chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 months later / only administered the lyophilized powder mixed with normal saline; Inappropriate dose of vaccine administered; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. In June 2021, the patient received the 2nd dose of Shingrix. In April 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In June 2021, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant stated that, the patient received the 1st dose of adjuvant suspension only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient went back 2 months later and only received the lyophilized powder mixed with normal saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No adverse events reported by patient. The reporter consented to follow up. This case is one of 9 linked cases reported by same reporter for different patients (both male and female patients involved).   Follow up information received from sales representative on 25 June 2021: The reporter stated that, the health care professional mixed the adjuvant portion with saline solution and administrated it as a first dose and later reconstituted the powder portion with saline solution as second dose. The event inappropriate preparation of medication for 1st dose updated to wrong solution used in drug reconstitution as stated that the health care professional mixed the adjuvant portion with saline solution. The reporter did not know exact date, patient's involved and outcome.  No further events were reported. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR138552:Same reporter US-GLAXOSMITHKLINE-US2021AMR138553:Same reporter US-GLAXOSMITHKLINE-US2021AMR138554:Same reporter US-GLAXOSMITHKLINE-US2021AMR138555:Same reporter US-GLAXOSMITHKLINE-US2021AMR138556:Same reporter US-GLAXOSMITHKLINE-US2021AMR138557:Same reporter US-GLAXOSMITHKLINE-US2021AMR138558:Same reporter US-GLAXOSMITHKLINE-US2021AMR138559:Same reporter US-GLAXOSMITHKLINE-US2021138628:FU1 deleted
fever, joint pain, body aches, muscle pain  ongoing low grade fever two weeks later.  joint pain two weeks later.  fatique two weeks later.  Nausea increase, frequent bowel movements
COVID fog/weird reactions; feeling lethargic; arm is swollen at the injection site; severe headache; cold chills all night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (COVID fog/weird reactions), LETHARGY (feeling lethargic), VACCINATION SITE SWELLING (arm is swollen at the injection site), HEADACHE (severe headache) and CHILLS (cold chills all night) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047N21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included LISINOPRIL for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced FEELING ABNORMAL (COVID fog/weird reactions), LETHARGY (feeling lethargic), VACCINATION SITE SWELLING (arm is swollen at the injection site), HEADACHE (severe headache) and CHILLS (cold chills all night). At the time of the report, FEELING ABNORMAL (COVID fog/weird reactions), LETHARGY (feeling lethargic), VACCINATION SITE SWELLING (arm is swollen at the injection site), HEADACHE (severe headache) and CHILLS (cold chills all night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient states that he has been having severe headaches, feeling lethargic with COVID fog. He also experienced cold chills all night yesterday. He says that he started experiencing the reactions yesterday, 18MAR2021, in the afternoon after receiving the shot.  Patient also says that his arm is swollen at the injection site since right after receiving the vaccine. He does mention having COVID in Oct-2020 and says that his current symptoms feel very similar to when he had COVID
It was reported by the patient that she received a Fluzone SV '01-'02 vaccination in her right deltoid and a pneumococcol administered in her left deltoid. The patient stated she felt hoarseness, nausea, cold and chills & ran low grade temp overnight of 100.5 F.  Her left arm was as she described "paralyzed for 3 days afterwards."
Rt arm (+) warm, tender, erythema at site. T 100.8. Rx with ice, KEFLEX x 10 day.
First blood pressure went up than it drop to low 80's. After while it went up to 148 by 89. Usually my blood pressure is 110 by 70 or 120 by 80
Significant pain, swelling, lump and redness, hot to the touch, itching.  Grew to inches in size before being treated.
Pt had SHINGIRX 5/2/18 and developed pain at site of injection, shoulder pain, and later decreased ROM shoulder. Did not follow-up with exam by MD until 10/11/18.
My symptoms were similar to hay fever. I had runny nose, sore throat. After about 48 hours that turned into laryngitis and a headache. When I had a positive COVID-19 test, I went to the Clinic and they did another positive test and prescribed me Paxlovid. I started Paxlovid Thursday evening. By Friday evening, I had no symptoms. I finished the whole course of the medication and stayed isolated. Once I was out and about again, I noticed that I was fatigued more easily than I was prior to COVID-19. That lasted about 2 weeks. My PCP recommended swimming and building up with exercise. I did that and now I'm back to normal. 4 weeks later, there was no more fatigue.
Developed irritability (mild), low grade fever (100.7) and a bulging tense fontanelle 24 hours after immunizations.
Vaccine was administered to a 17 year old male.   He did NOT have any adverse events associated with the vaccine.  I am submitting this report b/c this is an ADMINISTRATION ERROR since he is <18 years old
Rash within 2-3 hours, post vax of Hib vaccine. Persisted X over 2 weeks, especially on legs, most tense at vaccine site with some on trunk and arms. Treated with Benadryl and is recovering.
pt recv vax & devel GBS; pt's MD told the mother to file the report; pt refused to provide any addtl info stating that it is the MD's responsibility;
Significant asthma flare, fever (100.8 F), sore throat, hoarseness, very red eyes, migraine, back pain and malaise. I had great difficulty breathing with increased mucus production and significant and even sharp pain at times on inhalation. I absolutely did not expect the shot to trigger a hefty asthma flare. In retrospect, I probably should have gone to the ER for breathing treatments. The symptom onset was sudden and got progressively worse over the course of the evening. My inhaler didn't do much good. It's been 24 hours and most of the symptoms have subsided.
within 60 seconds of injection in left arm, my left underarm lymph node became tender and swollen. within about 2-3 hrs, after returning home, my left ankle lymphatic area became tender and swollen, to the point where I was unable to put hardly any weight on it. This has never happened to me before so that is how I know it is related to the vaccine, and also the lymphatic system runs through the ankle area. I do not have ankle pain or stability issues, as my medical records can confirm. I laid down and elevated my ankle for about 15 minutes and then fell asleep. When I woke up a couple hours later the swelling in my ankle was gone. Then, about 1-2 days later, I began to have tenderness and swelling in my right underarm lymph node. Over the next 2.5 weeks, including today, the tenderness in my underarm lymph nodes have continued and seem to alternate between my left and right underarm. Over time the discomfort has decreased, and is off and on, but still noticeable. I am due for my second shot July 2nd.
This is a spontaneous report received from a contactable consumer, the patient. A 63-Year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP 7534) via an unspecified route of administration in left arm on 24Mar2021 at 16:00 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient medical history included atrial fibrillation, chronic obstructive pulmonary disease (COPD), benign prostatic hyperplasia (BPH) and tinnitus. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), WELLBUTRIN, atenolol (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN), SYMBICOR received within 2 weeks of vaccination. The patient had known allergies to penicillin, terramycin and lomotil. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. On 25Mar2021 at 01:00, the patient experienced ongoing tinnitus in left ear that had intensified dramatically since vaccine dose. On 13Mar2021, the patient underwent nasal swab (rapid test) and the test result was negative. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome for the event tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Breakthrough case after two vaccines Moderna 3/27/21 Lot# 017B21A;  Moderna 4/24/21 Lot# 048B21A
Information has been received from a registered nurse concerning a 16 year old female patient, who on 02-NOV-2007 was vaccinated with the first dose of Gardasil (lot # not provided). On 02-NOV-2007, following the vaccination and while the patient was cheerleading, she developed blindness and was unable to see anything." She was taken to the hospital via ambulance, but it was unknown if she was admitted. At the time of this report, the outcome of the event was unknown. The nurse considered developed blindness to be disabling/incapacitating. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 12 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 18-JUN-2914 the patient was vaccinated with second dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J013324, expiry date: 12-FEB-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012657, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Information has been received from the vaccine nurse concerning a 66 year old female patient who on an unspecified date was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient developed a welt at injection site and injection site became bruised.  The patient did visit the doctor's office.  The patient's outcome was reported as recovering.  Additional information has been requested. Follow up information was received from licensed practical nurse concerning a 66 year old female, with an allergy to sulfa drugs, who on 12-SEP-2007, at 10:00, was vaccinated subcutaneously into the deltoid with a first dose of ZOSTAVAX (Lot # 657765/0585U). On 13-SEP-2007, at 02:00, the patient developed a softball size wheal and redness at the deltoid. There was no illness at the time of vaccination. The patient's sibling had shingles. The patient had no prior history of adverse events with previous vaccinations. No lab diagnostic testing was performed. The patient recovered on an undisclosed date. Additional information is not expected.
Patient complained of mild itching and redness at injection site. Symptoms appeared 15 to 24 hrs post injection. Reaction localized to injection site. No fever or other symptoms reported. Patient instructed to take BENADRYL and use ice if needed.
Information has been received from a physician concerning a 26 year old female who on an unspecified date was vaccinated with Gardasil vaccine (lot # 0530U) injection. The physician reported that the patient experienced severe pain after receiving the third dose of Gardasil vaccine. No further adverse event information was provided. This is one of two reports from the same source. Additional information has been requested.
Prior to my current miscarriage I had 3 pregnancy?s, 3 vaginal births (all pregnancy?s made it to term with healthy babies). My estimated due date for current pregnancy was 11/1/2021. I had an ultrasound at 8 weeks 0 days which was 3 weeks after my 2nd vaccine. The ultrasound showed a healthy heartbeat. 2.5 weeks later I had a second ultrasound that showed no heartbeat or movement. The baby measured at 8 weeks 4 days during the 10 week ultrasound. I have not delivered the miscarriage yet.
This spontaneous report was received from a certified medical assistant (CMA). It was reported that 7 improperly stored doses of GARDASIL injection 120 Y (dose, route, lot# not reported) had been administered to 7 patients on unspecified dates. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same source. Additional information has been requested.
Myalgias, pain at the site of injection, low grade fevers, chills, fatigue. Great improvement with bedrest only, took one day off work mostly because of degree of myalgias.
Chest Pain started about 5-7 minutes after getting injection.  Rated 8/10. Has a cardiac history and wanted to be seen in ED.  911 called for patient.
This spontaneous report was received from a 84 year old female patient reporting on herself. In approximately 2008, the patient was vaccinated with ZOSTAVAX (dose, strength and lot number were not provided). Concomitant therapies reported as 2 blood pressure medications (medication names unspecified). In approximately January 2013, reported as one year ago in January, the patient experienced shingles. Patient stated that she felt some pain for about a week. After a week of experiencing pain her daughter could see blisters across her shoulder; though her daughter informed her that the blisters had already began to crust. Patient stated that the pain she experienced was not a lot of pain and that the whole experience lasted for only a few weeks, she felt that it was a mild case of shingles. Patient stated that 5 months later, her physician could see the spots on her shoulder still from where the blisters had been. Lab diagnostic studies were not performed. Patient sought medical attention. At the time of the report, the outcome of the events was recovered. The causal relationship between the event and ZOSTAVAX was unknown. Additional information has been requested.
Two weeks possible post DTaP, IPV, HIB, pneu 7. SIDS event. Five days prior to SIDS seemed fussy. Mom feels baby different post 2nd set shots.
pt had a positive COVID test on 1/18/22 at SNF) where he was residing.  From our records, pt passed away at home on 2/11/22.
Fever 101.8 HR 121 tachycardia SP02 85% RA Chills Nausea/Emesis x 4
This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Feb2021 at 10:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and Intravenous (IV) contrast dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021 at 21:30, the patient experienced muscle spasms in left arm, lower back and eye. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle spasms in left arm, lower back and eye was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 11-DEC-2015, the patient was orally vaccinated with an improperly stored dose of ROTATEQ (lot # L004466, expiry date 02-AUG-2016, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient thought she was receiving the Flu vaccine instead; did not get any paperwork related to vaccination. Next day, in the morning at 8am, at site of vaccination right arm was red, warm, and swollenlike size of softball. By noon, patient felt weak, had headache and chills; patient got into bed 12-5pm and took some Ibuprofen. At night, patient felt weaker, head was hurting, used hot compresses and had no appetite. On Saturday, 9/1, felt too weak, had pounding headache so went to ER. Patient realized that day that she received the Pneumonia vaccine when checking doctor online records. Patient admitted 9/1-9/5; patient received saline and antibiotics while in the hospital and released with Keflex (antibiotics) and hydrocodone for pain. Patient reports that in the hospital white blood count was over 21,000. Patient reports changing primary care provider since then. Patient went to new PCP on 9/17. Patient is documenting progress on arm since then. At this point, patient is done with antibiotics; at the site of injection, swelling has reduced but dark redness is there still--looks like that vaccine from the 60s. Patient still reports pain; pain has reduced but patient continues to manage it with medications--hydrocodone. Pain described as prickly/crawling feeling on the inside of the arm that comes every 2 to 3 days. Patient report receiving the Flu vaccine on December 2017 with no problems. Next appointment with PCP scheduled for December 17th.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Dec2020 07:00 (Lot number: EJ1685) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension.The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain at the site of the injection"; FATIGUE (non-serious), outcome "unknown", described as "Feeling tired".No follow-up attempts are possible. No further information is expected.
mom states that evening the left thigh developed a small red, raised area but the child with not complaining yesterday the area of erythema grew to approx. 2 inches in diameter and was warm to the touch they called that office and were advised to try cool compresses with little to no relief but the child still did not have any complaints today the area is oval shaped, 4in x 2in in diameter warm and slightly firm but the child denies any pain, itching, fever advised to continue cool compress, can try OTC Benadryl and Motrin, discussed signs and symptoms of severe reactions and to call 911 or to ER if worsens.
Within 15 minutes post vaccine, complained of "scratchy throat".  HR 80 Resp 16   BP 130/90   Complained of tingling lips and hands.  color pink/flushed.  Agreed to transport to ER. In ER, further hyperventilating and developed wheeze.  EpiPen given.   In ER given benedryl and discharged within 3 hours with prednisone prescription.   On 02/26, denies any symptoms
Pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. The patient's last menstrual period was on 08-Jan-2021 and the estimated date of delivery was 15-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown. Not Provided          Reporter did not allow further contact
Dizziness, blacked out, confusion, throat tightening, wheezing, heart racing, pain.
Feeling nauseous.   Did not eat breakfast this a.m. V/S  B/P 124/50, HR 60, O2Sat 100%; 11:38am Pt. left at 11:38am verbalized that she is feeling better.