chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients administered Moderna vaccine while temperature excursion assessment was ongoing(possible temperature excursion); patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) and EXPIRED PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 25-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) and EXPIRED PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) and EXPIRED PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of DEC2021, JAN2022, and FEB2022. Reporter said that they are filling out a temperature excursion assessment with the State at this time and she was calling in to report the same to Moderna.  Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing. It was reported that no adverse reactions were reported by any patients  No treatment information was provided.
Cold like symptoms day after first shot. Cold like symptoms only lasted for a day then went away. I have several of these one day cold before my second shot. The day after my second shot I came down with what I thought was a cold and it has continued non stop. Had a appointment at medical center (04/09/21), they said it was not a cold but pollen allergy.  Prescribed Claritin and Fluticasone and it did not change anything. Called 04/19/21 for a appointment, waiting to hear back. They said the Covid shots had nothing to do with it. I am 79 years old and have never had allergies in my life, its my feeling the Covid shots effected my immune system and are the cause if my allergy.
This case was reported by a pharmacist via sales rep and described the occurrence of cellulitis in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), pain, erythema and swelling. On an unknown date, the outcome of the cellulitis, pain, erythema and swelling were unknown. It was unknown if the reporter considered the cellulitis, pain, erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced significant pain, redness and swelling. The reporter had to go but agreed to email the sales representative more information when she had a chance.
Rash, redness, and swelling on on the are of vaccines, and pain. Left thigh has erythematous base with 2 injection marks one bruised superiorly. The Erythema is approximately 3cm in diameter with surrounding papules in the perimeter. No vesicle. It is tender.  Difficult to assess whether allergic reaction or early cellulitis.
Patient/family refused 15 minute post vaccine wait-time in exam room.  Patient with vaso-vagal episode and reception desk.  Slow decent to ground to sitting then lying position. Witnessed.  Did not strike head on floor.  No LOC. Skin pale, clammy.
rash that is 10 by 15 centimeters; Itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash that is 10 by 15 centimeters) and PRURITUS (Itching) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, GLIPIZIDE, PRAVASTATIN, GABAPENTIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MULTI VITAMIN & MINERAL for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH (rash that is 10 by 15 centimeters) and PRURITUS (Itching). On 13-Feb-2021, RASH (rash that is 10 by 15 centimeters) and PRURITUS (Itching) 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.   Treatment details included topical Benadryl cream.
Exactly 2 weeks after receiving my Moderna booster shot, I started experiencing dermatographia. I have been experiencing this for over a week now.
Information has been received from a practice manager concerning a 74 year old male who on an unspecified date was inadvertently vaccinated with VARIVAX (Merck) (lot number not provided). Follow-up information received from the nurse who stated that the patient was given VARIVAX (Merck) (lot number not provided) instead of ZOSTAVAX (Merck). This was a case of the wrong product was grabbed by mistake. The nurse explained that they did not usually have VARIVAX (Merck), and the nurse grabbed it by mistake. It was not a case of product confusion. This is one of the several reports received from the same source. Additional information is not expected.
Shot was very painful. Has been in pain since she had it. Shooting pain at times esp at nite. Has been to the doctor. Said it irritated the nerves & will take a while to heal - pain.
flu; Initial information received on 26-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/ non-health care professional.  This case involved a patient of unknown age who had a flu (influenza), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient who experienced a flu (influenza), (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
This spontaneous report as received from a 62 year old male patient reporting on himself. On 09-SEP-2014 the patient was vaccinated with 1 single shot of ZOSTAVAX, subcutaneous (dose, lot number and expiration date not reported). On 09-SEP-2014, over the span of 2-4 hours after receiving ZOSTAVAX, the patient experienced injection site swelling, redness, and warmth on his left arm that were becoming more and more apparent. No treatment was given for the adverse events. The patient did not seek medical attention and none lab test was performed. At the tine of the report the outcome of the events was reported as not recovered. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL that was improperly stored. Concomitant medications were not reported. The nurse reported that an improperly stored GARDASIL most likely had been administered. The GARDASIL reached a temperature as low as 30 Fahrenheit (F) for an unspecified amount of hours. The nurse stated that she thought that the proper storage range for GARDASIL was 35 F to 46 F because she reports that they have always been considered in range at her office. No adverse effects were reported. The outcome of the events was unknown. Follow-up information as received from a Licensed Practical Nurse refers to 14 year old patient. On 11-JUN-2014, the patient was vaccinated with a dose of GARDASIL (lot# J009788, expiration date 17-MAR-2016) that was improperly stored. This case is linked to 1406USA009397, 1406USA009396, 1406USA009398, 1406USA009399 and 1406USA009282. Additional information has been requested.
Patient brought to ED with O2 sat 74%.  Patient admitted to hospital with Covid pneumonia.
Arms hurts; "I" m starting to feel as if "Im getting a cold; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Feb2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, contrast media allergy (allergy to contrast dye), food allergy (feed) and allergy to animal (hyena). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient took other medication in two weeks (Reg meds). The patient reported that he was fine until that day, 02Mar2021. On 02Mar2021, the patients arm hurts and the patient started to feel as if he was getting a cold. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm hurts and "I' m starting to feel as if I'm" getting a cold was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Blurry vision; Light sensitivity; Fast heartrate; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), PHOTOPHOBIA (Light sensitivity) and TACHYCARDIA (Fast heartrate) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NAPROXEN SODIUM (ALEVE) and MINERALS NOS, VITAMINS NOS (ONE A DAY [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurry vision), PHOTOPHOBIA (Light sensitivity) and TACHYCARDIA (Fast heartrate). At the time of the report, VISION BLURRED (Blurry vision), PHOTOPHOBIA (Light sensitivity) and TACHYCARDIA (Fast heartrate) outcome was unknown.            After the second dose the patient experienced these events. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-046322 (Patient Link).
shortness of breath; chest hurts when I breathe; This is a spontaneous report from a contactable consumer (patient).  This 66-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9269), via an unspecified route of administration in the left arm, on 02Feb2021 11:45 (at the age of 66-year-old) at single dose for COVID-19 immunisation.  Relevant medical history included rheumatoid arthritis (RA). Relevant concomitant medications included herbal supplements.  No other vaccine was received in four weeks. On 07Feb2021 12:00, the patient stated 'chest hurts when I breathe, and she had shortness of breath. No treatments were given. Pre-vaccination and post-vaccination COVID tests were not performed. The patient had not recovered from the events.  Follow-up attempts are completed. No further information is expected.
Patient felt dizzy, apple juice & crackers provided. Laid pt. down but continued to have dizziness as stated by patient. Pt. appeared lethargic. Mom stated she was taking her to grandma's to eat, then sleep. Walked out with mom.
12 hours later he felt nauseated and which he still is as of today. Then last night he threw up and felt shaky today.  He is sipping on powerade. Not eating much.  Drinks beer still.
Information has been received from a pharmacist concerning a female who on 14-JUL-2008 was vaccinated with GARASIL. The patient fainted 45 after receiving HPV vaccine. The patient was referred to the ER of a hospital. Additional information has been requested.
Headache that has persisted for one week so far.  Fatigue, slow-moving.  Sometimes I feel underwater like I've taken Benadryl, which I haven't.
blood clots; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 73 year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, administration date Jul2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (death) with onset 19Jan2022, outcome "fatal", described as "blood clots". The event "blood clots" was evaluated at the emergency room visit. The patient date of death was 20Jan2022. The reported cause of death was thrombosis. It was not reported if an autopsy was performed. Clinical course: The caller states she is not sure if the product is the Pfizer Covid vaccine. She stated evidently, they think it was the Covid 19 vaccine that caused his death. She further reported that the patient went to the Emergency Room on 19Jan2022 and had blood clots, that he was eventually put on a breathing machine, that the patient had a horrible reaction to the Covid vaccine last Jul2021 and his health had been declining ever since.   The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.; Reported Cause(s) of Death: Blood clot
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 51 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: "Ankylosing spondylitis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: Mar2011. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment,; Positive, notes: COVID rebound. Therapeutic measures were taken as a result of covid-19.  Clinical course: Antiviral treatment included Paxlovid from 21Sep2022 to 26Sep2022 for treatment of Covid-19. No known allergies were reported.
Nurse ordered and charted Moderna Bivalent vaccine, but administered Moderna Monovalnt but should have been given Moderna Bivalent.
Menstruation cycle started the day of the shot, 2 days early, and lasted 7 days instead of the usual 5. On day 8 I had no bleeding but bled again on day 9.  Next menstruation cycle was also early, and longer and heavier than normal.
Pt states that she received the injection, her arms went numb and was lightheaded.  She sat around for 30 minutes then went home.  The next day she got sick for 1 week.  The numbness is in both of her arms and radiates across to her back.  This is still currently going on.  Pt is going to make an appt with her doctor.
Adverse event - began about 6hrs after vaccination and lasted for 24 hrs; extreme fatigue; body aches, started mild then worsened; fever (100.6); headache; very very sore arm at injection site (right arm unable to bear weight or lift  more than a few inches) Pregnancy history: 34 weeks pregnant at time of vaccination; estimated date of delivery: 10/21/21; had several painful contractions during this time but no known complications to pregnancy due to adverse event; birth weight: n/a, have not delivered yet.
Developed body aches, fever and malaise at approximately 12 hours after vaccination that lasted until 36 hours post vaccination
sore arm (3 days), body aches (3 days), fatigue (3 days), vomiting (day 3, twice)
Dizziness; Hot flashes; Diarrhea; This is a spontaneous report received from a consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH6208), via an unspecified route administration in the left arm on 19Mar2021 at 10:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. Concomitant medication included TYLENOL for an unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 10:30, the patient experienced dizziness, hot flashes and diarrhea (after two hours of vaccine administration and lasted for several hours). The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events dizziness, hot flashes and diarrhea was resolved on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information was expected.
Mom reports, that after receiving #1 HAV and flu shot patient was acting - disoriented and bumped into things - unable to see.
This spontaneous report was received from a Registered Nurse and refers to multiple unspecified patients of unknown age and gender. Patients' concurrent conditions, medical history and concomitant medications were unknown. It was reported that doses of VAQTA Lot # L042039, expiry date 14-JAN-2017; lot # L030442, expiry date 19-DEC-2016 (dose and route were not reported) that had been exposed to 34.4 F for 2 hours and then back in the range, were given to unspecified patients on an unspecified dates. It was also confirmed that the vaccine had no previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Lot number L042039 has been verified to be a valid lot number for VAQTA. Additional information has been requested.
She thinks she had Covid a couple of weeks.; She thinks she had Covid a couple of weeks.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0168), in arm and on 01Jul2021 as dose 2, single (Lot number: WM5350) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Stress" (unspecified if ongoing), notes: is a stressor and is horrible.; "She is old and has to get her glasses" (unspecified if ongoing), notes: She is old and has to get her glasses; "Surgery" (unspecified if ongoing), notes: she had surgery. There were no concomitant medications. Vaccination history included: Flu shots (Caller said did not hurt and did not feel like anything and the flu shots hurt worse and she won't get the flu shot anymore.), for Immunization, reaction(s): "hurt". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "She thinks she had Covid a couple of weeks.". Clinical course: He has a caller on the line and she mentioned she got her first and second Pfizer Covid-19 vaccine and got really sick and she was so upset about it and wanted to get the legal department because she lost her job and wants to be paid the month for medical bills and sick for a year and 2 months and now and she can barely move and her whole body was falling apart. She mentioned she could barely walk and wanted to speak to someone to address this concern right away and wanted to speak to someone that was not going to hang up. The caller confirmed the details provided by the transfer agent. Caller said she has never been right and Pfizer saved a lot of lives and she was telling coworker that she does not have HIV and no diabetes and no heart disease and she got sick after the second shot and go to work from her desk to the program in (place name withheld) in the and she has not been right since then on 01Jul2021. She said she thought she had Covid a couple of weeks ago and no friends to give her a home test.; Sender's Comments: Based on the available information in the case, the causal association between the events 'Drug ineffective', 'Suspected COVID-19' and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202201182036 similar report from same reporter.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 18-OCT-2010, the patient was vaccinated VARIVAX dose1, lot # 666851/0280Z, expiry date 12-FEB-2012 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Within 2 hrs. after I had the shot, I had tingling on my left side.  I thought it would go away.  I went to the hospital the next morning & the MRI showed I had a stroke.  12/26/2008 MR received for DOS 11/15-16/2008 with D/C DX: Partially reversible ischemic neurologic deficit.  Esophageal reflux.  Iron deficiency anemia.  Hyperlipidemia. Pt presented to ER with c/o numbness and tingling on the L side of body which began several hours after receiving flu shot.  Neuro exam (+) for L sided paresthesia of arm, leg, face. Started on Plavix and ASA to be f/u as outpt.  02/01/2010 Follow-up: I have neuropathy (numbness) in the left hand and foot. Also some weakness in left arm and sometimes a fuzzy slight numbness in left chest area. The neuropathy causes me pain. Also I have loud ringing in my ears constantly.