chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was having a stroke; Its hard to sleep on the patient arm; the muscle at the very top of his shoulder feels like its numb; left upper muscle of his left arm collapsed and patient is not able to use it; sharp pain in his arm where patient got the vaccine; This is a spontaneous report from a contactable consumer (Reported for himself). A 60-years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0158/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 12Apr2021 (at the age of 59-years-old) as dose 2, single for covid-19 immunisation. Medical history included blood pressure measurement (Diagnosed to 12-14 years ago). The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER2613/Batch number was not reported), dose 1 via an unspecified route of administration on 17Mar2021 (at the age of 59-years-old) as dose 1, single for covid-19 immunisation. The patient experienced upper muscle of his left arm collapsed and patient is not able to use it on an unspecified date in Apr2021, patient was having a stroke, it's hard to sleep on the patient arm, sharp pain in his arm where patient got the vaccine and the muscle at the very top of his shoulder feels like its numb on an unspecified date. Outcome of left upper muscle of his left arm collapsed and patient is not able to use it and sharp pain in his arm where patient got the vaccine was resolving and other events was unknown.  Follow-up attempts are completed. No further information is expected.
Body chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Body chills), HEADACHE (Headache) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 01-Jan-2021, the patient experienced CHILLS (Body chills), HEADACHE (Headache) and PYREXIA (Fever). In January 2021, CHILLS (Body chills), HEADACHE (Headache) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  No concomitant medication was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Patient is a 79 y.o. female patient of, MD with history of coronary artery disease, s/p stent placement 2011, atrial fibrillation, rheumatic fever, COPD, arthritis, hypertension, who presented to hospital last night for left-sided chest pain and vomiting.      Chest pain-resolved Coronary artery disease  Elevated D-dimer Heart score=5 s/p stent placement Troponin's-11>16>20Covid-19 Virus Infection Pneumonia Date of onset of Echocardiogram limited-EF 66% Cardiology signed off- can follow outpatient with Cardiology- keep May scheduled appointment Continue ASA, Plavix, Imdur CT/PE- no pulmonary thromboembolic disease Pain management prn Care management for discharge needs Covid-19 Virus Infection Pneumonia Date of onset of symptoms: 3/31/23 Symptoms present on admission: yes Date of covid positive test: 4/1/23 Vaccination status: vaccinated Imaging: Chest x-ray-mild bilateral infrahilar lower lung linear opacities reflecting interstitial lung scar or interstitial edema/infiltrates Oxygen requirements on admission: yes Current oxygen requirements: 3 liters Medical therapy: continue  Rocephin, Azithromycin, Decadron, Remdesivir - discharge home with taper dose decadron  Consultants following: ID Anticipated special isolation end date: 4/11/23   Incentive spirometry Encourage prone position Wean oxygen as tolerated Inhalers prn Zinc oral daily Oral Vitamin D daily Sedrate, CRP, Vitamin D Sputum Cx-pending Needs repeat blood Cultures  - ordered    Chronic Paroxysmal atrial fibrillation - stable  No current anticoagulation Rate controlled Continue Atenolol Cardiology signed off Keep K+>4.0 Magnesium>2.0   Gastroenteritis - resolved Nausea and Vomiting - resolved  Continue Pepcid, Zofran Gentle IV hydration
Severe tinnitus in left ear; Body aches; Chills; Mild fever; Second dose severe headache; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Severe tinnitus in left ear), PAIN (Body aches), CHILLS (Chills), PYREXIA (Mild fever) and HEADACHE (Second dose severe headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 012L20A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and VITAMINS NOS for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced TINNITUS (Severe tinnitus in left ear), PAIN (Body aches), CHILLS (Chills), PYREXIA (Mild fever) and HEADACHE (Second dose severe headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 20-Feb-2021, PAIN (Body aches), CHILLS (Chills) and PYREXIA (Mild fever) had resolved. On 21-Feb-2021, HEADACHE (Second dose severe headache) had resolved. At the time of the report, TINNITUS (Severe tinnitus in left ear) had not resolved.            This case was linked to MOD-2021-119296 (Patient Link).
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml)(lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freeze) (R/F) for each time were 40, 34 and R; 136, 33 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
The patient stated she did not have a reaction from the vaccination that she received on 1/18/20 - no swelling, pain, or redness at the injection site, and no other adverse reactions. After she took a shower on 1/24/20 (6 days after the immunization), her arm was itching in the general area where she received her shot.  Her skin was extremely dry so she was going to try moisturizer and hydrocortisone cream, and had Benadryl at home.
Neck pain and rash on left side shoulder/chest. Shingles. Developed on Oct 23rd. Reached out to Doctor on 10/25 and received prescription. Currently taking prescription Valacyclovir 1mg every 8 hours for 7 days. Never had chicken pox, but did have the vaccine.
Fever starting approximately 10 hours after vaccine. Accompanied by chills, joint and muscle pain, and a headache.  Temperature max of 103.3 F, 25 hours after vaccine. Temperature brought down to 101.1 F with acetaminophen. Symptoms resolved after 36 hours.
stated that felt dizzy, vertigo & pain @ inject site; dizziness lasted a few hrs, pain several days;
1hr p/immun pt c/o nausea, headache, numbness of fingers & hands. Hyperventilation, inc temp & back pain.
Pt came in 6 days after the shot to inform of an irritation around the injection site. She complained of redness and itchiness.
THE PATIENT RECEIVED HIS SECOND DOSE OF COVID 19 VACCINE ON 04/29/21 AND TODAY HE HAS MODERATE TO SEVERE NAUSEA AND VOMITTING.
Developed blood clot in our lower calves; his started in his calf worked with ways up the leg and his was worse, his actually went to his lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 at 04:30 as dose 4 (booster), single (Lot number: GH9697) at the age of 66 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, 1st Pfizer COVID Vaccine LOT# and Expiration date: The very 1st one was PAA165969, Time for the 1st vaccine: It was around 11 in the morning, they were in the morning, Route of administration for the 1st vaccine: Reporter stated, "They were all intramuscular, all 4), administration date: 01Apr2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2, 11:45 in the morning, Route of administration for the 1st vaccine: Reporter stated, "They were all intramuscular, all 4), administration date: 22Apr2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 3 (1st booster), Route of administration for the 1st vaccine: Reporter stated, "They were all intramuscular, all 4, LOT# for the 3rd dose: Reporter stated, "Its EW0150), administration date: 22Nov2021, when the patient was 65-year-old, for COVID-19 Immunization. The following information was reported: THROMBOSIS (hospitalization, medically significant), outcome "unknown", described as "Developed blood clot in our lower calves; his started in his calf worked with ways up the leg and his was worse, his actually went to his lungs". Therapeutic measures were taken as a result of thrombosis (Heparin for two days in the ICU at the local hospital and Eliquis).
Severe Tinnitus, constant ringing in ears, shortly after receiving the booster shot #3.
Energy decreased/Run down; Tiredness; Chills; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Energy decreased/Run down), FATIGUE (Tiredness), CHILLS (Chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced ASTHENIA (Energy decreased/Run down), FATIGUE (Tiredness), CHILLS (Chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, ASTHENIA (Energy decreased/Run down), FATIGUE (Tiredness) and CHILLS (Chills) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medications were reported. No treatment drugs were reported.  The reporter's causality for the event(s) of tired, run down and chills with Humira(Adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
arm bleed a lot, evening fever came inc -t103 pt given APAP; body would jerk when trying to sleep; took to ER MD said it was from shots; Mortrin & bath in cool water;
The day of the injection my wife she rented another house then two days later took my child as a hostage for 14 days before disclosing her location and she was markedly delusional and psychotic and it seems that we have not been able to get her treated for any of these Neuropsychiatric side effects due to poor insight on her part into her symptoms
Sick; Fluish; Blood in his stool; This is a spontaneous report from a contactable consumer. A 45-year-old male patient (husband) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: FF2587 ) via an unspecified route of administration on 17Sep2021 (at the age of 45-year-old) as Dose 1,Single for COVID-19 immunization.  The patient's medical history and concomitant medications was not reported. The patient denied for any medical condition before covid and also denied for other medication. On an unspecified date in Sep2021, the patient experienced blood in his stool and on 17Sep2021 at 19:00 , patient was sick and felt fluish. On 17Sep2021, the patient underwent lab tests and procedures to see if he is okay to get the vaccine so the patient underwent laboratory and glucose test and found that all result were normal. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
At the time of injection 12:20 pm on January 4,2021 the vaccine when being pushed into my arm and after burned really bad. It felt like my arm was on fire for a few minutes but eventually went away. my arm became sore about an hour after the injection but it wasn't bad. a few hours passed and I started noticing my right arm that I received the vaccine in started really hurting and tingling was shooting down my arm and into my fingers. on January 5, 2021 I could not lift my arm with out crying because the pain was so intense. The sight of where the vaccine was administered was red and very swollen. there is a noticeable lifted knot on my arm the size of a gold ball. the sight around the area of administration is red, and sore and warm to touch. the tingling feeling also was present when waking up on Jan 5, 2021.  around 230 pm, my arm still very sore and the knot on my arm is still visible and sore to touch. the tingling feeling slowly starting to subside.
within 15 minutes - wooziness, within 1 hour dissociative, lability then giddiness, within 9 hours - severe depressive thoughts and anxiety, so emotional rollercoaster, at 12 hours, chills, headache, arm ache at injection sight.
HARD BUMP ON INJECTION SITE; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer, and allergy to iodine dye used in cat scan. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination in left thigh. No concomitant medications were reported. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced fatigue. On 22-MAR-2021, the subject experienced hard bump on injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on MAR-2021, had not recovered from hard bump on injection site, and the outcome of fatigue was not reported. This report was non-serious.
DIFFICULTY IN BREATHING; ITCHY EARS; THROAT CLOSED; FACE TURNED BRIGHT RED; BIT OF RASH; HEADACHE; LITTLE FEVERISH; This spontaneous report received from a patient . The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-APR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced difficulty in breathing. On 02-APR-2021, the subject experienced itchy ears. On 02-APR-2021, the subject experienced throat closed. On 02-APR-2021, the subject experienced face turned bright red. On 02-APR-2021, the subject experienced bit of rash. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced little feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty in breathing, had not recovered from throat closed, and the outcome of bit of rash, itchy ears, headache, face turned bright red and little feverish was not reported. This report was non-serious.
Severe shaking about 12 hours after injection. Started as shivering and turned into full body convulsions lasting just over an hour. Bundling up in blankets did not help as shaking intensified. Only other side effect was a sore arm at injection site.
Covid arm:  swelling and redness at site of injection spread approximately 3 1/2 inches down my left arm, felt sore and hot to the touch.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with the first, second and third doses of GARDASIL for prophylaxis (dose, route, lot/batch number and expiration date were not reported). On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 for prophylaxis (dose, route, lot/batch number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Patient was observed falling asleep in the baby swing by her grandmother. The grandmother states she observed the patient with a glassy eyed fixed stare and extended arms for approximately 2 to 3 seconds and then the patient resumed sleep.
Vaccine given 4:07 pm pt at approximately 11:00 pm described severe flu type symptoms - no fever but severe malaise, chills, shaking even though took hot shower.
Nausea, shakey prior to intranasal. Heart rate fine, no labored breathing. Nervous getting into room. No treatment. Allowed to rest. No concern.
No adverse event; Both formulations are pre-filled syringes. HCP accidentally picked up 2 Moderna COVID-19 pre-filled syringes and administered to the patient (Lot# 203E234 & Exp. Date: 27MAR2024).; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Both formulations are pre-filled syringes. HCP accidentally picked up 2 Moderna COVID-19 pre-filled syringes and administered to the patient (Lot# 203E234 & Exp. Date: 27MAR2024).) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 203E234) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ACCIDENTAL OVERDOSE (Both formulations are pre-filled syringes. HCP accidentally picked up 2 Moderna COVID-19 pre-filled syringes and administered to the patient (Lot# 203E234 & Exp. Date: 27MAR2024).). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Both formulations are pre-filled syringes. HCP accidentally picked up 2 Moderna COVID-19 pre-filled syringes and administered to the patient (Lot# 203E234 & Exp. Date: 27MAR2024).) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Both formulations are pre-filled syringes. HCP accidentally picked up 2 Moderna COVID-19 pre-filled syringes and administered to the patient (Lot# 203E234 &amp; Exp. Date: 27MAR2024).).    HCP accidentally picked up 2 Moderna COVID-19 pre-filled syringes and administered to the patient. She does not know how many previous COVID-19 vaccine the patient received previously.  She did not received the FLU Vaccine.  Reporter states that the patient refused to get the FLU shot after the mistake was communicated to her. Pharmacist observed the patient post vaccination and patient was fine. Concomitant medications were not reported.  No treatment information was provided by the reporter.
Information has been received from a physician concerning an approximately 24 months old patient who in October 2009, was vaccinated with the first dose of MMR II (Lot number 664655/0640Y, Exp. Date: May-2011). The physician reported that a "few months" after the first dose was given the patient was diagnosed with insulin dependent diabetes. The diagnosis of diabetes was made in June 2010. The patient was hospitalized on an unspecified date upon diagnosis. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Drs office called states patient's left deltoid red and swollen part of chest red and swollen. this was on 07/28/2005. RX Benadryl and Steroids given pt was told to put ice the 1st day, warm paks 2nd day. Tylenol every 4 hours. This was not done until 07/28/2005 at Drs office. 08/11/2005 follow up call to home no answer. Left message. 08/15/2005 PC left message.
Patient received both ZOSTAVAX and the flu vaccines on same day on 10/8/13. Next note in patient chart is on 10/17/13 where the patient spoke with nurse in stating she had a reaction to the shingles vaccine. Patient states injection site became edematous, red, and inflamed. Rash noted to forehead. Noted swelling to throat. The patient states symptoms are getting better, swelling to arm has decreased, swelling to throat is better, rash to forehead has resolved. Informed (the nurse) patient that symptoms should resolve and if symptoms get worse that she will need to seek care immediately at ER/UC. NOTE: Although the patient stated she had an adverse reaction to ZOSTAVAX, the note does not specify which injection site. She received both vaccines are different arms and by different nurses at different times (about an hour apart per electronic record).
Got the shot at 1 pm, 13 hours later, broke into a fever of 102, cold chills, hot/cold sweats, nausea, muscle aches, headache and severe fatigue. The above symptoms lasted 3 days, but the fatigue and chronic muscle inflammation and achiness persisted until treatment. The treatment that I had done was 10 pass Hyperbaric Ozone Therapy. Treatment dates were Oct 14 and 21st, 2021 A few days after the 2nd treatment, all symptoms from vaccine side effects were eliminated.
Patient received her 1st dose of Pfizer COVID vaccine on 02/26/2021.  She noted some wheezing and slight shortness of breath and shared this information with her PCP at her regularly scheduled visit on 03/01/2021.  PCP refilled inhaler at that time.  Her shortness of breath progressively worsened, and she was seen by another provider as a walk-in at the office of her PCP on 03/13/2021.  At that time, she was prescribed prednisone for 5 days, noting some improvement after a few days.  She received her 2nd Pfizer COVID vaccine on 03/19/2021.  The patient woke up on the morning of 03/20/21 with a swollen and painful leg and by 03/22/21 called PCP and was seen in the office.  PCP ordered D-Dimer and LE ultrasound. Per the patient, the D-dimer was abnormal and the LE U/S showed a blood clot.  PCP sent the patient to the ER, where a chest CT was ordered and showed a pulmonary emobolus.  She was admitted overnight and started on Eliquis, and discharged the next day after seeing a hematologist.