chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 68-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th February 2022, the patient received the 1st dose of Twinrix (intramuscular) and Twinrix Pre-Filled Syringe Device. On 9th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient inadvertently received an expired dose of Twinrix, which led to expired vaccine used. The reporter consented to follow-up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos thyroiditis" (unspecified if ongoing); "depression" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: walnuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was taken from 29Jul2023 to 02Aug2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed a low grade fever, nausea, vomiting and a papular, red rash on torso, face and extremities 10 days post vaccination.
Got violent shakes and chills; Got violent shakes and chills; Stomach pain; temperature suddenly got to 103.5; Blood Pressure was very high; flu like; 1st dose :20Mar2021; 2nd dose: 04Apr2021; 1st dose :20Mar2021; 2nd dose: 04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Apr2021 11:00 (Lot Number: EW0150) as single dose (at the age of 59-years-old) for covid-19 immunisation. Medical history included breast cancer, anxiety, depression, irritable bowel syndrome (IBS), Low Thyroid, arthritis. Patient had no known allergies. It was reported that patient received concomitant medications in two weeks prior to the vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration, administered in Arm Left (Lot number: ER2613) on 20Mar2021 12:00 PM (at the age of 59-years-old) for COVID-19 immunization. It was reported that patient received first dose on 20Mar2021 and second dose on 04Apr2021 (Inappropriate schedule). Patient stated that she had her second (2 nd) shot on 04Apr2021 (Sunday), was fine until 07Apr2021 (Wednesday). On 07Apr2021 at 15:00 she got violent shakes and chills, stomach pain, temperature suddenly got to 103.5. Patient went to Emergency room. Blood Pressure was very high. She was released and better on Friday but still flu like. They could find no reason for this and three doctors (Dr's) thought it was a reaction to the vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 3 days. She was treated with intravenous (IV's), Antibiotics, cat scan and X-ray, results unknown. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 07Apr2021. She was recovering from the events, at the time of the report.
No other concerns or issues noted; improperly stored VARlVAX had been administered; This spontaneous report was received from a customer and refers to a patient of unknown age and gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On 08-FEB-2022, the patient was vaccinated with improperly stored (41 degrees Fahrenheit for 45 minutes) varicella virus vaccine live (oka/merck) (VARIVAX) lot #U020238, expiration date: 28-JUN-2023 (dose, site and route of administration were not provided) for prophylaxis (product storage error). No other concerns or issues were noted (no adverse event).; Sender's Comments:  US-009507513-2202USA003311: US-009507513-2202USA003391:
Next morning post vax, the pt awoke with a fever of 101. Also, erythema and edema on right arm extending from sternum down to right arm to antecubital space. Pruritic in nature with slight tenderness to the touch.
Went over all patient information and vaccine information prior to administration. Patient was given VIS Fact Sheet for MMR-II vaccine. After vaccine administration patient fainted and fell to the ground. Patient did not lose consciousness and was verbal throughout encounter. He wanted to stand immediately after fall but was told to take a few minutes. He was then directed to chair and further monitored. He refused ambulance services and said he was feeling fine and stated that he had not eaten all day, he had only drank coffee. Patient left pharmacy in good and was feeling well.
The patient developed an itchy, red rash on her neck almost immediately after receiving the vaccine. She said she's had that type of reaction before. She's been to the allergist, and they said she's allergic to dustmites. The patient said she felt fine other than the rash. After the 15 minute period, there was no signs/symptoms of anaphylaxis. She drank water and took 2 diphenhydramine 25mg tablets.
This spontaneous report was received from a back office lead referring to a 19-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in right deltoid (a dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Awoke on 1/10/2021 with severe arm pain in left arm.  Unable to lift arm.  Thought odd that it hurt in arm opposite injection site.  on 1/12/2021 pain extended to right arm, next, down towards elbows.  Acitivities of daily living difficult.  Pain severe in morning, better throughout day, but still painful.  Unable to lift arms, pick up items.  Hips begain hurting within a week.   Started prednisone 2/2/2021 with very significant relief of pain.  Weaned every 3 days until 20 mg - continue to take 20 mg until seen by rhuematologist.   Continues to have morning bilateral arm and shoulder pain, improving throughout day, although not always complete relief.  In addition, vertigo started on 1/8/2021 and continues.
Aout 7 hours after receiving vaccine I was itching and noticed red bumps on my abdomen and back. I still have them (2.5 days later) only from my neck down to hips, occasionally itchy. I took benadryl one night but didn't seem to have any effect.
Redness presently cover entire body; one of my eyelids is swollen; itching; I also woke up during the night & I passed out.; lethargic; had the shivers; headache; soreness in my left arm; My body was covered in hives again / hives all over my body now, including the soles of my feet / chronic hives for the last few months which started a few days after getting the first dose of the vaccine; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (I also woke up during the night & I passed out.) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced URTICARIA (My body was covered in hives again / hives all over my body now, including the soles of my feet / chronic hives for the last few months which started a few days after getting the first dose of the vaccine). On 27-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (I also woke up during the night & I passed out.) (seriousness criterion medically significant), LETHARGY (lethargic), CHILLS (had the shivers), HEADACHE (headache) and MYALGIA (soreness in my left arm). On 03-Jul-2021, the patient experienced PRURITUS (itching). On 12-Jul-2021, the patient experienced SWELLING OF EYELID (one of my eyelids is swollen). On an unknown date, the patient experienced ERYTHEMA (Redness presently cover entire body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC HIVES RELIEF) for Adverse event, at an unspecified dose and frequency and PREDNISOLONE for Adverse event, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (I also woke up during the night & I passed out.), LETHARGY (lethargic), URTICARIA (My body was covered in hives again / hives all over my body now, including the soles of my feet / chronic hives for the last few months which started a few days after getting the first dose of the vaccine), PRURITUS (itching), SWELLING OF EYELID (one of my eyelids is swollen), ERYTHEMA (Redness presently cover entire body), CHILLS (had the shivers), HEADACHE (headache) and MYALGIA (soreness in my left arm) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-254121 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Non significant follow up appended; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On 22-APR-2014, the patient was vaccinated with an expired PNEUMOVAX 23 25/0.5 (lot # H014653, expiration date 19-APR-2014) 0.5 ml in the left deltoid (route was not reported). No adverse effects noted to patient. The patient did not seek medical attention. Additional information has been requested.
No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, 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. In 2022, the patient experienced UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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 UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    Concomitant drugs were not reported. It was reported that 20 adult patients received Bivalent booster from end of August to middle of October 2022. Treatment medications were not provided. The case was reported for Adult patient 5.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-663016, US-MODERNATX, INC.-MOD-2022-663014, US-MODERNATX, INC.-MOD-2022-662866, US-MODERNATX, INC.-MOD-2022-662861, US-MODERNATX, INC.-MOD-2022-662875 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663016:Patient 5 US-MODERNATX, INC.-MOD-2022-662881:Patient 5 US-MODERNATX, INC.-MOD-2022-662860: US-MODERNATX, INC.-MOD-2022-662866:Patient 5 US-MODERNATX, INC.-MOD-2022-662871:Patient 5 US-MODERNATX, INC.-MOD-2022-663014: US-MODERNATX, INC.-MOD-2022-662861: US-MODERNATX, INC.-MOD-2022-662875:
Excessive menstrual bleeding two nights in a row. First night lasted about three- four hours. Second night about six hours.
Approximately 10 hours post vaccine woke up with numb arm and stayed numb for quite some time then remained tingling sensation in pinky and ring fingers and wrist. Occasional sharp pain in wrist and difficult to keep fingers warm as they are tingling and feel cold. Symptoms have not improved since they started.
Light pink/red rash around the injection site; Light pink/red rash around the injection site; This is a spontaneous report received from a contactable other health care professional. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ER2613), via unspecified route of administration in left arm on 19Mar2021 at 17:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and surgery to fix tendonosis. The patient had no known allergies. The concomitant medication included claritin (LORATADINE), budesonide-formoterol (SYMBICORT), cetirizine (ZYRTEC), paracetamol (TYLENOL) and proair. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6200) via unspecified route of administration in left arm on 26Feb2021 at 16:45 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 19:00, the patient experienced light pink/red rash around the injection site (vaccination site erythema and vaccination site rash). The clinical outcome of the event light pink/red rash was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 29Oct2023 to 03Nov2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency; however, a contributory role of BNT162b2, BNT162b2 omi ba.4-5 to the events Drug ineffective and Covid-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300360590 same patient, different drug /event;
States he did have a sinus infection she thinks in between the Pfizer COVID Vaccine doses; This is a spontaneous report from a Contactable consumer or other non HCP (parent). This consumer reported for 12 years old male patient.  A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0176, Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 (age at vaccination: 12 year) as dose 1, single for covid-19 immunisation. Time the Vaccination Was Given between 1:30pm and 4:00pm in the afternoon. Medical history included asthma from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had a sinus infection she thinks in between the Pfizer COVID Vaccine doses (May2021) stated the sinus infection began right before holiday on that Thursday and he was put on a Zpack and took about a week to completely resolve from the sinus infection. Patient was fine from the sinus infection and had no illness at the time of the Pfizer COVID 19 vaccination. Patient did not have testing for covid. And no lot, expiry date or NDC to provided for the Zpack as it had been discarded and he started taking it the Thursday before Memorial Day and finished it 5 days later on probably Monday holiday. Therapeutic measures taken as a result of sinusitis with Zpack. Physician Office, hosp and emergency room reported as no. The clinical outcome of the event was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Dad reported coughing and low grade fever (99F-101F) lasting one week. He stated this happens every once in a while.
Initial misuse report received from a healthcare professional on 11 November 2013. A 10-year-old had received a dose of FLUZONE ID. No adverse event was reported. List of documents held by sender: none.
Pt reported feeling "funny" 1-2 min post vaccines. Upon reclining pt developed stiffness of arm, legs, fist - jaw clenched, and loss of consciousness. Pt responded quickly to ammonia inhalant. Pt was alert and examined by physician following episode. Pt kept in office 1 1/2 hrs post episode without further reaction.
1430 EE returned to Employee Health after receiving her 1st Moderna vaccine in our office @ 1300hrs. EE stated her Left arm was numb, assessment of Lt arm at vaccine site, bandaid removed, no redness noted, no raised area, no swelling of injection site,area not warm or hot to touch. 5/11/21  patient states the numbness is in her whole arm, she had movement in her arm and fingers, no tingling felt in fingers. EE was undecided as to what to do next, advised to put in an RL, and W/C/PP of Dr.s as well as Bill of Rights was emailed from Employee Health were told patient o ER.Reviewed RL. Late entry/employee entered RL: Employee came to EHS yesterday afternoon. Left deltoid Covid vaccination site appears asymptomatic, no hematoma, redness or swelling noted at site, site appears asymptomatic. She states her left arm is numb from left shoulder down to fingers. She is able to move her left arm, hand, fingers appropriately to commands. She states her left grip is a little weaker than her right one. Hands are cool bilaterally, she states they always are. Nurse with her states that she was sticking employee with a pin and employee couldn't feel any of it. Employee's affect is flat, she is not anxious and even states she is not anxious. I offered her an ice pack in case there is internal swelling pressing on nerve, she declined. I advised her that she can enter an RL and either choose to see MD/Urgent care on posted panel or wait a little while to see if feeling comes back and what she would like to do. She went in other exam room where she had received vaccine.
Systemic: Fainting / Unresponsive-Severe, Additional Details: mom arrived to store in the evening claiming her son was vaccinated earlier that day and not told to wait after immunizing. The son, then left after being immunized and fell/fainted outside, ambulance was called, and the pt was injured (facial/skull fracture) per mom.
Patient experienced reactions; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient experienced reactions) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 immunisation.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient experienced reactions). At the time of the report, IMMUNISATION REACTION (Patient experienced reactions) outcome was unknown. Not Provided   Concomitant product use was not provided by the reporter.   On 26-Oct-2022 it was reported that patient started treatment on an unspecified date with Moderna COVID-19 vaccine at dose 2 for COVID-19 immunization.  Treatment information was not provided.   Reporter did not allow further contact
Vaccinee experienced large indurated, erythematous, warm area at injection site (lt arm).  c/o moderate pain. Events occurred at time of injection.  route of injection was IM or "possibly SC" Reporting nurse indicated not known.
Erythema and warmth of the cheeks and upper chest.  Numbness/tingling from right cheek into right shoulder (NO urticaria, itching, shortness of breath)
Received second dose of Pfizer COVID 19 vaccine on 6/11/21. The night of Sunday 6/13/21, he developed back/neck aching, chest pain/pressure, and radiating pain down his left arm. Symptoms improved Monday morning with resolution of back/neck and arm pain but continued to have constant chest pain/pressure. Seen by PCP on 6/14 where labs were drawn which resulted on 6/15 and revealed elevated troponin. Patient directed to ED where EKG, labs concerning for myocarditis then transferred to hospital ED. He continues to be hospitalized on the floor at hospital (no ICU stay required) now with improving cardiac markers.