporter causal assessment between events "crohn's disease" and "unexpected therapeutic benefit" and BNT162b2 was possible. The reporter's assessment of the causal relationship of "arthritis" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. 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.
red circle around injection site. Some swelling/tender to touch - right arm. Very small reaction/redness in left arm from other vaccine.
Nausea 132/80, HR 62, O2Sat 96%, BS 142 Pt. reported feeling better, left site.  Patient was informed by EMS if patient still has symptoms to call 911 or primary care, understanding verbalized.
Breakthrough case admission after two vaccines Moderna 8/26/21 Lot# 005C21A;  Moderna 9/23/21 Lot#005C21A
Patient came in today on 1/17/22 indicating that the pfizer booster vaccine she received on 1/3/22 resulted in an injection site reaction with swelling and redness as well as radiating pain down her left arm as well as in her shoulders and neck. She went to her doctor on tuesday 1/11/22 and was given tramadol, methocarbamol and meloxicam for the pain. She was also given a steroid shot in the office on 1/11/22. When she came in today, the injection site was slightly red and looked swollen, and she was complaining that she cannot even lift her arm and is also having trouble sleeping at night due to the pain. She did mention the steroid shot seemed to help but wore off after a few days. I offered to call the doctor's office to see if they can prescribe a steroid pack and they did send one to pharmacy which is closer to the patient's home. I called the patient and made sure she was aware of the steroid rx and she said she will pick it up and was thankful for the follow up. I asked the patient to register with smartphone based tool and report her reaction and informed her we will be reporting to vaers as well.
Having what felt like a heart attack and ended up in the hospital for 4 days went home everything thing was fine but got admitted to the ICU  again for 5 days on 05/23/2021. ECG kept changing and issues in lungs. Followed up on June 9th had to get IV fluid in the office went and saw PCP on the 10th and all of her numbers shot back up so she got 2 different shots in the office. CRP was 700. Has a follow up on July 2th.
horrible case of the flu; Initial information received on 18-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced horrible case of the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site as prophylactic vaccination. Information on batch number has been requested.  On an unknown date the patient developed a non-serious horrible case of the flu  (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, Last flu shot gave me a horrible case of the flu so you can keep it thanks.  Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event (horrible case of the flu ).  At time of reporting, the outcome was Unknown for the event horrible case of the flu.
First day: lethargy all day.  Second day, 2-28 starting c 10PM got the shivers and shakes,, had trouble standing.  Lasted c  one and a half hours.  I lay down, it finally stopped
Pt started having nausea and then had difficulty breathing and hyperventilating. Pt was transported by EMS.
A few minutes after vaccine was administered, patient moved to the waiting room and we heard a bang from the waiting area. We looked over to see patient slumped over and seizing. My technician called 911 and I put a cool compress on his neck and he started to come to. The seizure stopped but the patient was still feeling lousy. I had him lay down with his knees elevated until the EMT's arrived
On March 24th, I awoke from sleeping to a thunderclap headache, 6/10 pain. I tried to treat the pain with Tylenol and benadryl, but it wouldn't go away. I also developed visual aura of zig zag lines on my peripheral vision. I presented to the ER on March 26th, and they did an MRI. MRI showed multiple bilateral strokes. My hospitalist stated I should report it to VAERS.