chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain all over body like when one exercises whole body. Continuous pain throughout body constantly moving, Cymbalta was first prescribed and caused other issues, Sabella was then issued for treatment. Testing for fibromyalgia. In Aug. had a new issue with a tingling (like pins and needles) feeling in left leg, felt cold, numbness on shin. Also, had a panic attack because thought it was a heart attack.
Full body hives and angioedema. Urgent care 3/26/2021 no tests provided - given prednisone.
allergies over reacted, lyphnodes  swollen, sore jaw. Jaw dysfunction abnormal taste.
Information has been received from a physician assistant concerning a 29 year old female patient who on 13-APR-2009 was vaccinated with GARDASIL IM. On 14-MAR-2009 night the patient experienced dizziness. The patient felt so bad that she went sleep and was better when she woke up. "Today" after working out, it came back. The patient was also having headaches that felt like migraines. The patient "currently" being seen at her physician's office. At the time of reporting the patient's dizziness and headaches felt like migraines persisted. Follow-up information has been received from the administration staff in the physician's office that on 14-APR-2009 the patient was vaccinated with her first dose of GARDASIL (lot # 658271/0558X) IM. The patient did not receive any other doses. There was a phone consultation on 15-APR-2009 when the patient complained of motion sickness and blurry vision. The patient came in on 15-APR-2009 and complained of dizziness and headaches. The doctor suggested taking EXCEDRIN MIGRAINE or TYLENOL for the headaches. No medications were dispensed. The patient was not hospitalized. The office had not heard back from the patient at this time. Additional information has been requested.
Nasal congestion, wheezing, slight sore throat,  coughing, laryngitis, inside fever and cracked lips.
Rash to face, swollen eyes, raised bumps on back. Child transported to hospital by ambulance.
Post vax, area on left deltoid became reddened, warm and swollen. On 3/15/2000, redness and swelling measured 5.3cm x 10cm. Also, complained of nausea for 1 day.
Not feeling good; Started having rashes on her hips on both sides/ the rash start to go to her abdomen, butt cheeks, and back; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling good) and RASH (Started having rashes on her hips on both sides/ the rash start to go to her abdomen, butt cheeks, and back) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   No Medical History information was reported.  In February 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced FEELING ABNORMAL (Not feeling good) and RASH (Started having rashes on her hips on both sides/ the rash start to go to her abdomen, butt cheeks, and back). At the time of the report, FEELING ABNORMAL (Not feeling good) and RASH (Started having rashes on her hips on both sides/ the rash start to go to her abdomen, butt cheeks, and back) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medication information was reported. No treatment medication information was reported. Patient's rashes are similar to mosquito bites and there are no big lesions. Patient takes  medications but reporter does not have a list. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Dizziness; Sore throat; Hot water hurt her skin; Arm is in so much pain the cannot move the arm.; Freezing cold at room temperature; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Hot water hurt her skin), PAIN IN EXTREMITY (Arm is in so much pain the cannot move the arm.) and FEELING COLD (Freezing cold at room temperature) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Hot water hurt her skin), PAIN IN EXTREMITY (Arm is in so much pain the cannot move the arm.), FEELING COLD (Freezing cold at room temperature) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Hot water hurt her skin), PAIN IN EXTREMITY (Arm is in so much pain the cannot move the arm.), FEELING COLD (Freezing cold at room temperature) and FATIGUE (Fatigue) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Pt. stated, "I started feeling tingling on my upper lip and numbness on my nose, 15 min. after getting vaccinated."  Vital signs done B/P 164/85, HR 86, O2Sat 97%, R 19.  At 12:56pm, pt. stated, "Tingling and numbness is going away."  At 1:10pm B/P was 140/78.  At 1:14pm pt. reported feeling better.  At 1:16pm pt. went home.
Soreness in upper arm and radiates to shoulder and back. Worse at night when trying to sleep on either side.
Inadvertently administered third dose. When checking database before the booster, discovered that the patient had already received both doses of the vaccine series in 2018. Both the patient and pharmacy manager were informed. Patient did not report any adverse reaction to the extra vaccine dose.
weak; dizzy; 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 ASTHENIA (weak) and DIZZINESS (dizzy) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak) and DIZZINESS (dizzy). At the time of the report, ASTHENIA (weak) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications were not provided.
I lost my sense of smell and a little bit of sense of taste. I could have a whole cap of lemon juice and it tasted sweet. This lasted about 5 days and slowly got better. My taste would be ok in the morning then would go away again in the afternoon. I had two telehealth visit and they had me tested for COVID, I tested negative. I tested again a few days later and was negative again. My Doctor said it was most likely a viral infection.
The patient developed raised redness and swelling approximately 1.5-2 inches in diameter after receiving the immunization.
she is not feeling well today; headache; numbness; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: unknown), via an unspecified route of administration on 06Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. After vaccination the patient experienced headache and numbness in Mar2021 and on 27Mar2021 she was not feeling well. The patient was request for a reschedule of her 2nd dose (due 27Mar2021) because she was not feeling well. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Moderna Covid-19 Vaccine Bivalent  Severe chills the first evening after the vaccine in the morning.  Normally my heart rate at night is low 60s but all night and through the next morning it raced to 110 BPM.  Spiked a temperature of at least 102 degrees over night.  Blood oxygen was about 94 fairly consistently. Low grade headache by the next morning.  Lost most of my energy by the next morning and through the next day.  Blood pressure was elevated for a couple of days. Blood sugar was elevated for at least 3 days.  The first day after the shot I started coughing strongly although it was a "dry" cough.  Throat was somewhat sore.  The second day my lungs were getting very sore from coughing.  Was able to cough up a small amount of "flem?".  The coughing still persists this the sixth day after the injection.  The other symptoms are pretty much subsided by now.
Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old patient who experienced received a dose of vaccines ACT-HIB via unknown route and site of administration and by mistake also received full dose of PENTACEL via unknown route and site of administration instead of HEPATITIS B VACCINE (Lot number was not reported for all of the vaccines) on 23-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and extra dose administered. It was not reported if the patient received a corrective treatment. It was unknown if patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: None.
This spontaneous report was received from a licensed practical nurse and refers to multiple patients of an unknown age and gender. No information regarding the patient's concurrent conditions and medical history was provided. On an unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored RECOMBIVAX HB (dose, route of administration, lot#, expiration date were not reported). The patients' concomitant therapy was not reported. There were no adverse effects reported. Product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm eight hours after the booster and is still on going) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. April 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 3, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 3, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient had pain in extremity (sore arm eight hours after the booster and is still on going). At the time of the report, pain in extremity (sore arm eight hours after the booster and is still on going): not resolved. No concomitant medication or treatment information provided. This case linked to MOD-2021-375348 (patient link).
Hives developed 3 - 4 days after receiving the vaccine.  Started on her arms and legs then spread to her trunk and neck.  Saw her PCP for treatment - received hydrocortisone.  3 days ago received a prednisone shot at her PCP.
GI system is still little bit sensitive; diarrhea; had 6 hives near the injection site that were not itchy or large for hives she has had in the past; extreme tiredness/getting very very tired; could not keep eye open past 19:30 to 20:00/literally falling asleep while doing things; metallic taste in mouth; Terrible Nightmares; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7533 and expiration date: Jul2021), via an unspecified route of administration on 29Mar2021 at 13:30 (at the age of 53-year-old), dose 1, single for COVID-19 immunisation. Medical history included asthma, allergy to animals, hives, and calcium deficit disorder. Concomitant medications included salbutamol (ALBUTEROL) over 20 years; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for one and a half year; fluticasone propionate (FLOVENT) for at least 5 years not 10 or more and Amphet/Dextr (as reported). The patient stated around 19:30, she had 6 hives near the injection site that were not itchy or large for hives she has had in the past. The patient stated she had extreme tiredness and could not keep her eyes open. The patient stated she had a metallic taste in her mouth that lasted several days. The patient also had diarrhea. The patient stated she has a history of asthma and would like to know if this would affect the reasoning for receiving the second dose and if others who received the vaccine had a history of asthma. The patient stated about 05:00, she was getting very tired, may be even earlier and she went off to bed and she was giving herself a message and she had terrible nightmares that night. The patient could not keep her eye open past 19:30 to 20:00, she was literally falling asleep while she was doing things.  In addition to that she had six hives near the injection site. The patient had a metallic taste in her mouth which she still has and had diarrhea the next day and her gastrointestinal system was still little bit sensitive. The patient stated none of the reactions require any medical attention, but her doctors has suggested that she should get in touch with Pfizer directly, because she given reactions, she thinks she should not get the second dose of the vaccine.  The patient called her doctor on the day of report. The patient had lab work done on 18Mar2021, the usual stuff for annual physical, cholesterol (as reported) which showed nothing unusual, everything was in normal range. The events were reported as non-serious. The outcome of the events metallic taste in mouth was not recovered and outcome of other events was unknown.  No follow-up attempts are possible; No further information is expected.
Onset immediate, result GBS. Hospitalization, intubation, 6 treatments plasma exchange. Rehabilitation inpatient and outpatient July 2009 - May 2010. Still debilitating residual effects - will be lifelong health problems.
devel rash, severe joint pain, dizziness, fever x 1 day; c/o of pain & joint pain;
Chills and elevated temperature of 100 F 12 hours after second vaccine dose.  Skin sensitivity (like a sunburn) and elevated pulse continues through next car.
Information has been received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported. On 06-DEC-2018, the patient was vaccinated with improperly stored VARIVAX injection, for prophylaxis, lot number R009821 with expiration date in 03-APR-2020 which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (dose, strength and anatomical location not reported). The VARIVAX was stored at a temperature range of -9 degrees Celsius (°C) to 8 °C (2.8C) for the time frame of 37 hours. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1812USA010605: US-009507513-1812USA008007: US-009507513-1812USA010606: US-009507513-1812USA010603:
Information has been received concerning a 10 year old female who within the last month (in July 2008), was vaccinated with the first dose of GARDASIL (Lot No. not reported). The patient complained that the injection was very painful and she cried. She was given 4 other injections after that. They gave her ice and elma after. The outcome of the adverse events was not reported. Additional information is not expected.
This spontaneous report as received from a nurse via a company representative refers to a 14-year-old male patient. The patient had no pertinent medical history and no concomitant medications. On 25-NOV-2014, the patient received the first shot of GARDASIL (lot number K006191) and the second shot on 02-FEB-2015 (lot number K006191), both intramuscularly. The patient never received a third dose of GARDASIL. On 23-MAY-2015, the patient began experiencing vomiting and headaches and he was taken to the emergency room of an unspecified hospital. He was not admitted. In April 2016, the patient was admitted to an unspecified hospital due to vomiting and headaches and was released on an unspecified date. On 19-MAY-2017, the patient went to the emergency room of an unspecified hospital because of experiencing abdominal pain and diarrhea. The patient sought medical attention and was treated. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010511.
Patient said that they were scared of needles. Patient was ok during her vaccine. Only after I finished the shot  she passed out. We called 911 to make sure she was o.k. even though she said not to call.
I'm sick one whole month and counting later after my shot.; Initial information received on 12-Dec-2020 regarding an unsolicited valid non-serious case received was received from a consumer (patient) via media.  This case involves an unknown age patient who sick one whole month and counting later after her/his  shot (illness), while he/she received vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, for Prophylactic vaccination.  On an unknown date, it was reported that the patient sick one whole month and counting later after her/his shot (illness) (Unknown latency) following the administration of Influenza Vaccine.  Final diagnosis was the patient sick one whole month and counting later after her/his  shot (illness).   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
None. Menactra was given in place of Prevnar. No symptoms or treatment to report.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot# reported as L013428, expiration date 03-FEB-2017, dose and site of administration were not reported) intramuscularly. No adverse effects were reported. Additional information has been requested.
Pt had a feeling of numbness after receiving shot. After receiving a dose of acetaminophen pt felt better however she started to have blood pooling and this continued until the 21st. The amount of blood pooling was decreased.
Got shot at 10:30-at 2:30, fever, chills, discomfory (lasted 3 hours). Took no medicine, woke up next day feeling fine.
Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with agencies to determine next steps for patient after discovery. Re-vaccination advised and outreach team contacting impacted patient and offering to speak with a physician to discuss.
Right side of body tingling and heaviness; Right side of body tingling and heaviness; slurred speech; difficulty walking; difficulty concentrating; urinary incontinence; This is a spontaneous report from a contactable other health professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiration date not provided), via intramuscular, in right arm, on 05Feb2021 10:30 (at the age of 40-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included known allergies, and hypertension. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication was reported as "no". Patient did not receive other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283 and expiration date not provided), via intramuscular, in right arm, on 15Jan2021 14:00  (at the age of 40-year-old), at single dose, for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Feb2021, the patient experienced right side of body tingling and heaviness, slurred speech, difficulty walking, difficulty concentrating, urinary incontinence. Patient was hospitalized for 2 days. Events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures after the vaccination, which included COVID-19 test (Nasal Swab) was negative on 12May2021. No treatment received for events. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the events of right side of body tingling and heaviness, slurred speech, difficulty walking, difficulty concentrating, urinary incontinence cannot be excluded completely. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to  Committees and Investigators, as appropriate.
adverse event they experiencing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse event they experiencing) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse event they experiencing). At the time of the report, VACCINATION COMPLICATION (adverse event they experiencing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
pt recv 2 doses of Hep B vax on 30MAY92 & 9JUL91; 9JUL92 pt exp joint pain & limited ROM; pt refused any tx & @ the time of report sx persisted;