chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have fast heartbeat, my heart is just beating fast; Feeling sick, It is not making me feel good right now; she said that she is feeling weird/ I didn't feel like this was normal, this is weird; Feels like falling over; I think she is experiencing dizziness; Don't feel like to go back to take the other one because this one is making me feel sick, it is not making me feel good, feel like I need to go to the emergency; This is a spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, (Batch/Lot Number: Unknown, Expiration date: Unknown), dose 1 via an unspecified route of administration on 12Jun2021 11:00 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Stated, she was calling was because she wants to know what to do after getting the first dose since she was feeling some adverse reactions, on 12Jun2021 at 11:00 she said that she was feeling weird and feels like falling over, so she think she was experiencing dizziness but she have not got any information from her because she refused to provide. Stated, Yes she have fast heartbeat, her heart was just beating fast and she start feeling sick but normally people say that the second dose was supposed to make her feel sick on 12Jun2021 at 11:00. Why was the first dose doing this? Can you just take one of them then she do not think she was going to take the second one then. Stated, No, she want to know if she can only take one, she do not feel like to go back to take the other one because this one was making her feel sick, it was not making her feel good right now on 12Jun2021 at 11:00. Right now she feel like she need to go to the emergency or something because she was not feeling good after she take this one. Again confirmed the name of the vaccine as Pfizer COVID 19 Vaccine. They will call then back and 'if she still don't feel' better she may be, then she should be calling, it feels like she have to go to the emergency. Stated, Yes go ahead if she can, she was feeling really dizzy right now, she hope it goes away, she so 'just pray' it goes away because she did not feel like this was normal, this was weird on 12Jun2021 at 11:00. Consumer was advised to visit the emergency room if not feeling well. Stated, "she do not have anything more, she don't feel, she don't have anything more, that was It. Outcome of the events are reported as unknown at this point of time.   Follow-up attempts are needed: Information about batch/ lot number has been requested.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (Office Staff) . This case involves a 6 months old patient of unknown gender who received PEDIARIX and IPOL along with PEDIARIX. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation on an unknown date. On 08-Nov-2018, the patient received a 0.5 ml third single dose of suspect IPOL Suspension for injection lot N1K931M via unknown route in the left thigh along with a non-company suspect, PEDIARIX on same date. It was a case of actual medication error due to extra dose administered. It was reported that patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 1:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 1:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator, it was the day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.  No treatment medications were provided.
I felt feverish and had a headache after my booster of Pfizer. The next day, I was napping a lot. I woke up from a nap and my fitness device said I had been exercising and reported high heart rate. My heart rate was high (around 135) for about 4 hours from 1PM ET to 5PM ET.
Patient presented to the ED and was subsequently hospitalized for NSTEMI within 6 weeks of receiving COVID vaccination.
Pain, fever, tiredness, headache, chills, diarrhea, worded muscle pain, joint pain, swollen lymph nodes, lost of appetite.
Started out being drained of energy and then fever and severe joint aches.  This lasted for 2 days.
EYES TO START BLEEDING; This spontaneous report received from a consumer via a company representative via social media (J and J) concerned a female of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: eye disease (ocular histo) and other pre-existing medical conditions included: The patient worked for 2 years at a hospital. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced eyes to start bleeding and she was unable to work since OCT-2021. It was reported that "My wife worked everyday for 2 years at a hospital where she was giving the order to take the shot or be fired at the end of 2 year pandemic. Her doctor told her not to take the shot because of her eye disease (ocular histo) she had a letter stating that which the hospital ignored. No doctors would say it was the shot (vaccine) that made her eyes to start bleeding and the medicine she has been receiving for 20 plus years no longer stopped the bleeding. She hasn't been able to return to work since October of 2021. Glad to see Johnson and Johnson doing so well, able to build a monument to the all mighty dollar they made from the botched COVID vaccine. What a wonderful country we have become. Ha. The hell of it is she is only 1 in probably millions with worst stories to tell". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eyes to start bleeding. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221210901-eyes to start bleeding. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Pt. stated she noticed arm being excessively sore p.m. of 12/21/16. Shot administered at approximately 10:00am. 12/23/16 injection site hot to touch, swollen by 3 inch x 3 inch area; red and tender.
pt was given the wrong vaccine for dose 2. pt was given a dose of janssen instead of the 2nd dose of moderna. There were currently no adverse side effects
Pt developed miliary rash on face. He had no lymphadenopathy, fever, or any other signs of rubella.
Hospital Course and Significant Findings: Patient was admitted and taken to the operating room where she underwent a laparoscopic cholecystectomy with drain placement.  She was admitted and placed on ceftriaxone and Flagyl.  She was started on multimodal pain regimen and her requested Relafen and percocet. Was transfused 1 unit of blood. WBC improved. Pt threatened to leave hospital on 1/27. Insisted on being discharged on 1/28. Her H&H was stable post transfusion with improved WBC and tolerated diet. Discharged with oral abs.
I called off work on 01/08/2021 and I woke up that morning around 2 am with a  headache and fever of 102.7. The headaches never went away and they were very persistent and pulsating. I made an appointment with my  PCP on 01/18/2021 at 11 AM and at this point I was getting very dizzy and nauseous. I made another appointment with my psych Doctor to make sure it wasn't an interaction with the medication I was taking. He said it shouldn't cause interaction. PCP wanted me to see Neurology and schedule  for an MRI. I continued to work and was taking Motrin and Tylenol. The Headaches were still persistent. By February I seen an Opthomologist because I was having blurred vision and still had pulsating on the left side of head. He said I had increased intracranial pressure and he asked about any history of glaucoma. He had me on these eye drops to decrease eye pressure on 02/08/2021. I had a F/U on 02/16/2021 with my other psych Doctor because I still felt the same. I had another follow up with PCP on 02/23/2021. I seen the neurologist on 03/12/2021 and the the pressure was getting worse and worse by this point and people were noticing at work that I was not myself. I had vision changes and blurred vision. The Neurologist stated that he does believe the vaccine plays apart in this. He said I have intracranial hypertension and would need spinal tap. On the 02/13/2021 I was at work I threw up because I was so dizzy. I went to ER and they could not do a spinal tap so they ended up doing a spinal tap on the 02/14/2021 and they removed fluid and I had instant relief from that. I was discharged on 02/17/2021and pretty much once they removed that fluid I felt better. I still have subtle headaches but something did happen to me where I had increased intracranial pressure. I had a follow-up on the 02/23/2021 and follow up 03/31/2021 with Dr. and things were starting to resolve and get better. Neuro has me on medication for fluid on brain (diuretic) and Topamax for the headaches.  MRI was done on  03/01/2021.
I have left arm pain which radiates to left breast. Pain gets worse with using arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I have left arm pain which radiates to left breast. Pain gets worse with using arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 028L20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I have left arm pain which radiates to left breast. Pain gets worse with using arm). At the time of the report, PAIN IN EXTREMITY (I have left arm pain which radiates to left breast. Pain gets worse with using arm) had not resolved.            No concomitant medication was provided by the reporter.  No treatment information was provided. The patient experienced left arm pain that radiated to the left breast.
I started getting symptoms of sore throat, pressure in my head, sinus issues, and runny nose. I did also have a heavy feeling in my chest. I took an at home COVID-19 test that was positive. I contacted a doctor through telehealth and I was prescribed PAXLOVID for a 5 day course. I feel that the PAXLOVID helped. My symptoms lasted approximately 5 days.
No known adverse effects; An administered dose of Rotateq underwent a temperatue excursion prior to being administered to a patient; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided.  On 30-JUN-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) injection, lot # 1661009 has been verified to be valid, expiration date reported as 25-MAY-2021, but upon internal review was established as 25-APR-2021 for prophylaxis (strength, dose, frequency, route of administration were not reported). Administered dose of vaccine experienced the temperature excursion with 51 Fahrenheit (F) for 45 minutes. Data logger was involved. There was no previous excursion reported. No adverse event was reported.
Soreness, red, swelling. Redness 4" long x 2.5" wide. Began 4-17-10 as light red in color. Progressed to darker red & increased swelling by the next day. When child came in on 4-19-10, the area was light red with swelling - size as above. Warm to touch but no soreness or tenderness.
Patient was given the 2nd Pfizer vaccine 7 days before the recommended time between the 1st and 2nd dose.  Patient has been notified of the vaccine administration error.
A 17 year old was given the moderna vaccine; A spontaneous report was received from a physician concerning a 17-year-old patient who received Moderna's Covid-19 vaccine (mRNA-1273).  The patient's medical history was not provided. Concomitant product use was not provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On an unknown date, 17-year-old was given the Moderna COVID-19 vaccine.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, a 17-year-old was given the Moderna vaccine, was considered resolved.; Reporter's Comments: This case concerns a 17-year-old patient who received the first of two planned doses of mRNA-1273 (Lot unknown), reporting product administered to patient of inappropriate age and at this time no adverse events were reported.
Within the first 20 minutes her arm was heavy. By 9:30 pm extreme arm soreness, chills, swollen and burning throat. That night intense fatigue but couldn?t sleep because of nausea and vomiting.  By morning a cough developed, sneezing and clogged and mucus dripping from nose. By 1:00 pm 4/17/2021  fever of 99.9. By 3:20 pm it is 101 degrees with a headache, body aches and straining eyes.
9 cm by 9 cm area erythema and hot to touch. Area sore. Also, generally HA, anorexia, nausea, fever--no measurement, chills, sneezing, dry cough, sweats. 12/20 Patient had 7 axillary nodes, WBC 12,200. Patient given SQ Epinephrine, Tordal, Vistarll. 12/21 Patient declined recheck visit. LPN saw improvement.
period was abundant, with too much bleeding; period was very painful; her period came a week earlier; pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the left arm), HEAVY MENSTRUAL BLEEDING (period was abundant, with too much bleeding), OVULATION PAIN (period was very painful) and MENSTRUATION IRREGULAR (her period came a week earlier) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     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 PAIN IN EXTREMITY (pain in the left arm). On 31-Mar-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (period was abundant, with too much bleeding), OVULATION PAIN (period was very painful) and MENSTRUATION IRREGULAR (her period came a week earlier). On 09-Apr-2021, HEAVY MENSTRUAL BLEEDING (period was abundant, with too much bleeding), OVULATION PAIN (period was very painful) and MENSTRUATION IRREGULAR (her period came a week earlier) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.
Nausea, headache on 10/13/13. Sxs resolved the next day 10/14/13.
Got very ill from the second dose of the Covid-19 vaccine; This is a spontaneous report from a contactable consumer (daughter in law). A male patient (Husband's father) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included covid-19 (Received Covid-19 vaccine less than 90 days after Covid-19 infection). The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 for covid-19 immunisation. Caller reported that her husband's father, the patient, was sent to the hospital after he received the second Pfizer Covid-19 vaccine. Caller reported that the patient got very ill from it. The patient had already had Covid while in a facility in (address withheld).  Caller reported that the facility didn't wait 90 days after the patient had a Covid-19 infection before giving him the Covid-19 vaccine. Caller reported that the second Covid-19 vaccine totally messed the patient up and he still had not recovered. The event was serious with seriousness criteria-Caused/prolonged hospitalization. Reporter seriousness for "got very ill from the second dose of the Covid-19 vaccine" was hospitalization. The patient underwent lab tests and procedures which included Covid-19 test on an unknown date with result positive. Event outcome was not recovered.    Information on the lot/batch number has been requested.
pt recvd vax 9NOV95 & 23NOV95 pt broke out w/about 200 pustules & devel a fever;no further details were provided;
granuloma; was put in, not into the entire muscle, that is more or less was subcutaneous; This spontaneous case was reported by a pharmacist and describes the occurrence of GRANULOMA (granuloma) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (was put in, not into the entire muscle, that is more or less was subcutaneous) in a 45-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Sep-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 12-Sep-2022, the patient experienced GRANULOMA (granuloma) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (was put in, not into the entire muscle, that is more or less was subcutaneous). At the time of the report, GRANULOMA (granuloma) had not resolved and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (was put in, not into the entire muscle, that is more or less was subcutaneous) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.  The doctor was extremely concerned that patient would not get a sufficient immune response from  an improperly administered injection and would like information as to whether or not patient can get her shot repeated.
Pfizer vaccine administered after being stored at regular freezer temps longer than recommended. Dose determined invalid,client contact and recommended repeat dose.
Vaccine administered on right arm on 4/8/2021.  Approximately, 12 hours later she began experiencing severe abdominal stomach pain, fever and general malaise (fever and malaise have generally resolved), numbness in her left arm, and elevated blood pressure.  She continues to have abdominal pain 7 days after immunization.  Advised to go to emergency room out of an abundance of precaution.
On Monday, March 1st noticed itchy, raised hives on both elbows, that were painful to the touch; thought they were an allergic reaction. The next day the hives had turned into blisters that then turned bright red.  A week later and my elbows are still red, blotchy & painful to the touch.
TESTED + FOR COVID  9-24-22 AT HOSPITAL.  ADMITTED 9-24-22   WITH ALTERED MENTAL STATUS, HAD JAUNDICE , BRUISING.  DX INCLUDE HEPATITIC ENCEPHALOPATHY, CIRRHOSIS, mrsa BACTEREMIA, ACUTE RESP FAILURE WITH HYPOXIA, SEPTIC SHOCK , ACUTE KIDNEY INJURY, FRACTURES OF RIBS, ACUTE METABOLIC ENCEPHALOPATHY, ACUTE COVID, THROMBOCYTOPENIA, AFIB WITH rvr,   TREATED WITH VANCO, ZOSYN AND LATER ZOSYN STOPPED AND GIVEN DAPTOMYCIN.  , IV FLUIDS, IV REMDESIVIR WAS ATTEMPTED TBUT HE DEVELOPED AFIB RVR.  GIVEN LOPRESSOR.  HIGH AMMONIA LEVELS.  GIVEN FLAGYL, XIFAXAN LACTULOSE  , pICC LINE.  INTUBATED DUE TO OBTUNDED MENTAL STATUS.     DECEASED 10-16-22 AS INPATIENT.  i DONT HAVE THOSE RECORDS.