chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administrated with Pediarix after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 9x3t5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th July 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The physician reported that, the patient was administrated with Pediarix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 29 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patient's concomitant therapies included sterile diluent. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # N014634 with expiration date 07-NOV-2018) and/or improperly stored doses of M-M-R II (lot # M045394 with expiration date 14-NOV-2018), both for prophylaxis (dose and route were not reported for the suspect therapies). No adverse effects were reported. It was stated that the temperature was -14 to -10 degrees Celsius with a duration of 33 hours and 46 minutes. A previous temperature excursion was reported with a temperature of -14 to -10 degrees Celsius for 16 hours and 53 minutes. A digital data logger was involved. Follow-up information has been received from Medical Assistant on 06-JUN-2018. A call was placed to the reporter. A request was made for patient identifiers and vaccination dates for the two lots involved. This is a non-valid report due to lack of patient identifiers. Upon receipt of follow-up information on 08-JUN-2018, it was determined that this case is now valid because patient identifier was received. On 27-SEP-2017, the patient was vaccinated with improperly stored PROQUAD reconstituted with properly stored sterile diluent. This is one of the reports received from the same reporter.
Flu-like symptoms including: chills/shivering, headache, joint pain, skin sensitivity, exhaustion - lasted about 9 hours and then all symptoms were gone.
vaccine inadvertently given to a 16 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine inadvertently given to a 16 year old patient) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 21-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine inadvertently given to a 16 year old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine inadvertently given to a 16 year old patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Reporter did not allow further contact
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: clamy skin-Medium, Systemic: Hypotension-Severe, Additional Details: About 5 min after received second dose, pt said she felt light headed. i lowered her to ground as she passed out. she did not fall. i elevated her feet and she came to right away. i had told tech to call 911. she was sitting in chair by time paramedics arrived. they took her bp and bs, bs was 97, paramedic said bp low. she started to pass out again while they were here. they lowerd to ground again. her bp had dropped 20pts so took to hosp. she came to quickly again. she called her Mom.
This spontaneous report as received form a other health professional refers to an unknown number of patients of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HB (lot number and frequency unknown) (dosing regimen and frequency unknown) which under went temperature excursions outside recommended temperatures. No concomitant medications were reported. No adverse event was reported. No product quality issue was reported. This case is related to case numbers 1403USA009427, 1403USA009543 and 1403USA009541 via same reporter link. Additional information has been requested.
Patient advised she is not fully vaccinated, she was inadvertently given Peds dose vs a Adult Dose.  She verbalized good understanding by stating she would schedule in 6months for Adult Hep A when she comes back in 6 months for her 3rd Hep B vaccine.    Dr. and Nursing Director, were notified.
Redness and swelling at injection site and limited range of motion in left arm (nothing above horizontal). As of 9-26-2019, patient states redness and swelling has subsided and full range of motion is back, but with soreness in elbow of left arm.
I had intense pain about 3 seconds after the injection of the needle, almost like a fire ran down my left arm. My entire arm was numb for hours after. I was unable to raise my arm and had a tingling sensation in my left ring and pinky finger for approximately 3 days. I also had extreme tenderness at the injection site. Then little by little (day by day), I was able to raise my arm higher and higher until my full range of motion returned. The numbness also started to subside after about 3 days. By about 8 days later, I was back to normal. I believe the adverse event was caused by the administration of the vaccine and not the vaccine itself.
Reported feeling like she was about to pass out, emesis.. Seen by Medics. Left in stable condition at 10:27. Recorded by RN.
Tested positive for first time with Covid 04Jul2022.; Tested positive for first time with Covid 04Jul2022.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: FL9266), in right arm, on 14Mar2021 as dose 2, single (Lot number: EN6205), in right arm, on 18Jul2021 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 12Oct2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "not recovered" and all described as "Tested positive for first time with Covid 04Jul2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2021) Positive, notes: Tested positive for first time with Covid 04Jul2022; (10Jul2021) Negative, notes: Tested negative for Covid 10Jul2022; (12Jul2021) Positive, notes: Tested positive twice evening of 12Jul2022; (12Jul2021) Positive, notes: Tested positive twice evening of 12Jul2022; (17Jul2021) Positive, notes: As of 17Jul22 still positive and minor symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: If vaccine received: Yes, Other medication in 2weeks: No, Tested positive for first time with Covid 04Jul2022 was linked case Prescribed Paxlovid on 04Jul2022 and started taking as prescribed. Tested negative for Covid 10Jul2022. Felt good. 12Jul2022 starting have symptoms again. Tested positive twice evening of 12Jul2022. Got mildly sick / symptoms. As of 17Jul2022 still positive and minor symptoms. Other medical history was None.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 23-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.    This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002769: US-009507513-1905USA002770: US-009507513-1905USA002753:
5x5 mm necrotic ulcer left triceps at site of vaccination with surrounding 2x2 cm area of slightly raised erythema, with several 2mm vesicular satellite lesions on left triceps at site of vaccine administration--originally a bullous lesion lanced by parents with a sewing needle draining clear fluid, also 10 papules scattered occiput, trunk, arms and legs; 1x1 cm soft tissue swelling over right proximal humerus; no fever, slight cough and rhinorrhea; symptoms began 6/11, VZV vaccine given 5/20, evaluated by pediatrician and myself (Ped ID) 6/13; treated with Clindamycin 40 mg/kg/day divided TID x 10 days for possible bacterial superinfection
Patient vaccinated on 3/7/21, on 4/2 presented pain in left leg and some redness, on 4/3 some dizziness,  lightheadedness, difficulty with vision in right eye, some slurred speech; on 4/5 his health agravated and EMS was called and taken to hospital; spouse informed that patient had a blood clot in stem of brain; on 4/6 patient died. No autopsy performed
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 25-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256: US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012263: US-009507513-1807USA012255: US-009507513-1807USA012254: US-009507513-1807USA012257:
After second vaccine, I had a mammogram  0 2/4/21 and on the opposite side of the injection, I had to have a biopsy due to an enlarged lymph node in my Right breast.
11/22/2021 vaccination. 5/13/2022 I started to feel symptoms to include scratchy throat, nose was running a lot. The day before, a co-worker had tested positive. He left immediately. I tested that day and tested positive; COVID positive. I did a home test and through the pharmacy. 5/24/2022 Still feeling residual fatigue.
knees swelled up; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 07Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "knees swelled up" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 14Feb2021, for COVID-19 immunisation. The following information was reported: JOINT SWELLING (medically significant) with onset Mar2021, outcome "unknown", described as "knees swelled up"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain". The event "knees swelled up" was evaluated at the physician office visit. Therapeutic measures were taken as a result of joint swelling which included fluid was drained from the knees. Clinical course: After the second shot the patient's knees swelled up, which was according to the patient happens periodically. The doctor said he cannot give the patient cortisone shots because he just got the second dose of the vaccine and needed to wait for 2 weeks. The reporter was asking if the patient can take an extra strength paracetamol (TYLENOL) for the pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient started having pain in his upper L shoulder around 11/2/19. He only notices pain when he tries to lift his left arm. Once it gets to shoulder height he starts to have pain in the arm. Patient hasn't noticed any tingling, burning, etc. no radiating pain. Patient has taken 800mg of advil and it helped "somewhat" but still had pain. Patient hasn't been seen by MD yet. Patient had normal muscle soreness 1-2 days after shot, then no pain then about 11/2/19 started having upper shoulder pain
student had immunizations, was told to wait 10 min after for observation. complained of dizziness and SOB. mom at Bedside. Epi 0.4 ml SQ, given 50 mg Benadryl, as per Dr. Paramedics called. Student with 4L O2/N and transported by Paramedics to medical center.
developed fever 101.0, body ache, fatigue at 0400 1/7, relieved with Tylenol. symptoms improved slightly by 1/8 to mild body ache, fatigue and temp 100.0
Painful injection, shoulder very painful, fever developed, intense painful pain in arm and shoulder, slight nausea, aches all over body, headaches lasting for about 18 hrs.
My left ankle was hurting and a little swollen on the left side from a sprain two months earlier.  The ankle was beginning to feel much better, though.  After the Moderna booster (shot #3) the right side of my left ankle and in fact the top of my left foot became swollen and there was a new pain from the right side of my left ankle.  It hurt when I was still and hurt very much while walking.  The pain woke me up at night.   The swelling and pain subsided on the tenth day after I received the Moderna booster shot.  My doctor's office was closed for the Christmas and New Year's holiday and by the time he re-opened the pain had subsided.
rash & fever 2 days p/vax;mom reported 3MAR98 states took pt to MD & states still has a bad ear infect & was started back on ATB;pt to MD 2MAR98 & was dx w/OM;
Sudden reaction day 2 Chest felt like it was going to explode, back pain. nausea, light headed    I went to the ER for the first time in my life.. I was there for 6 hours without seeing  a professional. they did numerous test.  They found nothing wrong.  I began to feel better about 5am the next morning.  I took several weeks before I felt like my normal.
arm was so sore; eye problems/It was sore/so sick; ulcer in eyelash; so sick; chills/Shaking; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was so sore), EYE PAIN (eye problems/It was sore/so sick), EYE ULCER (ulcer in eyelash), ILLNESS (so sick) and CHILLS (chills/Shaking) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm was so sore), EYE PAIN (eye problems/It was sore/so sick), EYE ULCER (ulcer in eyelash), ILLNESS (so sick) and CHILLS (chills/Shaking). At the time of the report, PAIN IN EXTREMITY (arm was so sore), EYE PAIN (eye problems/It was sore/so sick), EYE ULCER (ulcer in eyelash), ILLNESS (so sick) and CHILLS (chills/Shaking) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
First vaccine is being reported about 5 days after her vaccine she had a itchy throat and persistent cough. Went to PCP and was put on a inhaler for 2 weeks. Just had her second vaccine today.
A few days after vax pt had white patches all over her skin and she went to a dermatologist and was diagnosed with vitiligo  Pt said she was just overall sick with both vaccines, memory , concentration, fatigue, headaches. Pt says the 2nd vax also made her BP "go crazy"
right side up to my ear; TMJ; pain in the joint of my jaw; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (right side up to my ear), PAIN IN JAW (pain in the joint of my jaw) and TEMPOROMANDIBULAR JOINT SYNDROME (TMJ) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN JAW (pain in the joint of my jaw). On an unknown date, the patient experienced EAR PAIN (right side up to my ear) and TEMPOROMANDIBULAR JOINT SYNDROME (TMJ). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, EAR PAIN (right side up to my ear), PAIN IN JAW (pain in the joint of my jaw) and TEMPOROMANDIBULAR JOINT SYNDROME (TMJ) outcome was unknown.       On 16 Feb 2021, the patient experienced the pain in the joint of her jaw. On an unknown date, the patient experienced TMJ, yawning triggers and she can't put her teeth together and had pain on right side up to her ear.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.The outcome of events was unknown   No medical history and concomitant medications was provided by the reporter.  Patient stated that she tried Ibuprofen, but she said she is limited to how much she can take it, because she has reflux.
Fever, chills, body aches, difficulty breathing, tight chest, nausea, muscle aches, a stiff neck and back and headache.
Increased weakness and decreased mobility starting day after received H1N1 vaccination - had trouble getting out of bed next 3 mornings. States has had increased weakness ever since. Dental procedures are more painful afterwards. Another example is increase BP after eye exams. Generally more weak since vaccination.
I have been dizzy, light headed and nauseas.  I have lost a total of 27 pounds since February 19, 2021.
started day after injection as itching at the injection site, progressed in the following days to small area of redness with itching at injection site, and at 5.5 weeks since injection, injection site is red, raised, flaky, itchy, BSA=half a palm's worth at site of injection on upper left arm. Pt has been treating injection site with moisturizer, otherwise no other treatments.
I woke up with stomach cramps and diarrhea, an hour later started with chills, low grade fever  100.3, aches, pains, all over, exhausted .  Diarrhea continued for 12 hours,  Fever returned at 3:30 pm 100.4, feeling better but still achy.
Chest pain and elevated blood pressure for 3 days. Body aches, low grade fever, fatigue
After injection of Shingrix,  I developed very bad side effect symptoms which include muscle ache, flu like symptoms, fever as high as 101.5 F.  Pain at the arm, headache, upset stomach. and tiredness.