chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Next morning I was really wiped out\ felt very tired that morning; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Next morning I was really wiped out\ felt very tired that morning) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced FATIGUE (Next morning I was really wiped out\ felt very tired that morning). On 02-Jun-2021, FATIGUE (Next morning I was really wiped out\ felt very tired that morning) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reaction or allergies was reported. On an unknown dates in 2016 (dates ranging from 26-FEB-2016 to 04-MAY-2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (dose, route of administration, administration site, lot # and expiry date were not specified). Administered doses of GARDASIL 9 underwent temperature excursion of minimum 29 Fahrenheit degrees and maximum 39 Fahrenheit degrees for less than 12 hours. There was previous temperature excursion on 25-FEB-2016, with temperature of minimum 30 Fahrenheit degrees and maximum 39 Fahrenheit degrees for less than 12 hours. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
On the 3/7 I had a lot of congestion in throat and sinus and 99.5 fever, I still test positive. Like having a cold.
Severe Headache, Disorientation, Physical & cognitive impairment, Aphasia / Stroke-like symptoms Details: My dad has been in excellent health and lives independently. He received the Vaccine on THURSDAY, 1/14/21 at 11 pm. FRIDAY(1/15/21 at 11:45 a.m.) The following morning, I went into his home to check on him.  He was sitting in his chair with his undershirt and boxers that he wore to sleep. Normally, Dad would have showered and been dressed. He was holding his head in his hands and crying.        (CONT'D)
Patient received 3rd Pfizer COVID vaccine on 11/23/21. She was at 39 weeks of gestation with singleton pregnancy, EDD was 12/2/21.  Received all pre-natal care. 4 days after vaccine around 11/26/21 she experienced diffuse bilateral tender lymphadenopathy (axillary, anterior/posterior cervical, supraclavicular).  Had CBC checked, was found to have WBC of 31.7 with 58% peripheral eosinophilia. This was all new as compared to historical blood work. She went to facility and was admitted to hospital for above mentioned symptoms as well as fetal tachycardia and category II tracing. Underwent emergent c-section with healthy baby  viable female infant born at 2113 pm, apgars 9/9, weight 3380g, clear amniotic fluid, bilateral adnexa and uterus grossly normal.
WOKE UPWITH HEADACHE PROGRESSIVLY GOT WORSE DURING THE DAY BY EVENING STARTED VOMITING. CONUINUES THRU NIGHT ADDING WEAKNESS AND BODY ACHES THRU MONDAY OCT 4 2010. WENT TO DR. REPORTS SYMPTOMS TREATED FOR SINUS? GAVE MEDS FOR NAUSEA AND HEADACHE. NO INPROVEMENT BACK TO DR ON OCT 7 2010. STILL VERY ILL, HEADACHE NOW HAVE CHEST PAINS NAUSEA DIZZY VERY WEAK CAN NOT WALK ON OWN WITHOUT SUPPORT. RAN SEVERAL TESTS DETERMINED IT WAS REACTION TO FLU VACCINE.  OCT 8 2010 FIRST DAY OUT OF BED. STILL VERY WEAK.  WILL NOT HAVE ANOTHER FLU VACCINE.
Information has been received from a physician concerning a 15 year old female with depression and gastrooesophageal reflux disease (reported as "GERD") and no drug reactions and allergies who on 09-NOV-2010 was vaccinated IM in her left arm with the first dose of GARDASIL. Concomitant therapy included PROZAC and omeprazole. The patient experienced itching, headache, nausea, vomiting, fever and fainting that same day. The physician prescribed REGLAN for the vomiting. No lab diagnostics were performed. At the time of reporting the outcome was unknown. Additional information has been requested.
21NOV91 coughing, fever, chills, fatigue, weakness; hospitalized 24NOV91 MD does not feel condition is assoc w/flu shot;
Per patient she had severe sore arm followed by lethargy on day 1 and day 2.  It became hot to the touch and sore all the way to shoulder.  Starting day 3 she lost some range of arm motion, got severe neck pain and left sided headache that lasted for several days.
L forearm red, edematous and warm to touch from 2" below shoulder to elbow.
Atrial fibrillation; palpitations; tachycardia/heart rate 141; This is a spontaneous report from a contactable healthcare professional (HCP). This HCP reported similar events for 2 patients. This is 1st of two reports.  This 58-year-old female HCP (patient) reported for herself that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176) on 10Jan2021 at 0.3 mL single by intramuscular injection left arm for COVID-19 vaccination.  Medical history included ongoing hypertension and diabetes type 2, both diagnosed about 10 years ago (2011). Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot number: EH9899) on 21Dec2020 at single dose for COVID-19 immunisation. The patient reported that a few days after receiving the 2nd dose (on 14Jan2021), she went into atrial fibrillation and had been having palpitations ever since. She had a cardiology appointment in a few weeks and they started her on apixaban (ELIQUIS). Lab data on 14Jan2021 included EKG: normal sinus and Kardiamobile (a medical grade ECG): it showed tachycardia and at least one other time showed atrial fibrillation, heart rate 141. The outcome of palpitations was not recovered, outcome of other events was unknown. Reporter seriousness for atrial fibrillation and palpitations was medically significant.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of  atrial fibrillation cannot be fully 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.  ,Linked Report(s) : US-PFIZER INC-2021111803 same reporter/drug, similar events, different patient
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/last dose & titer result was 8.1, indicating a low pos response;
Episode of weakness, syncope w/in 45 min of inject, followed by minor confusion;
Painful headaches started 7 days after receiving the vaccine. Ongoing uncomfortable pressure in the head. Ongoing painless, non-itching rash at injection site developed 11 days after receiving the vaccine.
Patient hospitalized due to COVID after being fully vaccinated. Tested positive on 4/26/2021.
This spontaneous report as received from a nurse refers to a 10 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 12-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Pt developed symptoms of COVID-19 and was placed on bedrest on 03/28/2021. The patient was sent to local ED on 04/01/2021 and then tested for COVID-19 with a positive result. Patient was intubated and placed on ventilator. Pt. spent 22 days in ICU. Pt expired on 04/22/2021 with cause of death listed as MODS and COVID-19 related PNA. Related causes of death were listed as HTN, DMII, and ARDS.
Nothing at the time of vaccination. Was diagnosed positive with Covid-19 on 02/02/2022. Test was recommended by PCP. No fever, just persistent cough. Isolated quarantine for 10 days. After 2 weeks cough persisted and Dr. prescribed Prednisone 30mg/3 days and taper down the next 6 days. Also prescribed 7 days taking 2ea/day Amoxicillin Clavulanate 875-125mg. With these medications cough improved considerably. A lingering effect after Covid-19 is that I get tired easily, although it is improving after taking the medications prescribed.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FISH OIL, MONASCUS PURPUREUS (RED YEAST RICE), OMEGA-3 NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D NOS, CALCIUM, ESCITALOPRAM OXALATE (LEXAPRO) and ATENOLOL for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 19-Feb-2021, VACCINATION SITE PAIN (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-023232 (Patient Link).; 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.
I received the PNEUMOVAX 23 vaccination in the left deltoid on October 5, 2018. The reaction started at around 3 pm with swelling and tightness and pain with redness around the site. It was very painful about a 7-8 on a 0-10 pain scale. The next day the redness had spread completely down my upper arm following my bicep and deltoid muscles. The site was swollen and white.
Pain in vaccine shot site; Headaches; This is a spontaneous report from a contactable consumer (patient).  A 19-year-old male patient, who is 19-year-old at the time of vaccination, received first dose of bnt162b2 (BNT162B2), lot number: EL9261, via an unspecified route of administration at Left arm on 28Jan2021 13:30 as SINGLE DOSE for COVID-19 immunization.  Medical history included Brain trauma injury. On 28Jan2021 16:00, the patient experienced Pain in vaccine shot site and headaches. The outcome of the events was recovered. Therapeutic measures were taken as a result of the events which includes Tylenol and Motrin.  No follow-up attempts are possible. No further information is expected.
AFib followed by numbness in face, leg, and foot. HeadAches, Muscle aches,
Vials of Pfizer COVID vaccine were stored in the refrigerator with a use-date expiration on 10/19 at 1:30pm. On 10/25, the patient was given their first dose of COVID vaccine from this vial.
Recurrence of cancer which had been in remission for over 20 years. Remission was detected 2-3 months after receiving the vaccination during routine chest X-ray. Extremely small unusual spot detected on the X-ray. Advised to have it checked in 3 months. Due to the history of cancer, had it biopsied immediately.
Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with the first dose of GARDASIL (Lot# and expiration not reported). The physician reported that the patient received GARDASIL and had an episode of fainting. It was unspecified if the patient sought medical attention. At the time of reporting the patient was recovering. No further information is available.
4.15pm Contacted by security in the facility  .Witness incident by PD.  Client passed out on grass.  H/O seizures . Received second dose of Pfizer at 1.05pm.  Dismissed from post vac at 1.36pm.   PD called 911.  4.25pm staff assessed client B/P  100/60.  Rt. arm, skin clammy.  Pulse 90.  R22.  #2 B/P 100/62,   Responding to simple command.  Oriented X2.  FD arrived to location at 4>34pm.  FD V/s BS 113.  B/P 104/96.   HR 122.  R. 22.   Hx of  Epilepsy.  Has not had Tegretol 600mg. po in more than 1 month.  No money to purchase medicines.  Unable to also eat adequately.  Client discharged to care of FD at 4.40pm.
I have had increased heart rate, including sustained episodes of fast-beating or fluttering. I have experienced prolong periods of fatigue, headaches and migraines, muscle pain, sleeplessness, brain fog, forgetfulness, and dizziness.
CHILLS, FEVER, INFLAMED AND RED SCLERA, LETHARGIC....SYMPTOMS BEGAN AROUND 6PM, LASTED MOST OF THE NIGHT, AND WERE SUBSIDING WHEN REPORTED TO PROVIDER AT 10:30AM ON 11/09/2010.
This spontaneous report as received from a physician assistant through the field representative refers to a 89 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX. Patient sought medical attention through trip to ER visit. Patient was treated with acyclovir and lyrica for the adverse event. No product quality complaint was involved. The outcome of event was reported as not recovered. The reporter causality was unknown. Additional information has been requested.
26OCT93 in the early evening mom reports that pt started crying, screaming & hyperventilating & this cont off & on all noc; t100 ax & was ok p/24 hrs & has had no problems since;
complete loss of hearing in left ear; vertigo; This is a spontaneous report from a contactable consumer (the patient).  A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 10Feb2021 (at the age of 72 years) (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation.  The patient previously took the first dose of bnt162b2, Lot number=EN3249, on 20Jan2021 at 13:00 (at the age of 72 years), in left arm for covid-19 immunisation. Vaccination was administered at Doctor's office. Medical history included high cholesterol, blood pressure increased, hypothyroidism, allergy to egg, spices, and ace inhibitors, all from an unknown date and unknown if ongoing. The patient received unspecified other medications administered in two weeks. No other vaccine administered in four weeks. No covid prior vaccination. Covid was not tested post vaccination. On 15Feb2021 at 14:30 the patient experienced complete loss of hearing in left ear and vertigo. The events required emergency room visit. Therapeutic measures taken as a result of the events included anti-nausea medications and medication for dizziness. The outcome of the events was not recovered.
On 06/19/22 I sort of had a scratchy throat, but we had just returned from a trip and I thought it was just allergies but when I woke up the next morning, I felt like I had been hit by a truck. I had a low grade fever of around 100.5-100.9 for three days. I also had a very bad headache and head congestion, a cough, and severe diarrhea. I took an at home COVID-19 test on 06/20/2022 which was positive. I called my doctor who advised that I cancel my upcoming travel plans and to treat my symptoms with over the counter medication. All together, my symptoms lasted at least a week.
Booster dose: Currently Covid positive; Booster dose: Currently Covid positive; Booster dose: About 15 minutes after receiving booster dose lost sensation in nose; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 28 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 16:00 (Lot number: FF2593) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia", start date: 2020 (ongoing), notes: Verbatim: Fibromyalgia, Additional Information for Other Conditions: Diagnosed with mid year of 2020. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: 27Feb2021, lot: EN6200, NDC: Unknown , Expiration: Unknown , Route of administration: left arm), administration date: 27Feb2021, when the patient was 27 years old, for COVID-19 immunization, reaction(s): "pain on the side of injection"; Bnt162b2 (Second dose: 20Mar2021, lot: ER2613, NDC: Unknown , Expiration: unknown , route of administration: left arm), administration date: 20Mar2021, when the patient was 27 years old, for COVID-19 Immunization, reaction(s): "pain on the side of injection", "Fever", "Malaise". The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "Booster dose: Currently Covid positive"; ANOSMIA (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster dose: About 15 minutes after receiving booster dose lost sensation in nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive.  Clinical information: It was reported that, unusual side effects after receiving the booster dose Adult Pfizer Covid 19 Vaccine. The caller had no side effects with the first and second dose Adult Pfizer Covid 19 Vaccine except for typical side effects. Currently Covid positive: The reason the caller is calling Pfizer now is when the caller got sick with Covid, the caller didn't realize had Covid. The caller did not test positive for Covid until 12Jan2022. The caller got sick with Covid one week before.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 6 year old male who on 26-MAY-2000, was vaccinated with subcutaneous Varivax. On 11-JAN_2006, the patient experienced mild breakthrough varicella. Subsequently, the patient recovered from mild breakthrough varicella. Additional information has been requested.
Expired second dose of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired second dose of Moderna vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired second dose of Moderna vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired second dose of Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial (lot 047B21A) was placed in the fridge on 14-Oct-2021 (expired on 09Oct2021). The reporter reported that the vial was in the refrigerator and it had not been compromised. There was no temperatures excursion. The vaccine was injected into the muscle. It was reported that patient had not experienced side effects. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Followup received, updated patient information and narrative.
nausea; headache; fatigue; fever; muscle ache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever) and MYALGIA (muscle ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever), MYALGIA (muscle ache) and PAIN IN EXTREMITY (sore arm). At the time of the report, NAUSEA (nausea), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever), MYALGIA (muscle ache) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment medications were not provided.   This case was linked to MOD-2021-058049 (Patient Link).   Reporter did not allow further contact
pt co fatigue over the weekend and then developed chest pressure and hypoxia per pt on 12/28/20
I started feeling achy with muscle pain, joint pain in my hips and back, and general malaise. I felt cold in the night, nauseous, and sweated profusely as I slept. I woke up on 4/21 with an intense headache that remained for much of the day, and on 4/21 my brain felt foggy and it was hard to think and process. I was very tired.
Patient complained that a small rash developed below the shoulder. Patient was instructed to take diphenhydramine to treat rash. Rash resolved within 24 hours.
pt recv vax; lt shoulder & neck soreness;began to feel nauseated;vomited;began to feel achy in knees,lt shoulder,lower back & neck;sweaty;dull HA,some light lightheadedness;
slight fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "slight fever".  Additional information: the reporter's brother had Pfizer and had a slight fever. The reporter considered the event as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.