chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The platelets were still high; she has had a rash for ten days following vaccination/both legs then broke out/ her arms broke out//rash on back of right knee/rash on both legs/rash on both arms/rash is in a cluster on the back of her leg but other parts it is bumps all over; her arm was sore; This is a spontaneous report received from a contactable female consumer (patient)  reported for herself. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9264), via an unspecified route of administration, administered on the right arm, at the age of 69 years, on 25Feb2021 09:20 at a SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer, food allergy to shellfish, contrast media allergy, drug hypersensitivity Macrobid; all from an unknown date and unknown if ongoing. The patient mentioned she was a breast cancer survivor and she had breast cancer 18 years ago. Concomitant medications included acetylsalicylic acid (ASPIRINE); lansoprazole (LANSOPRAZOLE) taken for hiatus hernia; rosuvastatin (ROSUVASTATIN) taken for blood cholesterol increased and metoprolol (METOPROLOL); all start and stop date were not reported. The patient previously took amoxicillin and experienced hypersensitivity. The patient stated she has had a rash for ten days following vaccination. The consumer stated she didn't feel it but then her arm was sore that night. She took some Tylenol and the next day her arm was fine. Then she got a rash that started on the back of her right knee on 06Mar2021; both legs then broke out and on 07Mar2021 her arms broke out. She added she went to see her doctor on Monday 08Mar2021, who checked her platelets. The platelets were still high and that was normal for her for the last six years and her blood showed no infection. She added she has been taking  Benadryl and it is keeping her from itching but the rash was still there. The patient added the rash was in a cluster on the back of her leg but other parts it was bumps all over; on her arms it the rash comes and goes. She was scheduled to receive the second dose on 18Mar2021 but that was one thing she was calling about, should she get the next dose and if she had this reaction and what does she need to do.  Therapeutic measures were taken as a result of her arm was sore (pain in extremity). The outcome of the event platelets were still high was unknown while other events were not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Red rash with itching and swelling and warm to touch. At the injection site and moving down the arm almost to elbow.  Size  21x14cm that began 3 days after injection. Began taking keflex on April 13th.   April 14th the redness and itching was better but not gone completely.  Will take keflex for 5 days.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 16-OCT-2012 16:47, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Area became reddened, painful and with large lump; sterile abscess. Using warm packs and Advil.
DIZZINESS, NAUSEA, ROOM SPINNING, AND VOMITING.  GIVEN ONDANSETRON 8MG PT REFERRED TO ER
2 hours post vax, the pt developed emesis x 7 and presented somewhat hypotonic and dusky (hypotonic episode).
Janssen COVID-19 Vaccine EUA 34 y.o. male with GERD who presents with syncope and question of PEA arrest. He went for COVID 19 J&J vaccine on 3/13/2021.  A few minutes after getting the vaccine he started feeling nauseated.  His lips became gray.  He went unresponsive and was taken out of the car. He had agonal respirations.  He had  90 seconds of chest compressions and returned to his normal state of health.  He was seen in ED where labs were remarkable for mild hyperkalemia (serum potassium 5.5). Given worrisome syncope, chest compression he was admitted for observation. He did well overnight, No arrhythmias of telemetry and was discharged with Holter monitor.
This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a child patient who received FLUARIX QUADRIVALENT 2018-2019 season) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were received as follows: The age at vaccination was not reported. The office reported that the patient who received FLUARIX vaccine resulted positive for influenza. This case was considered as suspected vaccination failure case since the time to onset were unknown at the time reporting. The reporter did not agree to follow up from GlaxoSmithKline. This case was linked with US2019GSK000801 and US2019GSK000798, reported by the same reporter. Lab Comments: On an unknown date, the patient did laboratory test.
Burning sensation approximately 6"x4" on right bicep. Continued for approximately 3.5 days, with redness. Lump approximately quarter dollar size at injection site.
Pt developed joint pain after vaccination. This report was received from the pt's spouse and has not been verified by a physician or other health care professional. The vaccinee works as a contractor and is expose to ticks. He reportedly had Lyme disease in 1995, 1996, and 1997. The pt had no adverse experiences following receipt of the first two injections of Lymerix. His spouse reports that she developed Lyme disease after receiving 3 injections of Lymerix. Additional info was received from the treating physician on 10/17/2001. The physician indicated that the vaccinee developed pain in his right shoulder in April 2001. He then experienced pain in his left shoulder. The physician evaluated the vaccinee once for the shoulder pain, on 07/03/2001. No warm or swollen joints were observed on physical examination. No joint fluid was obtained. Erythrocyte sedimentation rate was 5mm/hr., rheumatoid factor was negative, and antinuclear antibody titer was negative. Lyme antibodies by ELISA werre positive at 1.26. Lyme IgM by western blot revealed 39kD and 41kD bands. The physician made a diagnosis of arthralgia and prescribed Celebrax 200mg daily. The physician considered the arthralgia to be mild in intensity and possibly related either to LYMErix administration or exposure to an infected tick. The physician reported thatt the arthralgia persisted as of 07/10/2001. The physician did not confirm the report of headache and fatigue.
pt recv vax & 2FEB97 pt exp metal taste & warmth in mouth;also exp periodic warm in one leg;
Pleuritic chest pain , moderate to severe. Treated with NSAIDS and colchicine.
Approximately 8 hours after the vaccination, I started having pain at the injection site.  Over the next 12 hours, I experienced fever, chills, nausea, headache and body aches.  No vomiting.  Symptoms began to ease approximately 24 hours after the injection.  Injection site pain lasted around 5 days, others approximately 48 hours post injection.  Missed 4 hours of work due to reaction.
Dizziness, Myalgia, Fever, Chills, weak, tired Narrative:
VERTIGO,   VERY DIZZY. STARTED 3 DAYS AFTER THE VACCINE.    SHE CALLED HER DR AND HE HAD HER TAKE SOME ANTIHISTAMINES, IT IS NOT COMPLETELY RESOLVED YET BUT SHE SAID IT SEEMS TO BE BETTER (1-9-21)
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 24-year-old male patient who received BEXSERO (batch number 159001, expiry date March 2018). Concurrent medical conditions included latex allergy. Concomitant products included GARDASIL. On 11th July 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 12th July 2017, 1 days after receiving BEXSERO, the patient experienced injection site pain. In July 2017, the patient experienced injected limb mobility decreased and injection site discomfort. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injected limb mobility decreased and injection site discomfort were unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and injection site discomfort to be related to BEXSERO. Additional details were provided as follows: The patient received the 1st dose of BEXSERO in left deltoid and GARDASIL intramuscularly in right deltoid and experienced severe injection site pain in the next morning. It was reported that, 1 days after receiving BEXSERO the patient experienced injected limb mobility decreased and injection site discomfort. He could barely lift his arm, but since then, his pain gradually subsided and he had full range of motion now. He did not experience any injection site reactions in his right arm, where GARDASIL was given. However, 15 days later, he still had discomfort when there was pressure applied to the area.
On 9-15-09 - arched back, body got stiff, shook. On 9-20-09 looked like convulsing, looked up i cleared his fists, shook.
Started having body aches later in day, arm soreness at COVID booster shot area (right arm), slight fever (99) later that night, went to sleep. Woke up around 7:00 AM, and had no hearing, at all, in right ear. Also noticed later that I had lost all feeling inside ear canal and around base of the ear. Later in day, hearing loss was replaced with an extreme amount of ear ringing which appeared to sound like a 40-50 decibel level speaker against the ear. My hearing loss and ringing remain as of this day 12-16-21.
Reports short term memory loss, inattention and concentration deficits after AVA in 2007.  Symptoms: Cognitive deficiency.
Pt vaccinated with DTP/OPV same day lethargic, & vomiting. Sister had previously had same reaction.
4 days p/vax given pt began to c/o h/a & cont to run a low grade fever; began to say throat was sore; temp remained elevated; also began to vomit; swelling in neck; dx poss meningitis; dx viral meningitis;
Information has been received from a registered nurse referring to unspecified multiple patients of unknown age and gender. There was no concurrent condition or medical history reported. The nurse reported that improperly stored GARDASIL 9 (lot # L013429, expiration date 21-JUL-2017) (dosage, strength and route not reported) were administered to the unspecified multiple patients on unknown dates. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. Since 11-OCT-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L030591 and expiration date 10-FEB-2017, lot # L008353 and expiration date 11-SEP-2016, exact doses and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
I had a raging fever of over 102, whole body aches, nausea and vomiting, weakness
anaphylactic reaction; Initial information received on 16-Aug-2021 regarding an unsolicited valid serious case from a pharmacist via Agency (Reference number- 00726317).  This case involves a patient (unknown demographics) who experienced anaphylactic reaction, while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date (2017-2018), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UI883AB and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (2017-2018), the patient developed a serious anaphylactic reaction (unknown latency), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a patient (unknown demographics) who had anaphylactic reaction, after receiving FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of the events, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of a vaccine cannot be assessed.
HCP reporting a patient older than 13 years of age was administered PROQUAD instead of MMR II and VARIVAX; HCP reporting a patient older than 13 years of age was administered PROQUAD instead of MMR II and VARIVAX; This spontaneous report was received from a nurse and referred to an older than 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (product use issue; wrong product administered).
localized site swelling of rt arm in deltoid area extends to elbow; c/o tingling fingers, h/a, painful @ site, nausea, poss fever;
I had no adverse reaction to the vaccine. I have a history of sciatica pain. In 04/2023, I had a flare up and went to the doctor and got a prednisone shot. I have been referred to physical therapy and will start this week.
recurring shingles/outbreak on my arm and around my stomach; This non-serious case was reported by a consumer and described the occurrence of shingles in a 57-year-old male patient who received Herpes zoster (Shingles vaccine) (batch number 58160-0823-11, expiry date 23-SEP-2023) for prophylaxis.   The patient's past medical history included shingles.   On 20-SEP-2023, the patient received the 1st dose of Shingles vaccine. On 21-SEP-2023, 1 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: recurring shingles/outbreak on my arm and around my stomach).  The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-SEP-2023 The patient self-reported this case. The patient took the vaccine before the 6 months was up for his recurring shingles was abated. The patient recovered from shingles in May 2023.  The patient now had the outbreaks on his arm and around stomach (at the time of reporting). The patient asked if it is dangerous to have gotten the vaccine before he was completely over the virus (recurring shingles). The symptoms were not treated. The reporter gave permission to follow up.
PT SITTING IN CHAIR BY CLINIC DESK. AFTER VACCINATION, PT TURNED TOWARDS DESK, LEANED FORWARD AND DROPPED HEAD ONTO DESK TOP. PHN LOWERED PT TO FLOOR WITH HELP OF FATHER. PT REGAINED CONSCIOUSNESS & RESTED ON FLOOR AND THEN PLACED UP ON EXAM TABLE IN SUPINE POSITION WITH ICE PACK TO BACK OF NECK. MD IN CLINIC CALLED TO CHECK PT. PT STATED HE FELT BETTER AND RAISED TO SITTING POSITION WHERE HE FELT SICK AND VOMITED X 1. PT LOWERED BACK TO SUPINE POSITION. PT FELT SLEEPY AND PHN CHECKED PUPIL REACTION WHICH SEEMED SLOW TO REACT TO LIGHT. PHN CALLED MD BACK TO ROOM TO CHECK. 911 CALLED. EMS ARRIVED AND PT CHECKED -, EKG WNL, VS WNL, PT PLACED IN SITTING POSITION TO CHECK BS WHICH WAS WNL AND PT VOMITED A SECOND TIME. EMS SUGGESTED TRANSPORT AND FATHER OF PT DECLINED. PT DISCHARGED TO HOME WITH FATHER WHO WAS ADVISED TO CALL 911 IF S/S WORSEN. PHN CALLED NEXT MORNING ON 8/10 AT 9:AM AND SPOKE WITH FATHER WHO STATED PT RESTED FOR AN HOUR UPON RETURN TO HOME THEN FELT FINE AND GOT UP AND ATE DINNER. PT WENT TO SUMMER CAMP 8/10 WITH ONLY COMPLAINT BEING SOME SORENESS AT INJECTION SITE.
9mm x 7mm warm, reddened area to left upper arm, no treatment done.
Returned to clinic 50 minutes after vaccine complaining of tight throat and side of face and neck. B/P 165/92 P 67 oxygen saturation 92. Treated with 50 mg Benedryl and sent to the ED
12 hours of headache, fever, chills, entire body aches, nausea, diarrhea, arm pain at the shot location.
Lethargy and very high fever over 104 degrees. Fever stayed in range higher than 102 for 48 hours --continued with low grade fever for a total of five days. Vomiting started after fever initially went above 104 and continued for 24 hours. 6 full days of low energy and lack of appetite.
Patient developed hives within 12 hours of immunization administration. No dyspnea / fever.
This spontaneous report as received from a certified medical assistant refers to numerous unspecified patients. The medical assistant reported that numerous unspecified patients received GARDASIL (dose, route and lot # not reported) that went through an unsupported temperature excursion. No adverse effects were reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (on 11th January 2019, the patient received 1st dose, for tolerance refer case number US2019045270). On 11th March 2019, the patient received the 2nd dose of SHINGRIX. On 12th March 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the following day (12th March 2019), she had a sore arm but no other side effects.
Patient given flu vaccine 10/29/07 - awoke 10/30/07 with hives encompassing torso and face.  Mother to child to urgent care and was treated with benadryl and prednisone.
A week after I received the vaccine my teeth started falling out. They would get loose and then once every couple weeks over a six month period I lost a total of 7 teeth.
Three separate adverse events/reactions. First, child experienced swelling at the vaccine injection site, along with a moderate fever of 101-102 for approximately 48 hours. Fever was treated with extra hydration (water). Child was not interested in eating or drinking much for approximately 96 hours, and lost approximately 1.5 lbs. Second, child experienced eczema breakouts on her face and back and arms within 48 hours of administration. This has not went away with passage of time and is being treated with prescription hydrocortizone and regular ezcema moisture cream (Aveeno). Third, child experienced an anaphylactic reaction on 3/13/19, approximately 3 weeks after receiving the vaccine to food and drink that she had consumer regularly. Child had consumed a cinnamon bagel with almond  butter, something she had regularly eaten since about 7 months old. Almond butter contained soy. Child consumer approximately 3 oz of Whole Milk during the meal, something she had also been drinking without issue for approximately 8 weeks at the time. Child immediately experienced swelling and hives on the face and neck, swelling of the lips and tongue, and wheezing. child was transported by ambulance from school to Hospital. Findings suggested a localized anaphylactic reaction, cause not determined in emergency room. Allergy test results pending.
About 30-40 small chicken pox-like lesions (non-blistered).
Woke at 3:30am to extreme joint pain, to the point I had trouble moving, walking. Extreme shivering, Extreme headache, all joints in my body hurt. Had fever, nausea, vomited. Very scary!Debilitating to the point I had to stay in bed all that day. All I took was TYLENOL. I was still nauseous the day after with slight headache, and felt fatigued. Day 3 headache and nausea are  gone, weak feeling. Was able to eat today. I have noticed extreme ringing in my ears.
2 days p/vax pt devel hives & was treated w/DPH;30JUN97 hives were beginning to resolve;
Fever (101.5) that lasted about 6 hours a severe headache the occurred simultaneously and ended simultaneously
This case was reported by a consumer via call center representative and described the occurrence of headache in a 80-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included back disorder. Concomitant products included tramadol. On 17th December 2018, the patient received the 2nd dose of SHINGRIX. On 17th December 2018, less than a day after receiving SHINGRIX, the patient experienced headache, muscle pain, weakness and tiredness. On an unknown date, the outcome of the headache, muscle pain, weakness and tiredness were recovering/resolving. It was unknown if the reporter considered the headache, muscle pain, weakness and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX around noon, on the right arm. Later on the same day, the patient experienced the events. The symptoms started to subside at the time of reporting. The patient did not provide consent to follow up.
expired dose administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter.  It was reported that that some patients who received the expired vaccine had reported flu-like symptoms after receiving the vaccination but she did not have details on that.   This case was linked to MOD-2022-449812 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: Report type changed from invalid to spontaneous. Added patient details and dose details.
Generalized rash & hand & wrist pain w/swollen finger joints; pain lasting 2.5 wks continues to have hand & joint pain;