chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 24-JAN-2018, the patient was vaccinated with an expired dose of ROTATEQ, orally, (lot # M025572 with an expiration date in 20-JAN-2018), for prophylaxis. No adverse effects were reported.
Itching at site.  Removed bandaid. Reddened area in triangular pattern along bandaid and below bandaid approx 3 inches. Site not hot, site firm. By 10:00 pm itching and redness resolved. Site remains slightly firm.
Head ack,Dizzy,Fever 102,nausa,Tired Blood pressure High 201 over168,weak,red arm swollen hot sore.
I was achy and tired; I was achy and tired; I was really, severely dizzy, like vertigo.  My head was swimming; I was really, severely dizzy, like vertigo.  My head was swimming; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 56-year-old female patient received bnt162b2 (BNT162B2, reported as Pfizer-Biontech Covid-19 Vaccine, Batch/lot number: EJ1685, Expiry Date of COVID Vaccine: Mar2021), via unspecified route of administration on 18Dec2020 12:30 at single dose for covid-19 immunisation. Medical history was none. Concomitant medications included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) Injections. She is a respiratory therapist. She states she got the vaccine on 12:30 PM on Friday. She states that Friday night by 09:30 pm was really bad. Her head was swimming. She said by Saturday she was achy, tired. Also, on Friday night she was severely dizzy and felt like she has vertigo. She is better now." Consumer stated, "It was just a shot." Th outcome of the events was recovering. Treatment was received and consumer stated, "The only thing I took was 800 mg Ibuprofen Friday evening." Consumer further added, "I was, just like in chart second vaccination I guess I am okay to take it. I talked to my doctor." Consumer stated "I got the covid vaccine on Friday and it was a bad night.  I was really, severely dizzy, like vertigo.  My head was swimming.  I got the shot at 12:30 that day, but the symptoms didn't start until 9:30 that night.  On Saturday I was achy and tired. But I'm better now."  Consumer questioned if dizziness was a reported side effect.
Immediate blood disorder; low iron, etc., which resulted in hospital critical care, then died 04Jun2021 of Acute Myeloid Leukemia
At approximately 7pm-arm got tight. had a "cold sweat", "passed out". Recovered in a few seconds. Did not see MD. nausea X 1/2 hr. Reported by his wife
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing and adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 87 with declining dementia and receiving hospice care at the time of his death and prior to receiving vaccine.
Pt reported: swelling from shoulder to elbow, hardness/lump in arm, feverish arm to touch, chills, back pain, N/V, weakness, headache. Started midnight after shot. Pt went to Dr. treatment unknown.
Fever over 100 F, chills, nausea for about five hours. Fever reduced to mild around 99 but lasted over 24 hours.
No Adverse Event; Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster; Vial caps and labels for Monovalent and Bivalent look too similar; Vial caps and labels for Monovalent and Bivalent look too similar; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.  No Medical History information was reported. On 21-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar). No concomitant medications were reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2022: Live follow up received contains Quality complaint number was added.
Patient states that within 24 hours, rt arm site where he received anthrax shot begin swelling. By the 48 hour mark, the swelling was 2.5 inches wide with satelite swelling 3/4 inch away with .5 inch swelling.
IMMEDIATE SHORTNESS OF BREATH, HEART RATE JUMPED TO 120 BPM, AFTER 10 MINUTES,   I WAS TOLD BY THE MEDICAL ASSISTANT TO WAIT FOR 15 MINUTES AND HAD TO WAIT FOR MORE THAN 2 HOURS TO BE RELEASED BECAUSE I COULD NOT CATCH MY BREATH,  EVER SINCE THEN I HAVE BEEN WITH BODY AND HEADACHES, EXTREMELY FATIGUED,  AND EVERY DAY AFTER THAT I BEEN WAKING UP CONGESTED  WITH A LOT OF MUCUS
I had a scratchy raw throat, sinus drainage, lightheaded, dizzy, I came home from work early. I was discussing my symptoms with my wife, she suggested I take a home COVID-19 test, when I did it came back positive. I called my doctor the next day, she prescribed the antiviral Paxlovid that I started that day. I started feeling better in a week, I wasn't one hundred percent, but I was much better than I was before I started the medication.
On 5/54/2021 I began noticing a change in breathing, erratic heartbeats, coughing with a small amount of phlegm, feet swollen to twice normal size, and soreness across top of left breast. The breathing was like bellows being squeezed, heartbeats were flutters, swelling in feet and legs were uncomfortable, and cough and clearing of throat were spasmatic. Note: I am able to induce the event by consuming foods high in sugar. For example, when I drink a soda (or coffee or tea with sugar) my breathing, heartbeat, cough, swelling in feet, and soreness all become aggravated within 1 minute of ingestion (it was an intentional experiment that I conducted after cutting the foods for one day).
Patient experienced flushing and sweating. BP 98/53 P86 RR18. No signs of respiratory distress, vitals stable. Patient given orange juice and crackers, felt better, possible lower blood sugar episode. Did not eat for more than 6hrs prior to vaccination. Discharged in stable condition.
Erythmeatous swelling of immunization site to 5cm with some iduration.
After receiving second dose, patient was experiencing sore and achy arms. However, now he's reporting that the pain has gone down to his elbow. He says, it doesn't hurt when he's moving his arm up and down, but is sore when he's pulling on something, such as a door knob
I broke out into a rash across my complete thorax. It itched and developed chest tightness and SOB. I took Benedryl and used an inhaler. The rash started to go away by the next day. 2 days post vaccine, I started getting soreness in my joints. So following up at my employer, after the vaccine, I was referred to an allergist and was advised not to take the second dose.
Extreme fatigue, pain at injection site and shoulder joint, and muscle ache in upper right arm.
1 of 2 pts who was immunized on the same day from the same lot & exp an inject site react consisting of arm pain radiating into neck & swelling of the deltoid; pt also exp swelling of the lt eye & face;
Arm sore after Hep B vaccine no III administered 4/14/07 at 8:20 AM. 8:45 AM donor stated she vomited, had headache. Donor rested. BP 9 AM, 113/71, P 87, T 98.6. 9:20 AM still nauseated and headache, 9:45 sleeping, 10:00 naseauted, no headache, 10:15 no nausea, 11:05 nausea, 11:15 left to go home still.
On 5/28/08, Pt was 7mo old and received a Tdap instead of DTaP. No known injury.
Information has been received from a registered nurse concerning an elementary school aged child who was vaccinated with a dose of varicella virus vaccine live. On approximately 23-FEB-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available.   Additional information has been requested.
This spontaneous case, initially received on 09-Jan-2017, was reported by a health professional and concerns a 64 year old female patient. Weight: not provided; Height: not provided. Concomitant medication refer to appropriate report section. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: 13749221A. No additional suspect drugs. On 03-Jan-2017, the patient was administered AFLURIA from a multi dose vial that was punctured over 28 days. No adverse effects were noted. Special circumstances: Drug administration error without adverse event.
I have lymphedema in my right arm.  My arm and thigh swelled after the RSV vaccination
Previously stable ulcerative colitis flared up 5 days after covid 19 Pfizer vaccine dose 2.
n,v, h/a, tenderness @ inj site;systemic sx for 3 days;3" x 3" induration; sick for  3 days;
Rec'd vaccine at 1500, reaction started at 1505- pt observed to be stiff posture, eyes rolled to back of head and unconscious. Pt transferred to a gurney and heard to be wheezing. Epi x1 given and 911 was called. Pt became arousable after a few minutes as ambulance arrived. Pt breathing improved and able to answer simple questions. Transferred to nearest hospital.
After vaccination pt reported "felt like the room was swaying". HR 73 sat 98% on RA. Pt monitored and then left home with Sister at pt side, sister drove her home. Pt called on 5/6/2021 by RN for update. Pt reported nausea and emesis x 2 episodes. Pt States she called advice nurse for work note excuse.  PT eating small meals, unable to keep food down. Small sips of clear liquids encouraged. Pt reported lightheadedness comes in waves, x 3 episodes while at home. Pt was called on  5/7/2021, pt reports that she had called her PCP and was given an Rx of Zofran. PT states vertigo improving and nausea reduced with Zofran.
still sick with midl symptoms; got Covid last week; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got Covid last week) and ILLNESS (still sick with midl symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced COVID-19 (got Covid last week). On an unknown date, the patient experienced ILLNESS (still sick with midl symptoms). At the time of the report, COVID-19 (got Covid last week) and ILLNESS (still sick with midl symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Pt. reports she developed aches and pain- low back and knee. Chills and an abdominal pain that started yesterday that lasted until she went to bed last night at 10 pm/
Seizure (generalized tonic/clonic) lasting approx 1-2 minutes occurring approx 3-4 hours after influenza vaccine (shot) in child w/ hx of febrile seizures. Patient not febrile w/ this episode.
Next day post vax, the pt noticed that her upper arm under injection site and down to the elbow was stiff, swollen, and hot to the touch.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 12-DEC-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N021475 and expiration date 03-JAN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
Fainted in the shower; A spontaneous report was received from a consumer concerning a friend who is a patient of unknown age and race that received Moderna's COVID-19 Vaccine (mRNA-1273) and fainted in the shower (Syncope).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient fainted in the shower. No treatment information was provided by the reporter.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, fainted in the shower was considered as unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments:  MOD-2021-031707:patient's case
Dizziness, Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, chills and fatigue. pain at injection site. Narrative:   Other Relevant History:
I am pregnant and I was told I have to register in the pregnancy registry; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (I am pregnant and I was told I have to register in the pregnancy registry) in a 37-year-old female patient (gravida 7, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroid issue. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROXYPROGESTERONE CAPROATE (MAKENA), ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ELDERBERRY [SAMBUCUS NIGRA] for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Oct-2020 and the estimated date of delivery was 17-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (I am pregnant and I was told I have to register in the pregnancy registry). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (I am pregnant and I was told I have to register in the pregnancy registry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date, post vaccination, the patient reported that she experienced symtpoms of exposure during pregnancy.  It was reported that, the patient had NIPT test and several ultrasounds on an unknown dates for which the result was unknown.  No treatment information was provided
Took one unrefrigerated dose of Vivotif; Spontaneous report received on 10FEB2020.  A pharmacist reported that a female consumer who "took one unrefrigerated dose of Vivotif" (PT: Product storage error). The consumer was receiving Vivotif capsule for immunisation. On 04FEB2020, the consumer took the first dose of Vivotif which was refrigerated. She left the second dose unrefrigerated (left out at room temperature for over 24 hours), and took the unrefrigerated dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took second dose of Vivotif which was unrefrigerated (product storage error). The second dose of Vivotif was left out at the room temperature for over 24 hours. Vivotif must stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is not applicable to Vivotif.; Sender's Comments: A consumer took second dose of Vivotif which was unrefrigerated (product storage error). The second dose of Vivotif was left out at the room temperature for over 24 hours. Vivotif must stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is not applicable to Vivotif.
August 18, 1991. "Hold up four fingers. That's right, you're four years old!" On patient's birthday he was coming down with a cold. August 19, 1991. On his day-after-birthday, patient received his four-year immunizations. He was sick. The doctor noted that patient had "no eye contact," was "known to have autism," and was "screaming all the time." Patient received three vaccines: for oral polio; diphtheria, tetanus, and pertussis; and measles, mumps, and rubella. One month later, at the request of the school, patient received his Haemophilus b conjugate vaccine. August 25, 1991. Patient began the regular fall semester of his Early Childhood Intervention program. "He reentered the Early Learning Program," I wrote in a letter to a friend, "and met all of his first year developmental goals within a month. His teachers are astounded. So are we." September 6, 1991. Which therapy was helping patient? I said vitamins; another said light. Careful to keep our disagreement from spilling over to patient, I wrote to Dr. for advice. He suggested that we try one therapy at a time and observe the results. We took patient off B6 and DMG. "By the third week in September," I wrote in my diary, "Patient was 100% un-potty trained and was using no language except 'eee-Up!' He was masturbating like mad." All systems were failing: potty training, language, attention span. November 5, 1991. I wrote, "Attempts to replicate last summer's light therapy results have not been successful We charted patient's behavior in potty training, masturbation, commands, eye contact, socialization, and use of language. After more than two weeks, there was no clear improvement in his behavior on the light therapy compared to baseline behavior in the categories we charted." Patient had cratered. We put him back on vitamin B6 and DMG. From a twenty-first century perspective, it's tempting to conclude that patient's four-year vaccinations were at least partially responsible for his regression. But in 1991, vaccines were not suspected as a trigger for autism. Because patient's regression didn't occur immediately after the shots, we didn't suspect a link. All we knew was that we were at the bottom of the crater, and patient wasn't responding to the B6 and DMG either. We were stuck.  6/4/09 Received medical records from parent reporter for 12/18/90-8/19/1991. FINAL DX: autism, mental retardation & Soto's syndrome Records reveal patient had delayed speech & language development & fine motor skills w/intermittent periods of regression.  Exam revealed only fleeting eye contact, no speech, repetitive play & self stimulation 6/17/10 Follow up: Inflammatory Goual disease, possible autistic enterocolitis and autism.
Whole part of my left face became swelled and very tender to the touch; Whole part of my left face became swelled and very tender to the touch; I was feeling like tingling like if you have eaten something sour; I have a salivary gland clog; swollen lymph node/left side of the salivary gland started to swell; I have a salivary gland clog; swollen lymph node/left side of the salivary gland started to swell; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Lot Number: EL9266; Expiration Date: May2021) (at the age of 68-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. Concomitant medication(s) included Clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported. On 17Feb2021, the patient experienced her left side of the salivary gland started to swell and feeling like tingling like if you have eaten something sour, on 18Feb2021, the whole part of her left face became swelled and very tender to the touch and on unspecified date in Feb2021, patient experienced swollen lymph node. The clinical details of the events as follows: She stated that on Saturday 13Feb she received her first dose of the Pfizer covid vaccine and on Wednesday night, her left side of the salivary gland started to swell. Next day it was tender and swollen. She went to the urgent care and they prescribed her antibiotic for it and night at around 10:30, she was eating something, and she was feeling like tingling like if you have eaten something sour and then whole part of her left face became swelled and very tender to the touch. She really did not think it was anything related to the vaccine because, she had the shot five days ago and had no reaction, nothing. She went to the urgent care today, who said she had the Covid shot who was a Nurse Practitioner, who thought that she had a salivary gland clog and she put her on antibiotic (Treatment) and she was talking to her daughter and her daughter said, she just read Pfizer again and swollen lymph node which was her gland is a side effect. Treatment: Consumer stated the only thing, she went to Urgent care and she gave her antibiotic and she actually taken one dose of that antibiotic, which she thought was Amoxicillin. She wanted to know if its ok to take antibiotic before her next dose of the covid vaccine. She wanted to know if it is possible side effects of the vaccine happened 5 days later. She has an ENT appointment on Monday. No Investigation Assessment was provided. This case reported as non-serious. The patient outcome of the events was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.