chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My period had ended four days before the vaccine. I always have very regular periods. The night of the vaccine, I started bleeding heavily with large blood clots and continue to do so.; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6206), via an unspecified route of administration administered in left arm on 03Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Medical history included long QT syndrome. The patient had no known allergies to medications, food, or other products. Concomitant medication included nadolol. On 03Mar2021  the patient experienced "My period had ended four days before the vaccine. I always have very regular periods. The night of the vaccine, I started bleeding heavily with large blood clots and continue to do so." The reporter considered the event as non-serious. There was no treatment received for the event. The patient was recovering from the event. The patient received the second dose of bnt162b2 (lot number: ER2613) on 24Mar2021 in the left arm.  No follow-up attempts are needed. No further information is expected.
He developed hypersensitivity of his skin; Stinging sensation all over his body; This is a spontaneous report from a contactable consumer (patient). A 85-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 for covid-19 immunisation on an unspecified date for covid-19 immunisation. On an unspecified date, the patient experienced developed hypersensitivity of his skin and stinging sensation all over his body. It was reported that, patient received both doses of the Covid vaccine and reports that no immediate reaction occurred. Reporter stated a couple of weeks after the second dose, on an unspecified date he developed hypersensitivity of his skin, in which he stated that it was bothersome when his pants to touch his legs and he had a stinging sensation all over his body. He stated that he saw a dermatologist, in which they stated that nothing was wrong with his skin and his general practitioner is clueless. He did not have a rash, hives, lesions, warmth, redness, or inflammation. He only had a hypersensitivity, and the vaccine had been the only new thing introduced to his body. He stated that his wife and himself took the vaccine and both doses were spaced more than the recommended period due to an unexpected freeze in (place). He stated that they received their vaccines 4 weeks apart. Reporter asked if there had been any similar reactions reported from the vaccine. Reporter asked how long did the hypersensitivity reactions last, if the reactions occurred immediately or delayed and if Pfizer had any treatment recommendations, if any autoimmune reactions have developed after the vaccine. Seriousness of events were reported as non-serious by the reporter. Outcome of events were unknown.   No follow-up attempts are needed. No further information is expected.
Information has been received from a health care professional concerning a pt who on approx. 10/10/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt experienced hives on the trunk of their body. As of 10/18/01, it was reported that the hives now look like a football on the pt's stomach. Unspecified medical attention was sought. The reporter indicated that the pt may have been vaccinated with pneumococcal vaccine 23 polyvalent before. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to an unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patients were vaccinated with improperly stored GARDASIL, (strength, lot #, dose and frequency were not reported). No adverse effects reported. The outcome of events was unkonwn. No product quality complaint (PQC) was involved. There was no additional information to report. This is one of several reports received from the same reporter. Additional information has been requested.
mom states child had onset of lips swelling on 30MAY98 in AM & had intermittent hives x 2-3 days;also relates that as a child was allergic to strawberries & has been eating berries over the weekend;instructed to contact MD;
Injection site on my left deltoid region is red; Injection site circular with defined borders; injection site painful; A spontaneous report was received from a consumer/physician/nurse/pharmacist/healthcare facility staff member/literature article concerning a 44 years old, female  patient who experienced injection site redness (vaccination site erythema), Injection site circular with defined borders (injection site urticaria), injection site painful(vaccination site painful).  The patient's medical history included rheumatoid arthritis. Products known to have been used by the patient, within two weeks prior to the event, included biologic. The patient's medication allergies included doxycycline and bactrim.   On 08-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 09-Jan-2021, patients experienced injection site redness, Injection site circular with defined borders, injection site painful. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events were considered not resolve/not recovered.
From Feb. 20th through Aug. 14th unable to lift anything with left arm & constant sharp pain in upper left arm - felt like it was frozen also because I couldn't raise my arm up or move it backward without sharp pains & inability to move the arm.  From Aug. 15th through today (Sept. 16th) have been able to move arm, but still cannot raise my arm up without pain.
Lightheaded, joint pain, shooting pains in arms, swelling at shot site 5 inches in circumference, chills, low grade fever. Burning pain at shot site. Abnormal headaches. Sense of balance disturbed.  Took 1200 mg of ibuprofen. Iced site 3 times a day for 15 minutes. Took it easy at work for over a week. Worked one 1/2 day.
Rash all over his body and with significant redness and hot to touch skin around injection site. Advised patient to seek medical attention. Patient visited ER and diagnosed with cellulitis around the injection site and prescribed Amoxicillin 875mg. Pt also was told to use cetirizine 10g for allergic Rxn. and fill RX for Prednisone if cetirizine fail to help
Heavy menstruation bleeding  few days after the vaccine. I had my period a week prior to vaccine. Never had such a bad bleeding
the second COVID19 Side effects: similar to the first, pain in my right arm and fatigue; the second COVID19 Side effects: similar to the first, pain in my right arm and fatigue; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 28Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE: 01), administration date: 21Mar2021, for COVID-19 Immunization, reaction(s): "pain in my right arm"; BNT162b2 (DOSE: 01), administration date: 21Mar2021, for COVID-19 immunization, reaction(s): "Fatigue". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Mar2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; PAIN (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "the second COVID19 Side effects: similar to the first, pain in my right arm and fatigue".  Clinical course: On the onset patient would like to express her appreciation for receiving her call last week. She had listed the schedule when her COVID19 vaccines were administered and side effects to give us an understanding of her personal experience. 21Mar2021 patient's first Pfizer Vaccine was given through the (withheld), the injection was administered in her right arm. Side effects: pain in my right arm and fatigue. 28Mar2021 Again through the (withheld), She received the second COVID19 Vaccine injection in her right arm. Side effects: similar to the first, pain in my right arm and fatigue. 28May2022 she was scheduled to take the second Pfizer COVID19 Booster injection, due to the onset of the Tinnitus, put it on temporary hold until she got more information. Currently, She was seeking medical attention to explore treatment options to address her Tinnitus.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient is having trouble moving arm up and out to her side and when she gets it up to a certain point she has shooting nerve like pain go down her arm.  I do not know exactly when this started but has been going on since after vaccine on 04/22/2022
pt. passed out after vaccination.  BP: 113/60;  FS 103; HR 72; Sat 98%
got the flu; Initial information was received on 14-Dec-2020 regarding an unsolicited valid non-serious media case from the non-healthcare professional.  This case was linked to case 2020C015444 (same reporter).  This case involved a female patient of unknown age who got the flu (Influenza), after she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza), some weeks following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.  There would be no information available on batch number for this case.
Hives - on both arms and legs and trunk front and back x 3days Also, c/o top lip having tingling sensation off and on.
One day post vax the pt experienced a fever of 104F and 20 skin lesions. The pts fever lasted for 10 days.
This spontaneous report as received from a physician refers to a currently 33 year old female patient. On an unknown date the patient was vaccinated with HPV vaccine (manufacturer unknown) (unknown dose number, dose, route and lot number). On an unknown date the patient experienced allergy to HPV vaccine. On an unknown date the patient experienced allergy to drug in NUVARING (MARRS# 1412USA002130). On 29-SEP-2012 at 16:40, the patient experienced worsening abdominal symptoms of clostridium difficile infection (MARRS# 1210USA006052). On 29-OCT-2012 at 18:00, the patient experienced recurrent anastomotic stricture in the area of the jejunum (MARRS#1210USA012013). The outcome of allergy to HPV vaccine was unknown. Additional information has been requested.
sore arm; headache; more than 35 days from first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days from first vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days from first vaccination). At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days from first vaccination) had resolved.            Concomitant medication was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-245767 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-245767:Dose 1 case
Patient received shingrix and was told to wait for 10 minutes before leaving. 5 minutes later,  pharmacist looked over at the waiting area, and patient seemed distress. Patient stated she was feeling lightheaded and stated this is similar when she receives IVs which usually passes with time. 20 minutes later, her daughter comes and picks her up. She was ambulatory but was still lightheaded.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-NOV-2015 at time- 06:44, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperatures at which the product was stored were 3.4 and 2.5 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Broke out red all over, Sunday night 6-29-14 legs swelled up, 6-30-14 her left leg is more swollen and has red rash, no pain or itching.
pt recv vax 19OCT98 & 20OCT98 c/o lt arm pain @ inj site;sl erythema, sl swelling;pt told to apply cool compress & mild rxn are common & may persist for <48hr;21OCT98 marked local swelling, pain in lt arm spreading to armpit w/erythema, hot
approx 10 minutes p/receiving vax area around inject site became reddened 3-4 areas like hives starting; had taken APAP & apply ice pack to area 15 mins later returned c/o numb feeling & reddened appearance lt arm;
Arm that received the injection was sore and tender to touch from time of injection. Major headache/slight migraine occurred about 8 hours after injection.  Not sure if related or not? 12 hours after shot, injections site became slightly raised and red, warm to the touch and very tender to the slightest touch or exaggerated movement. This lasted 2 days.  Day 3, swelling and redness are are gone but is still slightly tender when pressure is applied to injection site.
10 year old was administered PEDIARIX; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 5N259, expiry date 5th October 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th February 2022, the patient received Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 17th February 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The patient received Pediarix in left deltoid. The patient received Pediarix at the age of 10 years, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
red rash appeared on left arm near vaccination site about one week after vaccination administered; some soreness to left arm returned; skin feels swollen around vaccination site
Information has been received from a physician concerning an unknown number of patients who were vaccinated PO with doses (dose sequence unspecified) of ROTATEQ and experienced diarrhea after vaccination. The patients were seen by the physician or contacted the physician for medical attention. The outcome was unknown. There was no product quality complaint. No further details.
shingles shoulder to breast (right side) , right dermatome; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles shoulder to breast (right side) , right dermatome) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Shingles. Previously administered products included for Shingles: Zostavax (Patient received the first marketed Shingle vaccine years ago. LOT#044A21A).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced HERPES ZOSTER (shingles shoulder to breast (right side) , right dermatome). The patient was treated with VALACICLOVIR at a dose of UNK UNK, bid. At the time of the report, HERPES ZOSTER (shingles shoulder to breast (right side) , right dermatome) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Blood count: shingles (Inconclusive) Blood work performed and diagnosis was "shingles"..         No relevant concomitant medications were reported.   This case was linked to MOD-2021-082095 (Patient Link).
report 20010025331 describes an elevated level of alanine transaminase in a 46 year old male who received an injection of hepatitis B vaccine (Engerix-B). This report was received from the patient and has not been verified by a physician or othe rhealth care professional. concurrent medical conditions included "slight" hypertension. The pt has no known drug allergies. Concurrent medications included guanfacine (Tenex) 1mg twice daily, citalopram (Celexa) 20 mg daily, and dextroamphetamine (dextrostat) 15 mg daily. The pt received his first injection of Engerix-B on 01/24/2001. On 01/29/2001, his alanine trasaminase level was measured at 55 units/liter; this was determined to be an elevated measurement for this patient. As of 01/31/2001, the outcome of this event was unknown.
left arm is a little sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (left arm is a little sore) in a 49-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: FLU Shot 1 week before Spikevax (FLU Shot 1 week before Spikevax) in 2023. Past adverse reactions to the above products included No adverse event with FLU Shot 1 week before Spikevax.    On 12-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 12-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PAIN IN EXTREMITY (left arm is a little sore). At the time of the report, PAIN IN EXTREMITY (left arm is a little sore) had not resolved.            No concomitant medication was reported. The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.  The dosage text was reported as unknown. It was reported that the spikevax was administered on the left upper arm yesterday, but it was not given in the center of the upper arm. It was more to the side. It still went in the muscle. The left arm was a little sore but it was nothing. The patient had about 5 previous shots and had sore arm for 1 day. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745550 (Patient Link).
pt recv vax on 29SEP95 pt exp nausea & dizziness when got up;MD reported that the pt exp no problems while on therapy w/antenololchlorthalidone & potassium cl;pt's BP was sl elevated to 142/72;
Moderna Covid-19 Vaccine EUA Chills, Headache, Slight fever, nausea, fatigue
Site: Itching at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: PT SEEING DR 12/21/2021
1/26/21:  1-2 hours post vaccine- fatigue and heavy body 1/27/21:  5 am woke to extreme headache/migraine. Could not lift my head off the pillow but also could not sleep. Body aches began all over but especially in lower back. Chills and fever that went on and off throughout the day, peeking at 103 degrees.  Spent the entire day in bed. Extreme fatigue and heavy body. Noting slight lift in symptoms enough to get up and eat dinner but then went right back to laying down.   1/28/21: Extreme fatigue and heavy body. Moderate headache. Heart rate racing. Dizzy. Sweating profusely.  1/29/21: Moderate fatigue and heavy body. Moderate headache. Heart rate continues to race. Resting heart rate over 100 bpm just laying down.  Dizzy. Brain fog.  1/30/21: Slight headache. Fatigue and heavy body continue. Heart rate fluttering and elevated.  Dizzy. Brain Fog. 1/31- 2/3/21- Fatigue. Heavy body. Dizzy. Heart Rate elevations and fluttering. Brain Fog. All other symptoms have dissipated.
01/21/22 presents to Surgery for "Cervical spine tumor". PMHx of "MS"