chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The symptoms were mild. On August 13th COVID-19 home test negative; Aug 14th positive. I had a low grade fever for a few hours; congestion and fatigue. At the Urgent Care they prescribed Paxlovid for 5 days. My daughter was visiting and she originally came down with COVID-19 and the my husband and I had it. I tested negative on Aug 22
Information has been received from a nurse concerning a 17 year old female who on 20-JUL-2007 was vaccinated with GARDASIL (lot # unknown). Concomitant therapy included MENACTRA. On 20-JUL-2007 the patient fainted after receiving Gardasil for 3 to 5 minutes and came too and fainted again. Medical attention was sought. No additional information was provided. At the time of reporting the patient recovered. This is one of two reports from the same source. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 8/14/2007. On 16-AUG-2007 follow-up information was received from a nurse. The nurse reported that the patient did not have breakfast and had a medical history of reactive airway disease. The patient had experienced anxiety about the vaccinations that morning resulting in her need to use albuterol (2 puffs). The nurse felt that the patient's syncope reaction was caused by the pain from receiving 2 vaccinations. The patient was monitored for an hour and a half following the reaction and has recovered. The mother of the patient was contacted the following day and it was confirmed that the patient was recovered. This is one of two reports from the same source. Additional information has been requested.
irregular heart rhythm was first diagnosed by ECG in Doctors office 8/19/2021 - low BP, high Pulse has been happening on and off and was first noted the first week of June 2021 - before that I had felt strange but just put it off to being overly tired because of some remodeling work I was doing in the house starting 1st week of March. Looking back it was the same time frame that I received the Covid vaccine, 1st shot 2/17/21, 2nd shot 3/10/21. Who knows?
12 month old patient arrived accompanied by his mother who gave permission for her son to received 2nd dose of (PEDS) Moderna. Although child was properly position, and securely held by his mother, he was able to jerk his left, his flexed muscle ejected the needle before complete dose could be administered. Nurse confirmed that approximately .10 ml, still remained in the needle, discarded needle into safety hazard bin, and reported the event to the Lead Nurse.   Lead Nurse and Management discussed the matter with mother, who chose to go home.
Patient reported having fever, prolonged chills, kidney pain that was significant enough that her chronic pain meds did not cover it. Ongoing pain 12 days after first dose. Patient consulted pcp and pcp told her it was a reaction to the vaccination. Her and her pcp are still determining if she will get the second dose.
Pt recvd vax DTP/HIB 24JUL91; w/in 3 hrs got cold, looked blue then devel temp 104 AX; told to receive DT only;
6 hours after vaccine developed HA/Migraine, diarrhea loss of appetite, 24 hours later still has HA/Migraine
Hospitalized for altered mentation and generalized weakness felt to be persistent positive COVID PCR from positive test in August 2021.
Patient was administered a beyond use date moderna vaccine. The beyond use date of the Moderna was 2/6/2023. The vaccine was administered on 2/9/2023. Patient has been notified of the issue.  No adverse reaction.
Within 6 hrs patient's muscles became really tight. At 12 hrs. her eyes started to become unfocused. At 24 hrs. she was almost catatonic. 48 hrs. she was admitted to the ER by a neurologist. At that point patient stopped eating and was given an NG tube. She received an EEG, MRI and 2 different swallow studies with all of them coming back normal.
11 days post-vaccine (on the morning of 2/22), I woke to find that the area surrounding the injection site in my left arm was a little bit red and sore.  By the end of the day, the soreness in my arm radiated up into the left side of my neck.  I applied a heating pad, took a warm bath and went to bed early.  This morning, my neck is a little better but the arm is more sore and the red area has gotten larger and is swollen.  The pain med-to-mild and does not restrict range of motion or use of my arm.  No distinct pattern or broken skin.
tested positive on 08Apr2022; tested positive on 08Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 12:00 as dose 1, single (Lot number: EN6199), in left arm, on 26Mar2021 at 12:00 as dose 2, single (Lot number: ER8732), in left arm and on 10Dec2021 at 13:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "interstitial cystitis" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE HCL.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Apr2022, outcome "unknown" and all described as "tested positive on 08Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Positive, notes: having tested positive on 08Apr2022; (19Apr2022) Negative, notes: testing negative eleven days after my first positive test; (27Apr2022) Positive, notes: I tested positive again for Covid on 27Apr2022. Therapeutic measures were taken as a result of covid-19. Clinical course: Anti-viral details: product: Covid 19 Treatment, treatment start date was 08Apr2022 and treatment stop date was 13Apr2022; indication included treatment of Covid 19. Other medication in 2weeks included Amitriptyline HCL 25 mg. The patient had no known allergies. Adverse event: The patient tested positive again for Covid on 27Apr2022, after having tested positive on 08Apr2022, and taking a full dose treatment of Paxlovid, and testing negative eleven days after my first positive test. The patient do not have Covid symptoms now, but the patient tested because her husband also had Covid return a few days ago (he had symptoms again) after taking a full dose of Paxlovid and recovering from Covid. The patient read on the news that in "rare" cases this has happened. It is interesting that it happened to both to her husband and herself. They got original Covid cases about three or four days apart. Adverse event start date: 27Apr2022, start time 01:00 PM. No ae treatment ae.
Hives about 3 hours after injection. Appeared on chest first then stomach and arms and neck
Patient passed out momentarily while sitting in patient waiting area following vaccine administration: slid out of chair. Father stated that patient had same reaction to HPV vaccine however did not report this on screening checklist or interview. Syncope episode approximately 30 seconds.
Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received BNT162B2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "Pain".  Additional information: The patient's husband reported that he and his wife (patient) received the 1st dose on 24Mar2021 at noon. The patient was experiencing pain until at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient received an additional dose of the bivalent booster after reporting she had not had it yet.  She reported no bad reaction.
Red, itchy and swollen around the vaccination site. This adverse symptom popped up one week and 2 days after the vaccine was given
Angioedema swelling of left upper eyelid, felt strange Narrative: employee health clinic- issued benadryl 25 mg times 2 - sent home- to follow up with pcp
dizziness; tingling around their mouth; skin feels like sunburnt with spots around their face and neck that sting and burn; arm has a dull ache between the elbow and the shoulder; a vision problem where off to the left of their sight they see a zigzag multicolored pattern quite large, about 1/3 of their eye sight in size; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (dizziness), PARAESTHESIA ORAL (tingling around their mouth), RASH ERYTHEMATOUS (skin feels like sunburnt with spots around their face and neck that sting and burn), PAIN (arm has a dull ache between the elbow and the shoulder) and CHROMATOPSIA (a vision problem where off to the left of their sight they see a zigzag multicolored pattern quite large, about 1/3 of their eye sight in size) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, MECLIZINE HCL, OXYCODONE, olmesartan medox hctz, ZOLPIDEM, PANTOPRAZOLE and CELECOXIB for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), PARAESTHESIA ORAL (tingling around their mouth), RASH ERYTHEMATOUS (skin feels like sunburnt with spots around their face and neck that sting and burn), PAIN (arm has a dull ache between the elbow and the shoulder) and CHROMATOPSIA (a vision problem where off to the left of their sight they see a zigzag multicolored pattern quite large, about 1/3 of their eye sight in size). At the time of the report, DIZZINESS (dizziness), PARAESTHESIA ORAL (tingling around their mouth), RASH ERYTHEMATOUS (skin feels like sunburnt with spots around their face and neck that sting and burn), PAIN (arm has a dull ache between the elbow and the shoulder) and CHROMATOPSIA (a vision problem where off to the left of their sight they see a zigzag multicolored pattern quite large, about 1/3 of their eye sight in size) outcome was unknown.        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 meclizine.   Reporter did not allow further contact
Client presented at vaccination site on 12.09.21. Client reported she received first dose Pfizer COVID vaccine on 04/23/21 (lot #: EW0161) & received second dose Pfizer COVID vaccine on 05/14/21 (lot #: EW0177) both at Pharmacy. Client reported with first dose Pfizer COVID vaccine (4/23/21), she had headache, chill, fever, muscle ache, tiredness, fatigue, weakness, nausea but no vomiting within 30 minutes while driving home from vaccination site. She reported with second dose Pfizer COVID vaccine (5/14/21), she had headache, chill, fever, muscle ache, tiredness, fatigue, weakness, nausea but no vomiting within one hour. She reported with both dose the symptoms lasted for two days without taking any medications. She reported she didn?t follow-up with her PCP. Client denied SOB or dizziness with both doses. Client told she had Leukemia at the end of 2017 & beginning of 2018. Client stated she is in remission with leukemia and taking daily 420 Mg ?Imbruvica.? She told she has history of anxiety and controlled with homeopathic medications. She stated she ate breakfast at 0730 today and eating crackers, juice, and water provided by PHN at EMT station while waiting for medical consult. At 1250, PHN took her vitals: BP 114/70, HR 73, O2 Sat. 98%. Client is requesting for booster dose of Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator, requesting to proceed with the booster dose of Pfizer COVID vaccine. Per the doctor, approval to proceed with the booster dose of Pfizer COVID vaccine was obtained from medical consult team via text message from clinical project coordinator. Client received the booster dose of Pfizer COVID vaccine, LOT#:  FF8841 on 12/09/21 at 1309 by a nurse. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1339 unassisted and with a steady gait.
Pt recvd hep B vax;1st 2 doses were Recombivax;3rd dose was Energix-B.Test results on 19JAN90 & 09AUG90 were weakly pos for HBSAB.Addt'l dose of Engerix-B given 13AUG90 & repeat test was pos for HBSAB.
had Shingrix and Covid vaccines and suddenly has Dementia; This case was reported by a consumer via call center representative and described the occurrence of dementia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included covid-19 vaccine for prophylaxis.   On an unknown date, the patient received Shingrix and covid-19 vaccine at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced dementia (serious criteria GSK medically significant). On an unknown date, the outcome of the dementia was not recovered/not resolved.   It was unknown if the reporter considered the dementia to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's friend. The patient had Shingrix and Covid vaccines and suddenly had dementia. It was unknown if the reporter considered the dementia to be related to covid-19 vaccine. The reporter had very few details. All information was not available. The reporter did not consent to follow-up.
This spontaneous report was received from a medical assistant referring to an unspecified number of male patients of unknown age. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored doses of PEDVAXHIB lot # N034410 with expiration date 01-FEB-2020, and lot # N007749 with expiration date 29-NOV-2019 (also reported as "29-NOV-2018"), for prophylaxis (route of administration was not reported). No adverse effect was reported. It was stated that the vaccine was exposed to a temperature between 47 to 77 Fahrenheit degrees for 2 hours and 30 minutes. No previous temperature excursion was reported. A digital data logger was involved.
24 hours after receiving the vaccine, patient states that her arm was very sore to the touch and to move. It was sore from her shoulder to her elbow. She also noticed a red rash from her shoulder to her elbow which lasted about 24 hours. She stated that after two days it was mostly gone, barely visible. She did not seek medical attention and says she is perfectly fine now.
I had a headache. I felt a little tired and run down. I also had abdominal pain, gas.
Hadn't had a cycle in 10 months (perimenopause) and had a heavy one day after first vaccine.  Was very dizzy after the first vaccine, went to urgent care and they said it was benign proximal positional vertigo and that it was ok to have another vaccine.  My lower legs felt tingly after the first vaccine.  In August 2021 had a second vaccine at the same Pharmacy, same arm.  Had another period two days later and it was heavy (didn't have another cycle since).  Got hives/rash after second vaccine that were symmetrical on my arms and legs.  Went to Dr. and he had no idea what they were from thought contact dermatitis.  Went to urgert care once when hives/rash were covering my entire legs and was given a steroid shot, oral sterorids and steroid cream-the hives/rash lasted over 4 months and I still get them -most recent was 12/17/2022.  Got shingles January 2022 on my right leg.  Have leg cramping still on my right leg makes it hard to get up after sitting and never had this prior as I am an avid runner.  Went to APRN for pelvic pressure and she said my uterus was inflammed and sent me to a different ARNP for pelic health and she said my ovaries were huge.  I can tell my lower stomach area now sticks out and I have a thin frame.  Nothing was done for my female organs being inflammed.  Went to two ERs for chest pain.  Was hospitalized at Hospital in April 2022 due to feeling like my heart my being clenched/chest pain.  Now have borderline high blood pressure and anxiety.
Kidney Pain, Liver pain, joint and muscle pain, increased skin sensitivity, out of breath, nausea all starting 12 hours passed injection time.
About 4-5 days after my second dose, I began having non stop chest pain that was just a dull ache.   On Monday morning 050321, I went to my regular physician who ran an EKG in the office which was abnormal and he sent me directly to the hospital.    They admitted me overnight for observation and did a stress test which showed no signs of a heart attack even though the chest discomfort continues.    I was sent home the next day and the chest pain went away about 5 days after it began.    Later that same week, I broke out in hives on both ARM that lasted about 2 additional weeks.
a 4 year old patient received an expired Ipol 3 weeks ago, no adverse event; Initial information was received on 08-Jun-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient's mother).  This case involves a four-years-old female patient who received a dose of expired IPV (VERO) [IPOL] 3 weeks ago (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) (lot number and expiry date not reported, multi dose vial) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  The patient received an expired IPV (VERO) [IPOL] 3 weeks ago. It was reported that it was just a regular Polio dose. The patient received other vaccines which were not specified.  At the time of report, no adverse event was reported.  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 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.  There will be no information available on lot number.
Heart aches and burning feeling around 2:00 am in the morning of 7/1 Passing out around 9:30am 7/1 Severe nerve tingling/paralysis to upper bilateral site, hands and fingers for 5 mins after passing out. Feeling of impending doom on 7/15 while driving to work around 8:30 am  Shortness of breath, difficulty walking up stairs, heaviness on the chest since then.
parents were concerned that pts hair loss was related to hep B vax; pts hair loss was initially noted in late FEB95; dx hair loss secondary to tricotillomania; pt recv vax 2MAR93 & 13JUN94 & 3MAR95- hair loss occurred a/3rd hep B vax given;
PATIENT REPORTED RASH ON CHEST AND AROUND NECK THAT ITCHES, NO OTHER SYMPTOMS.
In addition to the typical expected reaction to the Pfizer vaccine (fever, sore arm, etc.), I have been suffering from abnormal menstrual bleeding since the vaccination. I felt as though it was necessary to report because my doctors have no idea what is causing this, and nothing else could be affecting it. I have been bleeding for 2 weeks now (starting April 5), with clots around 5". I had a full CBC in January and found nothing abnormal that could explain this, including no history of extended bleeding (historical max of 7 days).
Case number PHEH2013US017910, is an initial spontaneous report received from a nurse on 21 Aug 2013. This report refers to a 22 years old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: X13012 and expiry date: 21 Aug 2013) at dose of 0.5 ml, intramuscularly on 21 Aug 2013. The MENVEO was frozen overnight and then administered. No adverse event was reported following this administration error.
Client reports pain and limited range of motion beginning the evening of vaccination and continuing to worsen over the next 10 days.  C/O chills and hot flashes for approx 2 days following vaccination, denies fever.  Client reported reaction to Health Department on 10/28 and was advised to try heat and cold intermittently and to return if pain doesn't resolve.  Client reports went to Urgent  Care 10/29/2019 and was treated with 5 days Prednisone, and advised likely moderate to severe reaction to injection or vaccine.  On 11/6/2018 client reported to HD that she improved with medication but pain and limited ROM returned when discontinued meds.  Client stated she returned to Urgent Care (same HCP) 11/5/19. see below  Client reports blood test ordered to R/O infection (negative result) and treatment with 12 days of Prednisone was given.  Client reports she is scheduled to have Ultrasound of her arm on 11/8/2019.  On 11/8, client reported to HD that she received notice that test for CRP (C reactive protein) is elevated from normal.  This shows there is inflammation. 11/14/2019 - Report from client that ultrasound of her arm is WNL.  States she has been referred back to PCP for discussion of any further testing.  States she is currently being weaned off prednisone and is noticing pain slightly increasing.
pt recvd vax;concomitant vax MMR & DTPH & PPD; 3 days later devel hives; tx w/ dph & resolved;
11/2/2022 my left arm hurt where I had the vaccine. It continued to hurt more and longer than previous shots. Lifting my arm was hard. Within a week to two weeks, my shoulder began to hurt. Then two weeks later my right shoulder hurt and all my joints were very painful. I had never experienced this before. I then went to the emergency room and was given prednisone which helped. After I finished the prednisone, it came back. I followed up with various doctors and was diagnosed with Polymyalgia Rheumatica with Giant Cell Arteritis.
Patient received first Covid vaccine around 2:30pm.  At 2:42 pm this nurse called out to patients vehicle who is c/o difficulty breathing.  Patient reports her mouth feels like 'cotton mouth and tongue feels numb'.  Patient appears to be very short of breath.  Blood pressure 158/72.  Pulse 78.  At this time, patient reports she is having difficulty breathing and her throat is itchy and feels like it is closing up.  Patients voice has changed.  2:45pm - called 911.  2:46pm - 0.5ml Epinephrine given IM left upper thigh.   Lot 339384 Exp 8/21.  2:48pm - Patient continues to present with shortness of breath and still c/o throat tightness.  Diphenhydramine 50mg given IM left deltoid.  Lot 6020400 Exp 9/21.  2:51 pm- Patient reports she is starting to feel better and having a little easier time breathing.  Fire dept with responders arrive.   2:57pm - Ambulance arrives and assesses patient.  Patient refuses to go to ER.  She reports she is feeling much better.  She is requesting for brother to be called so he can drive her home.  Brother called.  3:15 ambulance and fire dept left.  This nurse stayed with patient until brother arrived.  Patient left at 3:40pm in stable condition with brother driving patients vehicle.