chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE1, MANUFACTURER, UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "Booster"; EPISTAXIS (non-serious) with onset 13Nov2021, outcome "unknown", described as "blood running from her mouth and nose"; MOUTH HAEMORRHAGE (non-serious) with onset 13Nov2021, outcome "recovered" (13Nov2021), described as "blood running from her mouth".  Additional Information: Originating AE Request: REQ-607510.Patient Age is unknown years.Reporter Subtype is Patient. No of attachment is 1. PQC Details:  Product: COMIRNATY Question: Was not able to collect demographic information from Caller before call disconnected.Unable to callback Caller due to no callback number being provided.Caller stated before the call disconnected that she had the booster dose of the purple cap Pfizer Covid-19 vaccine on 11Nov2021 and on 13Nov2021 she started having complaints blood running from her mouth and nose for 5 hours where for 2.5 hours of the 5 hours the blood was streaming out really bad then the pools started to congeal in her sink and were 3-5 inches across in length per Caller.Caller reported that she had complaints of a nosebleed that lasted for another 3-4 minutes on 19Nov2021 and another bad nose bleed 01Dec2021.Caller stated that she believes she called Pfizer MI a few weeks to ask if there was information about the above complaints on 13Nov2021 and was told there was no information available.Caller stated that she is calling again to see if there is any information at this time about the above complaints.Call disconnected while Caller while describing the events on 13Nov2021 and 19Nov2021.  DSU:e-transmitting AE due to call disconnecting and no callback number was provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tested positive for Covid19; tested positive for Covid19; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on an unspecified date (reported as "recently") (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he is scheduled to receive the second BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine shot within days, yet he has recently been tested positive for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatments for the event. The event outcome was unknown at the time of the report.  Information on the lot/batch number has been requested.
Dizziness, imbalance, vision changes, painful tingling in finger tips the same day after the second covid pfizer vaccine
Information has been received from a medical assistant reporting on a 15 month old patient of unknown gender. There was non information regarding the patient's concurrent conditions. The patient's concomitant medication included PREVNAR 13. The patient had no pertinent medical history. On 13-JUL-2017, the patient received an unspecified dose of M-M-R II (lot # reported as M098365; strength and expiration date were not reported) reconstituted with sterile diluent (manufacturer unknown) (lot number and expiration date were not reported), intramuscular (incorrect route of drug administration) for prophylaxis (anatomical location not reported). On the same date, the patient received an unspecified dose of VARIVAX for prophylaxis (strength, route of administration, lot number and expiration date were not reported). On 13-JUL-2017, the patient had an "immediate reaction"; the patient experienced local swelling, redness at site which increased into the next day. The patient was treated with BENADRYL as it was suggested by the medical assistant. No lab diagnostics/studies were performed. On an unspecified date in 2017, the patient recovered from the adverse events injection site erythema and local swelling; the reporter stated that the patient was doing fine. The reporter did not assess the causal relationship between the aforementioned events and therapy with M-M-R II, sterile diluent (manufacturer unknown) or VARIVAX. Lot number M098365 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live.
After 4 hours or so after getting vaccine  my arm began to hurt at injection site and progressively got worse to the point of hurting just to lift it and attempt to roll over in bed. The next day pain was spreading through shoulder, upper back and neck along with an exhausted feeling, loss of appetite, diarrhea and sluggishness. The third day, arm still hurt at injection site, soreness in neck upper back and shoulder while the soreness was creeping down into elbow and forearm along with very bad muscle aches as if the joints were swollen and overall body soreness. The fourth day all the same symptoms but soreness and pain was creeping into hands and fingers making my knuckles very stiff. Then the flickering headaches began with mild inability to focus on anything. This lasted at least 2 weeks. Arm is still a little sore at injection site.
Information has been received from a physician referring to an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose and route were unknown, lot # L043214 with expiration date 30-AUG-2017. The vaccines were exposed to temperature of 11 degree centigrade for 1 hour and 22 minutes. The vaccine also had a previous excursion (22.2 degree centigrade for 30 minutes) on unknown date. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Headache, swelling at injection site, enlarged and painful axillary lymph nodes, myalgias and arthralgias, fever.
Patient came into the pharmacy to complain about her severely reddened arm and how she has been dizzy and really sick since she received the vaccine 3 days ago. Told her that these were possible side effects but that she needed to go to the ER If she didn?t feel any better. I also recommended something for her dizziness
Left Arm pain all the way into the neck area, fever, chills, and shortness of breath. He died 2 days later unexpectedly.
Vomiting, diarrhea, dehydration, fever, sore throat treatment @ hosp-Tagamet, Glucose/dextrose, Amoxillin;
Extremely sore arm with heaviness, dizziness, fevers, chills, headache, nausea, fatigue, body aches
Soreness on her right arm; Extremely tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on her right arm) and FATIGUE (Extremely tiredness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness on her right arm) and FATIGUE (Extremely tiredness). At the time of the report, PAIN IN EXTREMITY (Soreness on her right arm) and FATIGUE (Extremely tiredness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
This case was reported by the mother of a consumer and described the occurrence of lethargy in a male subject of unspecified age who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. In February 2005 the subject received unspecified dose of ROTARIX at 1.0 ml, orally. In February 2005, two days after receiving ROTARIX, the subject experienced lethargy which resolved 2 days later. Approximately 4 months after receiving ROTARIX, the subject developed decreased motor skills. This event was unresolved at the time of reporting. No additional details were provided.
Elevated usual temp by 4.3 degrees (97.4 to 101.7).  ALL large & small joints very painful Whole body shaking & teeth chattering  uncontrollably  Feeling hot & cold at once Fear Lasted through the night By 7am fever reduced to 99.9 By about 5pm symptoms gone but I was ?wiped out? Used Tylenol 500mg  in early morning with Gatorade. When most needed I couldn?t ?think? to take any Tylenol
Five minutes after receiving injection , I felt lightheaded, faint, and a fast, pounding heart beat.  I also felt an overwhelming feeling of anxiety.  I reported my symptoms to the nurse, and she came and gave me a bottle of water and checked my pulse.  She did not disclose to me my heart rate at the time.  Within 15 minutes of receiving I decided to go home and rest.   On Saturday I felt body aches and exhaustion .  At times , I felt the fast, pounding heartbeat. I therefore rested.   On Sunday, 09/03/2021, while shopping, I again , felt lightheaded, anxious, fast, pounding heart beat.  I requested for ambulance service and they came and performed an assessment.  My initial blood pressure was 160/110.  But upon being in ambulance it was re assesesed and was 146/70, approximately.  My blood sugar was 97.  I therefore decided to attempt to go home and rest.  Upon driving approximately 1 mile, I again felt lightheaded, anxious, and a fast, pounding heart beat.  I therefore parked my car near by and contacted my parents to drive me home. I went to the Hospital for assessment and they discharged me stating my labs and test were ok. I do not have any history of cardiac issues.
Information has been received from a physician concerning a 14 year old female with exertional asthma and no allergies who on 25-JUN-2008 was vaccinated with the first dose of GARDASIL, IM 0.5 mL (lot # 659657/1487U). On 25-AUG-2008 the patient was vaccinated with the second dose of GARDASIL, IM 0.5 mL (lot # 660391/0063X). There was no concomitant medication. On 25-AUG-2008 the patient experienced headaches and lethargy since she received the second dose. The patient sought medical attention at the office. The patient's headache and lethargy persisted. The computed axial tomography, neurological exam and blood work were performed with no results provided. Additional information has been requested.
Fever, Chills, Body aches. I took Tylenol. I experienced these symptoms for almost 48 hours.
Employee administered Fluzone "high dose" Quadrivalent flu vaccine by 11-7 Supervisor on 10/5/21. Employee under 65 years of age. Currently, employee doesn't report any adverse reactions.
This spontaneous report was received from a medical assistant referring to an unspecified number of patient of unspecified gender and age. Since 05-FEB-2017, the unspecified number of improperly stored doses of the PNEUMOVAX 23 lot number M039060, expiration date 22-MAY-2018 (formulation, dose, frequency, route of administration and indication were not reported) were administered to the patients. From 05-FEB-2017 to 01-MAR-2017, the doses were stored 10 times in temperature colder than 32F (28.3F) for an unspecified period of time. It was also reported that the first excursion colder that 32F occurred on 15-FEB-2017. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Additional information has been requested. Sender's Comments: US-009507513-1703USA007375: US-009507513-1703USA007373: US-009507513-1703USA001520: US-009507513-1703USA007371: US-009507513-1703USA007372.
She got her vaccines, and she did not have a lot of reaction, just soreness as well as the day after just sore.  Then she felt like she was getting the flu, had the sick feeling like something was coming on.  It was not as bad as the other COVID shots.  The next day is when her head was on fire, the base of her back by her ears hurt when she moved her eyebrows on the left side.  She also had tingling down her arm.  She feels it radiated to the right side but it goes all the way down to her left leg.  It is just a tingling sensation.  She does not know what it is.  When she is in the shower the water hits her head and feel slike it is burning.  When she rubs her hands across her thighs sometimes it is such a prickly sensation.  Behind her left ear is sore.  Within the next few days her armpit lymph node was huge on the left side.  It just got so big, and then suddenly that went away.  Eventually the pain in her arm and soreness went away.  The tingling is still present and will not go away.  Sometimes it felt like it was moving, didn't feel like it was always only in the center of her head, sometimes if felt like it was a little more halfway down, but has stayed in the middle of her head.  At the neck as well as behind her ear, it goes behind her jaw as well.  It goes down her shoulders, top half of her arm, and then downward.  She had a bunionplasty and ankle surgery on 8/31/23 and it was getting better and suddenly when the bunionplasty is is very super sensitive again and she does not know if this is the surgery itself, or maybe starting to go into other areas.    She has contacted her doctor yesterday as she was on a virtual appointment with another doctor and he told her that it could be the COVID shot, and had no clue until she internet searched it and has an appointment to see her tomorrow.
Took the capsule at approximately 7:30am; one hour later became nauseated and vomited 3 to 4 hours later. Continued to feel ill the next day and also developed a rash to both cheeks. The day she took the capsule she also had abdominal cramps and a loose stool.
temperature excursion with our Moderna Covid-19 vaccine; No adverse event; The dose was administered to the patient post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion) and NO ADVERSE EVENT (No adverse event) in a 31-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     The information was unknown whether the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 17-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) and POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion).    No concomitant medications was reported. The temperature excursion occurred for both monovalent and bivalent. 27 total doses were administered post excursion.  No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master case
bumps on the hands and neck/1 or 2 bumps in the crook of his arm/ both arms to the hands/ on the back of his hands/ 4 or 5 on each hand to 25 on each hand/skin rash; The bumps on the back of his hands / are a deeper red / used to be more flesh colored; Condtion aggrivated; was diganosed with Granuloma annulare; This case was reported by a consumer via call center representative and described the occurrence of granuloma annulare in a 68-year-old male patient who received HAB (Twinrix adult) (batch number 3597P, expiry date 12th March 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult with an associated reaction of rash papular (1st dose received on 13th January 2020, experienced raised rash refer case US2020252584).   On 13th February 2020, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 22nd April 2020, 69 days after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced granuloma annulare and rash. On an unknown date, the patient experienced raised rash, erythema and condition aggravated. On an unknown date, the outcome of the granuloma annulare, raised rash, erythema, condition aggravated and rash were unknown.   It was unknown if the reporter considered the granuloma annulare, raised rash, erythema, condition aggravated and rash to be related to Twinrix adult and Twinrix Pre-Filled Syringe Device.   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: After vaccination, bumps continued to progress on the hands and neck of the patient. On 9th April 2020, the patient saw the dermatologist who prescribed stronger topical. On 22nd April 2020, the physician did a biopsy and the patient was diagnosed with Granuloma annulare. The neck area had almost completely cleared after that time but has returned. 1 or 2 bumps presented in the crook of the patient's arm and now had gone down both arms to the hands. The bumps on the back of his hands went from 4 or 5 on each hand to 25 on each hand and were a deeper red. They used to be more flesh colored. The patient opted not to get his third dose, due to adverse event from 2nd dose. The reporter stated that the patient received some other vaccines in preparation for a trip to another country but the bumps definitely presented after getting Twinrix not the other vaccines. The reporter consented to follow up.
first dose of Shingrix in 2018 and has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (got the 1st dose on an unknown date in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Age at vaccination was not applicable for this report. The pharmacist reported that, the patient had not received the 2nd dose yet still 2 years after 1st dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
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 15-DEC-2015 at 12:44, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 7.9 and 4.6 (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.
bruise at injection site; when she was pregnant in 2018 she received Boostrix; This retrospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In 2018, the patient received Boostrix. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Boostrix at an unknown time during the pregnancy. On an unknown date, unknown after receiving Boostrix, the patient experienced injection site bruising and vaccine exposure during pregnancy. On an unknown date, the outcome of the injection site bruising and vaccine exposure during pregnancy were unknown. The pregnancy outcome was unknown.   It was unknown if the reporter considered the injection site bruising to be related to Boostrix.  Additional details were provided as follows: The age vaccination was not reported. The patient received Boostrix when she was pregnat in 2018 (vaccine exposure during pregnancy) and experinced 2 cm small bruise at injection site. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020182599:same reporter US-GLAXOSMITHKLINE-US2020182602:same reporter
Pt reports chills, vomiting and SOB. Having muscle pain, dizziness and headache starting at 20:00 last night.  Pt had Johnson and Johnson covid vaccine yesterday.  APAP last at 0330 IBU last at 2200.
Initial health care professional report received on 15 Dec 2009: This patient received one dose of FLUVIRIN (batch no: 102139P1) 0.5 mL intramuscularly into the deltoid on 15 Dec 2009. Once the needle was withdrawn from the tissue, the reporter noticed that a small, unspecified volume of vaccine ran down the patient's arm. No adverse event was reported. No other information was available.
Shoulder pain; headache; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Sep2021 14:00 (Lot number: FF8841) at the age of 47 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Gall bladder removed" (unspecified if ongoing); "bicuspid" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 28Sep2021. The following information was reported: ARTHRALGIA (non-serious) with onset 30Sep2021 23:15, outcome "recovering", described as "Shoulder pain"; HEADACHE (non-serious) with onset 30Sep2021 23:15, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 30Sep2021 23:15, outcome "recovering", described as "tiredness". Therapeutic measures were not taken as a result of arthralgia, headache, fatigue.  Additional information: The patient had received other vaccine Flu vaccine in 4 weeks on 28Sep2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.