chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have not stopped menstrual bleeding. It started roughly one week (give or take) after my second dose. However, I did notice a change in my menstrual cycle after the first dose, however, the nonstop bleeding only occurred after the second dose.
A female patient with no current illness had received an intramuscular dose of Adacel, lot number C2457AA, in the left deltoid muscle, on 14/Jun/2006.  It was not reported whether the injection was administered in the right or left deltoid.  Three days post-vaccination, the patient did not seek medical attention, and no relevant diagnostic tests/laboratory data were performed.  It was reported that the patient had previously received a Tetanus Diphtheria vaccination over two years ago, but less than five years ago.  No adverse events were reported with that vaccination.  The recovery status of the patient was reported as recovered. The reporter for this case is the same as for case number reported through case number reported.
Day after vaccine: chills so hard I had charlie horses; bones ached; nauseous and diarrhea In May, Telemed visits to Dr.  sneezing, sore throat followed by coughing.  wheezing, tightness of chest, shortness of breath, tired, nauseous.  All COVID tests came back negative.  Blood test - no antibodies, no COVID,   Seeing a heart Dr. for continued shortness of breath and pressure on my chest.  Had stress test and echo test.
Diarrhea Reports 6x/day watery bowel movements since the morning after vaccination. 6 days so far. Narrative:
Pfizer-BioNTech Bivalent COVID-19 Vaccine EUA: case resulting in invalid dose given Patient has previously received Pfizer BioNTech Vaccines on 1/16/2021, 2/8/2021, 1/4/2022, Moderna Vaccine on 5/25/2022. Patient received Pfizer-BioNTech Bivalent vaccine on 1/16/2023 at 11:20AM. Pt inadvertently received vaccine drawn on 01/14/2023. Error was found while documenting DDC on 1/16/2023. No harm came to patient. Patient has been contacted, is doing well, and will return for revaccination per Pfizer and CDC recommendations.
Cellulitis (redness and swelling) of left upper arm. Parent took patient to ER dx w/ cellulitis (WBC count 10,000) afebrile. Patient received IV ROCEPHIN and put on oral AUGMENTIN.
Shingles; This is a spontaneous report from a contactable consumer.  A 74-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in the right arm, on 23Jan2021 (Batch/Lot Number: EN9581; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunization.  Medical history included rosacea, rash and CLL (chronic lymphocytic leukaemia); patient has history of CLL (leukemia) in remission for 6 years. Concomitant medications included hydroxychloroquine taken for rash, start and stop date were not reported; and doxycycline taken for rosacea, start and stop date were not reported.  The patient experienced shingles (herpes zoster) (non-serious) on 13Feb2021. The patient underwent unspecified lab tests and procedures which patient did earlier in Jan and stated that "all of it was fine".  The outcome of event was unknown. Therapeutic measures were taken as a result of shingles included Valtrex.  No follow-up attempts are possible. No further information is expected.
At 2:00 pm, client and her daughter had complaints of being vaccinated twice. RN placed clean needle into patient?s right arm and noted that it was an empty syringe. RN noted that plunger was up to the hub of syringe when she placed needle in arm. She removed needle from arm and explained to client that it was a clean needle with an empty syringe. RN proceeded to place needle with empty syringe in the sharps container and got a syringe with the full, correct dose of Pfizer inside and administered that. No air was injected into arm. Client had no complaints at this time. Client completed her 15-minute observation period with no complaints and was in no acute distress. She left vaccination facility in stable condition. At 2:00 pm, client and her daughter came back to vaccination facility with complaint explained above.
This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart Palpitations), DIZZINESS (Feel dizzy), DYSPNOEA (Difficulty Breathing), CONFUSIONAL STATE (COVID fog and gets confused) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not multi-task) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cancer (History of cancer reported twice.) and Sickness (Dizziness, Shortness of breath, Bronchitis) in December 2019. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-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 PALPITATIONS (Heart Palpitations), DIZZINESS (Feel dizzy), DYSPNOEA (Difficulty Breathing), CONFUSIONAL STATE (COVID fog and gets confused), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not multi-task) and POST-ACUTE COVID-19 SYNDROME (Post COVID symptoms). At the time of the report, PALPITATIONS (Heart Palpitations) and POST-ACUTE COVID-19 SYNDROME (Post COVID symptoms) outcome was unknown and DIZZINESS (Feel dizzy), DYSPNOEA (Difficulty Breathing), CONFUSIONAL STATE (COVID fog and gets confused) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not multi-task) had not resolved. No relevant concomitant medications were reported. Treatment prescribed included IM antibiotics and inhaler for shortness of breath. Action taken with mRNA-1273 in response to the events was not applicable.
A few minutes after patient was administered vaccine patient fainted. Paramedics called and patient rested until paramedics arrived. Paramedics checked vitals, all within normal limits. Hopsital ride offered but declined.
red circle on upper left arm that has a welt like appearance - hot to the touch and itchy per patient
sudden pain in my Jaw; the left side of my face is not equal to the right side of my face; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender started to receive BNT162B2 (lot number: EK3730), via an unspecified route of administration on 17Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Dec2020, the patient experienced a sudden pain in her/his jaw and now the left side of her/his face is not equal to the right side of his/her face. Stated, "I am getting ready to go into the ER and I have a work-up done but I want you to know if you all as well". The outcome of the event was unknown.
Patient received both doses of Moderna Vaccination, last dose on 1/26/2021, first dose on 1/2/2021. She experienced Flu like symptoms, fever, fatigue, generalized body aches within 24-36 hours post vaccination. Then, resolved. However, patient noticed being "more tired" about a month ago (event reported 4/3/21). She became more aware of fatigue & tiredness, overwhelming low energy within the last several weeks, more so now that she had to call in sick last week. Also, experiencing cold feet & Headaches. She has seen her PCP several weeks ago & found to be hypotensive with lowest known BP of 75/55. Now referred to GI/Gen Medicine MD who is providing medical care as well.
Redness/Swelling and hot at injectionsite; Redness/Swelling and hot at injectionsite; Hot at injection site; This is a spontaneous report from a contactable consumer. A 77-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 12Apr2021 at 10:00 (at the age of 76-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. 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 COVID vaccine. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 76-years-old), as a single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced redness/swelling and hot at injection site. 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 events. The clinical outcome of the events redness/swelling and hot at injection site were resolving at the time of reporting.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Tachycardia, Dizziness Referral to Specialist Patient reported feeling dizzy. Vitals - ranged from 167-184/77-96, pulse ox 99. Pulse 68-74. RN Provided water, ice to nape of neck, raised feet while in a sitting position. No hx of cardiac episodes prior. Family Hx of cardiac events. Stabilized and permitted to leave facility. Advised to follow up with PCP to report vaccine reaction
This spontaneous prospective pregnancy report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II, 0.5 ml, one dose while 3.5 weeks pregnant. The LMP and EDD was not known. The pregnancy outcome was unknown. No further information is available. The outcome of vaccine exposure during pregnancy was unknown. Causality for the event was not provided by the reporter. Additional information has been requested.
24 hours following vaccine arm very sore and red.  Beginning  24 hours later arm continued to swell to size of tangerine, very red, hot to touch. Unable to sleep or lay on side. No lymph node swelling. Unable to use. arm.  Took Tylenol first day only.  Took Ibuprofen for arthritis but not for arm.  Did find some relief from the over the counter meds.  Seen by private doctor who diagnosed cellulitis.   Told to take second dose but in different arm.
right arm muscle pain from hours after shot to present time, ache, pain when using arm for any activity from injection site to elbow. chronic  nearly constant if using, leaning or raising arm. A.ppears to be permanent, not worse
Shingles; This case was reported by a consumer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional information was reported as follows: The age at vaccination was not reported. Reporter stated that, her husband and she got only one shot of Shingles, reporter's husband no adverse effect, but the reporter had a case of it for a week.
Headache, mialgia, low fever, body ache, neck ache, nausea,
soreness at injection site of the arm; swelling at injection site of the arm; Redness; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching), MYALGIA (soreness at injection site of the arm), INJECTION SITE SWELLING (swelling at injection site of the arm) and INJECTION SITE ERYTHEMA (Redness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching), MYALGIA (soreness at injection site of the arm), INJECTION SITE SWELLING (swelling at injection site of the arm) and INJECTION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE PRURITUS (Itching), MYALGIA (soreness at injection site of the arm), INJECTION SITE SWELLING (swelling at injection site of the arm) and INJECTION SITE ERYTHEMA (Redness) had not resolved.            Treatment details included Benadryl Cream, Ice pack. Action taken with mRNA-1273 in response to the events was not reported.
Fever up to 104.0, generalized rash, vomiting and diarrhea, red eyes. Diagnosed with Kawasaki Disease.
expired Sep 2nd 2022, administered to patient Sep 8th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2AJ32, expiry date 2nd September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 8th September 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 8-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Pediarix, which led to expired vaccine used.
After about 1 minute after the vaccine was administered, he began to feel light-headed and then patient lost consciousness and experienced convulsions for less than a minute. He was guided to the floor and regained consciousness in about 20 seconds after convulsions ceased. EMS was called and then he was taken out of the store. He was given fluids by EMS and taken to the hospital to rule out a seizure and returned back to the store later that day recovered from event.
Severe pain at injection site, severe body aches, fever and chills, nausea and vomiting,  headaches,  tiredness (exhaustion).
After receiving the second dose of the Pfizer COVID vaccine, I had severe flu symptoms (chills, nausea, body aches, cold sweats, migraine, fatigue) starting about 7 hours after the injection and lasting for approximately 20 hours.  The evet that I was primarily concerned about was that, about a week after the vaccine, I started my menstrual cycle and got a period. My IUD has prevented me from having a period for 2.5 years, and so it was alarming to get one suddenly out of nowhere. While this was obviously not a life threatening event by any means, I wanted to report because of how unusual it was so that if other women are having this experience (or any changes in their menstrual cycle) there will be appropriate documentation to list it as a side effect, and help alleviate anxiety by informing women this is a possibility following being vaccinated.
hives on face- skin peeling difficulty breathing- leaching out.  Flu like feeling, dizzy, headache, diarrhea, throwing up.
Pt developed big red rash around the vaccination site. Went to dr. Dr has give naproxen 500 mg 1 PO BID #10 and cephalexin 500 mg 1 PO Q8H x 7F #21.
Numbness of face, lips, tongue on left side of face. Symptoms consistent with Bell's Palsy.  10/26/09:  Emergency Room records received for date of service 10/14/09.  DX:  Bell's Palsy.   Assessment:  Presented to the ER with Left side facial drooping and numbness, unable to close left eye completely, noticed liquid dribbling from left side of mouth.  Treated with prednisone and acyclovir.  Discharged to home.
Day after shot my lymph node under my left arm became swollen. Injection site became swollen, red, and very hot to touch.
did not get their second dose in time,administered greater than 42 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get their second dose in time,administered greater than 42 days) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get their second dose in time,administered greater than 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get their second dose in time,administered greater than 42 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.
Starting about 2 A.M.- chills, upset stomach. Then later in the day body aches and headache.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jun 18, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced electric shock sensation (electrical impulse felt on left leg; wrapped all the way around the left leg) and myalgia (left calf muscle pain sort of went away, then went to right leg with same sensation), onset 2021, with outcome of unknown. Additional information: Patient had side effects from getting the first dose of the Pfizer COVID-19 vaccine Jun 18, 2021. Patient also experienced "other symptoms." No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
The 38 yo received his primary SMPX on 1/26/06.  Two days later her reported increasing left arm site tenderness, pain, erythema, purulent discharge, and lymphadenopathy. He described "red streaks" coming from smpx site and was dx/tx for cellulitis at Acute care clinic. His tx included 1gm IV ancef then 14 days Diclox 500mg QID. He was given Ibuprofen for pain w/relief. He denied pain/swelling, erythema past his elbow or over the shoulder, no fever, chills, chest pain or breathing difficulty. As of this interview 2/15/06 his symptoms have resolved and he remains in good health completing antibiotic regime.  He will be receiving other Vaccinations today for deployment.
Patient experienced syncope about 5 minutes after the vaccine.  She was also sweaty.  Patient sat down and drank some Gatorade.  Syncope subsided and she was able to walk out of the pharmacy about 15-20 minutes.
Pain, red, hot, felt flu-ish (achey, headache) lasting 4 days.
Client received a Tdap Adacel immunization on 091606. Client called health department on 042007 stating that she has had severe pain in left arm since receiving the immunization. Sometimes it keeps her up at night. Hurts when she rolls over on that arm. Still has achey feeling in that area.
Severe headache, pain at injection site, fever from 103.5 to 101.5 (the entire next day), painful body, aches and pains.
Subsequent to receiving varicella virus vaccine live the pt developed a case of breakthrough chickenpox with 50 - 70 lesions on her trunk and back. Pt was treated with Atarax, Eucerin and Aveeno.
Developed severe swelling in the axillary lymph nodes in the right armpit. Swelling measures roughly 5 inches by 4 inches. The area is tender to the touch.
Pt reports she has a history of herpes and gets occasional outbreaks. Pt states she developed hives last night on right upper arm that resolved itself without intervention prior to going to bed. Pt states she thinks she is having a combination hives/herpes outbreak on arm. Pt noticed another outbreak on right arm in same spot as outbreak last night, shortly after receiving vaccine. Redness and raised bumps are localized to right upper medial arm. No spreading/worsening of symptoms while in medical observation. Pt reports itching at site, but refuses benadryl (spouse at bedside and available to drive). Pt reports she will use hydrocortisone cream at home. No s/s of distress noted. VSS. Pt escorted to exit with staff and spouse. VS are as follows: 1421: BP 159/89, HR 54, RR 17, O2 sat 97% on RA
Report received from RN who is also the patient on 23-Oct-2008.  An adult female (BLH) received AFLURIA on 22-Oct-2008 (the patient was unsure if dose was from pre-filled syringe or vial).  The patient experienced chest tightness, swelling or throat, and ears clogging 2 hours post-vaccination.  She took 25 mg BENADRYL and felt better 30 minutes later.  She went to the ER and received a SOLU-MEDROL shot and received prescription for PREDNISONE 20 mg twice daily for 5 days.  The patient reported she feels much better today (23-Oct-2008) and her symptoms are basically gone.  Patient reports history of allergy to penicillin and THIMERISOL.  Awaiting further information.  No serious criteria mentioned.  Causality: Possible.  Follow-up information received on 24-Oct-2008 from an RN (not the patient who is also a RN).  RN confirmed that this 54 year-old female received a single dose syringe of AFLURIA IM to the left arm on 22-Oct-2008 at 8:00am.  Lot administered: 01149111A.  At 11:00am on 22-Oct-2008, patient experienced chest discomfort and her voice became hoarse.  She has no prior allergic reactions to flu shots or allergies to the preservatives for the vaccine.  She was evaluated and treated in the emergency department.  Her EKG was normal (date/time not provided).  Patient took 25 mg PO BENADRYL for 5 days, SOLUMEDROL IM, and PREDNISONE PO.  Per the RN, patient has fully recovered.  It is not known if patient received any other vaccinations within 4 weeks prior to receiving AFLURIA.  No further information is expected.  No change in assessment.  Information derived from this AE report does not change the current safety profile of the product.
Headache; Fever; Chills; Pain on injection side; Injection side swollen,; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 22May2021 at 12:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration on 01May2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient received any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021 at 18:30, the patient experienced headache, fever, chills, pain on injection side and swollen, joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of headache, fever, chills, pain on injection side and swollen, joint pain were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.