chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STROKE; ELECTROLYTES BOTTOMED OUT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, within the first 3 weeks after vaccination the patient experienced stroke. On an unspecified date, three months later the patient experienced electrolytes bottomed out and three months after that, patient experienced seizure, that almost killed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, and electrolytes bottomed out was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221228686-stroke. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Agency Causality is considered indeterminate. The company causality is considered unassessable.
1/8/21 at 0830 sore arm 1/9/21 at 0200 chills 0800 fever, muscle aches, fatigue 1/10/21 at 1000 Fever resolved. Fatigue and muscle aches still noted
Patient with large pulmonary embolism. Associated thrombocytopenia. No provoking factor identified.
the pfizer covid vaccine I received a couple of years ago that is still making uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "the pfizer covid vaccine I received a couple of years ago that is still making uncomfortable".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pmr I. Remission for 4 years returned and also A heretic reaction landing me in the hospital; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 12:00 (Batch/Lot number: unknown) at the age of 86 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "PMR" (unspecified if ongoing), notes: other medical history: PMR; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. Concomitant medication(s) included: LEXAPRO; ZETIA; PRAVACHOL; PRESERVISION; VIT D; CALCIUM. Past drug history included: Macrolides, reaction(s): "Allergy: macrolides", notes: known allergies: macrolides. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 03Mar2021, when the patient was 85 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 03Feb2021, when the patient was 85 years old, for Covid-19 Immunization. The following information was reported: POLYMYALGIA RHEUMATICA (hospitalization) with onset 01Nov2021, outcome "recovering", described as "Pmr I. Remission for 4 years returned and also A heretic reaction landing me in the hospital". The patient was hospitalized for polymyalgia rheumatica (hospitalization duration: 3 day(s)). The event "pmr i. remission for 4 years returned and also a heretic reaction landing me in the hospital" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Feb2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of polymyalgia rheumatica. Clinical course: The patient did not receive any other vaccines within four weeks prior to the vaccination. Pmr I. Remission for 4 years returned and also a heretic reaction landing me in the hospital. Valtrex, cellcept received as treatment for the adverse event. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date was 09Mar2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient said she woke up the night she got the second does and felt she will faint. and for the last 2 weeks she has been getting dizzey several times each day.
body-wide rash; This non-serious case was reported by a physician via sales rep and described the occurrence of generalized rash in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). In OCT-2023, an unknown time after receiving Shingrix, the patient experienced generalized rash (Verbatim: body-wide rash). In OCT-2023, the outcome of the generalized rash was resolved (duration 6 days).   It was unknown if the reporter considered the generalized rash to be related to Shingrix.     It was unknown if the company considered the generalized rash to be related to Shingrix.   Additional Information: GSK Receipt Date - 31-OCT-2023 The reporter reported after Shingrix vaccination, the patient developed a non-painful, non-pruritic, body-wide rash that resolved after 6 days. Nothing else was reported.  The reporter consented to follow up
Her arm swelled and was red and hard at 2 days post administration. SHe went back to the pharmacy and they told her this was a typical reaction and use ice and Benadryl if needed.  she then went on to get, chills, body aches, swollen arm, nausea and the skin on her lips peeled off.
Menstruating since 3/2. Continuous bleeding and cramping. While I am used to heavy periods due to endo, they do not normally last more than 6-7 days.
Later on that evening I started feeling tired, chills, & fever. This lasted about 4 days on the 2nd or 3rd day I had a swollen lymph node under my left armpit. It lasted just a couple of days. On 3/21/2021 I missed my period I did not get it the month of march. Now on the month of April I first started spotting on April 7th it was very light then it went heavy till this day 4/13/2021 I'm still bleeding which is not normal because my period normally only lasts for 4 days. On 3/31/2021 I also had chest pain that lasted for 4 days then it started subsiding. On 3/12/2021 and on 04/11/2021 I got a weird abdominal pain that lasted for less than 5 minutes.
On 10/21/2018 patient was experiencing extreme pain in right arm from her right shoulder to right hand. She went to her PCP to have it evaluated. MD said it may be one of "the ingredients in the vaccine this year" because her has had a few patient with these symptoms. She had not eaten for >24 hours because of the pain so she later became lightheaded and nauseous. She went to the hospital where she had x-rays of arm and blood sugar was checked (was extremely low). Low BS was corrected and hospital told patient Calcium deposits may have been aggravated by the immunization.
Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effect reported
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 15:00 (Lot number: RC3180) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: Z-PAK. Vaccination history included: Bnt162b2 (product=COVID 19,  brand=Pfizer, lot number=FA7484, lot unknown=False, administration date=23Jul2021, administration time=03:00 PM, dose number=1), administration date: 23Jul2021, when the patient was 41 years old, for Covid-19 immunisation. The following information was reported: DYSPNOEA (non-serious) with onset 14Aug2021, outcome "recovering", described as "Shortness of Breath"; DYSPNOEA (non-serious) with onset 14Aug2021, outcome "recovering", described as "Unable to breath without coughing"; COUGH (non-serious) with onset 14Aug2021, outcome "recovering", described as "Cough"; PYREXIA (non-serious) with onset 14Aug2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 14Aug2021, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 14Aug2021, outcome "recovering", described as "Headache"; PAIN (non-serious) with onset 14Aug2021, outcome "recovering", described as "Body Aches"; FATIGUE (non-serious) with onset 14Aug2021, outcome "recovering", described as "Fatigue"; CHEST PAIN (non-serious) with onset 14Aug2021, outcome "recovering", described as "Chest Pain". The events "shortness of breath", "unable to breath without coughing", "cough", "fever", "chills", "headache", "body aches", "fatigue" and "chest pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures included Covid-19 test negative on Jul2021. Therapeutic measures were taken as a result of dyspnoea, dyspnoea, cough, pyrexia, chills, headache, pain, fatigue, chest pain. No follow-up attempts are possible. No further information is expected. Follow-Up (07Sep2021): No new information was received.
Light-headedness, full-body aches and pains including abdominal pain, loss of appetite; no treatment; inability to work for 36 hours, lingering pain for about 72 hours.
Pain and weakness in arm down to hands reported to us on 1/31, started soon after vaccine, was already getting better. Upon rechecks on 2/1/13 and 2/3/13 patient was much better, (slight pain, full movement).
patient stated less than 5 minutes after recieving the moderna vaccine she felt itching in her right ear. She felt warm on the same side the injection was given. The Nurse was notified immediately at approximately 2:53 pm b/p 170/100/, temp 98.0, pluse 96%, HR 84. Patient stated that she had not taken her blood pressure medication (lisinopril) that morning. Patient was informed by the nurse that she would be monitored for 30 mins. patient agreed. Nurse assessed vitals before patient left. b/p 170/102, hr 81, pulse 99%,. Patient states she feels fine. Patient exited the bldg approx. @ 3:20pm.
Pt developed red, swollen, hot arm. Reaction was severe spreading over entire upper arm on lateral aspect.
On April 9th received 1st dose of vaccine, approx. 12 hours later experienced bright red spotting, called MD and was seen and fetal heart tone was present on April 12th. Received 2nd dose of vaccine on May 1st and and approx. 12 hours later started to have bright red vaginal bleeding which then turned into spotting. On May 3rd at 1130pm started to have bright red bleeding and water broke. Came to the emergency room for evaluation where I was told I had lost the baby, no fetal heart tone present. I am experiencing a miscarriage @ 15 weeks gestation and 6 days today on May 4th 2021.
Information has been received from a physician and a nurse practitioner concerning her 21 year old daughter with no pre-existing allergies, birth defects or medical conditions, who on 16-MAR-2007 in the morning was vaccinated with the first dose of Gardasil vaccine (lot# 657006/0188U), injection (form) in the left deltoid. On an unspecified date in July 2007 in the morning, the patient was vaccinated with the second dose of Gardasil, injection (form) in the right deltoid. On 17-SEP-2007, in the morning, the patient was vaccinated with the third dose of Gardasil vaccine (lot #658556/1060U), injection (form) in the left deltoid. Concomitant medication was not reported. No illness was reported at the time of vaccinations. On approximately 24-SEP-2007 "one week after the last Gardasil vaccine injection, the patient experienced pubic hair loss. The outcome of the event was not reported. No product quality complaint was involved. Additional information has been requested.
1 week after both 2nd shot and after this booster dose 1/14/22, full body pruritus. First episode spontaneously resolved (pt did get mono at the same time it resolved). This episode ongoing- treating with pred and zyrtec
left thigh swollen, mild erythema swelling from groin to knee. nontender pt active playful, afebrile and evidence infection
Patient complaining of 6 inch red streak on Right arm at site of Zostavax immunization.  States it is warm to the touch and swollen.
Patient was fully vaccinated with Pfizer on 1/12/21 and 2/2/21. Patient was admitted 1/8/22 with COVID 19 associated with fever, chills, cough and body aches
Initial information received on 12 October 2011 from a consumer. A 72-year-old female received FLUZONE HIGH-DOSE, lot number unknown, intramuscularly in the left deltoid on 23 September 2011 at 10:00 a.m. Her past medical history included allergy to ALDOMET, hypertension, osteoarthritis, and elevated cholesterol. 12 hours following vaccination, on 23 September 2011 at 10:00 p.m., the patient developed itching all over her arms, armpits, neck, head, trunk, and hips. Her legs were unaffected. She took prednisone on 27 September 2011. She also took ALLEGRA and used cortisone cream. The itching lasted approximately one week. On 11 October 2011, the itching developed again. The patient stated she also developed a raised rash that was not red after scratching. She also complained of a moist cough. It was not reported if she required medical intervention for her symptoms. Her recovery status was not reported. List of documents held by sender: none.
Began having SOB and cough on 2/18/21, the day after his first vaccine.  Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints.   Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis.   Condition continued to worsen until patient passed away on 2/24/21 @ 1632.
Upper arm became itchy, red and hot to touch 1 week post injection. Heat subsided within about 2 days. Itching has been very minimal. Redness has continued.
2wks after 2nd dose severe sunburn despite being sunscreened up. Was put on 3 wks of prednisone and one prednisone shot.  Then  4 weeks after prednisone was finished started developing hives/ welts that were random. After several months sought out an allergist who put me on xyzal every night plus Pepcid in the morning. Ruled out allergies to new foods, lupus and Lyme disease as well as thyroid disease. Looked for uticaria positive titer to rule out T cells going haywire but titers were negative. She decided it has to do with the covid vaccine based on the timing of events. Over one year since 2 mid vaccine and still getting breakthrough hives and still on Xyzal even though they occur less frequently.
This spontaneous report as received from a consumer refers to her children of unknown age. On an unknown date, the patient was vaccinated with the second and third dose of RECOMBIVAX HB, subcutaneous (dose, frequency, lot number, not provided) 5 weeks apart and wanted to know if the 3rd dose was going to still be effective. No adverse event reported. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a 19 month old male patient. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 03-NOV-2017, the patient was vaccinated with improperly stored dose of VAQTA lot # N019924 in the left thigh (exact dose and expiry date were not reported) for prophylaxis. The dose of vaccine was stored in a temperature of 51 degrees Fahrenheit (F) for 4 hours and 50 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported (reported as everything went well).
soreness; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), PYREXIA (fever) and FATIGUE (tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack, COVID-19 (Covid positive during his stay in nursing home in summer of 2020) in 2020, Leg amputation in July 2020 and Stent placement (had heart attack during procedure which followed by getting stent.). Concurrent medical conditions included Drug allergy (Norco allergy).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (soreness), PYREXIA (fever) and FATIGUE (tired). At the time of the report, PAIN (soreness), PYREXIA (fever) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications was not reported.  Treatment medications was not reported.   This case was linked to MOD-2021-412501, MOD-2021-076510 (Patient Link).
Narrative:  Patient reported numbness, shaking, and tingling in extremities that progressed to the point of him requiring a walker to ambulate. He also reports losing his ability to drive due to these symptoms and multiple falls from tripping over his feet.
Patient came in to receive 2nd dose of pfizer, she warned me that with her first dose she had a reaction where she broke out in hives. I let patient know the risks of receiving the second dose but she wanted the vaccine anyway due to not wanting to lose her job. After receiving the second dose she waited around for the 15 minute time requirement in which she started to feel unwell. She became short of breath, and pale. I gave her some water to drink and placed a fan in front of her while she sat in the lobby. After about 15 minutes of not doing well, we made the decision to call ems. Patient left with ems.
missed getting my second dose by day 41; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed getting my second dose by day 41) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed getting my second dose by day 41). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed getting my second dose by day 41) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported , no treatment medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI follow up received on 25-may-2021
BOOSTER GIVEN EARLY. SECOND DOSE ADMINISTERED 6 WEKS AGO.
Began covid-19 symptoms on 6/07/21 and tested positive for covid-19 on 06/09/21
Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 14:00 at a single dose on left arm for COVID-19 immunization. The patient's medical history was not reported. No known allergies. Concomitant medication included drospirenone, ethinylestradiol (YASMIN) for birth control. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 21Dec2020 08:00 at a single dose on left arm for COVID-19 immunization. The patient experienced body aches, chills, headache, nausea - emesis x1 on 08Jan2021 02:00. No treatment received for adverse event. The outcome of the events was recovering. The events were assessed as non-serious. Facility type vaccine was Hospital. No other vaccine received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Pt is an medic with 8 recorded doses of AVA in his record.  He believes he may have received even more AVA doses in his 15 year career.  His last AVA dose was given 21 Feb 2020 in left deltoid.  He recalls that, with every AVA dose, including most recent, he experiences marked swelling in arm.  "Circumference expands by at least 4 inches."  Swelling seems to resolve over 2-3 days with NSAID use.   After swelling, however, he develops large firm lumps in deltoid.  He notes that left deltoid now feels like he has a "kneecap" in shoulder.  Firm lumps in deltoid are not painful and do not limit his activity in any way.  Immunization staff confirm that it is difficult to find viable IM injection site in left deltoid due to fibrosis.  [Immunization Healthcare team has written exemption from future AVA doses in pre-event setting.  AVA boosters may be considered only if >3 years from previous dose and if need validated.]
On 1/15/2021 at approx. 1115am, resident had an elevated temperature of 102.7 degrees F. Tylenol was given and the doctor ordered Ceftin 500mg BID for 7 days.
Varicella vaccine given Sub Q (R) thigh 2:05pm. Immediately patient c/o itching & pain. Redness began. MD notified & entered. Ice applied & BENADRYL liquid given at 2:10pm. 2:30 redness is decreasing. 2:40pm pt ok'd to leave with instructions.
Client presented to the Health Department on Tuesday, with a complaint of a possible vaccine reaction.  Client stated that on Sunday, 9-26-2004, at around 8pm, she noticed that her left upper arm had a circular reddish area that was warm to the touch and raised.  Client also stated that she was experiencing a dull achey pain from her shoulder extending downward to the elbow area.  Cllient was able to relieve pain with OTC Tylenol.  Today, Tuesday, September 28, 2004, the client states that the signs and symptoms that were present on Sunday are diminishing.  The area is presenting with less color, less pain and less warmth and less raisiing of the area.  She did state that the area was about the same size.  The area is measuring 90x60mm at this time.
Intense headache, intense joint/muscle soreness, bloodshot left eye, INTENSE fatigue, even after4 days