chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had time to walk to designated area, sit down and then I was being dragged out by someone on each arm and taken to emergency room. I do not remember anything at all (3 days) until I woke up with one of my coworkers praying at the side of my bed. I have spoke to many Reps, private doctors and ENT's concerning this matter. I feel as if no one can answer my questions or they do not want to get involved. I have been looking for answers for several years. I am submitting this information to you: As I do not know that it ever has been. I was told they almost killed me by attending nurses. I feel it should be know to you. I have refused any other vaccinations since age 17. At my current age and health I feel I should receive common vaccinations but fear them. To ask at my current age 54 should I fear necessary vaccinations. To ask if this situation could be responsible for or contribute to my consistent sinus, ear, teeth and heart problems I have developed since then. Any information or guidance you may provide in this situation would be greatly appreciated.
Fever; Headache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8730 and Expiration date: Unknown) via an unspecified route, administered in Left Deltoid on 04May2021 at 09:00 (69-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. The patient's medical history included COVID-19; he had the virus at one point previously in Jan2021. No family medical history, concomitant medications were reported. The patient had no history of all previous immunizations with the Pfizer vaccine. The patient was not administered with additional vaccines on same date of the Pfizer vaccine or within 4 weeks prior to vaccination. The patient had not experienced any AEs prior vaccination. The patient was not report related to a study or programme. The reporter mentioned that he got the shot and experienced some side effects. On 05May2021(Wednesday morning), he mentioned he had a fever and headaches. He also mentioned he had the virus at one point. He was calling to find out if these symptoms are normal. No investigation assessment was reported. No relevant test was reported. These adverse events did not result the patient to Emergency Room/ Physician's Office visit. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information was expected.
11/11 at approx 1850  Pt c/o not feeling well, stating she couldn't breathe.  Pulse 166, BP 139/89, O2 sat 79% on supplemental O2- transferred to emergency room via EMS,   follow up call placed to hospital later in the evening to check status- rec'd report from hospital staff that she was being admitted with bilat PE
Patient was administered a vaccine that was expired on 06/10/2023. No allergic reactions were noted at 10 minutes. Provider was informed and incident report was reported to clinic.
EXTREME ACHES,WEAKNESS, SLIGHT FEVER, LETHARGY, RUNNY NOSE.
One day post vax pt complained of headache, tired, lack of appetite, drinking fluids. Pt came to office with temperature of 100.7. Two days post vax temperature 101 during night - called clinic and talked to nurse; advised to give DT only due to high temperature and vomiting.
Upper respiratory with loss of voice completely  Worsening Crohn?s symptoms including RLQ pain, diarrhea, and fatigue. Started a few days after 2nd dose, still occurring as of right this moment .
Case number PHEH2015US06992, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 23 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) in left deltoid on 07 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Information has been received from a health care worker concerning a 70 year old female with  high cholesterol,  seasonal allergies, no food or drug allergies and a history of a prior immunization with pneumococcal 23v vaccine in 2000. On 01-NOV-2004 the patient was vaccinated with the second dose of pneumococcal 23v vaccine.  Concomitant therapy included risedronate sodium (ACTONEL), aspirin, unspecified vitamins, atorvastatin calcium (LIPITOR) and triamcinolone acetomise (NASOCORT).  On 02-NOV-2004 the patient developed redness, swelling and burning of injection site area.  The patient sought unspecified medical attention.  The events subsided in a few days with no treatment requires.  Additional information has been requested.
fever; sore arm; Periods have stopped; developed irregular spotting; prev dose administration date=26Jun2021, prev dose dose number=2,; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Jun2021 (Lot number: FA9091) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot_number=EX0904,, administrator route=Intramuscular,, DOSE 1, SINGLE, anatomical location=Left arm), administration date: 06Apr2021, when the patient was 40 years old, for COVID-19 Immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; AMENORRHOEA (non-serious), outcome "unknown", described as "Periods have stopped"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "developed irregular spotting"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "prev dose administration date=26Jun2021, prev dose dose number=2,". The events "fever", "sore arm", "periods have stopped" and "prev dose administration date=26jun2021, prev dose dose number=2," were evaluated at the physician office visit. Therapeutic measures were taken as a result of pyrexia. It was unknown if therapeutic measures were taken as a result of pain in extremity, amenorrhoea, menstruation irregular, inappropriate schedule of product administration.  Additional information: The patient had no to very mild immediate side effects: sore arm, fever (controlled by Tylenol in 2 hours) after second dose. The patient noticed that since 2nd dose and especially after booster she found a connection in affecting her menstrual cycle. Periods have stopped and developed irregular spotting. The patient did not have covid prior vaccination. The patient did not test covid post vaccination. There were no known allergies and there was no other medical history.  Follow-up attempts are completed. No further information is expected.
Delivered at 33-34 wks gestation.  Was vaccinated during pregnancy.  LMP ? May or June on depo.  Has been registered in registry.  Symptom: Amenorrhea.  Start: 06/2007
Breakthrough COVID-19 infection; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (breakthrough COVID-19 infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Antibody Response six months after SARS-CoV-2 mRNA Vaccination in patients with inflammatory bowel disease. Clinical Gastroenterology and Hepatology. Concurrent medical conditions included Inflammatory bowel disease. Concomitant products included IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) and MESALAMINE for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (breakthrough COVID-19 infection) (seriousness criterion medically significant). At the time of the report, COVID-19 (breakthrough COVID-19 infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (breakthrough COVID-19 infection) to be related. Concomitant medication included glucocorticoids. Treatment information were not reported. One patient had breakthrough COVID-19 infection two months after Moderna vaccine was on immunosuppressive regimen. Company comment: This is a literature case concerning a patient of unknown age and gender, with concomitant treatment with immunosuppressive regimen, who experienced the serious (due to medically important condition) unexpected, AESI of COVID-19. The event occurred approximately 2 months after the mRNA-1273 vaccine, dose number not provided. The outcome of the event was not reported. The rechallenge was not applicable. The concomitant treatment with immunosuppressive regimen remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a literature case concerning a patient of unknown age and gender, with concomitant treatment with immunosuppressive regimen, who experienced the serious (due to medically important condition) unexpected, AESI of COVID-19. The event occurred approximately 2 months after the mRNA-1273 vaccine, dose number not provided. The outcome of the event was not reported. The rechallenge was not applicable. The concomitant treatment with immunosuppressive regimen remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Previously I had contracted the Covid-19 virus on Jan 13th, 2021, I lost my sense of smell for 5 days but it returned without any issues and I had only minimal symptoms.   About 2 weeks post first Covid Pfizer vaccination April 22nd, 2021: -I experienced a terrible headache and stomach pain like none I had ever had before 10/10 pain scale. -I took 2 tablets of 500 mg of acetaminophen to treat the pain but it had no effect. After 8 hours past I then took 3 tablets of 200 mg ibuprofen which still had no response to pain.  -The following day my sense of smell was off and still is. It's like a rancid smell? I gave it some time to see if it would go away but it is still present. -I am also experiencing irregularities in my menstrual cycle such as heavy bleeding and very large clots (2-3 in in size). It has made me unable to go about my daily activities and I've been extremely fatigued. I've never had this issue previously and am not on any kind of medications or birth control.
pt recvd vax; muscle atropy at inject site; depression in skin; to MD 21jan93;
Neck was stiff and back of head/left side jaw/lips were numb and tingly on Thursday, 2/4. Tingly and numbness went away by Friday, 2/5. Neck stiffness and sore back lasted until Tuesday, 2/9.  Patient called on-call doctor and her PCP office and was informed to take Benadryl, but that did not help...patient took ibuprofen and reports that it helped reduce symptoms.
Initial report received on 25 September 2013 from a pharmacist. A 65 year old female patient appeared pale and had bloodshot eyes after receiving FLUZONE HIGH DOSE. On 20-Sep-2013, the patient had received FLUZONE HD (lot # U4718AA and expiration date 14-Apr-2014) on left deltoid. Four hours after receiving the vaccine the patient appeared pale and had bloodshot eyes. She went to the emergency room for evaluation. She did and they told her that they thought it was an adverse reaction to the vaccine and sent her home. The patient was discharged from the emergency room (ER). The pharmacist reported that she was doing well now. The outcome of the event was recovered. List of documents held by sender: none.
Had a febrile seizure late afternoon after her flu vaccine in the AM.  Temp @ time of seizure 101.
Immediately after shot the back of the hand got a little red, but was fine; skin feels itchy, it´s a mild itchiness, no rash; The entire body itches, including skull and face, inside vagina; "It bothers me", didn't sleep very well; the throat is a little sore; pain in injection site; felt fatigue yesterday; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Immediately after shot the back of the hand got a little red, but was fine), PRURITUS (skin feels itchy, it´s a mild itchiness, no rash), PRURITUS (The entire body itches, including skull and face, inside vagina), POOR QUALITY SLEEP ("It bothers me", didn't sleep very well) and OROPHARYNGEAL PAIN (the throat is a little sore) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Cholesterol, Arthritis, Osteopenia and Dry skin. Concomitant products included NAPROXEN for Arthritis, ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for Cholesterol, AVENA SATIVA, MELALEUCA ALTERNIFOLIA OIL (AVENO [AVENA SATIVA;MELALEUCA ALTERNIFOLIA OIL]) for Dry skin, ATENOLOL for Hypertension, VITAMIN D2 for Osteopenia.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced ERYTHEMA (Immediately after shot the back of the hand got a little red, but was fine), PRURITUS (skin feels itchy, it´s a mild itchiness, no rash), PRURITUS (The entire body itches, including skull and face, inside vagina), POOR QUALITY SLEEP ("It bothers me", didn't sleep very well), OROPHARYNGEAL PAIN (the throat is a little sore), VACCINATION SITE PAIN (pain in injection site) and FATIGUE (felt fatigue yesterday). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 25-Jan-2021, FATIGUE (felt fatigue yesterday) outcome was unknown. At the time of the report, ERYTHEMA (Immediately after shot the back of the hand got a little red, but was fine), PRURITUS (skin feels itchy, it´s a mild itchiness, no rash), PRURITUS (The entire body itches, including skull and face, inside vagina), POOR QUALITY SLEEP ("It bothers me", didn't sleep very well), OROPHARYNGEAL PAIN (the throat is a little sore) and VACCINATION SITE PAIN (pain in injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included multivitamin B complex and gyngko.
Approximately 12 hours after receiving the second injection I awoke at 2:00AM with uncontrollable full body shaking to the extent I could not use my phone to call anyone for help. I was absolutely unable to care for myself. The shaking continued for several hours subsiding for a brief period before the chills and nausea began. The pattern of extreme shaking, chills and nausea continued for 12 hours. I am naturally hot natured and keep my thermostat at 63-65 degrees F. The chills were so intense I increased the heat to 70 degrees F and required 8 blankets for relief. I never had an elevated temperature. A few hours later in addition to the chills and nausea,  a headache began than morphed into a full migraine that lasted approximately 24 hours before returning to a regular headache. My upper arm felt as if I had been beaten with a baseball bat and could not lift above my head. Approximately 48 hours after the initial side effects commenced I awoke fully drenched in sweat, no elevated temperature and completely exhausted. I knew in advance of the possibility of side effects but not to the severity I experienced.
Patient became light headed and briefly lost conciousness following vaccine administration. Regained conciousness shortly after. Patient was provided a coke for sugar.
On 530 DTP/HIB immun given; pt devel rash all over body & fever of102; Began vomiting; Taken to ER, mom advised to give pt APAP; rash gone 1wk later; Discontinue HIB/DTP; to be given ped DT;
Patient was having nausea that was coming and going. Injection site was sore.  On 09/10/2014 patient's mother called back stating that patient was running fever 102.5 with vomiting. Patient's mother also stated that 1st Vaccine given on 07/07/2014 patient did have severe pain in neck and arm. Patient did not report this at time of onset symptoms.
Myalgia, Arthralgia, chills, body shakes Narrative: onset of above s/s within 10 hours of vaccine.
her mother / experienced a fever of 102.5F; This case was reported by a pharmacist and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient was reporter's mother. The age at vaccination was not reported. The patient received vaccine under the watch and experienced a fever of 102.5 degree Fahrenheit, 2 weeks following administration. The reporter consented to follow-up.
had Shingles, then after Shingles vaccine/suspected vaccination failure; had Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shingles, then after shingles vaccine. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Person went to car for 15 minute wait period with partner.  Began feeling faint upon sitting down.  Per partner, had a brief syncopal episode (less than 30 seconds).  On site EMT's summoned.  Found patient pale.  BP initially 70/0 P48.  Moved patient to a cot supine and gave O2 2L via nasal cannula.  BP came up to 110/80 and 5 minutes later was 130/90 with P 68.  Color returned.  Another 5 minutes sat patient up, BP 140/90, remained consistent when standing.  Pt. stated he was had panic attacks and this felt like one. Was anxious about shot before arriving.  This was a typical reaction for him.
low grade fever, 99 degrees Fahrenheit starting the day following injection, lasting 1 day; Fatigue, moderate, lasting 1 day; Headache, moderate, lasting 1 day; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown) at the hospital, via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 28Dec2020, the patient experienced fatigue, moderate, lasting 1 day, headache, moderate, lasting 1 day, and low grade fever, 99 degrees Fahrenheit starting the day following injection, lasting 1 day. The events were considered as non-serious. No treatment was received for the events. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. It was also unknown if patient has been tested for COVID-19 since the vaccination. The events recovered on 29Dec2020.  Information about batch/lot number has been requested.
Patient recieved 2nd dose and reported immediately feeling dizzy and like his heart was racing.   He stated he had a history of hypertension and an hypertensive episode a few days after his first dose.   pt was taken to Med Obs for assessment.  His initial BP was 192/106, HR 74.  He reported "shaky" vision.   Pt rested on the stretcher and tried to relax.  His BP remained elevated.   He eventually denied feeling bad and wanted to go home.   We told him it was highly advised that he go to the ER via ambulance.  Pt refused and walked out of clinic on his own accord.
Near killed my; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced near death experience (Verbatim: Near killed my) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine.     It was unknown if the company considered the near death experience to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by the patient via interactive digital media. The patient received the Shingles shot last week from reporting and reported that never again and dam near killed his/her (unspecified). Follow-up would not possible as no contact details were available.
Sore arm; Didn't sleep well; Wasn't feeling well; headache; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), POOR QUALITY SLEEP (Didn't sleep well), MALAISE (Wasn't feeling well), HEADACHE (headache) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism, Acid reflux (oesophageal), Penicillin allergy and Drug allergy (Allergic to Sulfa drug and Zofran.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and PANTOPRAZOLE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), POOR QUALITY SLEEP (Didn't sleep well), MALAISE (Wasn't feeling well), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (Sore arm), POOR QUALITY SLEEP (Didn't sleep well), MALAISE (Wasn't feeling well), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.            Treatment medication was not reported.   This case was linked to MOD-2021-024115 (Patient Link).