chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rheumatoid and osteoarthritis. Always have some pain but it increased dramatically; rheumatoid and osteoarthritis. Always have some pain but it increased dramatically; This is a spontaneous report from a contactable nurse (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: not reported), via an unspecified route of administration on right arm on 29Jan2021 08:00 at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, ongoing osteoarthritis, CAD (coronary artery disease), hypertension, GERD (gastrooesophageal reflux disease), osteoporosis, lumbar stenosis, lumbar degenerative disc and Allergies: Sulfa.  Concomitant medication included carvedilol (COREG), prednisone, methotrexate, adalimumab (HUMIRA), fluoxetine hydrochloride (PROZAC) and risedronate sodium (RISEDRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not diagnosed with COVID-19 prior to vaccination. On 29Jan2021, 12:00 patient had rheumatoid and osteoarthritis. Always have some pain but it increased dramatically and almost unbearably. The patient pain med did help some. Lasted about 11 hours. The seriousness criteria were considered as non-serious. Since the vaccination, the patient been not tested for COVID-19. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect drug on reported Rheumatoid Arthritis aggravated cannot be excluded.  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.
2 consecutive years of developing facial numbness about 20 minutes after receiving flu vaccine, facial numbness lasted a few weeks w/o facial drooping.
7.0 cm area of erythema to (L) upper anterior thigh over 24; tx: cool packs, MOTRIN temp 97.8.
Pain at injection site starting around 7pm, extreme left arm pain by 11pm. Pain and weakness extended from the shoulder to the finger tips. Fever of 102 started around 2am 5/19. Dull headache at the back of the head and neck, no relief despite medicine. Rotated Tylenol and ibuprofen all day, fever broke at 10am 5/20. As of 5/20 no fever, headache, or extreme arm pain. Injection site still warm to touch but significantly less painful. Weakness still felt in left arm and hand.
Patient came in for booster. Presented vaccine card with dates of 4/6/21 & 5/4/21 - gave consent and then recieved vaccine. When logging vaccine, (AFTER if it was given) it was discovered that the patient had actually already recieved booster on 11/11/21 it apparently was just not updated on card.
This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 25-NOV-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (Lot # K024036, expiration date 26-NOV-2016) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Shingles infection involving left eye 1 day after vaccine treatment - Prednisone x 5 days, Valacyclovir 1000 mg TID x 7 days
This spontaneous report was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date since December 2014 the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have been made with regards to sore arms but that's nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient(s) who may have experienced the symptom. She stated that they "always" received complaints regarding sore arms after administration of vaccines. No further information was provided. The outcome of sore arm and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
2/19/2021 - (the next morning) - unable to get out of bed because of weakness and pain; then had 102* temperature for about 6 hours, then 101* - treated with rest, gatorade, and assistance as needed to get up; called primary office, but refused advice to go to emergency room for evaluation 2/21/2021 - (3 days later) - sinus congestion and headache for most of the day; unrelieved by Allegra 180 and pain medication  2/23/2021 - (5 days later) -  stomach cramps and diarrhea in the morning  complained arm sore for a week
Aches; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Aches) and FATIGUE (Fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 031M20A, 027H14B and 027L20A) for COVID-19 prophylaxis.     The patient's past medical history included Aortic stenosis (since about 5 years ago pretty stable during that time). Concurrent medical conditions included Post-traumatic stress disorder and Mood swings. Concomitant products included SERTRALINE for Post-traumatic stress disorder and Mood swings, METOPROLOL TARTRATE, OMEPRAZOLE, ROSUVASTATIN and MIRABEGRON for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Aches) and FATIGUE (Fatigue). At the time of the report, PAIN (Aches) and FATIGUE (Fatigue) outcome was unknown.            No treatment information was reported.   This case was linked to MOD-2023-748020, MOD-2023-747981 (Patient Link).
This information was considered medically important (OMIC). Information regarding Flumist nasal solution was received from a consumer regarding a 3 year old who developed the flu, pneumonia in the right lung, and vomiting, following exposure to her mother who received a dose of Flumist on 12/15/03. The reporter indicated that the patient has no significant medical history. The patient received a flu shot one week prior to the mother receiving a dose of Flumist on 12/15/03. Patient was not taking concomitant therapy. The child developed the flu several days after her mother received a dose of Flumost on 12/15/03. On 12/18/03, the child began feeling lethargic and sleeping during the day. On 12/22/03, the child developed pneumonia in her right lung and was prescribed an unspecified dose of amoxicillin for 10 days. She developed a fever up to 105 degrees F and the pediatrician was notified. The mother reported that the child developed vomiting several times due to the high fever. The fever was treated with Motrin alternating with acetaminophen as well as putting her in a tub of water to lower the fever. Her fever did not break until after 12/25/03. The mother indicated that cultures were not performed. The symptoms persisted for two weeks. No additional information was available at the time of this report. Follow up on 06/08/04 states: "On 12/15/04, during the first twelve hours after the mother received Flumist, the child became "clingy". On 12/18/03, the child "began feeling lethargic and sleeping during the day," and subsequently developed "the flu" (influenza). On 12/22/03, the child developed "pneumonia in her right lung" (lobar pneumonia) and was prescribed an unspecified dose of amoxicillin for 10days. She developed a fever "up to 105 deg F" and the pediatrician was notified. The mother reported that the child developed "vomiting several times due to the high fever." The fever was treated with MOtrin alternating with Tylenol as well as "putting her in a tub of water to lower the fever." Her fever "did not break until after 12/25/03." The mother indicated that "cultures" were not performed. After two weeks, the child completely recovered. The mother noted that the child did not come in contact with anyone else who had the "flu." Follow up informaiton received from the child's pediatrician provided laboratory test results and additional vaccination details:
Pt has large red bumps near arm pit aprox 1 month after small pox vaccination. Complains of itching, denies any other symptoms. Area evaluated by allergist and ER department. Determined likely unrelated to the smallpox vaccine.
Rash; muscle pain; headache; sore arm; This case was reported by a physician and described the occurrence of rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received on 29th July 2020, reference case US2020213894).   On 21st December 2020, the patient received the 2nd dose of Shingrix. On 21st December 2020, less than a day after receiving Shingrix, the patient experienced rash, muscle pain, headache and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash, muscle pain, headache and pain in arm were recovered/resolved.   The reporter considered the rash, muscle pain, headache and pain in arm to be almost certainly related to Shingrix.  Additional details were provided as follows: The patient experienced rash, muscle pain, headache and sore arm. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020213894:Same reporter
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series was 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 30-DEC-2021, the patient experienced suspected covid-19 infection (cough, fever, runny nose, congestion nasal and sneezing). Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211265944. This case was associated with product quality complaint number.; Sender's Comments: V0: 20211266272-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022; received vaccine past its 30 days of an expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2022 at 11:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Feb-2022 at 11:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine past its 30 days of an expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient received Booster dose.  This vaccine was administered up until its Mfg Exp date of 04-Apr-2022. No treatment medication was reported.
The patient did not experience any symptoms; A unspecified patient was administered a dose of expired ROTATEQ; This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 23-JAN-2020, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # R005869, expiration date 23-OCT-2019 (strength and dose were not provided) for prophylaxis. The patient did not experience any symptoms.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 04-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD lot number reported as L004005, expiry date 05-AUG-2016 (dose and route were not reported). No adverse effects reported and no Product Quality Complaints (PQC) involved. There was no concomitant medication provided. Additional information has been requested.
Patient passed out almost immediately after receiving vaccine. She had some seizure-like jerking however upon awakening she was not disoriented. She was aware of her surroundings but didn't remember passing out. Patient's mother, who was present, said patient had passed out on a different occasion after receiving a vaccination in the doctor's office. She stayed at the pharmacy for about 10 minutes after receiving the vaccine and no additional incidents occurred.
3 weeks and 3 days after 2nd Phizer shot, I was sitting at kitchen table and out of no where, the room started to spin.  Stumbled to the couch to lay down, and within a minute, began throwing up for the next several hours - throwing up bile and sips of water I had taken. Slept for 7 hours and when I woke up in the am., still was dizzy and began throwing up again when I sat up.  Went to ER and received fluids, medications and vomiting stopped.  Had an MRI which was clean.  Still dizzy leaving the ER, but vomiting stopped. Diagnosed with BPPV.  Dizziness is better but still feeling light headed.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneous route (dose, frequency, and anatomical location were unknown) with lot # N020015 and expiration date 17-JUL-2019 for prophylaxis, reconstituted with properly stored Merck sterile diluent with lot # N026286 and expiration date 06-FEB-2020. The administered dose of vaccine experienced the temperature excursion of -9 degrees C to 8 degrees C (7C) Celsius for 41 hours, and -14 degrees C to -10 degrees C (-9.6C) Celsius for 5 hours 44 minutes. There was a digital data logger involved, but there was no previous temperature excursion, and no adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA004211; US-009507513-1804USA004212; US-009507513-1804USA004213; US-009507513-1804USA004214; US-009507513-1804USA004215; US-009507513-1804USA004216.
4FEB91-7-FEB91 temp to 103.3; 6FEB91 6PM rash on face - 7FEB91 rash on back, abd, face, blotchy & red heavy distrib. also on palms & soles of feet. No cough, coryza, photophobia or koplick spots.
Area of redness, swelling, induration on left deltoid. Approx 3 inches of redness. Motrin and Cefzil given.
While going through records saw a first shot moderna given, appears to be charted correctly and vaccinator stated that he gave a full dose of moderna. Draw records show a full dose of Moderna was supplied that day. Other vaccinator states she was not sure that he gave a full dose, thinks there is a possibilty that it was a half dose. Called patients and left voicemail to return call, but unable to get a hold of patient.
This spontaneous report as received from a nurse practitioner refers to a 27 years old female patient who was not pregnant with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated intramuscularly with her first and only dose of GARDASIL (lot # 0121AE, expiration date 29-SEP-2014) on 30-MAY-2012. There were not concomitant medications. On 25-OCT-2012 the patient experienced a red, raised rash with one bump at the injection site. The patient called the reporting nurse practitioner for medical attention. No treatment was given. No laboratory diagnostics studies were performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Chills; Headache; Fatigue; Feel like I am burning; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated "I took the first dose of the Pfizer yesterday and I am experiencing like a (chills), headache and fatigue. I feel like I am burning. So, which kind of medication can I take? Can you take Tylenol or Ibuprofen (for treatment)." The outcome of the events was unknown.  Information on Lot/batch number has been requested.
Fever, temperature 102 at 11 pm.  Ibuprofen 600mg,Chills, sweating, muscle pain.  Started at 11 pm , persisted through next day.
Continue soreness/stiffness in neck, shoulder elbow since date of of dose 2 vaccine (3-24-21)
two doses on 24-FEB-2004 (3y 4m) and 28-AUG-2006 (5 y 10 m); Information has been received from a physician and a lawyer referring to a 3 years old female patient regarding a case in litigation. The patient's historical vaccines included hepatitis B vaccine (manufacturer unknown) (15-OCT-2000), Hib-Hepatitis vaccine (19-DEC-2000 and 26-FEB-2001), diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP) (19-DEC-2000, 26-FEB-2001, 26-APR-2001), pneumococcal vaccine conj 7v (CRM197) (PREVNAR 7) (19-DEC-2000, 26-FEB-2001, 26-APR-2001) and polio vaccine inact (IPV) (19-DEC-2000 and 26-FEB-2001). Concomitant vaccines included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP), polio vaccine inact (IPV) and varicella virus vaccine live (oka/merck) (VARIVAX). Concurrent condition and medical history were not provided.   On 24-FEB-2004 (also reported as at the age of 3 years and 4 months), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (therapy type unknown; route, dose, dose number, lot number and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).  This is one of two reports for the same patient (link # 2008USA012413).; Sender's Comments:  US-009507513-2008USA012413:
pt rcvd vax & had fever, vomiting, diarhea, puritis, edema polpebral distended abdomen;
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 26-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Mother calls health department today (7-28-14) at 10:00 am. States child started having hives the day after shots and started swelling at area of hives because she was itching them. Stated, "I do not know if she had a fever or not but she did lay down most of the day yesterday." Has not been evaluated by MD yet but instructed to do so.
Patient received Pfizer COVID vaccine on 1/5/21 and 1/26/21. On 1/18/22, patient admitted to our inpatient facility with right middle lobe pneumonia with sepsis, acute on chronic respiratory failure with hypoxia, and COVID19 infection. As of today (1/21/22), patient is still admitted in our med/surg unit.
Within 6 to 12 hours of my first shot I was launched into heavy cramping and menstrual bleeding which is mainly concerning because I have an IUD. I haven?t experienced menstrual symptoms of this sort for years.
8 days p/vax pt had restless nite;febrile for 3 days;temp highest 102 per ear;giving Ibuprofen;took pt to MD who was not sure if an immun rx;pt has no rash or other sx;behaving nl;
all over itching an hour after vaccine - no rash - took hydroxizine for itch Heart rate began to increase a few hours after injection - resting heart rate normally 68 - was 78, then 88 -  on 8/28/21 Any movement heart rate over 100. Sleeping - laying in bed alll day - heart rate up to 134 Body wracking chills - 103 temp headache 8/29/21 all symptoms gone other than sore muscles
Pt recvd 3 doses of Engerix-B 5NOV90, 30NOV90, & 9MAY91 & 8SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Developed swelling in right armpit 2 days after vaccination. E.R. visit, no treatment required.
No adverse event - reporting patient received a 4th dose of Gardasil.  Patient tolerated well, no problems.
1hr p/pt recvd DTP/OPV/MMR devel hives on face; No difficulty breathing; Taken to ER & given DPH later that night vomited x 2 & had one green stool; No fever;
On 11/16/2000 the patient developed chicken pox. Unspecified medical attention was sought. In follow up, the physician's office indicated that the patient developed a rash and not chicken pox. No further information was reported.