chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diffuse swelling of the entire upper arm; reported vaccine reaction that there was redness; fever; Initial information was received on 25-Aug-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 5 years old male patient who reported that diffuse swelling of the entire upper arm, reported vaccine reaction that there was redness and fever after receiving diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-Aug-2023, the patient received a dose 5 of 0.5 ml of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Suspension for injection) (Frequency : Once, lot U7564AA, Expiry date : 08-Nov-2024, strength was unknown) via intramuscular route in the right arm for Immunization.  On 23-Aug-2023 the patient developed diffuse swelling of the entire upper arm (peripheral swelling), reported vaccine reaction that there was redness (erythema) and fever (pyrexia) (latency : same day) following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (reported vaccine reaction that there was redness, diffuse swelling of the entire upper arm, fever).  At time of reporting, the outcome was Unknown for all the events.
Vaccinated 10/6/11. On 10/6/11 evening, eczema flare up occurred.
Reported to clinic on Tues 9/15/15 with c/o reddened area above vaccination site (given 9/12/15).  Inability to move arm on 09/13 and had 2.5"x5" area over site that was bright yellow and c/o headache 4/10 pain scale.  On 9/14 area progressed to raised reddened area and headache continued.  Now area raised and red, warm to the touch and has headache 2/10 pain.  ROM for left arm has increased, but still mildly sore.  Denies n/v/d, no CP or SOB, denies neck pain, denies n/t to distal extremity.  Taking 800 mg Motrin PO daily since Sunday 9/13.
no pain at left arm at  injection site but left arm tremor started approximately 8 hrs after injection and  developed into body chills, fever up to 102 degrees, body aches and pains which continued  for 17 hrs and then resolved with only OTC home treatment
Ringing in right ear occurring approximately 6-8 times per week. The ringing typically lasts 10-20 seconds. I have never had ear ringing or Tinnitus before.  I have developed a sudden allergy to deodorants and antiperspirants causing a rash in armpit.  I had been using same antiperspirant brand over a year with no issue. Upon getting rash in both underarms a few days after second Moderna  shot, I changed to a sensitive skin, aluminum free, antiperspirant which initially helped. After a couple months I switched to a deodorant only, with no aluminum or salts, and rash returned. Even switching back to the aluminum free antiperspirant gives rash. I have never had any allergic reaction to deodorants or antiperspirants prior.
A report was received from a health care professional on 11 November 2003 concerning 2 vaccinees of unknown demography who were inadvertently administered frozen Fluvirin vaccine on 11 November 2003. On 11 November 2003 2 vaccinees inadvertently received Fluvirin which had been frozen. At the time of the report the outcome was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
sore in the arm (left arm where the shot was given); hard (bump on the injection site); bump on the injection site; vaccination site itching; there is also a bit of rashes in the area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore in the arm (left arm where the shot was given)), VACCINATION SITE INDURATION (hard (bump on the injection site)), VACCINATION SITE SWELLING (bump on the injection site), VACCINATION SITE PRURITUS (vaccination site itching) and RASH (there is also a bit of rashes in the area) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore in the arm (left arm where the shot was given)), VACCINATION SITE INDURATION (hard (bump on the injection site)), VACCINATION SITE SWELLING (bump on the injection site), VACCINATION SITE PRURITUS (vaccination site itching) and RASH (there is also a bit of rashes in the area). At the time of the report, PAIN IN EXTREMITY (sore in the arm (left arm where the shot was given)), VACCINATION SITE INDURATION (hard (bump on the injection site)), VACCINATION SITE SWELLING (bump on the injection site), VACCINATION SITE PRURITUS (vaccination site itching) and RASH (there is also a bit of rashes in the area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment details include, cream and diphenhydramine for itchiness.
This spontaneous report has been received from a medical assistant referring to a 12 year-old patient of an unknown gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 16-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength, dose, route and anatomical location were not reported), lot # M034780 with expiration date on 15-APR-2019, for prophylaxis; which experienced a temperature excursion between 47 and 77 Fahrenheit degrees for 50 minutes on 16-MAY-2017 (also reported as 18-05-2017). Previous temperature excursion was between 47 and 77 Fahrenheit degrees for 3 hours. Data logger was involved. No adverse effects were reported and no additional information was provided. A product quality complaint was not involved. This is one of the multiple reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA008599: US-009507513-1706USA001035: US-009507513-1706USA001033: US-009507513-1706USA001034.
Patient approached triage nurse, reported of feeling tightness in her throat area and having difficulty to swallow, patient received pfizer booster vaccine at facility. Patient is given 50mg P.O Benadryl @1045, continue to monitor after receiving benadryl and mother of the patient is requested to call 911 due to that she did not want her daughter to receive EPIpen on site. Called 911 @1055 and remained to monitor patient, 911 arrived 1107 writer did the report to paramedics and patient departed with mother in the ambulance @1108
Unconsolable crying for over 24 hours, body shakes, muscle stiffness.
Sore throat; Swollen lymph nodes; injection site sore; fever; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 20Mar2021 at 10:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included WELLBUTRIN. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 20Mar2021, the patient experienced fatigue, fever, vaccination site pain, sore throat, swollen lymph nodes. The patient did not receive treatment for the reported events. The clinical outcome of the events fatigue, fever, vaccination site pain, sore throat, swollen lymph nodes was not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
LIGHT HEADED LOW BLOOD PRESSURE 86/56 HIGH PULSE RATE 144
CC both heels of feet hurt, looked bruised, hard to walk, warm to touch some stiffness of legs and cramping, also left wrist hurts as well. On 6/1/06 using crutches, can't walk no weight on foot, hurts. Advil taken.
Soreness, extreme tenderness at injection site.  Pins and needles sensation started in my feet and progressed upwards to my pelvis.  My fingertips started to go numb as well.  Went to emergency room as the numbness continued to spread.  Inflammation of spinal column was confirmed by MRI.  I passed out due to a Vegel/Vegas nerve response and was diagnosed with Transverse myelitis.  IV steroids x4 days with no results and then plasma exchange (5x
5 inch long swollen knot from site of injection down arm, 2 inch red itchy strip from site of injection across and down arm. 7-8 days for knot to disappear.
Swelling at injection site (R) upper arm. Swelling noticed 8-2-15. Patient complains of pain and warmth at site, off and on. Started 5 days after injection. Seen in office today.
fever; nausea; sore arm; This is a spontaneous report from a contactable consumer or other non hcp.   A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The Consumer reports that she administered with the first dose of the Pfizer's COVID-19 vaccine on Saturday, and they developed side effects after the administration of the vaccine. experienced fever, nausea and a sore arm after the administration of the first dose of the vaccine. The Consumer reports that the last 2 weeks she started to have the symptoms for COVID-19 infection again and she performed laboratory tests that denied having an infection for COVID-19 and Flu. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Very mild symptoms.  Lethargic and pain at injection site.  Completely back to ?old? self in 24 hours. Would I take it again?   ABSOLUTELY!!!!    My husband had no pain at injection but very mild lethargy.   He just took a nap yesterday...
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ehlers Danlos syndrome" (unspecified if ongoing); "POTS" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid on 02Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
original shot soreness then next day developed itch, then on 2nd day upon my evaluation had worse pain and red hot somewhat indurated round raised mass diameter 9.5 cm
RED, SWOLLEN, RIPPLED  TONGUE . HEADACHE LEFT-SIDE , FATIGUE
Headache, Sedation, Myalgia, Arthralgia, NauseaVomiting, Chills, night mares Narrative:   Other Relevant History:
Onset day 10 post injection of erythema, edema over an area of 5x7cm over the injection site.  Associated with mild tenderness, and moderate pruritis.  Slight increase in size over first 24 hours (to present).
Immediately after receiving the second Pfizer vaccine, she had a "rapid, heavy heart rate". It resolved but afterwards, she complained of dyspnea on exertion for 1.5 months (running on treadmill and walking to dorm on campus).
On or about 4/2/2021 I started having congestion, sore throat, headaches and stomach issues. I was so concerned that I even went to have a covid test. The test was negative, but the symptoms remained until now and have worsened over time. They became so bad that I had to consult with a gastroenterologist and immunologist. The gastroenterologist has found that many of his patients are reporting histamine reactions after the vaccine. Over the summer I experienced phantom smells, but the ENT never made the connection to the "vaccine". I also have had muscle aches, burning ear cartilage and burning eyes. The headaches never stop and my stomach hurts daily. I believe I have what would be described as GERD now.
Lt arm pain same day. Next morning fever 102.6 and nausea, worsening arm pain.
Numbness in arm / Numbness in pinky / Numbness in ring finger; Developed a dry cough; Severe muscle pain; Fever of 104; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (Numbness in arm / Numbness in pinky / Numbness in ring finger), COUGH (Developed a dry cough), MYALGIA (Severe muscle pain) and PYREXIA (Fever of 104) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 04-May-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. On 05-May-2021, the patient experienced HYPOAESTHESIA (Numbness in arm / Numbness in pinky / Numbness in ring finger), COUGH (Developed a dry cough), MYALGIA (Severe muscle pain) and PYREXIA (Fever of 104). At the time of the report, HYPOAESTHESIA (Numbness in arm / Numbness in pinky / Numbness in ring finger), COUGH (Developed a dry cough), MYALGIA (Severe muscle pain) and PYREXIA (Fever of 104) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Body temperature: other (High) Temp: 104F.         No concomitant medications or treatment details provided. No Treatment Medications were reported
Felt like was getting a sore throat; Felt tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of OROPHARYNGEAL PAIN (Felt like was getting a sore throat) and FATIGUE (Felt tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Felt like was getting a sore throat) and FATIGUE (Felt tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Felt like was getting a sore throat) and FATIGUE (Felt tired) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were provided by the reporter.
Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. Not Provided          Treatment information was not provided. Concomitant medications were not reported.
Red injection site; Swollen injection site; Painful injection site; Could not move right arm and shoulder; The site "might be infected"; shoulder mobility decreased; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, refer case US2019183587).   On 7th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 7th October 2019, 3 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain, injected limb mobility decreased, injection site infection and joint range of motion decreased. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and ibuprofen (Advil). On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site swelling, injection site pain, injected limb mobility decreased, injection site infection and joint range of motion decreased were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, injected limb mobility decreased, injection site infection and joint range of motion decreased to be related to Shingrix.  Additional information received were as follows: The patient developed a red, swollen, painful injection site on her right arm. She states the pain and swelling were so bad that she could not move her right arm and shoulder. She states that the pain decreased but persists, as did not the redness and swelling. She states she sought treatment with her dermatologist who stated the site might be infected. Treatment to site was ice and heat compresses and Advil. Th reporter consented to follow up. Emergency room visit required. The consumer did not have any further vaccine information for this adverse event.
Mild chills and sore arm with mild swelling on the day of injection. Sore arm/mild swelling for the next few days. Then everything improved/felt normal. But then a week after the injection, I noticed that my arm was suddenly more swollen than it was initially and my arm was itchy and had a mild rash around the injection site. This is the fourth evening since the reoccurrence (which was a week after injection) that my arm has had a mild itch, but the swelling has gone down dramatically. I feel mostly recovered, although my arm still itches in the evening a bit.
Been vaccinated / still got shingles/Suspected Vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient been vaccinated several years ago and still got shingles last year.  At the time of reporting this would be better to get. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
(R) arm pain, swelling at site, pain into (R) scapula, leg weakness, tingling in feet, fingertips off and on then weakness in leg like jelly then numb leg, stops at pubic area.
t103-104;pt taken to MD-said no infect-give pt APAP;lethargic, rash all over body, hard time breathing x 3 days;dx possible roseola;sleep excess;
stomach aches; swelling; redness; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9810), intramuscularly in right arm on 10Feb2021 at 14:20 as a single dose for covid-19 immunization. The patient was previously administered first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3249) intramuscularly in upper right arm on 20Jan2021 13:00 for covid-19 immunization. Vaccination Facility Type: University. Vaccine Administered at vaccine Facility: No. She has been having a diarrhea type problem the last couple weeks since a week after receiving her first dose of the covid vaccine experienced diarrhea on 27Jan2021. Medical history included ulcer, severe sepsis, kidney dialysis and flu shot. The patients concomitant medications were not reported.  She had a problem four years ago with an ulcer she did not know she had. She is lucky to be alive. She is not sure if this may have any bearing on what she is experiencing. She was in the ICU for 55 days and another 29 days in another hospital. She had severe sepsis and kidney dialysis. This occurred four years ago. HCP: She has not gone to her nurse practitioner in quite a bit, states she is out for a month. For a week her diarrhea was not the greatest, it was not much during the day, mostly at night. Then it started calming down where and she was ok through the night. She has a little bit in morning and she is ok during the day. States it is a runny kind of diarrhea type of thing. Wednesday (10Feb2021) she did not go at all. Yesterday (11Feb2021) and today (12Feb2021) she had a normal bowel movement. It was solid and a little bit of liquid. After lunch she ended up having to go to the bathroom again and she took Imodium. She has been taking Imodium off and on since she does not want to take too much. She had a stomach-ache this morning twice and she did not have stomach aches prior to this morning. She called the county and reported it to them and they told her they did not think it would be from the vaccine. With the first dose she had a sore arm the first night. With the second dose it was not as sore but there is redness and swelling. Outcome: States it is hard to say she would have to look at it, she noticed it more today. She is not on any medications she takes supplements and vitamins. States with the first dose it was nurses administering the vaccine and the second dose was administered by qualified personnel. She called her hcp and was told take Imodium. She is trying not to take too many Imodium. Patient did not visit to emergency room or physician Office. Prior Vaccinations (within 4 weeks):  none aside from first dose of vaccine. She had a flu shot on 04Oct2020. The patient experienced stomach aches, swelling, redness on an unspecified date. The patient underwent lab tests and procedures which included weight was lost on an unspecified date. States she is down to a third of stomach. The outcome of the events were unknown.
Shortly after patient returned home around 2pm in the afternoon  he went to sleep and then slept continuously for about 18 hours. No complaints or concerns besides excessive sleep, patient in fact feels very well after sleeping such a long period of time. Not excessively over-slept or under-slept prior to this excessive sleeping.