chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severely shivering; body was so sore I could barely stand up; full body was freezing cold; neck was sore in a lot of pain; face felt like it was on fire; lot of pressure to the Head; This is a spontaneous report received from a contactable consumer (patient). A 27-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 21Apr2021 at 14:30 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not take any concomitant medications. The patient did not have any allergies. The patient previously received dose 1 of BNT162B2 on 31Mar2021 at 14:30 as a single dose in the left arm for COVID-19 immunization. On 22Apr2021, at 03:00 (also reported as 02:00) the patient woke up severely shivering for a few hours. Following that her body was so sore she could barely stand up. Her full body was freezing cold but her face felt like it was on fire. Those symptoms lasted 24 hours. After that, day 2 and 3 her neck was sore in a lot of pain and every once in a while she got a lot of pressure to the head which felt like it was going to explode. The patient did not receive any treatment for the events. The outcomes of shivering, body was so sore, full body was freezing cold, face felt like it was on fire, neck soreness and pain, and pressure to the head were recovered with lasting effects. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
61-year-old female presents the ED for evaluation of lightheadedness.  Patient reports shortly after receiving first dose of Covid vaccine, began to feel lightheadedness 15 minutes later.  Patient reports that she started off with a right-sided headache, and when she went to stand up took 2-3 steps forward and fell lightheaded, and and sat back in her chair.  Denies loss of consciousness, chest pain, shortness of breath.  Denies alleviating or exacerbating factors.  Patient reports that they taken her blood pressure after symptoms, was found to be elevated, 200/100 systolic.  Patient denies previous history of blood pressure medications.  Denies previous reactions to vaccines
The vial was initially stored in the refrigerator on 11-Apr-2023 and was administered on 13-May-2023; No adverse event; Dose administered after 30-day Use By Date; Patient had received Moderna Bivalent previously in Nov-2022 in addition to bivalent on 13-May-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Apr-2023 and was administered on 13-May-2023), EXTRA DOSE ADMINISTERED (Patient had received Moderna Bivalent previously in Nov-2022 in addition to bivalent on 13-May-2023) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    In November 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 13-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 13-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and EXTRA DOSE ADMINISTERED (Patient had received Moderna Bivalent previously in Nov-2022 in addition to bivalent on 13-May-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Apr-2023 and was administered on 13-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Apr-2023 and was administered on 13-May-2023), EXTRA DOSE ADMINISTERED (Patient had received Moderna Bivalent previously in Nov-2022 in addition to bivalent on 13-May-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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Apr-2023 and was administered on 13-May-2023) and EXTRA DOSE ADMINISTERED (Patient had received Moderna Bivalent previously in Nov-2022 in addition to bivalent on 13-May-2023).    No concomitant medications were provided. The vial size was 2.5 ml.  The vial was initially stored in the refrigerator on 11-Apr-2023 . The vial did not undergo any temperature excursions. No reports of side effects were reported by patient after receiving the vaccine. No treatment medication was provided.
Patient received 2nd dose of covid vaccine 1/9/2020 around 1100.  Report having mild reaction (flu-like sx) with first dose. She began experiencing feeling like she was outside of her body about 10 min after receiving her booster. BP was taken and was slightly elevated 140s/90s.  Ice packs were provided for hot flashes.  Warm blankets provided for chills.  BP was trending up to SBP 160s then started to decline to normal.  Patient was accompanied to restroom by clinic staff and was able to walk without incident.  Patient was observed in covid clinic for total of 2 hours and reassured that she was not likely to have worsening of sx at this point.  Patient was walked to mother's car by clinic staff and left feeling better.   1/10 - patient presented to ED with low grade fever (100.4), chest pain, severe joint and muscle pain, nausea and "fog brain."  She reports BP being 187/101 in ED.  Given 1L of normal saline, zofran, toradol, and dilaudid.  Observed until BP drcreased to SBP 140s.  Nausea improved enough to allow her to eat.  Labs were WNL, CK normal.  Discharged home with diagnosis of "adverse effect of COVID-19 vaccine"
Temperature on arrival was 97 degree 18 minutes after the vaccination it was 103.4/six days running a 100degree fever; my blood pressure went to 170/100; my oxygen dropped to 88%; vomiting; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient (non-pregnant) received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in right arm on 02Feb2021 09:45 AM (at the age of 91-year-old) as single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease/COPD, asthma, hypertension. The patient has no known allergies. Concomitant medications were not reported. Patient took unspecified other medications within two weeks of vaccination. No other vaccine in four weeks. Patient was not tested positive for Covid prior vaccination. On 22Feb2021 at 10:15 AM, the patient experienced vomiting, blood pressure went to 170/100 and oxygen dropped to 88%. She was in bed end of the care of her daughter for six days running a 100 degree fever. Temperature on arrival was 97 degree 18 minutes after the vaccination it was 103.4. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient was not tested positive for Covid post vaccination. No treatment was taken for events. Outcome of events was recovered in 2021.  Information about lot/batch number has been requested.
This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 02-JUN-2017, the patient was inadvertently vaccinated one expired dose of with GARDASIL lot # L035105, expiration date on 14-MAY-2017 (strength, dose number, route and anatomical location were not provided) for prophylaxis. No adverse events were reported. Additional information has been requested.
t104.5 approx 24hrs p/until given Motrin & cool bath-tx for infect;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2022 as dose 4 (booster), single (Lot number: FK9895), 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 had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Valdecoxib, reaction(s): "Known allergies: Valdecoxib".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient did not received other medication in 2weeks. COVID 19 treatment, brand: Paxlovid. Patient administered paxlovid on 08Jun2022 and stopped on 12Jun2022, indication for treatment of COVID-19. Adverse event: recurrence of sore throat day 4 after finishing Paxlovid. Adverse event started on 18Jun2022; 08:00 AM. Patient was recovering form AE. It was unknow if patient received treatment for adverse event. known allergies: Valdecoxib. Other medical history: None. Patient was not pregnant at time of vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
8 days after I received the moderna  vaccine, I noted a red, indurated rash/hive at the vaccine site. I was told by a provider that this delayed reaction was noted in some of the Moderna vaccine trials and given that I had no other symptoms (no fever, no warmth or signs of cellulitis) it would most likely go away in 3-5 days.  The next morning I woke up and my body was covered in hives. It is manageable with Benadryl. My roommate also had the exact same reaction, same timing, symptoms, etc and we both got the Moderna vaccine, same location, same lot, same time. Neither of us have allergies, and the other apartment mate has no symptoms (and has not received the vaccine).
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is very sore), PYREXIA (low grade fever) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011N20A) for COVID-19 vaccination. Concomitant products included INSULIN GLARGINE (LANTUS), DULAGLUTIDE (TRULICITY), METFORMIN, LANSOPRAZOLE, ESCITALOPRAM OXALATE (LEXAPRO), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), BUPROPION and ATORVASTATIN for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is very sore), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (arm is very sore), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication was reported.
Breakthrough case admission after 3rd vaccine Moderna 3/17/21 Lot# 002B21A Moderna 4/14/21 Lot# 037B21A Moderna 12/2/21 Lot# 045L21A
Positive albumin upon dip at Dr. office.  Not followed up on til June 25th when I went to Hospital ER for chest heaviness.  Lab worked showed Nephrotic Syndrome (low albumin and Protein levels in blood work).
Gave vaccine that had been out of the refrigerator and diluted for a total of 30 hours. Contacted Pfizer and they were unable to "support stability" of vaccine. Notified mother that per CDC dose given is invalid and needs repeated immediately. No symptoms or adverse effects at this time.
Tingling hands, weakness of arms and legs on 11/23/05. Patient seen at ED 11/23/05. Transferred to another hospital for possible admission. Symptoms resolved completely. Patient discharged to home that evening.
Inconsolable screaming &/or crying for 23 hrs; No treatment needed; no other problems;
Headache, Myalgia, NauseaVomiting, Soreness at injection site, fatigue Narrative:  Per nursing report: " 2nd dose of Moderna yesterday morning, C/o soreness at injection site, restlessness, tiredness,body aching,headache and just feeling tired, also states had some nauseousness."
arm was swollen; arm was sore for 7 to 8 days; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen) and PAIN IN EXTREMITY (arm was sore for 7 to 8 days) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Allergy to poison ivy and oak). Concomitant products included HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN/HYDROCHLOROTHIAZIDE) for Hypertension.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen) and PAIN IN EXTREMITY (arm was sore for 7 to 8 days). At the time of the report, PERIPHERAL SWELLING (arm was swollen) and PAIN IN EXTREMITY (arm was sore for 7 to 8 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medications were not provided by the reporter.   This case was linked to MOD-2021-231544 (Patient Link).
About 10 minutes after receiving immunizations, patient developed a stomachache, felt like he was going to vomit, headache, then fainted and hit his head
Minor was given initial Covid 19 vaccine on 11/29/22 and inadvertently given second dose on 12/7/22
Within twelve hours I developed a high fever of 100.6 which lasted till the following morning. I was treated at home with ice packs and 600 mg ibuprofen every six hours. At 8:00am the next morning the fever had broken. No other issues were observed.
Glandular swelling including thyroid.  Reported on first dose, occured after all 3 doses.
Swelling of the heart, chest pressure/pain and arrhythmia.  Took to the ER on  12/13.  Seen by Doctor. Symptoms are still on going.
Hospitalization, Dizzy, lightheadness,  nausea, and vomiting   Body part and time not know for vaccine Covid Tested on 7/14/2021 tested positive  Patient is currently in hospital
Systemic: Seizure-Severe, Additional Details: Within a few seconds after administration, the patient started having seizure-like activity, including spasms of extremities, dizziness lasting 10-15 seconds.  After the event, patient was cognitively aware of everything that happened immediately before and after event, but not DURING the event.  Also, upon regaining function, he was sweating profusely all over his body, and thirsty.  EMS was notified who checked patient thereafter.
More reaction than the first dose; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (More reaction than the first dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 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 VACCINATION COMPLICATION (More reaction than the first dose). At the time of the report, VACCINATION COMPLICATION (More reaction than the first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication provided.   This case was linked to MOD-2021-406038, MOD-2021-406057 (Patient Link).
a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 24-APR-2019, the patient was vaccinated with an improperly stored vaccine of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) one dose, with lot number R021078 and expiration date on 12-JUN-2021 (dose number, route of administration and anatomical injection site were not reported) for prophylaxis; or rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral vaccine, with lot number R028189 and expiration date on 06-JUN-2020 (dose and dose number were not reported) for prophylaxis.  It was reported that on an unknown date, the vaccines were exposed to a temperature excursion of 52.5 Fahrenheit (F) degrees for 4 hours and 40 minutes. There were no previous temperature excursions. The call was placed because of a Digital Data logger report.
This spontaneous report was received from a healthcare professional concerning a patient of unknown age and gender who on 24-JUL-2012 was vaccinated with a expired dose of VARIVAX (merck), subdermal (lot number 668404/0972Z, expiration date 21-JUL-2012). Additional information is not expected.
Sore in roof of mouth, painful like a blister.  No treatment; symptom still present
Pain in the left arm so bad that I don?t have strength in the limb, cannot raise the arm and move. Nausea related to the pain.
Severe flu symptoms starting ~12 hours after injection gone after 48 hours (fatigue, aches, nausea, vomiting, fever, fever chills). Developed evere sinus infection after flu symptoms cleared (runny/stuffed nose with colored mucus, new fever, headache and tenderness at sinuses, wet cough, lost voice, nausea, vomiting)
Pt recv vax on 1/20/99; within 1 hr post vax pt exp fine, red raised rash over entire body; tx=Depomedrol, Benadryl PO
Redness on face followed by bright red rash on neck, back, chest, abdomen and arms. (Rash, red spots and red blotches).
I experience tachycardia and severe anxiety 3 days after the vaccine. My heart rate went up to 187 on my apple watch. By the time I got the ER, I was at 160 and the rate would not drop below 120 for at least an hour if not more.  Initially I had attributed that to anxiety but doctors did not believe it was anxiety as I was obviously not anxious (after a while, I was scared when I arrived at the ER)
Pain and stinging at inj. site-later radiating pain into back and shoulder, mild spasms. Tx Clebrex 200 #30 tqd seen 11/12/02.
rash appeared on my chest/back.arms and eventually legs; headache; This is a spontaneous report from a contactable consumer (patient, self-reported). A 72-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number EL9265, expiration date unspecified), dose 1 via an unspecified route of administration in the left arm on 09Feb2021 at 09:00, as single for covid-19 immunization. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number EN6202, expiration date unspecified), dose 1 via an unspecified route of administration in the left arm on 02Mar2021 at 09:00, as single for covid-19 immunization. The patient's medical history included that she took erythromycin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other medications within 2 weeks prior. On 09Feb2021, after the first shot, the patient experienced headache in the evening that went away with Tylenol and another headache in the morning that also went away with Tylenol. On 02Mar2021 15:00, about 6 hours after the second shot patient face turned red and inflamed. About 4 hours later a rash appeared on my chest which took about 12 hours to spread first to my back, then my arms, and eventually my legs. Now, 48 hours later, my face is a little better, but the rash on my body remains. It does not itch. The patient was treated with Tylenol for the events. The patient was not tested for COVID-19 since the vaccination. The outcome for the event headache was recovered on Feb2021, and the other event rash was not recovered.  No follow up attempts are possible. No further information is expected.
Patient received Pneumovax at the clinic on 5/31/06. Developed redness and swelling at the injection site. Emergency room visits x 4 (given Rocephin x 2, Rx for Keflex and later Augmentin). Admitted to hospital on 6/4/06 for IV antibiotics, started on Clindamycin and Zosyn. Later Zosyn discontinued and Vancomycin initiated.
p/ recv vax on 4/3/98 approx 9 days later pt devel ``body-wide varicella like rash w/fever of 100. pt treated w/acyclovir
Chills, body aches, fatigue, headache, diarrhea   Pain, swelling, redness at injection sited
Vomiting within 1 hour after receiving vaccination.  Vomiting occurred off and on for 5 days.  Some mild lethargy for about 24 hours after vaccination.  (None of my other children were sick and none of them showed signs of being sick after.)
Extreme vertigo; dizziness; fatigue; This is a spontaneous report from a contactable health care professional, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 at 14:30 (at the age of 32-yeasr-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications included eletriptan hydrobromide (RELPAX), vitamin d nos (VITAMIN D), ascorbic acid (VITAMIN C), ibuprofen (ADVIL), prenatal vitamin (MANUFACTURER UNKNOWN) on unknown date for unspecified indication received within 2 weeks of vaccination. The patient previously received ciprofloxacin (MANUFACTURER UNKNOWN), COMPAZINE and lactose (MANUFACTURER UNKNOWN) and had drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Prior to the vaccination, whether the patient was diagnosed with COVID-19, was unknown. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 12:00, the patient experienced extreme vertigo, dizziness and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the reported events. The clinical outcome of the events extreme vertigo, dizziness and fatigue was not recovered at the time of this report.   No follow attempts are needed; Information about lot number cannot be obtained.
Pt was vaccinated with the first and second doses of varicella virus live on 07/16/1998 and 08/13/1998. On 10/23/1998 laboratory evaluation revealed a lack of response.
pt in SNF for dementia and weakness; tested positive for COVID on 7/4/22; pt passed away in the SNF