chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster and severe complications. In 2013, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, 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 was unknown. Causality assessment was related. Additional information has been requested.
Extreme soreness in the arm that received the shot; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was unknown), via an unspecified route of administration in arm on 28Jan2021 10:15 AM at single dose for COVID-19 immunization in workplace clinic. The patient's medical history and concomitant medications were none. The patient did not have allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced extreme soreness in the arm that received the shot on 28Jan2021. The event was considered as non-serious by the consumer. No treatment was received for the adverse event. The outcome of the event was recovered on an unspecified date in 2021.   Information on the lot/batch number has been requested.
experienced the event of atrial; This is a solicited report from a specialty pharmacy based on information received by Pfizer. A contactable other HCP reported that a 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; treprostinil sodium (IH TYVASO, delivered by Tyvaso Inhalation Device (TD-300/A)) oral from 06Mar2015 (Lot Number: 2101911; Expiration Date: 31Oct2021) and ongoing at 60-120 ug (10-20 breaths) 4x/day for pulmonary arterial hypertension. Medical history included ongoing secondary pulmonary arterial hypertension. Concomitant medication included warfarin. The patient got second coronavirus disease (COVID) shot and then went into atrial fibrillation about seven day later, so they were unsure if that had anything to do with vaccine or not. But, she would be going to get an ablation done on 17May2021. She had no issues with her breathing, no chest pain or other side effects. She had a history of atrial fibrillation a while ago. The action taken in response to the event for treprostinil sodium was unknown. The outcome of event was unknown. The reporter did not provide causality for the event of atrial fibrillation.  Senders Comment: The company has assessed the serious adverse event of atrial fibrillation as not related to IH treprostinil and TD-300/A device. The event was likely due to complications of secondary pulmonary arterial hypertension. Underlying medical condition which led to secondary pulmonary arterial hypertension also likely contributed.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed. No further information expected.; Sender's Comments: The association between the event atrial fibrillation with BNT162b2 can not be completely excluded based on the temporal relationship. The pre-existing pulmonary arterial hypertension may have been contributory as well.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Headache, Fever, NauseaVomiting, chills, weakness, fatigue Narrative:
Increase in redness posterior Right arm today. Tx with Keflex 8/9/04 in ER. Tx with Benadryl 25mg PO BID #60, Zantac 150mg PO BID #30, Prednisone High dose pack, 8/10/04.
A 70 y/o female who presented to Urgent Care for arm pain (left arm was swollen, itch and redness after getting COVID vaccine 8 days ago).  At the initial visit, the provider thought the patient had cellulitis.  Therefore a course of 7 days of Keflex was given. Patient finished her antibiotic and those symptoms still persisted. She came back to her primary care with still mild erythema and warmth of the left lateral arm.  At this time, her doctor diagnosed her with a local reaction to the COVID vaccine  and the patient was sent home with triamcinolone which she had.
Within 8 hours after vaccine would not bear weight on left leg, screamed almost incessantly from 10pm to 3:30am, and subsequently, whenever the affected leg was moved ?.
patients arm  near injection site became hot after 2 days. Also patient had red bump, sore and itchy lasting more than 1.5 weeks. Arm has been feeling a little better past 2 days.
Pharmacy notified by patient on 11/01/2016 - complaint of pain in left arm radiating down the arm. Spoke with Pt. on 11/02/2016, 11/03/2016 and 11/09/2016. Recommended to Pt. to see MD, try Ibuprofen. To date Pt says Ibuprofen helps but pain returns. Has not seen doctor. Note: No bleeding or swelling at injection site.
Sore Throat, Runny Nose, Congested lungs, Productive Cough and body aches. Lasted 2 1/2 days.
FLUBLOK given to a 17 year old patients in error with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist via Medical Information(Reference number- 00322487) and transmitted to Sanofi on 19-Oct-2020.  This case involved a 17-year-old patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] in error (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age).  Relevant medical history, past medical treatments, vaccinations details, Concomitant medication and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, patient had not experienced any adverse 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 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.  There will be no information available on batch number for this case.
Booster dose administered sooner than 6 months. Patient verbally confirmed it had been that long and did not have her vaccination card with her. When adding dose to Database, realized that it had not been 6 months since other doses.
I received the shot on 1/6/21 and had soreness and a red spot at the injection site for the first 3 days. The red spot persisted, then on Sunday 1/10 the red spot became hot, itchy, and raised. There was a quarter sized red circle around the injection site, and then a larger and lighter red spot around that about 4 inches in diameter. This bigger irregular circle lasted through Friday 1/15 when it began to be less hot, itchy, and red. The quarter sized red spot around the injection site is still there as of today 1/20/21 though is mostly faded.
Chest Congestion     C19+ since Thursday, has cough, a lot of flem, having trouble laying down flat with chest congestion. denies shortness of breath or chest pain ? Cough     HPI  88-year-old male with extensive past medical history including CHF, hypertension, atrial fibrillation on Coumadin, presents for evaluation of generalized weakness, shortness of breath, orthopnea.  Patient and family member at bedside states that patient was found to be Covid +3 days ago, he was started on prednisone by his PCP for Covid treatment.  Patient states since Thursday has had worsening nasal congestion and cough.  Patient states his cough is dry.  Patient denies chest pain, abdominal pain nausea or vomiting.   Review of Systems  Constitutional: Positive for activity change.  HENT: Positive for congestion and rhinorrhea.   Respiratory: Positive for cough and shortness of breath.   Cardiovascular: Positive for leg swelling. Negative for chest pain.  Gastrointestinal: Negative for abdominal distention, nausea and vomiting.  Endocrine: Negative for polyphagia and polyuria.  Genitourinary: Negative for dysuria and penile pain.  Musculoskeletal: Negative for back pain and myalgias.  Skin: Negative for pallor and rash.  Neurological: Negative for dizziness and headaches.  Psychiatric/Behavioral: Negative for agitation and behavioral problems.
w/in 24 hrs p/inject started having aching in upper back, progressed to severe pain w/in 3 days then localized in lt scapula area & exists till present time; deep pain; also has severe h/a, top of head, temp inc 100 since 1 wk p/sx; flu sx
DIZZINESS; VERTIGO; JOINT PAIN IN SHOULDER AND RADIATED TO LEGS; HEADACHE; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: type 2 diabetes, non-smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient was previously treated with paracetamol for body pain, dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride for body pain, and dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol for body pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. Concomitant medications included dulaglutide for type 2 diabetes, insulin aspart for type 2 diabetes, and insulin glargine for type 2 diabetes. On 08-MAY-2021, the patient experienced dizziness. On 08-MAY-2021, the patient experienced vertigo. On 08-MAY-2021, the patient experienced joint pain in shoulder and radiated to legs. On 08-MAY-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, vertigo, joint pain in shoulder and radiated to legs, and headache on 09-MAY-2021. This report was non-serious. This case, involving the same patient is linked to 20211115070.
Provider documentation of event provided below:   Pt has an adverse reaction to a vaccine  that she received at visit (likely HPV). She got up to go to the bathroom and felt dizzy. She because weak and unresponsive. She was taken to room by staff safely. Vitals taken. HR was low in the low 70;s initially. BPs normal. Patient was in and out of responsiveness. She never had any trouble breathing.  Evaluated every 20 min. Before leaving was alert and oriented X3. Was eventually able to walk out of the clinic without dizziness. Tylenol was given for headache. ER precautions printed and sent home with father.
redness; bump; soreness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), INJECTION SITE MASS (bump) and PAIN (soreness) 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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ERYTHEMA (redness), INJECTION SITE MASS (bump) and PAIN (soreness). At the time of the report, ERYTHEMA (redness), INJECTION SITE MASS (bump) and PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
15 days, post vax, pt developed more than 50 generalized vesicular skin lesions on the face, trunk, and extremities. Pts temperature was a maximum of 97. Pt was not exposed to varicella or shingles. Follow-up information from a physician reported that on 9/26/99 the pt recovered.
Small pox vaccine placed 10/24/03 developed redness, swelling approx 3" diameter surrounding site on 11/1/03. Rx with Tripack #1 on 11/3, RTC 11/6 skin edges surrounding pustule remain erythematous, scab over small pox site skin remains warm to touch, no lymphoids. 2nd dose of Tripak given, RTC on 11/10, cellulitis resolved.
allergy symptoms; moderate flu symptoms; congestion in head; sinus symptoms; didn't feel like doing anything all day long; fever, temperature of 101; a little bit of chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergy symptoms), INFLUENZA LIKE ILLNESS (moderate flu symptoms), SINUS CONGESTION (congestion in head), SINUS DISORDER (sinus symptoms) and FEELING ABNORMAL (didn't feel like doing anything all day long) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C211A) 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 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced HYPERSENSITIVITY (allergy symptoms), INFLUENZA LIKE ILLNESS (moderate flu symptoms), SINUS CONGESTION (congestion in head), SINUS DISORDER (sinus symptoms), FEELING ABNORMAL (didn't feel like doing anything all day long), PYREXIA (fever, temperature of 101) and CHILLS (a little bit of chills). At the time of the report, HYPERSENSITIVITY (allergy symptoms), INFLUENZA LIKE ILLNESS (moderate flu symptoms), SINUS CONGESTION (congestion in head), SINUS DISORDER (sinus symptoms), FEELING ABNORMAL (didn't feel like doing anything all day long), PYREXIA (fever, temperature of 101) and CHILLS (a little bit of chills) was resolving.            Treatment included cetirizine.
4/2 vaccination  4/8 severe HA, leg, arm, lower back pain, chest pain, diarrhea, bad anxiety with shaking 4/9 PCM (NP) appt; CT scan of abdomen and blood panel 4/10 felt worse, nauseous. Diarrhea continued 4/11 At 11PM, pain right side of neck, to jaw, and toes turned purple.  4/13 PCM; vit D prescribed as they were extremely low, extra strength Tylenol release for leg and arm pain, ordered a D-dimer for possible blood clot.  Doppler for right leg. COVID; neg  4/17 chest pain was extremely severe. Radiated to L arm. Went back to ER. EKG, CT Scan, BNP. All normal. Stated probably really bad heartburn.  4/19 Prilosec. I called my dr on 4/22 to follow up. They told me to keep eye on BP as been elevated thru this whole thing.  4/22 My chest, arm and leg pain with HA are still present despite Tylenol and Prilosec. My PCM said to come back in . She prescribed Prednisone and Pantropical and did a blood test to check for inflammation which was normal. I have been taking both medications since Tuesday.  *My HA still present. My right side still has pain and I still have chest pain.
Narrative: Covid infection following COVID vaccine series 04/16, Pfizer, dose #1 05/10 Pfizer, dose #2 09/04 pt cc: chills, cough, fatigue, fever, headache, myalgias, rhinorrhea, dyspnea, sore throat , loss of taste or smell exposure: unknown 09/09 COVID swab, result: detected 09/14 SARS-COV-2 Variant Sequencing result: pending 09/17 clinically resolved
No adverse event; On 15-Feb-2023 Patient received the bivalent vaccine as their first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (On 15-Feb-2023 Patient received the bivalent vaccine as their first dose) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy to nuts.    On 15-Feb-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 15-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (On 15-Feb-2023 Patient received the bivalent vaccine as their first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (On 15-Feb-2023 Patient received the bivalent vaccine as their first dose) 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 WRONG PRODUCT ADMINISTERED (On 15-Feb-2023 Patient received the bivalent vaccine as their first dose).    No concomitant medications were reported.  No treatment information was provided.
Information has been received from a physician and the office manager concerning a 6 month old female patient who on 12-MAR-2009, was vaccinated with PNEUMOVAX instead of PREVNAR by mistake due to an office error.  It is unknown if the patient sought medical attention.  Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X).  There was no illness at the time of vaccination.  No reactions or adverse events were reported.  The patient did not seek medical attention.  This is one of several reports from the same source.  Additional information is not expected.
got the first dose / November 2020 / has not gotten the second dose; developed shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In April 2021, 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported for the first dose and was not applicable for the second dose. The patient stated that he got the first dose of Shingrix and developed shingles. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Mid grade fever presented 8 days post vaccine and did not subside for 9 days. After 9 days of consistent fever, he was two days free of fever. Since this, the mid grade fever has presented intermittently. Additional symptoms include non-productive cough and extreme irritability.
Blurred vision - onset 1420 hours. eyesight still has not returned to baseline  Headache - onset 1425 hours. Left side excruciating sharp head pain. Continue to have low-grade head pain on the left side Hot flashes - 1530 hours. Full body sweats for three days.  Temperature - 1540 hours. low grade temperature for three days.  Body pain -- 2000 hours. Allover body pain lasting 5 days.  Left arm pain - 2015 hours. Pain persisted for 10 days.  Itching -- 2100 hours. All over body itching for three days.  Chest pain -- 2130 hours. Sharp without radiation for three days.
Fever/102 degree Fahrenheit; Headache; Nausea; Loss of appetite; Body ache; Very bad chills; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever/102 degree Fahrenheit), HEADACHE (Headache), NAUSEA (Nausea), DECREASED APPETITE (Loss of appetite) and MYALGIA (Body ache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METOPROLOL and SPIRONOLACTONE for an unknown indication.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PYREXIA (Fever/102 degree Fahrenheit), HEADACHE (Headache), NAUSEA (Nausea), DECREASED APPETITE (Loss of appetite), MYALGIA (Body ache) and CHILLS (Very bad chills). At the time of the report, PYREXIA (Fever/102 degree Fahrenheit), HEADACHE (Headache), NAUSEA (Nausea), DECREASED APPETITE (Loss of appetite), MYALGIA (Body ache) and CHILLS (Very bad chills) outcome was unknown.            treatment to the events not reported. nurse advised patient to drink plenty of water to keep hydrated.
Heart racing, pounding, lightheadedness starting a few weeks after Almost fainted in March 2021. Finally diagnosed with unknown cause sinus tachycardia December of 2021
arm described by employee as "swollen 3-4 inches below injection site, red and warm to touch"
Swelling of site below injection site, redness, pain. It got so bad I went to ER the following day. My entire upper arm was swollen, hard and warm to the touch. The redness became a purplish color. I was clearly having an allergic reaction.