chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients; No adverse event; vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022 at 12:28 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 dosage form. On 23-Sep-2022 at 12:28 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients).    Concomitant medication information was not provided. The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients. The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle. The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle. No treatment information was provided.   This case was linked to MOD22-025077 (Linked Report).; Sender's Comments:  MOD22-025077:
injection site arm hurt after first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site arm hurt after first vaccination) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site arm hurt after first vaccination). At the time of the report, VACCINATION SITE PAIN (injection site arm hurt after first vaccination) outcome was unknown.        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.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-339177 (Patient Link).   Reporter did not allow further contact
Report 2001003520-1 describes joint pain in a 76 year old female who received Lymerix. This report was received from a lawyer and has not been verified by a physician or other health care professional. On 05/27/99, the vaccinee received her first dose of Lymerix. "shortly therafter" she developed a "large rash on her stomach, joint pain, fatigue, and general flu-like symptoms". She was placed on unspecified oral antibiotic therapy starting on 06/10/99 and ultimately was administered intravenous antibiotics from 10/29/99 through 11/26/99. The intravenous antibiotics reportedly relieved "many" of her symptoms. As of 02/01/02, the vaccinee continued to experience joint pain and fatigue. The adverse event of "arthralgia" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Patient is a 26 y.o. female who received the Moderna Covid-19 Vaccine, mRNA-1273 (PF) 100 mcg/0.5 mL IM Susp, Lot 001B21A on 3/9/2021.  The patient experienced the following reaction(s) during the immediate   of observation:  Pt reports feeling a bit of numbness and tingling in her fingers in her left arm. Patient was treated/managed as follows:   Pt observed and vitals taken.  1611: BP 138/82 HR: 92 O2: 97% RA 1621: BP 144/80 HR: 88 O2: 98% Pt reports tingling has subsided.  Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.  Pt escorted to car at 1627 by RN.
Reports feeling hot, hot sweat BP: 102/67 HR: 80 Sp02: 96% seen and cleared by EMS
2 cm x 1 cm red raised area at injection site - (Local Reaction). Tx with hot compresses several times a day.
Shingles; Severe headaches; Vomiting; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's sister) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on an unspecified date, as first dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine and then got shingles and experienced severe headaches and vomiting on an unspecified date. The second dose is scheduled for tomorrow (29Apr2021) and they are wondering if she should take it. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 at 14:30 as dose 1, single (Lot number: EL3248), in left arm, on 04Feb2021 at 15:15 as dose 2, single (Lot number: EN5318), in left arm and on 28Oct2021 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "BPH" (unspecified if ongoing); "AdHD" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 13Jan2021; TAMSULOSIN HCL, start date: 17Mar2020, stop date: 20Jun2022. Past drug history included: Vyvanse -shire, start date: 11Feb2020, notes: Vyvanse 50 mg; Atarax 25 mg, start date: 13Mar2019, notes: Hydroxyzine 25 mg prn, Atarax 25 mg. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: 102 Fahrenheit, notes: controlling my fever, before it was 102F or during treatment and day before. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure (LOE) and COVID-19 cannot be ruled out.
Pt recvd 3 doses of Engerix-B 4MAY90, 6JUN90 & 2JUL90; First 2 doses were uneventful; on 29AUG90 p/3rd dose of Engerix-B pt exp transient arthralgia & myalgia, malaise, lethargy & serum sickness; reporter also states pt non-responsive;
Pt received Moderna COVID 19 vaccine at 4:55 PM, 0.5 mL intramuscularly.  10 minutes later, she informed me her lips were tingling.  I sat with her and gave her a bottle of water.  I gave her 10 ml of Benadryl elixir (12.5 mg/5 mL).  She described the sensation she was having when she took Metoclopramide and had an anaphylatic reaction.  I told her then I was going to administer Epinephrine with an EpiPen device.  I informed my technician to call 911.  I administered 0.3 mg of epinephrine.  I stayed with her to make sure symptoms would diminish.  5 minutes later she still was coughing and complained of shortness of breath.  I administered a 2nd dose.  The fire department came shortly later.  Her difficulty of breathing improved slightly.  The fire department monitored her until the EMTs arrived.  They took her to the hospital.
On Tuesday night at 11:30PM I experienced sharp pains under my skin on the right side of my torso. (Neuralgia of the right flank (M79.2). The pain steadily increased until I saw a doctor at Urgent Care one July 29 at 8:30AM.
Patient was nervous prior to receiving the vaccination. Patient sat down in a chair to wait 15 minutes and about 2 minutes later he passed out cold in the chair.
temp below nl from 30APR96 thru 3MAY96;c/o sore throat&swollen tonsils 2MAY96,nausea&dec appetite x 4 days,melange x 4 days p/vax;mom didn't take to ER or MD from 30APR96 to 6MAY96;
the next morning after i received the shot, i collapsed in the morning. not unconscious, but could not stand. waited, got up and then fell again. this happened once again on morning #2. then was dizzy all weekend. i am NOT disabled or elderly or not fit. have never has such an experience in my life.
The vial was initially stored in the refrigerator January 26 2022 and administered  March 3 2022; 7 patients received a Moderna vaccine past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator January 26 2022 and administered  March 3 2022) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator January 26 2022 and administered  March 3 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator January 26 2022 and administered  March 3 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  On 26 January 2022  the vial was initially stored in the refrigerator. Reported was unaware if vial undergo any temperature excursions. The dosage was reported in the verbatim as Booter .25  No treatment medication information was provided.
Itching and received Benedryl 50mg IM on the right deltoid; vital signs post taken; at 11:40 itching subsided; at 12:10 139/76 heart rate 57; SPO2 97% on R/A; was alert and oriented; itching subsided and associate was discharged home
pt brought to hosp with progressively worsening SOB, cough, poor appetite, decrease in ability to smell and taste; 5 days ago tested positive for COVID; sx have worsened; A Fib with RVR; treated and sent to ICU; Decadron, O2 supplementation, ABX; eventually required intubation; suffered acute heart failure, acute respiratory failure, multi-organ failure; comfort measures instituted; pt extubated and died in the hospital
Needle not properly attached by mistake; Vx leaked about half of the dose; Vx leaked in patient´s arm; Vx leaked in  patient´s arm; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong technique in drug usage process in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 3FE44, expiry date 17-JUN-2024) for prophylaxis.   On 27-MAR-2023, the patient received Shingrix (unknown arm). On 27-MAR-2023, an unknown time after receiving Shingrix, the patient experienced wrong technique in drug usage process (Verbatim: Needle not properly attached by mistake), accidental underdose (Verbatim: Vx leaked about half of the dose), inadvertent exposure to vaccine (Verbatim: Vx leaked in patient´s arm) and exposure via skin contact (Verbatim: Vx leaked in  patient´s arm). The outcome of the wrong technique in drug usage process, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK receipt date: 27-MAR-2023 The reporter reported that the needle was not properly attached by mistake when administering a dose of Shingrix to a female patient and vaccine leaked about half of the dose in the patient´s arm and the table, so a less than recommended volume was administered. The reporter consented to follow up.  At the time of reporting, the needle was not properly attached by mistake when administering a dose of Shingrix to a female patient and vaccine leaked about half of the dose in the patient´s arm and the table, which led to wrong technique in drug usage process, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, on 16Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm and on 17Feb2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "overactive bladder" (unspecified if ongoing); "herniated disc" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05May2022, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
anaphylactic reaction to Tetanus toxoid vaccine; face and eyes welled shut; face and eyes welled shut; Initial information was received on 06-Apr-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional via non-licensed partner This case involves a 6 year-old female patient who experienced anaphylactic reaction to tetanus toxoid vaccine (anaphylactic reaction) where her face and eyes welled shut (swelling face) and (eye swelling), after she received vaccine TETANUS TOXOID.  It was unknown if the patient had any medical history, concomitant disease or risk factor and the patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported   On an unknown date, the patient received a dose of suspect TETANUS TOXOID, produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious anaphylactic reaction to tetanus toxoid vaccine (anaphylactic reaction) where her face and eyes welled shut (swelling face) and (eye swelling) (Unknown latency) following the administration of TETANUS TOXOID. These events were assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events and she was then told never to receive tetanus toxoid again.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  Result of assessment was not reported.  There will be no information available on batch number for this case.; Sender's Comments: This case involves a 6 year-old female patient who experienced anaphylactic reaction, swelling face and eye swelling after vaccination with TETANUS TOXOID (unknown manufacturer). The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Patient received Covid-19 1st dose as Pfizer Lot # FC3184 on 9/22/2021 and received Covid-19 2nd dose as Moderna Lot # 012F21A on 10/21/2021 at 12:40pm. Patient has no adverse effects as of 2:10pm on 10/21/2021 (time of filing the VAERS report).
Left arm and lymph node in armpit are still very sore every day since booster shot on 12/14/21 was administered. If arm is stationary for more than a few minutes pain escalates and only is temporarily relieved when arm is moved, this includes when trying to sleep. Quality of life is affected.
Headache; hurt right below my chest and in stomach; skin became extremely prickly; Low grade fever like 99; Dimer test showed kind of high levels with mainly blood clot; some fiber or Fibrogen which was for thickening of blood/ supposed to be between 400 and 420, his was 879; have COVID, it was positive COVID antigen test; have COVID, it was positive COVID antigen test; felt pressure in his back almost like pneumonia; Chills; sweat; Hot flashes; Stomach was cramping/ hurt right below my chest and in stomach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right shoulder single dose for COVID-19 immunization; second dose with lot number: EV10161 on 22Apr2021, first dose with lot number: EP7533 on 01Apr2021, at 49-year-old. Medical history and concomitant medication were not reported. The patient was non-smoker, non-drinker. The patient had a little headache with the second shot but 2 weeks later on 03May2021 started having chills every night and would sweat. He was having chills and hot flashes and stomach was cramping and when inhaled like taking a deep breath, felt pressure in his back almost like pneumonia like lungs were filling with fluid or clotting. On the 07May2021, he took a little flu medication Theraflu over the counter (treatment) thinking that'd clear it up. Every time he took a deep breath, it'd just hurt right below my chest and in stomach and skin became extremely prickly. He'd have like a low-grade fever like 99. This was 2 weeks after the second shot, so he went to the ER on 07May2021 and was given a COVID test, a fluid test and lab work trying and figure what he was having. One of his blood test - Dimer test showed kind of high levels with mainly blood clot so they gave him a CT scan, scan showed no blood clots, no kidneys stones or anything like that should had any sweating. ER doctor gave him an antibiotic (ciprofloxacin) for infection like diverticulitis or diverticulosis. The doctor said the patient did not have a stomach infection, his tests showing such high levels for clots so the doctor did more lab work a PRC, CRT, TRP or CPR, a CRT lab work and some fiber or Fibrogen which was for thickening of blood. Those numbers are supposed to be between 400 and 420, his was 879 today (17May2021). The patient did have COVID, it was positive COVID antigen test, I got those results today (17May2021). Outcome of the events was unknown.
Report fever of 102 and body aches.  Treatment: Tylenol Outcome: Fever resolved, body aches improved. Did not interfere with ADLs. continue to work
Arm was sore and she had headache and malaise starting on Wednesday afternoon. On Friday morning, she formed a welt on her left arm 3 inches long and 2 inches wide. Her malaise and headache have improved, but her rash is still present. She said she had full movement.
Erythematous, inflammed area about 8 cm in diameter, warm and tender to palpation on right arm at injection site. Afebrile. Applied ice to the area. Localized reaction had already begun to resolve by the following day, 6/19.
This spontaneous report as received from an immunization coordinator refers to an unknown number of patients of unknown age and gender. No information regarding their pertinent medical history, concomitant medications, drug reactions, or allergies was provided. Since an unknown date in January 2017, the patient was receiving incorrectly stored doses of VARIVAX (lot # M030138, expiration date: 15-JUN-2018; lot# M033214, expiration date: 13-JUL-2017; lot# M04584, expiration date: 27-JUL-2018; lot# reported as M038557, expiration date: 14-SEP-2018; dose and route of administration were not provided). No adverse effects were reported. Administered doses of vaccine experienced the temperature excursion of above 46 degrees Fahrenheit (F) but below 77 F for an unspecified time. There was the following previous temperature excursions: above 14 F but below 46 F (above 10 degrees Celsius but below 8 degrees Celsius) for 23 hours, and above 46 F but below 77 F (above 8 degrees Celsius but below 25 degrees Celsius) for 12 hours. Digital Data Logger was involved. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to contact the reporter.; Sender's Comments: US-009507513-1702USA010130:
Muscle aches & pain to the bone; chills so bad I couldn't stop shaking for three hours no matter how many covers; full-head headache to the point I could barely open my eyes; lasted approximately 12-15 hours overall