chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very tired; Body aches; Cannot stay awake; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included slight hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included paracetamol (TYLENOL), lisinopril (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), vitamin D NOS (MANUFACTURER UNKNOWN) and lisdexamfetamine mesilate (VYVANSE); all for an unspecified indication from unknown date and unknown if ongoing. The patient previously received morphine (MANUFACTURER UNKNOWN) and azithromycin (ZITHROMAX) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 17:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021 at 10:15, the patient experienced very tiredness, body aches and cannot stay awake. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tiredness, body aches and cannot stay awake were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient felt dizzy 15 minutes after receiving the Pfizer vaccine on 1/26. Her BP and pulse continued to elevated and she stated that she was short of breath.  I contacted our rapid response team and she was transported to the ED for evaluation.
Developed runny nose, sneezing, muscle aches/joint pain, nausea, scratchy throat, sinus pressure, rash on chest/neck, fatigue. Saw medical provider on 2/02/2021 who suspected above due to receiving 1st dose of covid-19 vaccine.
Woke up this morning with the what feels like the onset of a sinus infection and headache possibly caused by the flumist.
chills, tired.  toes cramped up several days in a row after shot.  Very hard to get the cramp out of toe
low grade fever, body aches, chills, fatigue; all symptoms resolved within 18 hours
The pt. developed a fever the day after vaccines were administered. The fever was 102 and lasted for five days. It resolved on 5/4/10. On 5/3/10, the child developed erythematous, macular rash to trunk & diaper area.
covid vaccine breakthrough case   dose 1 Pfizer 1/28/21 EL9261 dose 2 Pfizer 2/18/21 EL9265
THE PATIENT EXPERIENCE A FEW DAYS AFTER THE INJECTION A DISSEMINATED RED CIRCULAR RASH ON HER BACK AND CHEST.  SHE APPLIED TRIAMCINOLONE CREAM 0.1%  AND THE RASH DISAPPEARED WITHIN 7 DAYS.
No adverse event; Dose administered after 30-day Use by Date to 7 patients; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients).    No concomitant medications were reported.  No treatment information was provided.  This case was reported for patient 7 of 7 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-721391 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721391:Patient 1 out of 7 patients
Pt reports he had Zostavax at hospital Nov 07. Presents to this clinic 12-29-07 - reports started noticing shingles 2 or 3 weeks ago - confirmed by doctor - active shingles noted.
79-year-old male multiple medical problems who presents with complaint of generalized weakness.  Per ER report patient said generalized weakness for the past 10 days.  Patient was recently seen in the emergency department approximately 3 days ago for similar complaint.  Patient found to be Covid positive.  Patient not eating or drinking at home.  EMS was called patient was found to have a glucose of 52.  Amp of D50.  Patient was given another amp of D50 in the emergency department.  At this time patient denies headache or acute visual change.  Patient drowsy but improving.  There is no chest pain shortness of breath or palpitations.  There is no abdominal pain, nausea vomiting.  No history of fever chills or rigors.  Patient has no other concerns.  Patient to be admitted for further evaluation.
Felt tightness in his throat; Felt soreness in his throat; Very slight associated difficulty breathing; tongue was little swollen; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of THROAT TIGHTNESS (Felt tightness in his throat), OROPHARYNGEAL PAIN (Felt soreness in his throat), DYSPNOEA (Very slight associated difficulty breathing) and SWOLLEN TONGUE (tongue was little swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced THROAT TIGHTNESS (Felt tightness in his throat), OROPHARYNGEAL PAIN (Felt soreness in his throat), DYSPNOEA (Very slight associated difficulty breathing) and SWOLLEN TONGUE (tongue was little swollen). At the time of the report, THROAT TIGHTNESS (Felt tightness in his throat), OROPHARYNGEAL PAIN (Felt soreness in his throat), DYSPNOEA (Very slight associated difficulty breathing) and SWOLLEN TONGUE (tongue was little swollen) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Blood pressure measurement: 164/108 mmHg ten minutes after vaccination and 128/98 mmHg ninety minutes after vaccination. On 06-Jan-2021, Heart rate: 110 heart beats per minute ten minutes after vaccination and 65 heart beats per minute ninety minutes after vaccination. On 06-Jan-2021, Oxygen saturation: 94 percent thirty minutes after vaccination and 96-98 percent ninety minutes after vaccination.     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.   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.; Reporter'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 first developed heart problems and seizures, then horrible digestion problems, chronic neurological Lyme disease, PCOS, and Endometriosis all after receiving this vaccine. I had no previous food allergies or medical conditions.
Itchy rash all over body; Dizziness; Nausea; Fever; Chills; Headache; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Aug2021 at 09:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included anemic. The patient had no known allergies to medications, food or other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Aug2021 at 11:00, the patient experienced itchy rash all over body, dizziness, nausea, fever, chills and headache. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with Benadryl. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy rash all over body, dizziness, nausea, fever, chills and headache was recovering at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
spots around the left eye; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and RASH MACULAR (spots around the left eye) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 28-Jan-2021, the patient experienced RASH MACULAR (spots around the left eye). At the time of the report, PAIN IN EXTREMITY (Sore arm) and RASH MACULAR (spots around the left eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Follow-up contains non significant  information.
PATIENT WAS UNDER AGE TO RECEIVE THE VACCINE, RN ADMITS THEY MADE A MATH ERROR CALCULATING THE AGE OF THE PATIENT. PT DID NOT HAVE ANY SIGNS OR SYMPTOMS OF ALLERGIC REACTION.
4x6 cm redness and warmth to left leg.  Treated with heat/ice.
after taking the second dose and booster dose, she had the COVID arm - red, hot, itching, bumps, not blisters; shaking [after second and booster doses]; Within 24 hours, she got fever between 100-101 [after second and booster doses]; chills [after second and booster doses]; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (after taking the second dose and booster dose, she had the COVID arm - red, hot, itching, bumps, not blisters), TREMOR (shaking [after second and booster doses]), PYREXIA (Within 24 hours, she got fever between 100-101 [after second and booster doses]) and CHILLS (chills [after second and booster doses]) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (had codeine allergy), Drug allergy (had sulfa allergy), Drug allergy (had Ultram allergy), Hypertension (from 20 years ago) and Osteoarthritis (from 15 years).   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE REACTION (after taking the second dose and booster dose, she had the COVID arm - red, hot, itching, bumps, not blisters), TREMOR (shaking [after second and booster doses]), PYREXIA (Within 24 hours, she got fever between 100-101 [after second and booster doses]) and CHILLS (chills [after second and booster doses]). In March 2021, VACCINATION SITE REACTION (after taking the second dose and booster dose, she had the COVID arm - red, hot, itching, bumps, not blisters), TREMOR (shaking [after second and booster doses]), PYREXIA (Within 24 hours, she got fever between 100-101 [after second and booster doses]) and CHILLS (chills [after second and booster doses]) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 100-101 100-101.         No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-481278 (Patient Link).
At injection site in L/thigh, developed a hard, rounded mass, tender, deep to the dermis, not resolved yet.
L upper arm firm, swollen and tender. Not hot to touch. Cool compresses, ibuprofen 800mg TID, rest.
Patient stated that more than normal aches, pains and nausea compared to previous years with influenza vaccine. Patient has developed a non-uniform (asymmetric) welt approx. 6 inches below injection site.
I had a headache the evening after receiving my injection. It?s very rare that I get headaches so I feel it?s associated with the vaccine. The next morning I felt a bit strange, almost like a dizzy sensation in my head that dissipated by the evening. I was still able to move about and do everything I needed to do without difficulty.
Rash described by mom as extending from top of arm to elbow "hive like rash" (mild pink flat non-itchy rash with swelling on arm. Rash gone by afternoon Sunday. Only on face of arm not on sides.
PAIN IN GROIN, RIGHT LEG AND SOME TIMES IN LEFT LEG AND RIGHT KNEE. GOING TO SEE DOCTOR TODAY
10 days after vaccine administration went to ER not feeling well, had pneumonia. Admitted on 2-2-10, released 2-12-10.
Blacking out, racing heart, felt like a heart attack, severe rash, approx leads than 20 hours after booster.
Patient noticed a hive like outbreak in left armpit.  Denies itchy, pain, no fevers.  Area was warm to touch.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient received bnt162b2 (BNT162B2), on 09Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 24 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
PT. Presented w/ Facia iching and slight Redness on upper chest. PT. was A/Ox4 & vital signs Taken x3. On site Dr. gave 25 mg OF Benedryl AFTerabout 20min Redness & Ichig disapared. PT .was monitored For a ToTal OF 40 min and discharged home. PT. was Told TO SEEK additenol medical attetion IF needed Facial itching Starting about 20 min after vaccine Redness around NeCK and upper chest. PT. was moved TO Private are For monitorig PT. was monitored w/ vital signs. PT was A/O x4 Dr. on site gave 25 mg OF Benarryl AFTer about 20 min. Redness Disappeared and iching went away. PT. was monirord For a ToTal OF 40 min and discharged home. Pt was advised TO seak additional medical attentin If Needed  Dr. on site gave 25mg Benadryl.
Patient was seen at hospital for leg pain and total body pain. Started on Thursday with total body aches. Ruled out blood clots at ER. Was given Flexeril 10mg, Motrin, and APAP.  Patient was seen at hospital on 4/26/2021 for leg pain and total body pain. Patient is unable to walk on her own. needed crutches to walk. Patient's pain has increased each day until today (4/27/2021)
Patient has a vaso-vagal episode while in parking lot. She was awake, alert and cool and clammy. She was  wheelchaired back into the office, given water to drink and lay down on exam table. Her BP was 80/40 and 15 min later it was 100/60. Color improved, her clamminess was gone and she walk to her car unassisted. Dr. told mom this was a Vaso- Vegal response to the vaccines and we discussed this with regards to future procedures.
Lightheaded, short of breath, tightness across chest, unsteadiness in legs, cloudy brain. Went to ER with labs done (tryp 4.8). Discharged.
Within five minutes of vaccine administration 2:30 pm patient's face became very red, eyes started to swell, and coughing and itching noted. Also tongue started to swell and welts noted on upper part of body.2:35 pm:  Adrenalin 0.2cc given subq into rt upper arm.  Symptoms improved.2:47pm:  Ambulance arrived and patient was sent to Hospital ER where he remained for observation for over an hour.  Was sent home on Benadryl and Prelone.  Spoke with Mom on 10-03-07 and patient was doing fine.
Guillain-Barré syndrome (GBS)- sensory variant, symptoms of diffuse numbness/tingling and electrical shock
bled really bad; This is a spontaneous report from a contactable consumer reported for a patient (consumers son) via a Pfizer sponsored program. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 03May2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter mentioned his son got his 2nd dose that day and mentioned upon administering the vaccine he bleed really bad on an unspecified date. Reporter asked if it was injected in the vein or in his blood vessel. Reporter stated that his son did not take blood thinners. The outcome of the event was unknown.  No follow up attempts are needed. Information on lot/batch number cannot be obtained.
mistakenly given the adjuvant only rather than reconstituted Shingrix; mistakenly given the adjuvant only rather than reconstituted Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: mistakenly given the adjuvant only rather than reconstituted Shingrix) and inappropriate dose of vaccine administered (Verbatim: mistakenly given the adjuvant only rather than reconstituted Shingrix).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-SEP-2023 A long-term care facility patient was mistakenly given the adjuvant only rather than reconstituted Shingrix for her first dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The healthcare professional plans to correct this error by giving a properly reconstituted vaccine but till the time of reporting the patient had not yet received a properly reconstituted dose. Nothing else was reported. The reporter consented to follow up. Follow up with reporter/pharmacist or HCP (primary care HCP).
No adverse event; Doses were administered after the 30 day BUD; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215H22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Flu vaccine on 19-Jan-2023. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 15-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD).    No concomitant medications were reported.  The BUD was reported as 08-Feb-2023.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-711736 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711736:Master case (Patient: D-Y)
About an hour after injection patient started to feel very tired. As time went on she developed depression, extreme fatigue & headache.
She had a baseball size red rash around the injection sight. Rash was stiff and hot to the touch.  I took her to the DR and she was diagnosed with cellulitis.