chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore neck; Stiff neck; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 15:00 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic to cats" (unspecified if ongoing); "Grass allergy" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "allergies Opiates" (unspecified if ongoing), notes: allergies Opiates. The patient's concomitant medications were not reported. Past drug history included: Rye, reaction(s): "Drug allergy". The following information was reported: NECK PAIN (non-serious) with onset 22May2021, outcome "not recovered", described as "Sore neck"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 22May2021, outcome "not recovered", described as "Stiff neck". Therapeutic measures were not taken as a result of neck pain, musculoskeletal stiffness.  Additional Information: The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itching started at night and got progressively worse to the point of hives. On 10/07 felt nauseated, dizzy, woke up with perspiration. 10/11 called doctor and waiting for prescriptions to arrive. Complains of hoarseness.
A report has been received from a Pharmacist concerning a 41 year old, Female subject, who had been receiving Nasal FLUMIST, 0.2 Millilitres, Unknown. FLUMIST started on an unknown date. The patient experienced severe watery eyes and severe nasal congestion which started on 10-Jan-2013. At the time of reporting, the event of watery eyes and nasal congestion was ongoing. The report was considered to be non-serious by the reporter.
I have not had a period in 8 months.  The night I had my 2nd dose, I started my period that lasted 3 days.  I have not had cramping for 2 years.  I cramped for 2 days.
This spontaneous report was received from a 66 year old female consumer regarding herself. The historical drugs included DEMEROL, CIPRO and NOVOCAIN. She had a current condition of fibromyalgia. The patient was allergic to following drugs DEMEROL, CIPRO and NOVOCAIN and also allergic to adhesive tape. On 22-OCT-2014, the patient received pneumonia vaccination (manufacturer unknown) (strength, dose, frequency, product lot#, expiry date, route not reported). It was also reported that adverse event was reported for PNEUMOVAX 23 as the product because PNEUMOVAX 23 could not be ruled out as the vaccine the patient received. Concomitant therapy included NORALOX. The patient reported that on 22-OCT-2014, after receiving vaccine, she experienced the following injection site reactions: soreness, swelling and itchiness and also reported the following systemic adverse reactions: chills, myalgia, pain, ecchymosis, and erythema. She stated that both the injection site reactions and systemic reactions began immediately after receiving the vaccination. The patient applied ice to the injection site to treat her injection site reactions. No laboratory diagnostics studies were performed. The patient sought medical attention. On an unknown date in 2014, the patient recovered from all the injection site reactions, but had not recovered from any of the systemic adverse reactions. The causality of the events was unknown. Additional information is not expected as patient would not answer any more questions.
On 12/1/22 resident was in respiratory distress and sent to the hospital. She was sent back with a dx of COPD excaberation started tx at that time. On 12/5/22 The resident had AMS and was not responding. NP saw the resident and her RP and it was decided to place her on comfort measures at that time.  On 12/6/2022 the MD saw the resident and believes that the events are related to her poor respiratory conditiona dn covid vaccine complications.  He continued comfort measures as discussed with the residents daughter.  On 12/7/2022 the resident passed away.
Vigorous chills (afebrile); Some sensitivity over his nose; Painful and tender lymphadenopathy on the axillary area on the same arm as the injection site; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, on 11Jan2021, at a single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously had his first dose of COVID-19 vaccine on an unspecified date. It was reported that the patient had the second dose of the COVID-19 vaccine on 11Jan2021, and on 12Jan2021, he had a painful and tender lymphadenopathy on the axillary area on the same arm as the injection site. He had no issues with the first shot. He also reported that he has been taking an antihistamine and the lymphadenopathy is going away. He also had vigorous chills (afebrile) when the event first took place for 2-3 hours. He had some sensitivity over his nose which was also improving with the antihistamine. The outcome of the events "painful and tender lymphadenopathy on the axillary area on the same arm as the injection site" and "some sensitivity over his nose" was recovering, and the other event was unknown.
Severe headache lasted a couple of weeks  Working memory issues that are still ongoing weeks late such as mental fog, exhaustion, trouble focusing, trouble with attention
Redness, swelling and edema to (R) arm (deltoid). Cellulitis of (R) upper arm. Pt given Rx for KEFLEX 500mg qid x 7 days.
Mom stated that infant experienced increased irritability 1 day post vaccine with hives to right leg. Tylenol was given by mom. Seen in MD's office and rash was subsiding.
PT. STATED THAT AFTER RECEIVING THE VACCINE SHE EXPERIENCED NO STRENGTH IN ARMS AND LEGS, HAD THE CHILLS AND SWEATS, HER BODY WAS STIFF AND SHE SLITHERED OUT OF BED AND WAS ON THE FLOOR UNABLE TO MOVE FOR CONSIDERABLE AMOUNT OF TIME UNTIL SON FOUND HER. SHE TOOK TYLENOL FOR PAIN
Localized reaction to site 8 x 10 cm erythema, slightly raised, warm to touch and slightly itching.
Enough to keep me awake at night; Pain on injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Enough to keep me awake at night) and VACCINATION SITE PAIN (Pain on injection site) 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 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced INSOMNIA (Enough to keep me awake at night) and VACCINATION SITE PAIN (Pain on injection site). At the time of the report, INSOMNIA (Enough to keep me awake at night) and VACCINATION SITE PAIN (Pain on injection site) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Information has been received from a physician via a company representative referring to a 20 (currently 21) years old female patient of unknown age. "2 to 3 years ago", in approximately March 2013 the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly. Concomitant medications were not provided. The physician stated that "about a year ago", in approximately March 2015 the patient began complaining of headaches which gradually increased in frequency to a daily occurrence with occasional sharp pains which physician described as "atypical headaches". The physician stated the patient was seen by an unspecified pediatrician and referred to an unspecified neurologist. The physician stated there had been at least one 'normal' Magnetic Resonance Imaging (MRI) completed (date unspecified) but headaches were becoming increasingly debilitating for this patient and the patient was "now" demonstrating emotional issues (in approximately March 2016). It was also reported that the patient had received multiple diagnostic tests, Computerized Tomography (CR) scans and unspecified blood tests to try and determine the cause of the headaches. The physician stated the patient took TRILEPTAL and was prescribed an unspecified antidepressant "today", on 11-MAR-2016. The physician stated the patient, at unspecified time since headaches started, "she tried anti-seizure medications (not specified) that did not do much." The physician stated the patient was not a drug user and appeared healthy. The physician stated the patient was scheduled, at an unspecified time, for a lumbar puncture as "everything (other diagnostic tests) came up negative". Outcome of the events was reported as not recovered. Additional information has been requested.
This case involves an eight-years-old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation. On 08-Nov-2021, the patient received a 0.5 mL (once) dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry date not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination. It was an actual medication error due to product administered to patient of inappropriate age. (latency: same day). It was reported "on November 8, 2021, an 8-year-old patient was immunized with a dose of Quadracel. As the patient is under vaccinated, can this dose count as a catch up dose?" At time of reporting, no adverse event reported. There will be no information available on the batch number for this case. 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.
Narrative:  Patient is a 98 year old male who received 1st dose of COVID-19 vaccine 1/16/21 and has prior hx of testing COVID-19 positive 10/27/20 w/ brief hospitalization for poor intake but recovered with minimal residual complications (reports taste/smell is still intermittently impaired). On 1/26/21, patient called telephone care program to report loose stools x 4 weeks. Patient was dx with overuse of laxatives. Per 1/26/21 general medicine clinic note, after hospitalization for COVID-19 patient developed constipation and was prescribed bowel regimen with prune juice and numerous laxatives (bisacodyl, PEG, senna, psyllium) PRN that he had been taking every day. Patient was advised to discontinue laxatives and continue psyllium. No further follow-up in chart.
Breakthrough COVID infection and symptoms following vaccination series and booster with Comirnaty; Breakthrough COVID infection and symptoms following vaccination series and booster with Comirnaty; booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58 year-old patient received bnt162b2 (COMIRNATY), intramuscular, administration date 11Nov2021 09:30 (Lot number: FF8839) at the age of 58 years as dose 3 (booster), single, intramuscular, administration date 12Mar2021 11:30 (Lot number: EN6203) as dose 2, single and intramuscular, administration date 19Feb2021 10:15 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "T2 Diabetes", start date: 2011 (ongoing), notes: Illness/AE: T2 Diabetes, Onset Date: 2011, Stop Date: Ongoing; "HBP", start date: 2011 (ongoing), notes: Illness/AE: HBP, Onset Date: 2011, Stop Date: Ongoing. Concomitant medications included: METFORMIN taken for type 2 diabetes mellitus, start date: 2011 (ongoing); FOSINOPRIL/HCTZ taken for hypertension, start date: 2011 (ongoing). The following information was reported: IMMUNISATION (medically significant) with onset 11Nov2021 09:30, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant) with onset 23Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 23Dec2021, outcome "recovered" and all described as "Breakthrough COVID infection and symptoms following vaccination series and booster with Comirnaty". The patient underwent the following laboratory tests and procedures: glycosylated haemoglobin: (Oct2021) 7.6, notes: Blood labs (Quarterly); lipids: (Oct2021) normal range, notes: Blood labs (Quarterly); sars-cov-2 test: (2021) positive; (24Dec2021) positive, notes: At home test. Therapeutic measures were not taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.  Follow-up (21Jan2022): This is a follow up spontaneous report from the same contactable consumer (patient). Updated information: patient details (age and age at vaccination), medical history, suspect vaccine details (route of administration, administration dates), event updtaed to vaccination failure, vaccination facility details, concomitant drugs, and lab data.
I woke up the next morning with cold sweats, nauseated, very weak feeling. Lasting until the morning of 12/6/02.
According to patient's husband who is a physician, patient has a rash on her back dermatone on right side. Patient experienced pain at site of injection and hypersensitivity after 3 days of the vaccination. Pigmentation up to upper back. Patient visited Dr. for treatment of the adverse side effects and  was given a course of Valtrex after 5 days of vaccination.
allergic reaction; rash all over my neck and its spread up to my eyes and my cheek; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. Medical history included severe allergies and severe sulfur allergy. The patient's concomitant medications were not reported. Consumer stated, "I have for the COVID vaccine on Sunday and I spoke to someone yesterday because I am having allergic reaction, I have a rash all over my neck and its spread up to my eyes and my cheek. I went to the dermatologist this morning and I have severe allergies and severe sulfur allergy and the dermatologist is wondering if they can treat me with Prednisone." Outcome of events was unknown.    Information on the lot/batch number has been requested.
She did not have an adverse reaction to the vaccine.  She developed a cough before testing positive for COVID-19 on 02/11/2023. We contacted her doctor via telephone and a got a prescription for Paxlovid. She tolerated the medication and completed taking the full script.
ITCHING ALL OVER THE BODY; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced itching all over the body. Treatment medications (dates unspecified) included: hydroxyzine, and diphenhydramine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching all over the body. This report was non-serious.
On day of vaccine 1/26/21, had minutes of right arm paralysis. On 1/29/21, had hours expressive aphasia and the hour of right arm and leg weakness with fall. On 1/30/21, has stroke with expressive aphasia and some right arm weakness. Was admitted to hospital 1/30/21. MRI showed multiple infarcts left hemisphere and carotid dissection. Heart monitor after discharge showed new onset paroxysmal atrial fibrillation. Echocardiogram normal. Symptoms have improved over weeks.
Patient complained of swelling in area afternoon after shot.  Some itching.  Pink area 7 cm x 5.5 x cm with dark, red area in center 3 cm x 3 cm.
Initial unsolicited report received from a health care professional (physician assistant) on 11-Aug-2017. This case involves a 46 year old female patient who was vaccinated with a first dose of ADACEL via intramuscular route (Batch number: U5593AA, expiry date: 07-Mar-2019, dose not reported) in left deltoid on 11-Jul-2017. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported as patient had no known allergy. Illness at the time of vaccination was also reported as none. Any other vaccinations within four weeks of vaccinations was not reported. On 12-Jul-2017, one day following the vaccination, the patient had soreness in left arm and tingling in left arm going to 5th and 4th fingers and 1/2 of 3rd finger. 2-3 weeks the tingling persists. Patient required emergency room (ER)/ doctor visit as patient was referred to a neurologist. Laboratory investigations were not reported. Patient had warm compress which relieved the soreness. On an unknown date patient was recovered from soreness in left arm. Outcome of the tingling of extremity was not recovered. List of documents held by sender: none.
10 day after the flu shot, I got the flu for about 2 weeks, it went away for about 3 days and returned. In december 1999 I had my first flu shot, I kept the flu off and on for 2 months.
Vaccine was administered at 11:36am, patient left immunization room at 11:37am, and walked toward front of store. Patient stated she became lightheaded and dizzy after shot. She almost fainted, but never lost consciousness, and was lowered to floor by her mother.  Emergency was called around 11:38-11:40. Patient was sat in a chair at the photo station and instructed to place her head between her knees.  Given one tablet of Banophen 25 mg at 11:42am. EMT arrived at 11:45 am and assessed patient's condition, vitals were all clear and blood sugars were good. Patient left store with mother.
01/15/2021 AROUND 10:30AM HEADACHE STARTED THROUGH THE DAY CONTINUE TO GET WORSE TOOK TYLENOL DIDN'T HELP MUCH. BY 11:00 PM ON 01/15/2021 STARTED GETTING FULL BODY CHILLS AND SOME SLIGHT DISCOMFORT IN MY CHEST. BEFORE DAY SATURDAY MORNING 01/16/2021 CHILLS WENT AWAY WHEN I WOKE UP HEADACHE WAS DULL TYLENOL HELPED WITH IT SATURDAY STAYED NAUSEATED AND FATIGUE FEELING ALL DAY STATURDAY. VACCINE WAS GIVING IN MY RIGHT ARM SATUURDAY NIGHT MY LYMPH NODES UNDER MY RIGHT ARM HAD SWOLLEN AND SORE. SUNDAY 01/17/2021 FINALLY FELT BACK TO NORMAL EXCEPT FOR LYMPH NODES STILL SWOLLEN WHICH IT FINALLY WENT DOWN SUNDAY NIGHT AND WAS COMPLETELY DOWN MONDAY. MONDAY AND TODAY TUESDAY 01/19/2020 ARMPIT WHERE LYMP NODES WAS SWOLLEN IS SORE .I FEEL BACK TO NORMAL.
Patient stated on CDC form and questioned in person if he had received a COVID-19 vaccine.  Patient stated NO.  Moderna vaccine was administered at 10:03 a.m. At 4pm while entering vaccine in state immunization system (MIIX), patient had received 1 dose of Pfizer COVID_19 vaccine on 2/8/21 .  I called patient at 6:30 p.m., he again denied getting a Covid-19 vaccine prior.  Based on MIIX he had received a vaccine of Pfizer and then I administer Moderna on 8/13/21.
Case number PHEH2012US015692 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to an 11-year-old patient of unspecified gender. This patient was vaccinated only with MenCWY-135 liquid component of MENVEO (batch number: M11033) without being reconstituted with Men A component of MENVEO on 05 Jul 2012. Thus this patient received only partial dose of MENVEO. No adverse event was reported. No other information was available.
I had all over muscle pain, my right ankle ache, dehydrated, headache, fatigue. Felt like a bad 72 hour flu.
pt recvd vax 3JUL95 & 5JUL95 pt exp h/a;7JUL95 devel fever & began to break out in lesions;@ time of report pt had 100 lesions;9JUL95 pt exp diffuse vesicular rash;
pt recvd vax & 3 wks later exp aching throughout body, pain back & neck, fever (101), vomiting, diarrhea; did not receive treatment; sx persist;
Patient received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 30th March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-Mar-2022 Reporter's comment: On the date of reporting the patient received an expired dose of Twinrix. The consent to follow up was given. Additional Supportive Information: The patient received Twinrix which was already expired on 28th February 2022, which led to expired vaccine used.
FOUR MINUTES OF OBSERVATION PATIENT STARTED HAVING BLURRED VISION AND DIZZY. VITALS WERE TAKEN  BP 126/70, HR 46, O2 99. COLD PACK WAS PLACED ON THE BACK OF NECK. VITALS WERE REPEATED AND WITHIN NORMAL RANGE. PATIENT WAS CLEARED .
Description: 45 y/o WM, ADSM is referred to the health center from the Joel SRC for a history of fever, chills, clamminess, myalgias, and decreased appetite since the evening of the receipt of AVA #5 and Typhoid vaccines. Symptom: Fever Start: 10/01/2007 Comment: Undocumented fever alternating with chills and clamminess since the evening of 10/1. Symptom: Chill Start: 10/01/2007 Comment: Alternating with fever. Symptom: Anorexia Start: 10/02/2007 Comment: Minimal food intake due to 'not feeling like eating' for past 2 days. Symptom: Headache, general Start: 10/01/2007 Comment: Mild non-migrainous headache, relieved by Motrin. Symptom: Muscle Pain Start: 10/01/2007 Comment: Described as 'muscle aches'.