chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STROKE; BRAIN BLEED; BRAIN FISTULA; VOMITING; HEADACHE; This spontaneous report received from a patient concerned a 53-year-old female. The patient's height, and weight were not reported. The patient's past medical history included hormone replacement therapy: bioidenticals, and surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 1 administered for prophylactic vaccination. Vaccination site was unknown. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, after two week of vaccination, the patient had a brain fistula which was considered as a stroke because it was a bleeding not a clot. She had really bad headache and was throwing up all night (vomiting). She called her primary health care physician they told her to visit hospital. First she went to the community hospital in her local city from where she was transferred to another hospital for surgery. The surgery occurred in first week of April. She was currently hospitalized. Number of days in hospital were unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, vomiting, brain fistula, brain bleed and stroke was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments:-covid-19 vaccine ad26.cov2.s-Haemorrhagic stroke . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt recv vax 10NOV97 & 13NOV97 pt exp a hypersensitivity/allerg rxn consisting of erythemic nodules over the entire body including the neck, chest, & arms;rash was reported as non-specific, w/no pain involved;sx worsened on 18NOV97;
Slight itchiness, but not numbness on upper lip area and lip line and nostrils; Slight itchiness, but not numbness the next day (today) on upper lip area and lip line and nostrils with 99.4F temp; Slight tingly/numb or dullness in face (forehead and cheeks) and maybe finger tips; Slight tingly/numb or dullness in face (forehead and cheeks) and may be finger tips; Raised heart rate in the evening; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 26Apr2021 at 09:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN) and ethinylestradiol/levonorgestrel (CHATEAL); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received sertraline hydrochloride (ZOLOFT) on an unknown date for an unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EE0151) via an unspecified route of administration in the left arm on 05Apr2021 at 09:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Apr2021 at 17:00, about 7 hours after shot, the patient experienced slight tingly/numb or dullness in face (forehead and cheeks) and maybe finger tips and raised heart rate in the evening. On 27Apr2021, next day of vaccination, the patient experienced slight itchiness, but not numbness on upper lip area and lip line and nostrils with 99.4 degrees Fahrenheit temperature. On 27Apr2021, the patient underwent lab test which included body temperature test and the result was found to be 99.4 degrees Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events slight tingly/numb or dullness in face (forehead and cheeks) and may be finger tips, raised heart rate, slight itchiness, but not numbness on upper lip area and lip line and nostrils with 99.4 degrees Fahrenheit temperature were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Arm pain following administration of PNEUMOVAX 23. Patient's wife reported that the pain started shortly after receiving the vaccination and initially the pain was localized to the injection site (left deltoid) but developed later to extend to cover the whole arm from shoulder to hand.
The 1st 3 doses of Anthrax in 1999 caused small / mild local reactions. During and after last 3 doses in 2000 noted worsening lt shoulder / scapular region pain and muscle spasm.  Follow up on 05/31/2001: "Patient partially recovered from adverse event.  lack of energy/constant tiredness, malaise, reduced concentration, short term memory loss."
6 days after the vaccine, patient reported feeling problematic nasal congestion. We gave him a cetirizine and started him on Flonase. The next day, he reported ongoing symptoms, so he repeated the actions from the day prior. By mid day, he was still feeling puny, so we took him to an urgent care for evaluation. I asked for a PCR COVID nasal swab (which they performed by swabbing both nostrils), and they diagnosed him with a viral illness as he was afebrile. I gave him some Flu and Cold med (acetaminophen, dextromethorphan and phenlyephrine) and checked his temp, which was 100.4F. I left the house for the afternoon and returned hours later. He was laying on the couch, still looking pretty sick. I rechecked his temp and it was 102.3F. He was easily arousable and took fluids, and reported eating a bowl of noodles and drinking a protein shake earlier, so I let him sleep some more. As of writing this form, he has a temp of 103F, still taking fluids easily, intermittently coughing , denies sinus pressure/pain.  I'm still thinking it's a viral illness, but since he had COVID shot in the past 7 days I thought I'd report this reaction.
Parent describes pain left arm at site of injection immediately after receiving immunization. Pain slowly up arm, shoulder neck and head. Headache began 2 hours after injection. Compresses applied to injection site and Ibuprofen taken. Began vomiting x2 at 2AM. 11AM Now pale and doesn't feel right. Taking liquids and solid foods without further vomiting. Denies hives or itching. Has pain neck, head and arm. No vomiting; has nausea. reports "gland" left side under chin tender and swollen. Left arm can feel knot at site of injection when massage site. Swelling size of baseball; left arm at injection site.
Called on 12/14/11 to report itching & rash to BLE following day of injection (12/8). "Red dots, itches, below knee, shin, primarily at sock line". Denies any other symptoms. Instructed to apply BENADRYL or take po. Has scheduled Dr. appt.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
sore left arm; sore left hip; Sniffles; Trouble sleeping; Tired; Tender and swollen under left arm; Tender and swollen under left arm; Shot # 3- Booster; Shot # 3- Booster; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 3180), via an unspecified route of administration, administered in Left arm on 16Aug2021 16:30 at the age of 45-years-old as dose 3, single for covid-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medications included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported received within 2 weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on an unspecified date as single dose and second dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 6201), via an unspecified route of administration, administered in Left arm on 24Mar2021 08:15 at the age of 44-years-old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 17Aug2021. On 16Aug2021 at 16:30, the patient experienced shot # 3- booster (off label use), shot # 3- booster (extra dose administered) and on 16Aug2021 at 21:00, the patient experienced sore left arm, sore left hip, sniffles, trouble sleeping, tired, tender and swollen under left arm. No treatment was received for adverse events. The case was reported as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of events was unknown.  Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.
Nausea, headache, body ache, lethargic, diarrhea that have lasted every day for the past 30 days.
Mother called the health department yesterday to report that patient's right arm was reddened, swollen, warm to touch, and painful at the site of the Varivax that was administered on 9/24.  The reaction did not appear until yesterday morning.  Denies fever.  She was referred to pediatrician for advice.  PCP would not give advice over the phone without an appointment with the physician.   Patient is a student.  A nurse there looked at the site yesterday and determined that it appeared to be a normal but pronounced inflammation from the vaccine.  According to mother this morning the area appeared much less reddened, much less swollen.  Patient reported to her that it is also much less painful today.
GBS w/pain,imbalance,areflexia,mild quadriparalysis,onset 3DEC95;tx w/plasmapheresis;pt has improved
Case, reference number 1999016507, is a spontaneous case from a wife/physician assistant referring to her 61 year old husband. No known drug allergies. The patient has hypertension and takes blood pressure medications (nos), anti-inflammatories (nos) and Vicodin.  On 05/08/98, the pt received his first dose of Havrix for prophalayxis of Hep A. Subsequently, in 1998, he experienced alopecia. No treatment was given. Havrix was discontinued. The latest information, received on 07/01/99, reported the condition of the pt is not yet recovered.
Fatigue, headache, nausea, and muscle soreness lasting about 36 hours. Took ibuprofen.
2 days post vax, pt experienced swelling of face and eyes, slight shortness of breath,and legs and back ached.  On the third day pt went to ER and got some "little orange pills", (does not know name) for swelling. After 3 - 6 days pt recovered.
This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been received from a nurse practitioner concerning a 26 year old female with no pertinent medical history who on 18-DEC-2006 was vaccinated intramuscularly, into the left deltoid with a first 0.5 ml dose of Gardasil (lot # "0604F"). Concomitant therapy included vitamins (unspecified). On 18-DEC-2006 the patient experienced soreness at the injection site, sacral back pain, mild low abdominal cramping, nausea, generalized itchiness, mild dizziness and "felt feverish with chills." Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. The patient recovered in 1 week without treatment. Additional information has been requested.
myalgia; extreme fatigue; felt so bad, didn't want to get the second dose; This case was reported by a physician via sales rep and described the occurrence of myalgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia, fatigue and feeling bad. On an unknown date, the outcome of the myalgia, fatigue and feeling bad were recovered/resolved.   It was unknown if the reporter considered the myalgia, fatigue and feeling bad to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself, who was also the physician.  The age at vaccination was not reported. Patient received 1st dose of Shingrix and experienced myalgia, extreme fatigue and felt so bad symptoms persisted for about 3 to 4 days. Patient didn't want to get the second dose.
After receiving ZOSTAVAX vaccine on 3/15/15, pt. developed swelling, tenderness, heat at site of injection. Pt. consulted with his MD, and MD diagnosed as skin infection and prescribed a course of antibiotics to treat.
Patient received Pfizer dose as he needed to receive Pfizer 12+. Patient did not have any Adverse reaction.
Tinnitus constantly since the day following the second dose.  Worse at night and when tired.  Never experienced it before vaccinations.  It affects ability to relax and sleep.
incorrect dose in series given. Bivalent dose #3 given instead of dose #1 in series
@10:48am Patient reported chest tightness and face numbness right after receiving the vaccine, c/o headache and that she felt like she was rocking.  Benadryl was given, @10:51am provider evaluated patient and after 45 minutes of observation patient was still not feeling well. 11:25am
17MAY91 began having pain in rt hip; 20MAY91 began to have swelling knees, pain in shoulders, elbows & neck; 23MAY seen by MD began taking ASA; Advised to discontinue running; Fingers & elbows inc soreness;
Fever; felt really bad; Pain in the injection site; A spontaneous report was received from a Consumer concerning a 71 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- pyrexia, vaccination site pain and malaise.   The patient's medical history was not provided. Patient was taking cholesterol pills as concomitant medication.    On 19/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection.  Patient reported she received the first dose of the Moderna covid-19 vaccine on 19Jan2021 at 12:15 am and mentioned she felt really bad on 20 Jan 2021, she has fever 101 °F on 19 Jan 2021 and pain in the injection site (left arm) on 19 Jan 2021.  Laboratory data include- She was having fever, 101°F.  Patient did not take any medications for treatment for the events.  Action taken with mRNA-1273 in response to the events was not reported.   On the reported date, the outcome of the events, fever, pain at the injection site and malaise were unknown.
A total of eight pts had local reactions following vax; 1 of the eight pts exp swollen lymph nodes in arm; no treatment initiated; required ER/MD visit;
I have monocular disturbance in the left eye. There is an ongoing discomfort. I have visual movements that cross paths. I have had 2 appts with my eye doctor and 1 doctor with my PCP. There is no detached retina or glaucoma. I had a follow up last week. There is no other medical reason for this. This is impacting my well being. I can not see as I usually do. Once I had the 4th dose of Pfizer on 4/2/2022 lot number FK9893, my eye issues became much more worse.
Local erythema, Pain, edema "like a softball".  Fever reported up to 103.4.  Ibuprofen and warm pak.  Temp 102 next day and normal day after that.  One episode of emesis.  Wt down 2 pounds.
Wrong dose has been given for a booster vaccine. They were given a dose of 0.5mL instead of 0.3mL
p/vax pt exp joint pain, diarrhea & flu like sx but ultimately devel an iritis in lt eye;no prev eyes illness history;flu likes aches, pain @the site of inj;gastrointestinal distress, flatulence & diarrhea;
Fever started within a couple of hours the first night, didn't take temp during night but could feel that it was VERY hot.  Extreme arm pain thru night and achy.  Next day,  fever of  just under 100o (my normal is 97.6) all day (didn't take any pain relievers or fever reducer), exhaustion, achy, felt yucky. fever started to go down very slightly until normal by bedtime.   Next morning: no appetite, fever gone, exhaustion and less arm discomfort.  Today
p/vax pt exp a pruritic, fine, pink papular rash on anterior thighs bilat & on entire circumference of the ankles;10/1/98 pt exp inj site redness, warmth, swelling & pruritus;tx w/DPH & hydrocortisone cream;
Lips swelling approx 3 hours after vaccine administration. No itching, no redness, no SOB.
Patient started new blood pressure medication this morning. Vitals at beginning of ADR: BP 91/56, HR 66 therefore, rapid response called, vitals were BP 105/67, HR 73.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. This patient had not reported any symptoms or side effects. The vial does not undergo any temperature excursions. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2022: Follow-up received includes No new information. On 15-Jul-2022: Follow-up received includes No new information.
Swelling, erythema and urticarial lesions on the thigh all around the vaccination site - swelling encompassed the entire thigh. Recommended BENADRYL.
Vaccine administered about 24 hours after 1st puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered about 24 hours after 1st puncture) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03acz1a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered about 24 hours after 1st puncture). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered about 24 hours after 1st puncture) 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 and treatment medications were reported.
Vaccine 10/23/09 at 140 pm and adverse event 10/25/09 AM.  Woman is unsure if laid on her neck wrong or if from vaccine.  All sx resolved in 2 days. On 11/9 sx returned.
headaches; This is a spontaneous report from a contactable consumer (patient).  An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she took the Covid shot number one and a couple days later I got headaches. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
bad kidney pain; bladder is swollen; kidneys swollen; wasn't able too fight off allergies; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (bad kidney pain), BLADDER HYPERTROPHY (bladder is swollen), KIDNEY ENLARGEMENT (kidneys swollen) and HYPERSENSITIVITY (wasn't able too fight off allergies) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney infection (Kidney was septic) in October 2019.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL PAIN (bad kidney pain), BLADDER HYPERTROPHY (bladder is swollen), KIDNEY ENLARGEMENT (kidneys swollen) and HYPERSENSITIVITY (wasn't able too fight off allergies). At the time of the report, RENAL PAIN (bad kidney pain), BLADDER HYPERTROPHY (bladder is swollen), KIDNEY ENLARGEMENT (kidneys swollen) and HYPERSENSITIVITY (wasn't able too fight off allergies) outcome was unknown.            Concomitant drug was not reported.  Treatment medication included antibiotics for 7 days tid.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Added events swelling and hypersensitivity.
Information has been received from a physician and via medical records. A 45 year old male with gastroesophageal reflux disease, irritable bowel syndrome, allergy to SKELAXIN and IMITREX, migraine and a history of hernia repair, was vaccinated with a dose of PNEUMOVAX vaccine  (lot # 662599/1076X) 0.5ml, IM into his right deltoid on 05-FEB-2009 at 8:45 am. At time of vaccination, the patient had polycythemia. On 06-FEB-2009 the patient complained of streaking of the skin and pain with movement of the right shoulder. On 07-FEB-2009, the patient went to the emergency room and presented with redness and pain on the right biceps and was given KEFLEX. On 10-FEB-2009, the patient denied fever, chills and sweats, nausea, vomiting and diarrhea, shortness of breath and chest pain. On the same day, physical examination resulted normal. Heart rate was 80 and blood pressure measurement was 130/80 and 110/70. Total heartbeat count was 80. The patient's body temperature was 88.2. The  patient was diagnosed with right shoulder cellulitis. The patient was recovering from cellulitis and was asked to continue with antibiotics until finished. The patient was advised to use warm compress and to return to office if symptoms return. The patient's GERD and IBS were stable. It was reported that the patient was not in medication for GERD and IBS. No further information is available.