chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hesitant and nervous to get the second dose; felt like paranoid; hyperventilating; Heart beating fast for about 5 -10 minutes; Muscle spasms; Her allergies were trying to activate; This is a spontaneous report from a contactable consumer (patient). This 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 02Apr2021  11:56  (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included two weeks prior to receiving the Covid vaccine she was on antibiotics for diverticulitis from Mar2021 for 10 days. Two weeks prior to receiving the Covid vaccine she was on antibiotics for diverticulitis for 10 days. She wonders if she should have waited longer. Concomitant medications included ongoing Zinc from Mar2020 at 50mg daily to keep immune system fully activated, she thinks she needs more, ongoing Vitamin D3 from Mar2020 at 5,000IU/125mcg every other day to keep immune system fully activated, ongoing bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lact, bacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) from 2020 at 10,000,000,000 viral daily to keep good bacteria in her stomach to keep immunity good, and ongoing Multivitamin from Mar2020 at every other day to keep immune system fully activated. She received the first dose of the Covid-19 vaccine on 02Apr2021. She was fine until that night, early in the morning. 03Apr2021 at 2:00 am she was paranoid and was hearing a voice. She felt like she was hyperventilating a little bit on 03Apr2021. That lasted for 10 minutes and went away. The next morning on 03Apr2021 her heart was beating fast. That lasted for 5-10 minutes. She felt like she was having muscle spasms on 03Apr2021 that lasted for 5 minutes. She felt like her allergies were trying to activate on 03Apr2021. She took an allergy pill and it worked for her allergies to keep them from acting up. After that she didn't experience anything else. She was hesitant and nervous to get the second dose. The second dose is scheduled 23Apr2021. She was taking Metronidazole 500mg twice daily for 10 days. No emergency room and physician office. Outcome of the event paranoid and heard a voice, hyperventilating, heart was beating fast, Muscle spasms was recovered on 03Apr2021. Outcome of the event allergies were trying to activate was recovered on 04Apr2021. Outcome of other event was unknown.  No follow-up attempts are needed. No further information is expected.
130AM elevated temp tx w/APAP; repeated APAP 330-4A; 7AM started sz @ 10 mins & trouble breathing; parents could not find pulse; when met the ambulance-vomited & started to respond; taken to ER:
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a nine-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which as reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
p/vax pt arm became swollen & tender;pt expressed concern that the swelling spread distally towards in lt elbow;there was no SOB, swelling of throat, or rash;pt reported that has not reacted badly to tetanus or other vax in past;seen by MD
One day subsequent to receiving one dose of Lymerix, the pt experienced a minor rash with itching which resolved. One day subsequent to receiving second dose of Lymerix, the pt experienced a larger, entire upper torso and face rash. Pt was treated with Allegra.  As of 08/03/2000 the outcome was unresolved.
patient given menveo in error. Patient should have received meningococcal B (Bexero)
APPROX 13 M INUTES AFTER RECEIVING INJECTION PATIENT BEGAN FEELING SUDDEN ITCHING SENSATION ON ARM AND CHEST. SHE STATED SHE FELT LIKE SHE WAS STARTING A REACTION, AND BEGAN SCRATCHING CHEST, ARMS, AND THROAT  PATIENT TAKEN DIRECTLY TO EMERGENCY DEPARTMENT WHERE SHE WAS TREATED  AS SOON AS SYMPTOMS STARTED. AT THE TIME OF THIS REPORT, PATIENT IS IN ER AND STABLE, PROJECTED TO BE DISCHARGED AFTER OBSERVATION.
Received a ZOSTAVAX vaccination at his pharmacy. In less than 24 hours he developed a painful blistery rash which I diagnosed as herpes zoster.
Per pt's mother, 1-1/2 hours post vaccine administration, pt fell asleep in carseat. When she was picked up, she was completely limp, persisting 10-15 minutes. Seen at physician's office for Hypotonic event, 1/2 hour later. Pt wnl.
pt recv vax 15JUL97 830AM & 16JUL97 6PM mom noticed pt entire lt side of neck was red & swollen; pt felt was insect bites;next AM 17JUL97 had redness in the lt armpit area & areas of a red, raised rash on lt abd & groin area;v;seen by MD;
Low drug level; Flu; Feeling cold; Fatigue; Blood in stool; Colon inflammation; FACILITATED COLLECT  This is a Solicited report (Manufacturer Control No: 21K-163-3987994-00) from a contactable female consumer reporting for herself.  A 26-year-old female subject received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA, 40 mg), subcutaneous from Sep2014 and ongoing (Batch/Lot number was not reported), at 40 mg for rheumatoid arthritis and colitis ulcerative.  Medical history included moderate to severe rheumatoid arthritis and moderate to severe ulcerative colitis, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient experienced blood in stool on an unspecified date with outcome of recovered, colon inflammation in Jun2021 with outcome of recovered, low drug level on an unspecified date with outcome of unknown, flu on an unspecified date with outcome of recovered, feeling cold on an unspecified date with outcome of recovered, fatigue on an unspecified date with outcome of recovered.  The patient underwent lab tests and procedures which included colonoscopy: inflammation in May2021, drug level (Humira levels): low on an unspecified date.  The action taken in response to the events for adalimumab was dose increased. Causality for HUMIRA: causality for the event of Inflammation in colonoscopy was a reasonable possibility; for the events levels were low and blood in stools was not provided and for the events of Felt cold/Flu symptoms and a lot of Fatigue taking COVID Vaccine was no reasonable possibility. Causality for COVID Vaccine: causality for the event felt cold/flu symptoms and fatigue was possible; not reported for the other events.  The reporter's assessment of the causal relationship of the event with BNT162b2 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 possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Haematochezia, Colitis (non-serious), Drug level decreased (non-serious), Influenza (non-serious), Feeling cold (non-serious), and Fatigue (non-serious) and BNT162B2.  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.
I95.9 HYPOTENSION 3/30/2023 CKD STAGE 3A (GFR 45-59)
pain and swelling of left knee with an effusion; pain and swelling of left knee with an effusion; pain and swelling of left knee with an effusion; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "fibromyalgia" (unspecified if ongoing), notes: A 70 year old female with fibromyalgia received 2 doses of Pfizer COVID vaccine. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: JOINT EFFUSION (non-serious), ARTHRALGIA (non-serious), JOINT SWELLING (non-serious), outcome "unknown" and all described as "pain and swelling of left knee with an effusion". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of joint effusion, arthralgia, joint swelling.  Additional information: It was reported that A 70 year old female with fibromyalgia received 2 doses of Pfizer COVID vaccine. 6 months later she received a booster. Within 7-10 days she noted pain and swelling of left knee with an effusion. No change in X-ray findings and no relief with steroid injection after 2 months. What further treatment is indicated and should she ever receive another booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Immediate arm soreness, which spread to armpit and shoulder about 8 hours later (and began to subside about 40 hours after injection). Jaw pain starting about 10 hours after injection (and began to subside about 30 hours after injection). Fatigue and shortness of breath about 20 hours after injection. Chest tightness about 44 hours after injection. Ibuprofen has helped with soreness and pain.
c/o abd and back pain. pt undergoing chemo for recently dx breast CA. CT abd showed opacities in lung bases, possible COVID PN, + COVID test, O2 @3L, UTI. PT placed on zinc, singulair, remdisivir, and dexamethasone, cefepine and vanc emperically.  Pt is asymptomatic for COVID except for O2 requirement. Day of DC, pt on RA sats 95.
Arm soreness (start: ~8 hrs post-vaccination, duration: 4 days) Fever & Chills (start: ~14 hrs post-vac, duration: 1.5 days) Fatigue (start: ~24 hrs post-vac, duration: 1 day) Joint & Muscle pain (start : ~24 hrs post-vac, duration: 1 day) Headache (start ~24 hrs post-vac, duration: 8-12 hrs) Armpit/upper breast pain (start ~48 hrs post-vac, duration: 2 days)
Patient received a 2nd dose of MMRV, and DTAP\IPV vaccine. he has already receive his correct does 11/11/22 for his 4 year well child check.  he came in for a 4 year well child check on 9/15/23.  It was missed that he already had his check up and vaccines in Nov,2022
Information has been received from a physician concerning a 2 year old female with egg allergy who was allergy skin tested with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live and diluent. There was no concomitant medication. Subsequently, the patient experienced a local skin reactivity. Testing was being conducted to see if the patient could be vaccinated with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. the local reaction occurred about 15 minutes after the start of testing. It was noted that the reaction was not dose related. No laboratory or diagnostic studies were performed. The local reaction resolved and there were no other symptoms. Unspecified medical attention was sought. Additional information has been requested.
injection site redness; Injection site hot; muscle ache; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2019, the patient received Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced muscle pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the muscle pain was recovered/resolved and the outcome of the injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received vaccine at reporters local pharmacy. Till the time of reporting, It had been a week and although the muscle aches went away after 4 to 5 days and the injection site remains red and hot. The patient asked whether they should be concerned.
Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 62 year old white male of unknown ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 24-AUG-2021) dose was not reported, 1 total administered in left arm on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in AUG-2021, 2 Weeks ago, patient did a rapid antibody test at his local pharmacy and the results showed zero antibodies. Laboratory data included: SARS-CoV-2 rapid antibody test (NR: not provided) Negative. Patient heard that these tests that you get at a local pharmacy was not always accurate so he decided to get another test done at his doctor's office. On 20-AUG-2021 he got blood drawn and today on 25-AUG-2021 the antibody test results came back as negative. Laboratory data included: Antibody test (NR: not provided) Negative and the patient experienced confirmed immunological vaccine failure. He does not know the name of the test but it's similar to the Test. His doctor was aware of his test results and told him that these tests were not recommended. He wanted to know if he was still protected in this case. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was associated with a product quality complaint: 90000191002. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210852120-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine 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
Narrative:  Patient died from complications of covid infection. LTC outbreak of covid after 1st dose of covid vaccine was given. No other details of death reported. Reporting due to instructions.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Patient called pharmacy on 07/20/21 stating they were have issues with chest pain and tightness the night and morning following a covid vaccination. We advised them to follow up with primary care office as soon as possible.
pt recv vax & w/in a wk devel elevated liver enzymes, dark urine, arthralgia, & fatigue;Er or MD visit was required;pt RN noted that might have recv 2cc inj rather than the recommended 1cc;liver funds tests returned to nl 8NOV95;
Diagnosed as Bells Palsy on right side of face.  Started on 5/24/21 with headache in right side of frontal lobe, neck pain slightly below right ear, and right side of tongue being numb.  Tongue numbness spread to right, interior side of lips over next few days. On 5/28/2021 I noticed paralysis on right side of face (unable to smile on right side, unable to control direction of spit, unable to wink/close right eye (unless while closing both eyes), unable to furrow brow on right side, unable to keep right side of lips closed when trying to hold breath in mouth (air leakage).
and redness.; develop swelling; the injection site was warm; and painful,; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number H25YE, expiry date 4th December 2021) for prophylaxis.   On 21st August 2020, the patient received the 1st dose of Shingrix. On 22nd August 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and injection site pain were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and injection site pain to be related to Shingrix.  Additional information was provided as follows: The patient received the 1st dose of Shingrix and the next day started to develop swelling and redness. The patient still had these symptoms (Registered Pharmacist saw her in the morning at the time of reporting) and the injection site was warm to touch and painful, but she said that according to the patient symptoms were getting better. The reporter consented to follow up.
Initial information was received on 26 November 2008 from a health care professional in the USA. A 55 year old female patient received a right arm injection of FLUZONE (lot number and route of administration not reported). The date of vaccination was not provided. The patient called the doctor's office to report "tingling in and down her right arm" since FLUZONE was administered three weeks prior. The patient's recovery status was unknown at the time of the report. No further information is provided. Follow up information was received on 22 December 2008 from a health care professional. On 06 November 2008 the patient received FLUZONE (lot number U2754AA). Immediately following the vaccination the patient experienced tingling down her arm. On 11 December 2008 the patient went to the neurologist who ordered a cervical MRI (Magnetic resonance imaging), EMG/NCV (Electromyography/Nerve Conduction Velocity). The results were not provided. The neurologist believed it was "an uncertain relationship to the "FLUZONE". No further information was provided. Follow up information was received on 20 January 2009 from a health care professional. The reporter did not have any updates at the time. Follow-up information received on 27 February 2009 from a physician. The patient had undergone outpatient MRI scan of the cervical spine and EMG/NCV analysis since her last neurology visit on 11 December 2008. The Cervical MRI scan revealed significant foraminal disease at C5-6, and the EMG/NCV analysis was normal. The patient was re-evaluated by neurology on 14 January 2009. She had previously received treatment with Naprosyn (start date not provided) and had some relief from her pain. A comprehensive neurological examination was performed that day that revealed reduced cervical lateral range of motion and normal shoulder shrug, strength and tone. There was reduction of sensation in the right C6, but reflexes were symmetrical in all four extremities with flexor plantar responses; and the patient had no cortical release abnormalities. The patient's coordination was intact in the upper and lower extremities with normal mobility in the back. The back had no tenderness and the patient had a negative bilateral straight leg raise (SLR) test. The patient was diagnosed with right cervical radiculopathy secondary to spondylitic disease and was started on a short course of Prednisone 40mg for seven days, then 20mg for five days. After that, she was to resume Naprosyn and return in four weeks for follow-up consideration. Per this new information, this case was upgraded to serious. List of Documents held by Sender: None.
Time of vaccination 1 hour after injection tongue & lips became numb. Next morning outer right arm became numb then right small toe & outer right foot became numb. It felt like when NOVOCAINE is wearing off after dental work.
Woke up at 6 a.m., Friday April 2, feeling buzzing feeling in right arm, right leg, and feeling of swelling on right side of throat, rapid heart rate.  Duration of feelings lasted for approx. 1 1/2 hours.  In general felt strange.    On April 13, developed bothersome headache, had to take tylenol to alleviate. On April 14, developed bothersone headache, had to take tylenol to alleviate. On April 15, developed bothersome headache, had to take tylenol to alleviate.
Patient received COVID vaccine and was sitting in the monitoring area.  She was unable to sit still and flagged the RN monitor.  She c/o feeling hot, itching, and "scratchy" throat making it "feel funny" to swallow.  Strong pulses, patent airway, no hives noted, speaking in full sentences. ED Charge RN contacted and ED RN transported to ED without incident via wheelchair.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with refrigerated improperly stored doses of M-M-R II lot number M029919, expiration date 13-JUN-2018 (dose and route not reported) for prophylaxis. The vaccines were exposed to temperature of 47°F to 77°F (9° C to 25 °C) (15.8°C actual temperature) for 1 hour 34 minutes. The vaccine doses were not exposed to a previous temperature excursion. The call was placed because of a Digital data logger. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA006822: US-009507513-1703USA011934: US-009507513-1703USA011932: US-009507513-1703USA011933.
Right arm with 3 1/2 x 3 1/2 red and warm.  Center with 1" x 1/2" firmness and tenderness.
PATIENT GRADUALLY STARTED TO BREAK OUT IN A RASH...GOT PROGRESSIVELY WORSE OVER THE NEXT COUPLE OF WEEKS.  SOUGHT TREATMENT FOR HIVES ON 10/11/2016.