chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Some Chillls; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (Some Chillls) in a 78-year-old female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and CHILLS (Some Chillls). At the time of the report, HEADACHE (Headache) and CHILLS (Some Chillls) outcome was unknown.            No concomitant product use was reported  No treatment information was provided
ADMINISTERED 2.5ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 211A21A expiry: 14-DEC-2021) 2.5 ml, administered on 13-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-NOV-2021, the patient experienced administered 2.5ml of the vaccine. On 13-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered 2.5ml of the vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220129, 20211220916, 20211200769, 20211200675, 20211200717, 20211201082, 20211200994, 20211201168, 20211201179, 20211201286, 20211201304, 20211201351, 20211201392, 20211201443, 20211201450, 20211202161, 20211202199, 20211220262, 20211220250, 20211219871, 20211219926, 20211219681, 20211219871, 20211202207, 20211220619, 20211219926, 20211220145, 20211220155, 20211202246, 20211202250 and 20211202371.
Right side facial paralysis, without evolution. 50 mg Prednisone. Physical Therapy.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 72 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EN5318), on 12Feb2021 as dose 2, single (Lot number: EL9269), in left arm, on 02Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunization. The patient's relevant medical history included: "known_allergies:latex" (unspecified if ongoing); "known_allergies:ACE inhibitors" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course Paxlovid treatment taken for Covid-19 on 28Dec2022..  No follow-up attempts are possible. No further information is expected.
her face got flushed; her face got warm; her lips started tingling; felt irritated; flank pain on her right side; headache; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (her face got flushed), FEELING HOT (her face got warm), PARAESTHESIA ORAL (her lips started tingling), IRRITABILITY (felt irritated) and FLANK PAIN (flank pain on her right side) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: VITAMIN D COMPLEX and SYNTHROID.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FLUSHING (her face got flushed), FEELING HOT (her face got warm), PARAESTHESIA ORAL (her lips started tingling), IRRITABILITY (felt irritated), FLANK PAIN (flank pain on her right side) and HEADACHE (headache). The patient was treated with APRONAL, DIPHENHYDRAMINE SALICYLATE, DIPROPHYLLINE (SEASICK) at an unspecified dose and frequency and LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, FLUSHING (her face got flushed), FEELING HOT (her face got warm), PARAESTHESIA ORAL (her lips started tingling) and IRRITABILITY (felt irritated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Per patient: I became disoriented and had instant VISIONS. And I had extreme bad dreams and my arm is very sore to the point that it's hard to move.
Patient said she "felt weird". She was observed for 20 minutes and returned to work, stating she felt better. She came back approx. 30 minutes later and stated she still didn't feel well. She was given a cold compress for her forehead, propped her feet up, was given something to eat (she hadn't eaten since early that morning), and 50 mg of BENADRYL because she said she thought maybe she was having a hard time swallowing. She then stated that she felt that maybe she'd thought about it for too long, making herself feel worse. She eventually felt well enough to go home around 5 pm and was picked up by her boyfriend so she didn't drive and could be further observed. She was given the pharmacy contact card to call with any further issues or questions.
swelling in right hand; right hand pain; right hand pain worsened; This is a spontaneous report received from a contactable consumer. The consumer reported for an 86-year-old female patient (mom) that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, and Lot Number: EL9269) intramuscularly administered in right arm on 09Feb2021 11:30 as single dose for COVID-19 immunization. The patient medical history included atrial fibrillation (diagnosed about 15-20 years ago, more like 15 years), thyroid, blood pressure, and for heart issues, sinus issues, cholesterol and arthritis all are ongoing. Concomitant medications included atorvastatin, fexofenadine hydrochloride (ALLEGRA), levothyroxine, metoprolol tartrate, spironolactone and warfarin. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, and Lot Number: EL3249 or EL2249) intramuscularly administered in right arm on 19Jan2021 11:30am as single dose for COVID-19 immunization and She has been getting the flu vaccine for years. On 10Feb2021, the patient experienced pain in her right hand, she got the vaccine shot in her right arm. On 10Feb2021, the right hand pain was reported as worsened. On an unspecified date, the subject noticed swelling on her right hand, the patient did not think she had the swelling before. It was reported that the swelling was not huge, but it was troublesome, and the patient had to take her coffee with her left hand. It was reported that it had just been 36 hours after the patient had the injection and she was still experiencing the pain. Around 9 or 10 last night her mom was complaining, and she wonders if it happened because of the injection. The patient did not experience injection site swelling. The patient did not take any treatment she was just resting. The outcome of events right hand pain and right hand pain worsened was not recovered and swelling in right hand was unknown.
vaccine given after the vial has been open for 6 hours and refrigerated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vaccine given after the vial has been open for 6 hours and refrigerated) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine given after the vial has been open for 6 hours and refrigerated). At the time of the report, PRODUCT STORAGE ERROR (vaccine given after the vial has been open for 6 hours and refrigerated) had resolved.        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.   No Concomitant medications were reported  No treatment medications were reported
Injection site pain and swelling within 2 1/2 hours. Of vaccination. This morning lymph node under left arm is very swollen and warm. This morning also running a low grade fever.
Vial had been removed from Deep Freezer to cooler & kept in cooler beyond recommended time frame; was not noted until after administered to employee (patient).  Patient experience expected side effects of chilling, body aches and fatigue next day,
Erythema and induration, 6X4cm erythema at left deltoid, status: unchanged.
Pt developed hive looking rash on face.  Mom called answering service and reported this to Dr.  Advised to give Benadryl by Dr.  Pt also had fever of 103 degrees.  Rash resolved with dose of Benadryl.  Fever persisted through the next day.  She is fever free today.
This is a spontaneous report from a contactable other health professional (patient). A 45-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration in right arm on 06Feb2021 09:30 as single dose for covid-19 immunisation. Medical history included asthma and allergies, known allergies were Latex and bees. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), reported as advir 500/50; bupropion hydrochloride (WELLBUTRIN); levocetirizine dihydrochloride (XYZAL) and BP medication, all concomitants were taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included first dose of BNT162B2 via an unspecified route of administration, administered in right arm on 23Jan2021 09:30 (Batch/Lot Number: EK9231) for covid-19 immunisation. On 07Feb2021 01:00, the patient experienced major headache, body ache, fever, nausea and swollen lymph nodes. No other vaccine in four weeks.
Body aches, joint pain, headache, feeling light headed, intestinal cramping, chills
This is a spontaneous report received from contactable reporter(s) (Other HCP). A 9 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 31Dec2021 (Lot number: FK5618) at the age of 9 years as dose 1 (tris), single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 02Jan2022, outcome "recovered", described as "rash/come and go rash"; HYPERSENSITIVITY (non-serious), outcome "un-known", described as "having allergic reaction"; URTICARIA (non-serious) with onset 02Feb2022, outcome "recovered", described as "Had hives all over body"; PRURITUS (non-serious), outcome "not recovered", described as "very itchy". The events "rash/come and go rash" and "had hives all over body" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, urticaria, pruritus. Additional information: Nurse stated, they did not put one on the like we got the COVID record card from the patient they did not put expiration date. For NDC and UPC numbers Nurse stated, I do not, we just Location pediatrician so, we just have the vaccination record card we are not sure which, they got their vaccine from a different clinic. Vaccination facility type was Other. Vaccine did not administer at military Facility. Prior vaccination before four weeks, the patient has not received any vaccine prior vaccination before four weeks. There is not anything to help when problem. Father of child reported to clinic that patient having an allergic reaction, had hives all over body was given Benadryl. Advised to follow up if symptoms not improving. 03Jan2022 MOC calls 18Jan2022 stating rash had returned and similar to rash on 03Jan2022 offered patient Benadryl. Patient came into clinic for appointment on 19Jan2022. Examined by Physician, 09-Year-old female with rash that started after the Covid vaccine. The rash comes and goes. Very itchy, raised. Then disappears and shows up somewhere else. Benadryl helps, then comes back when it wears off. The reporter does not know the vaccination time, but the date was 31Dec2021. Adverse event Required visit to Physician Office. Given Benadryl for active rash Claritin or Zyrtec once daily. Relevant test was reported as None. Specific Relevant Test for Thromboembolic Events with Thrombocytopenia was None. No follow-up attempts are possible. No further information is expected.
Chills, body aches, joint pain, fatigue, fever, nausea, vomiting
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In January 2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. During July 2016, the patient was treated by a physician for symptoms of a blistering vesicular rash, which was diagnosed as herpes zoster, or shingles. She suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Started with a sore throat. Felt like a knot on right side of throat. Lasted about 3 days. Went away and came back 2 days later except on opposite side of throat. Nerve pain that is debilitating ever since I got the shot. Nerve pain goes from one part of my body lasting 2 to 3 days and then moves to other parts of my body. Moves from hand and wrist then upper leg hurts so bad I can?t walk or sit or  even lift it.  Moves them to shoulder where I can?t lift arm. Then moved to other shoulder can?t move arm. Then moved to lower arm left. Then moved to right foot. Couldn?t apply any pressure to foot. Couldn?t walk again. Each instance of pain last about 3 days before moving to another spot on my body.
Injection site swollen up, hard; Injection site swollen up, hard; Red area under the swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Injection site swollen up, hard), VACCINATION SITE SWELLING (Injection site swollen up, hard) and VACCINATION SITE ERYTHEMA (Red area under the swelling) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, HYDROCHLOROTHIAZIDE for an unknown indication.   On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, the patient experienced VACCINATION SITE INDURATION (Injection site swollen up, hard), VACCINATION SITE SWELLING (Injection site swollen up, hard) and VACCINATION SITE ERYTHEMA (Red area under the swelling). At the time of the report, VACCINATION SITE INDURATION (Injection site swollen up, hard), VACCINATION SITE SWELLING (Injection site swollen up, hard) and VACCINATION SITE ERYTHEMA (Red area under the swelling) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-398553 (Patient Link).
This patient attended a free vaccination event held in the community.  She was administered dose #1 of Pfizer.  When we returned to the clinic and entered consent forms into system, we noted that this patient had already received 2 doses of Moderna.  She did not mention this during the Pfizer vaccination event; in fact, she denied having any other immunizations at that time.  She does not have a phone, so we have attempted to contact her via letter to determine any adverse reactions from receiving 3 doses of covid vaccine.
bad allergic reaction; This is a spontaneous report received from a contactable Physician for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "bad allergic reaction". The lot number for bnt162b2 was not provided and will be requested during follow up.
Covid Arm Swollen hard lump, red 2+ inch size itchy and very sore
Neck pain after Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of neck pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced neck pain. On an unknown date, the outcome of the neck pain was unknown.   It was unknown if the reporter considered the neck pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comments:  This case was received from patient via interactive digital media. The reported stated was it common to had a neck pain after Shingrix Shot. The follow up would not possible as no contact details were available.
Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 6/25/2023 Discharge Date: 6/29/2023  Active Issues Requiring Follow-up * Pneumonia of both lungs due to infectious organism Assessment & Plan Cough, chills, shortness of breath, fatigue and sinus congestion progressing over the last 2 weeks despite antibiotics and steroids.  COVID-19 PCR positive on 06/25/2023.  Although likely onset of COVID 2 weeks ago. Chest x-ray: Moderate coarse strandy and hazy/patchy multifocal/bilateral airspace disease.  Pneumonia felt to be viral in nature secondary to COVID Discontinue antibiotics at this time     COVID-19 Assessment & Plan Symptom onset date approximately 2 weeks ago. COVID-19 PCR positive on 06/25/2023. Presentation outside window for remdesivir.   CXR: Moderate coarse strandy and hazy/patchy multifocal/bilateral airspace disease.   Current oxygen requirement: SpO2: 92 % O2 Flow Rate (l/min): 2 l/min   CRP: 53.4  D-dimer: 960.   Albuterol INH 2 puffs q 4 hours Dexamethasone - 6 mg oral prescribed at discharge to complete 10 days of therapy.        Acute respiratory failure with hypoxia  Assessment & Plan Secondary to COVID-19 and superimposed bacterial pneumonia. Patient was requiring up to 6 L of oxygen at her worst Overall improving respiratory status and oxygen needs.   Home oxygen at discharge. 2 Liters at rest and 6 Liters with activity.        Pulmonary nodules Assessment & Plan CTA from 06/23/2023: Few small (less than 5 mm) noncalcified/indeterminate apical nodules. Question infectious or inflammatory nodules. Given size, no additional follow-up is indicated if the patient is low risk for lung CA.   Likely inflammatory given current COVID-19 viral illness and superimposed bacterial pneumonia. Follow- up with PCP regarding need for follow- up imaging.    Granulomatosis with polyangiitis  Assessment & Plan Rituximab infusion every 6 months.    Moderate persistent asthma without complication Assessment & Plan Continue home inhalers at discharge.  Follow up with pulmonology outpatient     GERD (gastroesophageal reflux disease) Assessment & Plan Continue PPI
sore, stiff, red, pffy area on lt deltoid about 6"x8" in size;mom states was informed 2 days p/shot;
Patient came to public clinic with neighbor to receive COVID vaccine. Dr. medically screened the patient, she asked if she was able to answer her own screening questions to which the caregiver neighbor stated ?absolutely? the patient was oriented and stated name, date of birth and address and answered all screening questions.  They received Moderna 006b21a by  NP in their right arm and then a family member showed up at the door stating ?she?s already had it? . Patient had received Pfizer COVID vaccine on 2/3/2021 and 2/24/2021.  Family member states she had a mild reaction after her series, with injection site pain and abdominal discomfort. Patient was monitored for 30 mins without reaction. PCP has been notified and HCP  is aware as well. She has visiting nursing 4 times a day at home and I will follow up with HCP this afternoon for re-eval.  Board of health physician Dr.  notified. Patient and family members present have been counseled on adverse reactions and when to seek medical care. Information will be reviewed with HCP today as well.
Fever 100.6 - 101.4; Both arms are sore; Doesn't feel like doing anything; Chills; Red spot the size of a grapefruit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.6 - 101.4), PAIN IN EXTREMITY (Both arms are sore), VACCINATION COMPLICATION (Doesn't feel like doing anything), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red spot the size of a grapefruit) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot the size of a grapefruit). On 29-Mar-2021, the patient experienced PYREXIA (Fever 100.6 - 101.4), PAIN IN EXTREMITY (Both arms are sore), VACCINATION COMPLICATION (Doesn't feel like doing anything) and CHILLS (Chills). At the time of the report, PYREXIA (Fever 100.6 - 101.4), PAIN IN EXTREMITY (Both arms are sore), VACCINATION COMPLICATION (Doesn't feel like doing anything), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red spot the size of a grapefruit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment taken was not reported Second dose: 29Mar2021, Lot number: 007B21A.   Reporter did not allow further contact