chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 5-8 days after her shots I noticed that she was, what I thought to be daydreaming. After several more "episodes" of this, I realized that I could not get her attention during these "staring spells". She had at least one a day, that I noticed, between 8/19-8/29. We took her to her pediatrician on 8/30/2004 and she said that it sounds like she is having "petit mal seizures". We have kept track of them since then.  She is in school from 8:00am to 2:00pm so we have a hard time telling when or if they happen then.  08/31/04 5:45pm duration 5-10secs.  09/01/04 5:30pm, 6:30pm, 7:00pm, 7:45pm 6-10 seconds each. 09/02/04 3:30pm, 4:00pm 6-8 seconds each. 09/03/04 2:15pm, 3:30pm 20 seconds, 5:30pm, 6:00pm,7:00pm lasting up to 20 seconds. Took her to ER. Had a CT scan normal, blood test normal. 09/04/04 9:00am, 9:30am
During administration a vessel was hit and patient had immediate swelling at site and a hematoma formed and she returned with a rash and swelling at the site. I had her apply an ice pack for 10 minutes and looked at site the swelling had lessened but still bumpy rash and hematoma. Discussed with her if she felt any more symptoms to seek medical advice.
Low grade fever of 99.1 while taking Tylenol. Site of injection red at about 20cm and swollen the size of a baseball. Also blisters on side of tongue the length of .5cm. Pinpoint blisters on tongue and throat.
28OCT97 pt recv vax & 3 days later fever, aching;pt had to go to MD for medicine;pt c/o cold sx, chest congestion & coughing up greenish blood tinged mucous;dx bronchitis;
pt recvd vax; exp severe inject site rxn such as pain, swelling, redness;
12/6/99 at 6:00pm pt had a fever of 101, was very cranky and irritable. Pt had two diarrhea diapers before bedtime at 8:30 PM. On 12/7/99, diarrhea continued all day and pt had a temp of 99.1 at noon. Pt took a 4-5 hour nap. On 12/8/99 pt had spots all over body around 10:00. Mom called MD's office to schedule appointment for that afternoon. Pt had a fever but was cranky and irritable and still had diarrhea. MD discovered a bad ear infection in right ear. When questioning MD about spots all over the body, the MD stated it could be chicken pox, but felt that the vax given 9 day previous was not the cause of the spots all over body. Treatment given by MD was Augmentin, Antipyrine/Benyocaine. Mother feels the chicken pox vaccine administered to her daughter caused her to come down with spots all over her body because of the fact that she was not sick and did not have any of these symptoms before the vaccination and because of time period between the date of the vaccination and the date she became sick. Pt recovered from symptoms by 12/13/99.
a patient received a dose of FLUZONE which was stored at 0.7 Celsius for 25 hours and 24 minutes/ No AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from the other health care professional (medical assistant) via Medical Information (Reference number: 00444786).  This case involves a 4 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] that was stored at 0.7 Celsius for 25 hours and 24 minutes lot UJ452AB, Expiry date: 30-Jun-2021 via intramuscular route in unknown administration site on 12-Dec-2020 for prophylactic vaccination.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due to incorrect product storage (latency: same day).  Description: Call received from medical assistant (MA) reporting a temperature excursion of unknown cause. Caller reporting PENTACEL, IPOL, FLUZONE QUADRIVALENT Multi Dose Vials (MDVs) AND PREFILLED SYRINGES, MENACTRA, ADACEL and DAPTACEL at 0.7 Celsius for 25 hours and 24 minutes. Caller reported opened IPOL MDVs and opened Fluzone Quadrivalent MDVs. Caller reporting excursion occurring in December 2020. Caller reporting 11 doses of Fluzone Quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines.   At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperature and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 30-SEP-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Pt has a reddened circle area surrounding injection site that started within 24 hours of immunization.
Within 24hours pt with fever, myalgia, chills, rigors, weakness and extreme dizziness with headache and episode of syncope. Had waves of flushing in body with central abdominal pain and redness and pale extremities.  Abdominal pain "burning" recurrent for 6 days with diarrhea, nausea and vomiting and stools pale. In clinic 4/16/2021 pt appeared greenish/yellowish on day 6 and had weight loss from baseline 4lbs in 9 days when she was last seen.  Pt labs done and normal.  Night of 4/16/2021 started with palpitations racing heart. 4/17/2021 presented to ER for worsening palpitations with flushing and diaphoresis.  Labs CXR normal. send home. Anxiety like symptoms fluctuating. Was given diazepam.  4/21/2021 seen in clinic again feeling slightly better. Still with nausea and also now dysgeusia. EKG normal. palpitations better. 4/23/2021 seen on video appt doing better. able to keep food down but still tired and weak. no longer needing diazepam. Taste improving.
I had a runny nose, cough, headache, and a low-grade fever. I contacted my doctor and took a COVID-19, Flu, and Strep test. I tested negative for all of them. I was prescribed benzonatate for my cough. I also took elderberry syrup, SUDAFED, TYLENOL, and NYQUIL.
Leg swelling and refusal to bear weight immediately after vaccines, which progressed to worsening swelling on 3/31/17, and hive like rash. Seen in the pediatrician's office 4/1/17 and sent to ED for continued refusal to bear weight to obtain labs and XR (results are pending at this time).
Around noon the day following my vaccine I became very achey. I was very painful in my joints and am over my body. I felt very feverish and was uncomfortable all day. I was unable to get a temperature reading but my husband said he felt like I was burning up. Ibuprofen helped, but I ended up taking some night time flu medicine to be able to sleep. My symptoms went away over night. I felt better when waking up on the second day after the shot.
hemangiomas; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the parent.  A 26-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: HAEMANGIOMA (non-serious), outcome "unknown", described as "hemangiomas". The event "hemangiomas" was evaluated at the physician office visit.  Additional information: Caller states that her 26-year-old daughter is experiencing the same side effect and has only received 2 doses of the Pfizer COVID-19 vaccine. Her daughter has been seen by 3 doctors regarding this side effect. All of the providers say that this side effect is either not from the Pfizer COVID-19 vaccine or that it is harmless. Caller asks if it is likely that the same side effects experienced, hemangiomas, would occur again for her daughter if she were to receive a third dose of the Pfizer COVID-19 vaccine. Case assessed as non-serious by the reporter.  The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200411138 Same reporter/drug/event, different patient.
8 days after first dose on 1/7/21 around injection site was itchy, red and swollen up about size of palm of my hand. Symptoms started 12 hours after my 2nd dose which was on 2/4/21.  Symptoms were chills, fever was 101.8 (my normal is 97.3), head was very heavy, headache , body aches, I was mostly in bed for about 24 hours. Worse lasted 24 hours after they started but slowly decided over next 24 hrs. I did not take medicine or seek help.
Contact with and (suspected) exposure to covid-19 Acute upper respiratory infection Nausea
pt recv 2nd dose of vax & exp ill feeling, numbness in extremities & severe sensory effects;pt seen by neurologist;pt stated sibling devel chicken pox & devel neuro sx when ill;
dizziness; like nauseas to my stomach; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness ), NAUSEA (like nauseas to my stomach) and VACCINATION SITE PAIN (sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included ATORVASTATIN, VITAMIN B3 and FLUOXETINE for an unknown indication.   On 16-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 DIZZINESS (dizziness ), NAUSEA (like nauseas to my stomach) and VACCINATION SITE PAIN (sore arm). On 16-Feb-2021, DIZZINESS (dizziness ) and NAUSEA (like nauseas to my stomach) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information was not provided.
Swelling, redness and pain (R) upper arm since 15 Sep 2010 after anthrax vaccine & was seen on 17 Sep 2010.
Patient reported minor swelling in left arm and fatigue, flu-like symptoms beginning on day after vaccination.
Patient received one dose of Moderna's COVID-19 vaccine on 2/12/21. He had a rash at injection site with inflammation but no pruritis which migrated down his arm. On 3/2/21 (28 days later), he returned for his second dose. The arm was still slightly swollen with sloughing of skin at the tricep area. Pharmacist did not give second dose and advised patient to see his primary care physician.
Patient reported pain and swelling on right upper arm the day after the immunization. She said that swelling occurred almost within a couple of hours after the injection.
small bump under left arm (not near injection site); rash appeared on both legs on upper thighs, slight itch, blotchy, red; rash appeared on both legs on upper thighs, slight itch, blotchy, red; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EK9231; expiration date not provided), via an unspecified route of administration on 23Dec2020 16:00 at a single dose at left arm for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medication included desogestrel, ethinylestradiol (KARIVA) and fish oil. The patient previously took aspirin (E.C.) for gastro upset and experienced allergies. It was reported that rash appeared on both legs on upper thighs, slight itch, blotchy, red, no leg swelling or pain; no pus or discharge. On 11Jan2021, the patient had a small bump under left arm (not near injection site). The patient underwent lab tests and procedures which included SARS-COV-2 test (nasal swab) on 14Jan2021 which showed negative. The patient received hydrocortisone cream as treatment medication. The outcome of the event was recovering.
I am currently breastfeeding my 3 month old baby; Since receiving the vaccine, he has been much fussier than he normally is; This is a spontaneous report from a contactable nurse. This nurse reported information for both mother and baby. This is a baby report.   A 3-months-old male patient started to receive bnt162b2 transmammary. The 28-year-old mother received BNT162B2 (Lot Number: EK5730) dose number: 1 on Left arm at single dose on 20Dec2020 04:00PM for COVID-19 immunisation. The mother had hashimoto's and previously used Amoxicillin, had known allergies: Amoxicillin. Concomitant medication included levothyroxine sodium (SYNTHROID) and ibuprofen. The mother was currently breastfeeding my 3 month old baby, since receiving the vaccine, he had been much fussier than he normally was. This could be completely unrelated. The event onset data was provided as 21Dec2020. The events were reported as non-serious. The event outcome was unknown. No treatment received for the adverse event. Prior to vaccination, the mother was not diagnosed with COVID-19. Since the vaccination, the mother had no been tested for COVID-19.; Sender's Comments: Based on the temporal relationship and lack of an alternative etiology, the association between the reported events with BNt162b2 can not be completely excluded.,Linked Report(s) : US-PFIZER INC-2020511430 mother case
Mild testicular pain started one week after the Covid Vaccine and has lasted longer than a few days. Also experincing tightness and pain in the right side of the chest, as well as an oval-shaped red rash on both thighs.
Unable to sleep; Gas from both ends; Stomach cramps; Constipation; Her injection arm is sore; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9264), via an unspecified route of administration, administered in left arm on 11Feb2021 15:30 as single dose for COVID-19 immunisation (because of the pandemic and she is 75). Medical history included being diabetic. Concomitant medications included warfarin and varicella zoster vaccine taken for an unspecified indication, start and stop date were not reported. The patient previously had a flu shot back in Oct2020 and experienced sore at the injection site. The patient was unable to sleep last night due to stomach cramps and constipation. It has been horrible. Worst part was gas from both ends. The events began 9PM or a little earlier on 11Feb2021. The patient also reported that her injection arm was sore on Feb2021. This is the first time she has had a reaction like this and not been able to sleep. Asked if she should drink some lemon water, take a laxative, or what to do. Advised the patient to follow up with primary care physician for treatment recommendations. The patient underwent lab tests and procedures which included blood pressure: 124/78 and A1C: 5.9 on an unspecified date; international normalised ratio (INR): 424 on 08Feb2021. The outcome of the event her injection arm was sore was unknown and not recovered for the rest of the events.
Started feeling some extra fatigue in May and occasional headaches and also insomnia. I told I my doctor - I had a physical completed - I scheduled the physical for the symptoms I was experiencing. No treatment except she said if I needed melatonin I could take that. I started using the Olly Sleep Formula gummies with Melatonin - 3 mg per dose and it also has some herbs and amino acids. I take two which is one serving at night. Sometimes it helps with my insomnia and sometimes it doesn't.  I started noticing Chest stinging  - a sting which makes me pause - It started two days ago - it happened in the evening a couple of times and yesterday it happened more at night at 10 pm. It isn't a persistent thing - it goes away. My ring finger feels numb. I had to actually remove the ring. The two fingers next to the ring finger feel tingly and numb. The numbness is persistent but they are not totally numb. I feel it in the tips of my fingers that are next to my ring finger. My ring finger I felt it more in the base.  I haven't been able to speak with doctor about these things yet. I still have extra fatigue and the headaches I have on occasion still.
11/1/2020-11/7/2020 flashes of headache -  11/08 - 11/14/2020 lower back aches , head ache, fever, sweats, numbness/tingling torso hands feet. 11/15/2020 first noticed binocular vision.  diagnosed - 2/2/2021 and 3/14/2021 Dr  Bilateral 4th nerve palsies with peripheral neuraphy from post vaccine Guillian Barre Syndrome.  Small left hyperdeviation in right gaze and small right hyperdeviation in left gaze, V pattern esotropia, 15 degrees of excyclodeviation on Double Maddox Rod. Areflexic. Difficulty with tandem gait.  Symptoms stable -no further testing.
Body aches; Fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body aches) and PYREXIA (Fever) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 08-Apr-2021, the patient experienced PAIN (Body aches) and PYREXIA (Fever). At the time of the report, PAIN (Body aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
SHE STARTED HAVING BLISTERS IN HER ARM AND FOOT, THEY ITCH
patients received Expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported. Patient received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown dates the patient was administered GARDASIL (dose, route and lot number were not provided), at 0, 2 and 4 months on unspecified dates, in regard to the full series of GARDASIL. Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Heart pain (level 4 pain) lasting several hours, sporadic days. Hip pain (level 6 pain) stiffness and soreness - lasting several minutes after inactivity. Dissipates after a few minutes of activity. Returns throughout the day. Foot pain came with second dose having same frequency as hip pain. Difficult to walk on both feet until pain dissipates after a few minutes of walking. Exterior of left foot pain constant - level 2 pain, tender to touch. Heart pain increased in pain level (5-6) and frequency after 2nd dose. Occurs several times in a month.
had the booster shot and the test became positive; her husband tested positive; he doesn't feel good/ felt ill; had the booster shot and the test became positive; had the booster shot and the test became positive; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's wife) and from a Pfizer Sponsored Program. An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number BO130 EA or 8A), via an unspecified route of administration on 20Sep2021 as dose 3 (booster), single for covid-19 immunization. The patient medical history included blood pressure and prostrate. The patient was taking unspecified medications for his blood pressure and for his prostate. Concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL3249), via an unspecified route of administration on 09Jan2021 as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9252), via an unspecified route of administration on 04Feb2021 as dose 2, single for covid-19 immunization. The reporter stated that she had called for husband and herself. They both had received the Pfizer-BioNTech Covid19 Vaccine booster shot on Monday 20Sep2021 (extra dose administered). The patient had felt ill on Tuesday 21Sep2021 and stated that he had not felt good. The patient had only mild symptoms and still able to work and do house chores. The reporter queried if the vaccine or booster shot that they had got caused them to be positive with Covid19. The patient underwent lab tests and procedures which included blood test with unknown results on 21Sep2021 and on Thursday 23Sep2021, covid-19 virus test and the result was positive. The outcome of the events was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Patient reports she received TDAP on 2/25/20. Patient states the day after vaccine had rash on torso that spread to arm/face. Patient states did not improve on Sunday went to UC. Patient was given medrol injection, prednisone for 1 week. Patient states went to ER last night - with hives on face, swelling of face, numbing around cheeks/mouth. Patient states she was given medrol, was prescribed pepcid, prednisone 60 mg for 5 days.
Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No current or historical conditions were reported. Between late DEC-2014 and early JAN-2015, the patients were vaccinated with an improperly stored dose of GARDASIL (route, dose, Lot# and expiration date not reported). No adverse effects were reported. Additional information has been requested.
Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced COVID-19 (Covid). At the time of the report, COVID-19 (Covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No other relevant concomitant medication was reported.  No treatment information was reported.
Lightheadedness, dizziness, legs feeling heavy and tingly, chest pain (this started one day after receiving my dose), shortness of breath, back pain