chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per the insurance company, when she got to the car after the vaccine, she started to feel odd,  her arm swelled, and became immobile.  She went to an urgent care clinic, and was given an antibiotic which was not helpful.  Her arm and hand burned, and were double the regular size, so she then went to an ER, where she was told the vaccine may have been placed too high- possibly in the bursa.  She had a CT.  She went to her PCP for follow up on the 19th.  Per the doctor's office, she had a visit 11/16/22, and is being treated for cellulitis and tendonitis.  She is experiencing joint pain of hand, elbow, and shoulder, though the swelling and pain has decreased.  The CT shows calcific tendonitis of the supraspinatus tendon, which is not related to the vaccine.  She has no abnormal fluid collection,  no abnormal fat collection, and no hematoma.  She has been through two courses of clindamycin, and one round of Keflex, and is currently being treated with a short duration of low dose prednisone.
L upper arm swollen and red from elbow to shoulder. Ice applied fever 102 Tylenol given. Monday deltoid and shoulder still swollen. No more fever.
Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Had considerable body aches; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Had considerable body aches) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Patient had never tested COVID-19 positive.  Previously administered products included for Product used for unknown indication: Shingles vaccine (With 2nd dose of vaccine) and Shingles vaccine (With 2nd dose of vaccine). Past adverse reactions to the above products included Myalgia with Shingles vaccine; and Shivering with Shingles vaccine. Concurrent medical conditions included Drug allergy (Sudafed allergic, cause Tachycardia). Concomitant products included NADOLOL for an unknown indication.   On 07-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. In September 2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced MYALGIA (Had considerable body aches). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (Had considerable body aches) had resolved.            Patient received 0.5 mL of first dose of Moderna COVID-19 vaccine on 25-Mar-2021, Lot Number 002B21A. Patient received 0.5 mL of second dose of Moderna COVID-19 vaccine on 27-Apr-2021, Lot Number 009C21A. Patient received 0.25 mL of third dose of Moderna COVID-19 vaccine on 05-Nov-2021, Lot number 033F21A.  Patient received 0.25 mL of fourth dose of Moderna COVID-19 vaccine on 11-Apr-2022, Lot number 005M21A.  It was reported that the Body aches persisted for 18-24 hours.   This case was linked to US-MODERNATX, INC.-MOD-2022-658071, US-MODERNATX, INC.-MOD-2022-658065, US-MODERNATX, INC.-MOD-2022-658064, US-MODERNATX, INC.-MOD-2022-658061 (E2B Linked Report). This case was linked to MOD-2022-658188, MOD-2022-658148 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658071:Husband Dose 5 US-MODERNATX, INC.-MOD-2022-658065:Husband Dose 4 US-MODERNATX, INC.-MOD-2022-658064:Husband Dose 2-3 US-MODERNATX, INC.-MOD-2022-658061:Husband Dose 1
Onset of nerve damage after receiving the vaccine. Currently, a year later, increasing numbness in center back, arms, legs and feet. No pain. Complete numbness. I am loosing the sensation of touch on all parts of my body. Numerous testing is all negative. I am at my wits end. May be effecting my vision and now the onset of neck pain.
Case completed the 2 dose Covid vaccine series on 2/8/21, then was hospitalized for Covid Pneumonia on 8/10/21
This spontaneous case reported by a consumer, describes the occurrence of headache and myalgia (body aches) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jun 13, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 14, 2021, patient experienced headache and myalgia (body aches). At the time of the report, headache and myalgia (body aches): unresolved. No concomitant medication or treatment information reported.
Swelling of the lymph nodes on both sides of my neck; Muscle aches; Difficult to breathe; Weakness; Sore throat; no longer hungry; Headache; Chills; Feverish; Pain at the injection site; Swelling of arm; Soreness of arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficult to breathe), ASTHENIA (Weakness), PERIPHERAL SWELLING (Swelling of arm), PAIN IN EXTREMITY (Soreness of arm) and OROPHARYNGEAL PAIN (Sore throat) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 30-Dec-2020, the patient experienced PERIPHERAL SWELLING (Swelling of arm), PAIN IN EXTREMITY (Soreness of arm) and INJECTION SITE PAIN (Pain at the injection site).   On 31-Dec-2020, the patient experienced DYSPNOEA (Difficult to breathe), ASTHENIA (Weakness), OROPHARYNGEAL PAIN (Sore throat), APPETITE DISORDER (no longer hungry), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Feverish) and MYALGIA (Muscle aches).   On 26-Jan-2021, the patient experienced LYMPHADENOPATHY (Swelling of the lymph nodes on both sides of my neck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency.   At the time of the report, DYSPNOEA (Difficult to breathe), ASTHENIA (Weakness), PERIPHERAL SWELLING (Swelling of arm), PAIN IN EXTREMITY (Soreness of arm), OROPHARYNGEAL PAIN (Sore throat), APPETITE DISORDER (no longer hungry), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Feverish), INJECTION SITE PAIN (Pain at the injection site), MYALGIA (Muscle aches) and LYMPHADENOPATHY (Swelling of the lymph nodes on both sides of my neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Negative.   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.   Concomitant product use was not provided by the reporter. Patient was using hydrating and sleeping drugs for his symptoms.
severe chills 7-11 hours after injection body aches 9-14 hours after injection severe headache & nausea 14-24 hours after injection
8 x 10 cm erythematous welt at injection site-started within 24 hrs and progressed.
Within 5 hours of receiving  vaccine  I began to have generalized itching and headache. Itching subsided after approximately 12 hours, headache continued with onset of back, leg pain, then nausea. It has been 24 hours since receiving vaccine. I have taken excedrin aspirin to relieve pain which has helped. Though symptoms are still present but decreased
My arm was a little sore after the vaccination but no other symptoms.  And on 12/30 I woke up with a sever fever, vomiting and diarreah.  Went to the ER and was diagnosed with CHF because my feet were so swollen and was given lasix and released.  I continued to feel bad so on that Sunday 1/3  I went back to the hospital and was admitted and tested positive for COVID-19. I spent from Sun-Wed in the hospital
About four hours after shot, I started feeling funny. I was not able to sleep all night. During the night,  I felt as if I needed to urinate. My feet and rest of body were extremely cold to touch.  Later, I develop a headache and fever. It was hard to get out of bed. My body felt as if I had a boulder holding me down.  Around 2:30 I decide to take 800 ml of Tylenol. When I tried to open my eyes, I could  not keep them open for more that three seconds. I lost my appetite for more than 14 hours feeling nauseated.  For 18 hours I was tired and irritable.  For all the reasons above, I had to call in sick to work. I had night sweats two nights.
During the administration of covid-19 vaccine (pfizer) to patient, almost all of the vaccine leaked out of the syringe. Authorized dose was administered immediately. Patient was observed for 30mins. Patient experienced slight dizziness and nausea after 25minutes. No other adverse events was observed. Patient. was closely monitored and kept hydrated. Patient stated she was feeling a little bit better.  (Patient birth date might not be accurate on this form)
He was seen on 11/12 for symptoms of asthma for 2 days, possibly in the context of a mile URI without fever.  He was started on albuterol aerosols and was seen the next day.  He had improved and was given the influenza vaccine on 11/13.    On 12/8 (iover three weeks later) he developed facial urticaria.  This progressed to bilateral warmth, swelling, and erythema of both elbow areas with overlying wheals.  He had fever of >102 rectally.  No other symptoms were present and he hs limited contacts with other children.  A rapid strep assay was negative.    He was treated symptomatically with antipyretics and diphenhydramine.    He tolerates eggs without reaction. No medications were being given other than the albuterol three weeks previously, which had been stopped.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No medical history or concurrent conditions were provided. On an unknown date in December 2013, the patients were vaccinated with GARDASIL (dose, route and lot numbers were not provided). No co-suspect or concomitant therapies were reported. The registered nurse reported that the GARDASIL administered to the patients had been improperly stored. The registered nurse was unable to confirm the exact number or identities of the patients involved at the time of the report. No adverse effects were reported. This case is linked to cases MARRS # 1402USA009065 and MARRS # 1402USA010129 (same reporter link). Additional information has been requested.
I  took the first dose on 03/29/21. I felt my teeth were very sensitive less than 30mn after and it lasted days. I asked whether people reported similar effects the day I took the second dose on 04/29/2021; however, I was told at the desk that she hadn't heard any report. Nonetheless, estimated a week after the second dose, I woke with partial facial paralysis. I immediately went to the emergency at the request of my primary care; I was diagnosed with Bell palsy. It has been over four months of battling to recover, however, I have not fully recovered from it. I have been experiencing unprecedented body aches and at this point and would like to find out all the possible side effects known thus far to determine whether the vaccine may have caused my recent health issues.
Administered 0.5mL GARDASIL (3rd dose) to patient. Approx. 30 sec after administering, patient became pale, fainted, and had body jerking in upper body for approx 10-15 sec. No hx of seizures. T 97.6. Vitas post incident - 88/52 BP, 50 P; 5 mins - 92/58 BP, 54 P; 20 mins - 90/60 BP, 58 P
Patient received his 2nd dose of Pfizer vaccine on Thursday, Sept 16.  He woke up on Friday feeling fine, went to school, but was sent home by 11:00am due to: feeling like he would faint, was confused and did not remember recent events, was unable to coordinate his legs when he walked "they went in different directions" requiring 2 person assist to prevent a fall. The school RN is also a seasoned ER RN and recommended that he go to the ER as she was concerned about his neurological status. Mom took him home, hydrated him and let him sleep.  The above symptoms diminished and were replaced with URI symptoms and fever up to 101. Sun he felt a bit better, but tanked again on Monday.. Appetite has been significantly decreased, per the Mom. Went to ER on Wednesday, 9/22.  He was discharged from the ER with a diagnosis of URI, and advised to remain home from school until next week. Tylenol PRN only meds he's had. Patient has no previous reactions to vaccines.  he is 5 feet 3 inches tall and weighs 112 pounds.
TIA; stroke; trouble walking; feeling like my left side of body is being stung all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "TIA"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "trouble walking"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling like my left side of body is being stung all the time".  Clinical course: "I believe with all my heart. I got the 3rd shoot booster, I was healthy, within 2 1/2 weeks after getting the shot, I had TIA's and then a stroke. I am now left trouble walking, feeling like my left side of body is being stung all the time, plus other issues I never had before. I wish I never had gotten the shots."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient is oriented to person time and place next to her mother, vaccine is administered patient is tearful and anxious when vaccine is administered patient collapses. Feet are elevated and vitals are taken P76 ox 93. Jackets were on patient to keep her warm at all times, giving her alcohol to smell. Pressure was 110/50, after a few minutes patient reacts, she is given 2 snacks to eat and water. When is time to leave P120/90, sat 98, pulse 85 patient is oriented to person, time and place.
Son woke up coughing complaining of a severe headache and had high fever. Could not get symptoms to subside took him to the ER. Was treated in ER and sent home. 2 days later both parents became ill with H1N1, comfirmed by family DR.
Employee was given the vaccine by a coworker from the peer to peer packet on the unit. The vaccine was given in the upper back side of her left arm and not in the deltoid, she stated it hurt really bad at the time and she continues to still have pain, including numbness that goes up into her neck.
TENIVAC vaccine expired on 08Oct2022 and it was given today 12Oct2022 with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited non-valid non-serious case received from a other health professional.  This case involves a 81 years old male patient and reporter reported tenivac vaccine expired on 08oct2022 and vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was given today 12oct2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Oct-2022, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (Lot: U6831AA, expiry date 08-Oct-2022) (unknown administration site)(strength:standard) 0.5 ml total at once via intramuscular route for immunization    On 12-Oct-2022 the patient was administered with tenivac vaccine expired on 08oct2022 with no reported adverse event (expired product administered) following the administration of vaccine.  No lab data reported.  Action taken was not applicable.   At time of reporting, the outcome was Unknown for the event     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
The patient developed a rash approximately 1 week after the vaccine dose. On the way to urgent care, he had a syncopal episode and was found to have paroxysmal atrial fibrillation. He was admitted to the hospital. The syncopal episode was preceded by feeling hot and lightheaded. The rash was evaluated by a dermatologist who diagnosed erythema multiforme minor. A skin biopsy is pending. No other common causes for erythema multiforme was found. Of note, the patient previously tested positive for COVID-19 on 3/18/2021 (symptomatic infection not requiring hospitalization)
This spontaneous report as received from a physician via a company representative, refers to a male patient in his early 70's. The patient's concurrent conditions and medical history were not reported. In approximately 2011, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prevention of shingles. There were no concomitant therapies reported. In approximately January 2017 (reported as "about a month ago"), 6 years after received ZOSTAVAX, the patient developed shingles. The patient sought medical attention by office visit. No product quality complaint was involved. The patient was recovered from the event on an unknown date in 2017. The causality between ZOSTAVAX and the event was not provided. This is one of two cases from the same reporter. Additional information is not expected as no permission to contact the physician was provided. Sender's Comments: US-009507513-1702USA004934.
I had light flashes in the right eye. I had never experienced that before. I researched the symptom, and retinal detachment is one of the causes. I then researched causes of retinal detachment, and Hepatitis B is one of the causes.
Not know if the medical condition got worse; This case was reported by a pharmacist via call center representative and described the occurrence of anemia aggravated in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included anemia.   On 9th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced anemia aggravated. On an unknown date, the outcome of the anemia aggravated was unknown.   It was unknown if the reporter considered the anemia aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a blood transfusion on March 2020, and before the blood transfusion, the patient received 1st dose. The patient did not know if the medical condition got worse because of the first dose of Shingrix. The patient wanted to receive 2nd dose of Shingrix. The reporter did not consent to follow up.
About 30 minutes after the vaccine, I had a metallic taste in my mouth and my head started hurting. Around 0230 am the following morning while lying in bed I started to have chills and total body bone pain, with continued headache. My temperature was up to 100 degrees F. I took ibuprofen but could not fall back to sleep. I had continued chills and pain the day after the vaccine up until 10/30/22 morning. I did take around the clock ibuprofen/acetaminophen on 10/29/22.  Currently, I have reflux (which I do not typically suffer from), fatigue and a mild headache with a swollen armpit in the arm that was vaccinated. I experienced a similar side effect profile with the 1st booster from Pfizer (dose 3).
3-10-21PM RASH TO BOTH ARMS - RED/ITCHING. NO SOB/DYSPNEA, NO DIFFICULTY BREATHING OR SWALLOWING.  6:15PM BENADRYL 50MG PO. 6:40PM DECREASED ITCHING AND REDNESS NOTED. HAS SOME RASH AND ITCHING TO ABD AND RT CHEEK. NO DIFFICULTY SWALLOWING.  7:35PM 'FEELS BETTER' NO ACUTE DISTRESS NOTED. PINK, W/D, NO SOB. TO EXIT PER W/C TO BE TAKEN HOME PER DAUGHTER. 3-12-21 10AM TC: 'STILL HAS RASH - TAKING BENADRYL EVERY 4 HRS. STATES ALLERGIST ADVISED HER NOT TO GET DOSE #2, SHE WILL GET ANTIBODY TITER IN 6 WKS'.
Patient had syncopal episode, possible seizure for 10 seconds. Patient reported by bystander to have hit the back of his head.  Blood pressure 148/85, O2 saturation 97%, HR, 103,  blood glucose 101 mg/dl.  Patient described the event as he "blacked out". Patient c/o thirst. Patient has no complaints of tenderness or pain in back of head. Patient transported to hospital for further evaluation.
Dose of Boostrix on Aug 14th / Already received Boostrix vaccination on February; pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 67-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 374LB, expiry date 20th June 2022) for prophylaxis.   Previously administered products included Boostrix (received 1st dose in February 2020).   On 14th August 2020, the patient received the 2nd dose of Boostrix. On 14th August 2020, unknown after receiving Boostrix, the patient experienced drug dose administration interval too short. In August 2020, the patient experienced pain. On an unknown date, the outcome of the pain and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the pain to be related to Boostrix.  Additional details were reported as follows: The patient received a dose of boostrix on 14th August 2020 but after they administered they realized patient already received boostrix vaccination on February 2020 as well. The patient received 2nd dose of boostix, before than the recommended interval, which led to shortening of vaccination schedule. The patient experienced pain and reporter wondered if it was related to receiving the vaccine (Boostrix) at such a short interval. The reporter consented to follow up. No further details provided.
Patient stated she "felt short of breath, and her entire body ached". This occurred approx. one hour after vaccines were given. Pts father called 911 and pt was taken by ambulance to the ER. A partial nebulizer treatment was given in the ambulance. No other medications were given. Pt was discharged home-diagnosis was Adverse reaction to vaccine, initial encounter.