chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within hours i not only had a sore arm, i had a fever, was bedridden, had right ear pain and weak. Symptoms then included sore throat, congestion  cough and i am still sick.
fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication taken. No treatment information provided.
Rash appeared on right arm about 1.5 weeks after injection.  Not raised or hot, not too itchy.
Pt. rec. 2nd RABAVERT on 5/23/16. Reports severe aching (especially in legs) began that night 5/23. Unable to work 5/24. Symptoms did not resolve until evening of 5/26/16.
Patient reported low grade fever, extreme exhaustion and severe pain on hands, elbows, knees and joint.
vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; It appears I have eye shadow; peeling/dryness of skin around lips; peeling/dryness of skin around lips/It appears I have eye shadow but peeling is not visible; burning and itch of lip region; burning and itch of lip region; muscle spasm; Neuralgia; medium-severe headache; nausea; sensitive to light; mild confusion; lack of concentration; This is a spontaneous report from a contactable nurse (patient herself). A 36-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular in 28Dec2020 08:30 at a single dose in the left arm as COVID vaccine. Medical history included history of Grave's disease at age 19 which has resolved without medication for many years. The patient had no known allergies: no allergies to medications, food, or other products. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications.  The patient had no other vaccine in four weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not taking any daily medications. On 28Dec2020 (day 1), patient had no significant symptoms. On 29Dec2020 (day 2), patient had medium-severe headache, nausea, sensitive to light, mild confusion and lack of concentration. On 30Dec2020 (day 3), patient had muscle spasm that wake from a sound sleep in biceps tendon region, and neuralgia in left upper and lower extremities. On 31Dec2020 (day 4), patient had peeling/dryness of skin around lips, burning and itch of lip region. On 01Jan2021 (day 5), patient had post vaccination burning, itching redness to eye lids. Patient realized patient should photo her journey. It appeared patient have eye shadow but peeling was not visible due to moisturizer and bacitracin "ito" try and sooth the pain. Patient can send at additional request since patient can't upload. The patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of the event "peeling/dryness of skin around lips/it appeared patient have eye shadow but peeling was not visible". No treatment received in response to the other events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The outcome of the events medium-severe headache, nausea, sensitive to light, mild confusion, lack of concentration, muscle spasm, neuralgia in left upper and lower extremities, dryness of skin around lips, "peeling/dryness of skin around lips/it appeared patient have eye shadow but peeling was not visible", burning and itch of lip region, post vaccination burning, itching redness to eye lids, and "it appeared patient have eye shadow" was not recovered.  Information on the lot/ batch number has been requested.
Atrial Fibrillation; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer-sponsored program.   A male patient (reporter's husband) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on 30Jun2021, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had his 1st dose of Pfizer Covid 19 Vaccine (30Jun2021) and 2nd dose will be on (21Jul2021) it's just that after having the 1st dose (withheld) was admitted at the hospital and experienced AFib - Atrial Fibrillation so (Withheld) wanted to get information about the reactions of the Vaccine. Outcome of the events was unknown. Information on Lot/Batch information has been requested.
Information has been received from a nurse concerning a 17 year old female patient with an allergy to BIAXIN who in June 2007 was vaccinated IM with a first dose of 0.5 mL GARDASIL vaccine (yeast) (lot # 655503/0012U), in August 2007 was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot # 658282/0929U), and in December 2007, was vaccinated with a third dose of GARDASIL vaccine (yeast) (lot # 659055/1522U). There was no concomitant medication. It was reported that the patient experienced weight loss, fever, fatigue, and bulging veins. The patient has had a 20 pound weight loss between March 2008 and May 2008. The patient sought medical attention by phone and office visit. The patient was in the office on 05-MAY-2008 because of a "fever for the past 2 days and off and on diarrhea in February and March 2008. "Laboratory diagnostic studies performed were complete metabolic panel, CBC, sed rate, mono spot, EBV titers, thyroid, and urinalysis. All tests were normal except one of the tests showed patient had "MONO" in the past. Subsequently, the patient recovered on an unknown date. Additional information has been requested.
74yr old female who presents to ED with complaints of not feeling well.  Patient states she woke up yesterday morning with a headache and body aches.  Patient states she has had a fever and an increase in her cough.  Patient states she has been coughing up thick, yellow phlegm.  States she feels short of breath with exertion. Patient on O2 via NC at 4L, states this is her normal at home. Patient states she has diarrhea but states this is not new for her.  Patient states she has had the dry heaves.  Patient states they had a family gathering over the weekend.  Patient states she has been vaccinated for covid.  Pneumonia due to COVID-19 virus  AIRBORNE PRECAUTIONS    CONTACT PRECAUTIONS   INFECTION CONTROL REFERRAL   CULTURE, BLOOD   FERRITIN   LDH TOTAL   CK   cefTRIAXone (ROCEPHIN) in D-2.22% 50 mL IV piggyback (DUPLEX) (premix) 2,000 mg 2. Cough  INFECTION CONTROL REFERRAL   SARS-COV-2, INFLUENZA A+B, AND/OR RSV NUCLEIC ACID TESTING PANEL   COMPLETE BLOOD COUNT WITH DIFFERENTIAL   COMPREHENSIVE METABOLIC PANEL   C-REACTIVE PROTEIN (INFLAMMATION)   LACTIC ACID   ESR   BLOOD GASES VENOUS   albuterol-ipratropium (DUO-NEB) 2.5-0.5 mg/3 mL inhalation solution 3 mL   methylPREDNISolone sod succ (SOLU-medrol) injection 60 mg   PROCALCITONIN   XRAY CHEST PORTABLE - 3. Nausea  ondansetron (ZOFRAN) injection solution 4 mg   ondansetron (ZOFRAN) injection solution 4 mg 4. Other headache syndrome  INFECTION CONTROL REFERRAL   SARS-COV-2, INFLUENZA A+B, AND/OR RSV NUCLEIC ACID TESTING PANEL   COMPLETE BLOOD COUNT WITH DIFFERENTIAL   ondansetron (ZOFRAN) injection solution 4 mg   ketorolac (TORADOL) intravenous injection 15 mg 5. Shortness of breath  INFECTION CONTROL REFERRAL   SARS-COV-2, INFLUENZA A+B, AND/OR RSV NUCLEIC ACID TESTING PANEL   COMPLETE BLOOD COUNT WITH DIFFERENTIAL   COMPREHENSIVE METABOLIC PANEL   C-REACTIVE PROTEIN (INFLAMMATION)   D-DIMER QUANTITATIVE   TROPONIN I   EKG   LACTIC ACID   ESR   CULTURE, BLOOD   BRAIN NATRIURETIC PEPTIDE   albuterol-ipratropium (DUO-NEB) 2.5-0.5 mg/3 mL inhalation solution 3 mL   methylPREDNISolone sod succ (SOLU-medrol) injection 60 mg   PROCALCITONIN   XRAY CHEST PORTABLE -   CTA CHEST   TROPONIN I 6. PAH (pulmonary arterial hypertension) with portal hypertension  BLOOD GASES VENOUS 7. Elevated troponin level    8. Positive D dimer  CTA CHEST 9. Elevated serum lactate dehydrogenase (LDH)    10. AKI (acute kidney injury)  URINE DIP, REFLEX TO MICROSCOPIC, REFLEX TO CULTURE   sodium chloride 0.9% (bolus) IV solution 250 mL 11. Liver cirrhosis secondary to NASH  PROTIME/INR   PTT     ASSESSMENT/PLAN/DECISION MAKING: -Transferred to another healthcare facility.
Information has been received from a registered nurse concerning a 12 year old male with no pertinent medical history and no known allergies who was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) in 1999, a second dose of varicella virus vaccine live (Oka/Merck) in AUG 2007, and a third dose of varicella virus vaccine live (Oka/Merck) on 08 NOV 2007 (Lot # 658405/1076U). On 14-NOV-2007 the patient's mother reported that the patient had developed rash in the groin, buttocks and chest. At the time of reporting the patient had not yet recovered, and is scheduled for a follow up visit. There were no lab diagnostic studies performed. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 9:49 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 71.49 years.  No concomitant product use was reported.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored on cooler 1, on 28 Feb 2021, Excursion duration at 9 am: 27, at 10 am 40, at 11 am 44, at 12 am 46, at 1 pm 26, at 2 pm 37, at 3 pm 43, at 4 pm 45.  On 28 Feb 2021, excursion time and temperature at 09 am and 1 pm was 27 and 26 respectively, total doses given for the day was 152, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24 Feb 2021, vial was moved to clinic on 27-Feb-2021. 20 vial was moved to clinic. Vaccine BUD date was 26-Mar-2021.  Vials only punctured right before administration.  Temperature recordings were taken by using a traceable temperature monitor at every hour. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
one week post vaccine ..hypersensitivity reaction ...large hive , red indurated warm and itchy about the size of an orange, three days later , less red but now no longer circumscribed
Experienced shingles outbreaks; 1st dose 12Feb2020, 2nd never; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number LH7ED, expiry date 25-MAR-2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12-FEB-2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: Experienced shingles outbreaks) and incomplete course of vaccination (Verbatim: 1st dose 12Feb2020, 2nd never).  In FEB-2023, the outcome of the shingles was recovered/resolved. The outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-Mar-2023 The pharmacist reported that a patient never returned for second dose.  The patient had experienced shingles outbreaks a couple of times after receiving the first dose.  The most recent case just resolved about a week ago.  At the time of reporting, a second dose had not administered. The reporter consented to follow up.
Chills, headache behind eyes, fever, muscle pain/aches; now only bad headache and body aches;  time now is 10:05;
LITTLE BLEEDING ON BANDAID AFTER SHOT; NEXT FEW DAYS NOTICED BRUISING AROUND INJECTION SITE; PATIENT STATES NOT ON ANY BLOOD THINNERS; NO NUMBNESS OR TINGLING.
Fever >100.4,  Subjective fever (felt feverish), Chills,  Cough (new onset or worsening of chronic cough),  Shortness of breath or difficulty breathing,  Fatigue or tiredness,  Nausea or vomiting,  Headache, Hospitalization, ICU admission. Patient states on 8/20/2021 she was cold in the house and went outside on her deck and fell asleep, in the heat, Patient husband thought she had had a heat stroke and called 911. Patient was taken to the hospital, she was tested for Covid was positive and was admitted and stayed in the hospital until 8/26/2021 and returned home with home oxygen but states her SATS are at 100% and she is not using the oxygen. Patient said she started to go into organ failure and had Covid pneumonia and possible PE's.
Throat scratchy; Swollen under the cheek; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Throat scratchy) and SWELLING FACE (Swollen under the cheek) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Vitamin C. Past adverse reactions to the above products included Allergic reaction with Vitamin C. Concomitant products included PROGESTERONE (PROGESTIN) for Birth control, LEVOTHYROXINE for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced THROAT IRRITATION (Throat scratchy) and SWELLING FACE (Swollen under the cheek). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, THROAT IRRITATION (Throat scratchy) and SWELLING FACE (Swollen under the cheek) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient asked his age and said he was 49 yrs old and completed a questionnaire which asked if he was younger than 2 yrs old or older than 49 yrs old and he again answered no. The computer system was down at the time so he registered on paper and, as the nurse vaccinating, I reviewed his answers to the questions but did not double check his birthdate to confirm his age was between 2-49. He was administered the FluMist intranasally. Called him today to inform him of the error and he said he tolerated both vaccines well and is not experiencing any side effects.
10/20/2021, I noticed something strange, I was having problems with my throat and pain in my bones. As the day advanced the symptoms were getting worse. I continued to work because I work far from home, and I thought I had a cold. After 2 days, I was twice as tired and in pain. And my throat was closing. I continued to feel worse and mentioned it to my supervisor. On Friday, 10/22/2021, I tried to get up and I could not get up, I had like a fainting spell. I had vertigo. I could not move my head, not even a little. I could not get up. That was the moment I knew I could not go to work. I was having severe muscle pain, diarrhea, cough, vomit, severe fatigue. That is when I considered I probably had COVID-19 because I have never felt this bad before. I had all the symptoms, with the exception I never had high fever, if I had fever, I did not feel it. My extreme symptoms, like the vertigo, where I could not get up, lasted for like 4 days. At the medical clinic I was given supplements.
Breakthrough case of COVID, she had a fever and very tired and run down, no energy, sore throat and stuffiness. When she went to the urgent care center they said to take over the counter meds as needed, hydrate and get plenty of rest.
Pt was given meningococal vaccine subcutaneous and as a result she had a local reaction. The site was red and swollen but no other reaction was noted.
Patient received 2nd dose Moderna on 4/30.  Went to UC on 5/2 with dx of dyspepsia, nausea and vomiting.  Seen in Hospital on 5/4 altered with GIB.  Dx DIC
This spontaneous report was received from a nurse practitioner regarding an unspecified number of patients of unknown age and gender. Information on the concurrent condition, pertinent medical history and drug allergies of the patients were not reported. On an unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot# L046318, expiry date 28-SEP-2017 or an unspecified lot and expiry date) (dose number, dose units, route and anatomical location were not reported). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Complaint (PQC) involved. This one of the reports from the same reporter. Additional information has been requested.
Patient states pain in her left arm 4 weeks after the vaccine was administered and limited mobility of that arm.
This spontaneous report was received from a medical assistant referring to a 4 months female patient. The patient's medical history and concurrent condition were not provided. Concomitant therapies included a dose of PEDVAXHIB, PEDIARIX and PREVNAR 13. On 04-MAR-2019 the patient was vaccinated with the second dose of ROTATEQ batch/lot # N022001, expiration date 03-FEB-2019 (strength, frequency were not reported), orally for prophylaxis. The dose was expired (expired product administered). No adverse effects reported.
Mom called stating that she has been acting tired and lethargic. Not acting herself. No treatment just told to watch and if not improved then needs to be seen.
PATIENT WANTED THE PFIZER COVID-19 VACCINE NOT THE JANSSEN COVID-19 VACCINE THAT HE RECEIVED.
dizziness within seconds of getting injection: nausea, dizziness, body aches, headache and fatigue onset about 3 hours after the injection next day woke to joint pain and eye sensitivity nausea stopped bu dizzy and body aches continued with no fever. 24 hours after injection same symptoms going on plus low-grade fever and extreme fatigue I could hardly get out of bed and continued with other symptoms nausea and dizziness came and went headaches never go away not even with migraine meds, Tylenol, or ibuprophen.  Headaches and eye issues have continued for weeks I did go to the ER my dr was afraid I was having a stroke or a clot I had neither but was given 50 mg Bendryl iv and another medication that starts  can not remember which took the headache away for awhile and I was able to sleep, but when I awoke it was back with a vengeance. I have been dealing with it and issues with blurriness and sensitivity to light everyday since the injection and seems like it will never go away sometimes I hide under my covers and relieves the pain and discomfort, but I have a 4 yr old and can not do that. I feel this injection has ruined my life.
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. ; Sender's Comments: US-009507513-1804USA005153:
Patient seen in the ED on 7/17 for shortness of breath and hypoxia. At baseline she is on 2-3L O2 via nasal cannula. Additionally patient reported cough, rhinorrhea, and sore throat. COVID-19 PCR test done in the ED was positive. She was admitted from 7/17-7/21 for acute on chronic hypoxic respiratory failure, volume overload due to excessive fluid intact associated with end-stage renal disease, and recurrent right-sided pleural effusion, acute on chronic, acute portion resolved. Per medical notes, provider states respiratory symptoms were not consistent with COVID pneumonia, and strongly suspects presentation with acute respiratory failure was due to volume overload. Patient has been vaccinated against COVID-19. This meets criteria for vaccine breakthrough case review.
large red bump on arm near vaccination, sensitive, swollen, sore to touch achy left arm and underarm