chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am dizzy; very exhausted/extremely exhausted; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 26th August 2020, the patient received Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 27th August 2020, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced dizziness and exhaustion. On an unknown date, the outcome of the dizziness and exhaustion were unknown.   It was unknown if the reporter considered the dizziness and exhaustion to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: After receiving Shingrix and Influenza vaccine, the patient was dizzy and very exhausted.
99.8 fever, chills, headache.  Took Tylenol only lasted about 3 hours.
MOM STATED PT GOT A SORE ARM UNTIL LATER THAT NIGHT OF THE DAY OF VACCINE
Pt received second dose Pfizer at site.  Pt known PMHx of syncope.  Pt was instructed to wait 15 min in observation lot in case of adverse reaction.  While attempting to drive to observation lot pt lost consciousness, slumped onto steering wheel and gas pedal, and lost control of vehicle per pt statement.  Pt car came to a stop past the tree line on the NW side of the property with airbags deployed. Healthcare providers immediately responded and 911 was called.  Pt was placed in C-Collar and instructed to remain stationary.  Vitals were obtained; BP 138/88 (105), HR 102, SPO2 94% RA, FSBG 108. EMS arrived, pt family was notified, pt was transported to hospital via EMS.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. Initial information was processed with additional information received from Regulatory Authority on 06-JUL-2022. The patient's height, and weight were not reported. The patient's past medical history included: cancer (3 time cancer survivor). Concurrent conditions included congestive heart failure and had some other issues. Patient was allergic to Polyethelene glycol 100 and possibly Polysorbate 80. The patient previously received two doses of covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, administered on an unspecified date for prophylactic vaccination. It was unspecified whether patient had experienced any adverse events following vaccination with covid-19 vaccine (dose number in series 1). The patient additionally received booster of company suspect covid-19 vaccine ad26.cov2.s (dose number in series 2) (form of admin not reported, route of admin not reported, batch number: 213A21A, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date for prophylactic vaccination. Concomitant medications included palbociclib for cancer. On an unspecified date, patient contracted Covid (suspected covid-19 infection and suspected clinical vaccination failure) two months after the first booster (dose number in series 2). It was a severe case but patient was able to get the monoclonal antibody infusion. Patient felt that the vaccine offered some protection from more severe illness and the earlier forms of the Covid. The action taken with covid-19 vaccine was not applicable. The outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This report was associated with product quality complaint: 90000239586.; Sender's Comments: V0:20220664235-Covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure . The event(s) has 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. Therefore, this event(s) is considered not related. V0:20220664235-Covid-19 vaccine ad26.cov2.s- Suspected covid-19 infection. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
The next day of vaccination my lymph node was swollen. I saw a doctor the weekend after to get it evaluated to make sure it was not breast cancer related.
Initially tenderness at the site.then one week later swelling into upper arm with soreness/ Has taken advil for the past three days with relief fromswelling and pain
Pale sitting in waiting area after vaccinations received, customer "fell on left side" due to dizziness.  Patient was pale is color and confirmed feeling dizzy.  Patient then accidentally had a vomit episode.  I advised patient not to drink water because it would most likely worsen nausea and cause more vomiting.  Patient drank a small amount of water followed by a vomit episode.  After several minutes of dizziness patient felt better.  Patient declined use of paramedic care.
Approx 30 min after vac developed erythemous face & ears, warm to touch, eyes glassy, sclera reddened pruritis, slight wheezing in chest bilat. Denied diffic breathing/swallowing.  To ER via ambo.
Initial report received on 09 November 2008 from the consumers parent. An 11-year-old male patient with no concurrent illnesses, and unknown past medical history, had received an intramuscular injection of ADACEL, lot number C3003 (lot number UF452CA); and an intramuscular injection of MENACTRA (Lot number U2734AA) on 17 October 2008. The routes and sites of administration were not provided. At an unspecified amount of time later, the patient began having symptoms of severe headache (head pain), severe back pain/soreness (including low back pain), and his back was stiff with numbness and spasms. The patient was evaluated by his physician ten days later, and at that time, the back pain had improved somewhat, and the patient was additionally experiencing muscular tenderness, left arm pain, neck pain; and continued head pain. He also had chills, however he was afebrile. Diagnostic tests performed revealed the patient was positive for Lupus. Date, name, type and results of diagnostic tests were not provided. It was not reported whether the patient had received any corrective treatments. At the time of this report, the patient had not recovered. Documents held by sender: None.  11/26/2008 MR received from PCP including neuro consults.  Mencatra (U2734AA) and Adacel  (UF452CA) given 10/17/08. Pt RTO 10/23/08 with c/o muscle stiffness and soreness and arm and shoulder pain, as well as not sleeping well. Nummbness and tingling in fingers of L hand. Assessment: Muscular tenderness post vaccination. Returned 10/27/08 and 10/28/08 with c/o arm, head, neck and back pain-unimproved. Referred to neurology.  Neuro consult 10/28/08. Pt reported injection site burning following vax on 10/17/08 and since then has had H/A, neck pain, burning patches in extremities, difficulty sleeping and stiff neck. PE (+) for inability to flex head forward- severe pain. Sent for MRI. Started on neurontin. F/U 11/12/08 still with sx.  Sleeping better. Pain 10/10 all over. ? RSD. 1/20/2009 Additional records received from recent Neuro consult 12/9/08. PE WNL except decreased sensation to cold and pinprick on R arm from elbow to wrist. Likely conversion disorder, no neurological cause for sx. F/u with PCP 1/9/09 almost completely recovered from RSD.
Mom states baby had fever (low grade) after shots about 1 week. Then temp increased and baby was admitted to hospital for 3 days. Given antibiotics. Follow up: Additional symptom: rash developed a few days after vaccination. Admitted to hospital 12/3/04 to 12/06/04. Meningitis was ruled out. Discharge Summary received on 2/16/2005 states rhinorrhea, sneezing, productive cough, petechiae on earlobes, pink papules over abdomen and crusted papules on upper and lower extremities, SOB, decreased appetite, decreased sleeping, and abdominal tenderness.
Onset severe chills, body aches, fever of 102 seven (7) hours after receiving influenza vaccine
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication information was reported. It was reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised patients. It was reported that CDC had recommended to re-vaccinate the patient with full dose of 0.5mL. No adverse events were reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:same reporter
Devel fever in afternoon of 7MAY92 w/a staring episode, lips turned blue, face white & pt made gurgling sounds; was nonresponsive; event lasted 3-4 mins; @ hosp t105.8 adm for observation;
Patient was receiving her second dose of Pfizer vaccine. After receiving her vaccine, patient was light headed due to anxiety. Ambulance was called.
flu-like symptoms; fever; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy. Concomitant products included ESTRADIOL (ESTROGEN) for Hysterectomy, VITAMINS NOS for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever). The patient was treated with PREDNISONE at a dose of 20 mg twice a day. On 19-Jan-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications include Topical Cream.   This case was linked to MOD-2021-251767 (Patient Link).
Face turned hot and red about 30 minutes after the vaccination. A few minutes later, a tingling sensation began, followed by a general feeling of fullness throughout my face, as if my face was swelling. This was very concerning, and I began checking in the mirror for physical swelling in my face.  The sensations of tingling and fullness continued for 30-45 minutes. My face was still red and hot for 6 hours after the vaccination.
Approximately 2 mins after injections, mom came out of room saying patient could not hear or see. Lead MA and supervising provider came in obtained vitals, laid pt. down, applied cold wet cloth, elevated legs, Provider eval. Pt. Pt. admits to having nothing to eat. Juice given & observed til discharged with stable vitals, feeling better.
Patient was under the age of 18 years when she received the first dose of her COVID-19 vaccine. There were no issues identified with the first dose, and it was decided to administer the second dose to finish the vaccination series.
3-4 days after initial shot the injection site became red very itchy and swollen, a hard knot at injection site the size of a golf ball was felt.
The pt experienced a fever, woke up in the middle of the night with "burning up", did not check temp. Awakened the following morning with a temp of 102 (ear). The pt was listless, shaky, weak, did not respond to name, Called PMD and was instructed to give Tylenol alternately with Motrin. Symptoms continued until 9:00 am and then was ok except for a continued fever. No further symptoms.
Patient received intramuscular vaccine at approximately 10:40am on 3/31/20201 and at approximately 10:45am she began experiencing the following symptoms: headache, dizziness, weakness, blurred vision. Her blood pressure was 192/100, her heart rate was 66, and her pulse ox was 98% at room air. By 11:05am, she sat down on a more comfortable chair, she stated that she began feeling better, her case manager arrived, and her blood pressure came down to 155/98. She stated that she had not eaten breakfast, she had an onset of chest tightness with pain raidiating to her back. At 11:25am, she became short of breath and bagan to cough. Weazing was also noted. She self-administered 2 puffs of her Albuteral inhailer. She was 99% on room air. EMS arrived at 11:32am, she had difficulty speaking on EMS arrival. Chest tightness had improved and her lung was all cleared.  She was transported via ambulance to emergency department.
Patient received Pfizer for her second COVID vaccine dose and she should have received Moderna. Patient had no adverse events and did discuss with doctor before she left the office.
Patient recieved expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient recieved expired vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient recieved expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient recieved expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Patient had received second booster dose of Moderna vaccine. Treatment information was not provided. The expiry date of the vaccine was reported as 27-Mar-2022
This is a literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the "safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer
Moderna was administered as the 2nd dose in error. Patient should have received Pfizer.
This case involves Adult and unknown gender patient who got injured from a flu injection while receiving vaccine influenza vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number; formulation; strength: not reported) via unknown route in unknown administration site. On an unknown date the patient developed a non-serious event "got injured from a flu injection" (injury) (unknown latency). There were no lab data/results available. Action taken: Not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event got injured from a flu injection.
Got my first dose 1/6/21 but did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got my first dose 1/6/21 but did not get the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got my first dose 1/6/21 but did not get the second dose). On 01-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Got my first dose 1/6/21 but did not get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.   Reporter did not allow further contact
Atrial fibrillation; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), on 05Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 19Jan2021, for COVID-19 immunisation, reaction(s): "Atrial fibrillation". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Feb2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; ATRIAL FIBRILLATION (medically significant), outcome "unknown". Clinical course: Caller stated that he received 3 doses of the Pfizer BionTech COVID-19 vaccines on 19Jan2021, 05Feb2021 and 06Oct2021. Caller stated that he received a fourth shot but, he was not sure. Caller would like to know if he could get another COVID-19 vaccine if there was a fourth and fifth shot. Caller mentioned that he was over 75 years. He had Atrial fibrillation and wanted to know if there was any risk Precautionary AE form created.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300317383 same patient/event, different dose;US-PFIZER INC-202300315993 same patient/event, different dose;
administering vaccinations past the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administering vaccinations past the expiration date) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administering vaccinations past the expiration date). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administering vaccinations past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, the vial was initially stored in the refrigerator on 01-Dec-2021 and vials did not undergo any temperature excursions. No concomitant medication was reported. No treatment medication was reported.
Received my flu shot and my second Shingles vaccine on the 11th of October, 2021.  Ever since then I have had severe chills, shaking, body and joint aches, severe fatigue, headache, and diarrhea.  I am unable to do anything at home because simply walking up or down my stairs exhausts me to the point I have to lay down.  I am on my 3rd week of this and it does not seem to be getting any better.  I feel like I am in a very severe fibromyalgia flare