chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not reconstituted with antigen; Only adjuvant was administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 24R7T, expiry date 26th January 2024) for prophylaxis.   On 28th November 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 28th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: No other information was provided. The reporter did not consent to follow-up. This is 1 of 2 linked cases reported by same reporter. Additional supportive information: The patient received only received adjuvant vial of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022189762:Same reporter
Patient became lightheaded ~5 minutes following vaccine administration. He voluntarily moved from the chair to lying on the floor without falling or losing consciousness. Blood pressure at that time was 118/74 pulse 56. I asked him to remain in that position until he felt better. He rested for about 20-30minutes before walking out with someone as his driver.
103 degree F fever for a day Recurring headaches several times a day... cokes and goes in waves. Taken ibuprofen but no impact. Still happening more than 72 hours later.
Temperature Excursion; Initial Report Received on 11-Jan-2023  A registered nurse reported that a patient (Patient 5) (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11 Mar 2023 or Lot # 938794, expiration date 09-Oct-2023). The NDC #, injection site, and route of administration were unknown. These two HEPLISAV-B Lot #s affected by the temperature excursion occurred between 22-Aug to 15-Nov (year not reported). For 97% of the time, the temperature was between 8°C - 12.31°C.   No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Left deltoid area of erythema 30mmx90mm warm, painful to touch, itchy around area. Benadryl. 3rd day placed on Zyrtec, Benadryl and Augmentin.
Started complaining with joint pain, backpain, headache, and face red the day after the vaccine.
COUGH; WHEEZING; DIZZINESS; ACHE/PAINS; CHILLS; SORE  ARM; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, on 06-MAR-2021 administered at left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced cough. On 2021, the subject experienced wheezing. On 2021, the subject experienced dizziness. On 2021, the subject experienced ache/pains. On 2021, the subject experienced chills. On 2021, the subject experienced sore arm. On 2021, the subject experienced fever. On 2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, cough, wheezing, chills, ache/pains, sore arm, headache, and dizziness. This report was non-serious.
Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0175) as) via an unspecified route of administration, administered in Arm Left on 18May2021 13:30 DOSE 1, SINGLE for COVID-19 immunization. Medical history was None. Concomitant medications included escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient did not diagnose with COVID-19. Since the vaccination, patient did not test for COVID-19. On 18May2021 15:30 the patient experienced diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on. Device Date: 19May2021.Patient did not received treatment for adverse events. The outcome of the events was recovering.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Pulmonary Embolism right lung and blood clot in right leg. No travel or other events  or activities are known that might have contributed  to blood clots in leg and lung. Symtoms of embolism first appeared about 10 days following 2nd dose of Pfizer vaccine.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE OBSTRUCTIVE SLEEP APNEA 7/3/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
heart was beating really fast; breathing kind of hard; tachycardia; pain at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 09Dec2021 14:15 (Lot number: FH8030) at the age of 52 years as dose 2, 0.3 ml single for Covid-19 immunization. Relevant medical history included: "Chemotherapy" (unspecified if ongoing), notes: Received chemotherapy 5 years ago for a duration of 1 year. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Route, Anatomical Location: Intramuscular; left arm, Lot Number / Expiry Date: FH8027), administration date: 18Nov2021, when the patient was 52 years old, for Covid-19 Immunization, reaction(s): "pain at the injection site".  The following information was reported: TACHYCARDIA (non-serious) with onset 11Dec2021, outcome "recovered" (11Dec2021), described as "tachycardia"; DYSPNOEA (non-serious) with onset 11Dec2021 11:30, outcome "recovered" (11Dec2021), described as "breathing kind of hard"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021, outcome "recovered" (10Dec2021), described as "pain at injection site"; HEART RATE INCREASED (non-serious) with onset 11Dec2021 16:30, outcome "recovered" (11Dec2021), described as "heart was beating really fast". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Patient received vaccine on 05/29/08 (pediarix)mom reported that evening temperature of 102.6. Patient examined in office on 05/30/08 and was a completely normal examination. On 07/29/08 patinet received second Pediarix mom reported temperature of 101 and fever resolved in less than 24 hours.
Pt received Hep-A #2 on 1/14/02 and returned home and developed itchy rash on trunk. Also had swelling followed by a fever X 2 days about 102F-103F. Seen by MD on 1/18/02 and dx'd with urticaria (allergic by Hep-A). Pt also was admitted to hospital ER on 1/19/02 with a high fever of 105.2F and dx'd also with allergic reaction from Hep-A. No further complication.
Child received vaccine 6/30/04. Presented to office 7/12/04 and parent reported that child had had significant redness and swelling at site of vaccine. Also experienced vomiting (no fever, no diarrhea) for approximately 2 weeks after vaccine given. Mother reported that she also experienced similar effects after having Hepatitis A vaccine.
Highly irregular menstrual cycle - Have had my menstrual cycle for 3 weeks straight, inconsistent in flow and duration and with painful cramping -  I?m not sure when it will end and how it will affect my ovulation and birth control regulation. I have had a normal consistent cycle every month until I got the vaccine.
9 days post vax pt rant temp of 103.5 @ noc;pt not self-moaning, not responsive, freezing cold-body temp 96 temp under arm, uncomfortable, depressed behavior;rash;to MD, ear infect, tonsil infect;
Received Pfizer vaccines on  1/28, 2/18, 10/7/21 COVID-19 positive by PCR on  1/19/22 admitted to hospital on 1/20/22 w/ pneumonia and pleural effusion
Patient had redness and swelling, sought treatment at urgent care. She was diagnosed with cellulitis and given a course of antibiotics.
Rash treated with 5 days of prednisone no relief after 5 day course
Headache, Clammy Skin, Dizziness, Lower extremity Weakness
prior to day 6 I had no injection site pain other than what is normal with a vaccine  day 6 after receiving my vaccine: radiating pain on my left side around the trapezius muscles and up into my neck, turned into a migraine, treated with ibuprofen day 7: pain in my left arm from near the injection site, radiating up into trapezius muscles and down my arm, treated with ibuprofen day 8 (current): injection site was tingling, is radiating pain down my left arm and up into the trapezius muscles, treated with ibuprofen, still currently radiating pain  I had almost zero injection site pain until day 6. If it does not get better in the next couple days I will seek medical attention.
Extremely hot face and ears; Weakness; Short time chills; Itching left neck and shoulder; 8-12 hours.
Immediately after administering, Pt developed hives - no other s/s. Doctor ordered BENADRYL and save Rx for BENADRYL
Information has been received from a physician concerning a 14 month old male with no pertinent medical history and no allergies who was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (on an unspecified date). There was no concomitant medication. Subsequently, the pt experienced mild breakthrough varicella (date unspecified). Unspecified medical attention was sought and no diagnostic or lab tests were performed. The present status of the pt was not reported. No product quality complaint was involved. Additional information has been requested.
My primary doctor did know what cause my vein going to my middle finger, left hand to roll to the left and there is swelling.  She suggested I see a surgeon.
This spontaneous report as received from a nurse practitioner via field representative refers to a 1 year old patient of unknown gender. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot#, strength, dosage and route unknown). On an unknown date, "1 week" after an unspecified patient received VARIVAX (Merck) the patient developed a "varicella rash and blisters" around the injection site. The outcome of the events was unknown. Additional information has been requested.
On 01/22/2021, I started getting specific pain in my heart in specific spots, shortness of breath, I felt tachycardia , fatigue, easily winded, hot flashes, chest pain. Discomfort in my chest was like a constant.  What made me see the doctor, 02/02/2021, is when it was coming more constant, it was like on the left side of my chest when I took a deep breath, and light headedness and dizziness at that time.  The hot flashes started with my 1st vaccine, but that is the least of my concern, compared to the cardiac stuff.
booster; itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2021US186639. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; omalizumab (XOLAIR) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster "; PRURITUS (non-serious), outcome "unknown", described as "itching".  Additional information: Patient stated she took her Xolair Medication three days after receiving her Covid booster shot. The patient advised that after this she began to experience itching and that it felt as though her shot did nothing for her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After receiving vaccines, pt with syncope-lying down on table, pale, out for approximately 20 sec feet were raised; HR=60; BP 98/62; PT given lollipop and soda to drink (Pt did not have anything to drink or eat prior to vaccine administration). Pt stayed in office for 20 min-HR=60 BP 102/70. Pt walked out of office accompanied by mother.
side effects included swelling and intense pain around the vaccination site  (40 hours) all over aches, muscle soreness, stiffness (36 hours) headache off and on (48 hours) night sweats and chills (8 hours) I did not take any pain reliever, no tylenol, no ibuprofen, nothing.
Pt devel elevated temp to 105 several (approx 5) hrs p/vax given; given antipyretic & freq cool bathes;
Case number PHEH2013US023953 is an initial spontaneous report received from a consumer on 14 Nov 2013: This report refers to a female patient of unknown age. She was vaccinated with FLUVIRIN (batch number: unknown) on an undetermined date. Within 12 hours of receiving the vaccine, on 17 Sep 2013, her arm was 'real sore' and by evening it was red and hot. She was not able to lie on her arm at night. Next morning the reaction had spread all the way around and down to the elbow. Her arm was 'super red', very painful and feverish. She was given a steroid shot and two different unspecified antibiotics. The reaction subsided on 25 Sep 2013. No additional information about seriousness and causality was mentioned.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 04-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # K008185, expiration date was reported as "52-DEC-2015", dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Entire deltoid red and feverish.  Hard knot under the skin about 2 1/2 inches in diameter.  Very painful. Not relieved with tylenol or ibuprofen.
This child had generalized papular rash over entire body (torso, arm, legs, face) occurred 5-7 days post injection. The child was taken to Med-Express. Treatment given was one dose of steroids, the mother stated decrease in symptoms. 2-3 days increased symptoms; the child was taken to ER and treated with steroids for a week.
2.5 X 5cm red patch w/some induration on left thigh 1 day after vaccine.
body aches; tested positive for COVID-19; This is a spontaneous report from a contactable consumer. A 38-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 04Feb2021 (at the age of 38-year-old) (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced body aches and on 12Feb2021, the patient was tested positive for covid-19. The patient stated that, her boyfriend tested positive for the covid-19 virus the day after she received her 1st dose of the covid-19 vaccine and then she tested positive for the covid-19 virus on 12Feb2021. The patient had to take off from work for 5 days and bring in a negative covid-19 virus test before she could return to work. She said the whole time she felt fine. She said it was not until after she got the covid-19 virus test that she had only body aches. She said she had no fever or any other symptoms after she tested positive for the covid-19 virus and stated that she was able to get her covid-19 vaccine because she is a caregiver to an elderly patient. The patient was scheduled for the second dose 25Feb2021 and would like to know if she should receive the second dose of the vaccine on 25Feb2021 since she recently had the virus and has developed antibodies. The seriousness of the events was reported as non-serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
1-3 days after 2nd injection I had mild fever, aches, and arms soreness which subsided after a couple days.  It has been over two weeks and I have been constantly experiencing a lingering brain fog. I feel a mild pressure in my head and I find it difficult to concentrate, rememer things, and even sometimes focus with my eyes. I also find I have been more tired lately.
administered YF-Vax to a patient intramuscularly instead of subcutaneously with no reported adverse event; Initial information was received on 23-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 36 years old female patient who reported that administered yellow fever vaccine - [YF-VAX] to a patient intramuscularly instead of subcutaneously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Aug-2023, the patient received a dose 1 of 0.5 ml of suspect yellow fever vaccine - (Solution for injection) (Frequency : Once, lot UJ818AA, strength, expiry date unknown) via intramuscular route in unknown administration site for Immunization and administered yellow fever vaccine - (YF-VAX) to a patient intramuscularly instead of subcutaneously with no reported adverse event (incorrect route of product administration) (latency : same day).  It was reported that "Caller also inquired whether the vaccine needs to be readministered using the correct route."  Action taken with yellow fever vaccine (YF-VAX) was not applicable.  At time of reporting, the outcome was Unknown for the event administered YF-VAX to a patient intramuscularly instead of subcutaneously with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
passed out and the next day the ambulance came and took him and he always passes out; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were unknown), via an unspecified route of administration, on an unspecified date as unknown dose, single for COVID-19 immunization. Medical history included needle phobia. The patient's concomitant medications/other products was unknown. On an unspecified date, the patient passed out and on the next day, the ambulance came and took him to the hospital as he always passes out. It was unknown if the investigation's assessment was reported. The outcome of the event was unknown at the time of report.   The lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Loss of consciousness and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Bexsero administered instead of Engerix-b; Bexsero administered to a 9 months-old; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 9-month-old male patient who received Men B NVS (Bexsero) (batch number 3YB52, expiry date 30th April 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's comments: A health care professional reported that the patient had received a Bexsero dose, but he was intended to receive an Engerix-b dose. The reporter had consented to follow-up. Additional supportive information: A 9 month old patient had received a dose of Bexsero instead of Engerix-b, which had led to wrong vaccine administered and inappropriate age at vaccine administration.
Administered 6/3/16. Mom advised office of rash on 6/7/16. Office visit on 6/7/16 for ongoing persistent rash. Mom states rash started 24 hours after administration of immunizations.
Incorrectly given Pfizer 5-11 dose for second dose instead of the 12 and older dose   No symptoms reported
No additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions and allergies was not reported.  On 04-MAR-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, orally (concentration  and vaccination scheme frequency were not reported; lot number 1660942 and expiration date 06-FEB-2021) as prophylaxis. No adverse effects were reported for the patient.  According to the reporter, the multiple temperature excursion was below 2 degrees Celsius (1.28 degrees Celsius) for a time frame of 2 hours and 30 minutes on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger.
Facial edema and local urticaria, slight shortness of breath-all resolved with Benadryl after two days.
8/11/00: vaccine (varicella #2).  8/12/09: L arm swollen, not feeling well overall, some neck & upper back discomfort.  8/13/09: arm swelling increased & increase in arm pressure, more neck & upper back pressure.