chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loss of appetite; food doesn't taste right; mild headache; tiredness; sore throat for 3 days; 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 parent.  A 17 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), when the patient was 17 years old, for Covid-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "recovered", described as "sore throat for 3 days"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; DYSGEUSIA (non-serious), outcome "unknown", described as "food doesn't taste right"; HEADACHE (non-serious), outcome "unknown", described as "mild headache"; FATIGUE (non-serious), outcome "unknown", described as "tiredness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
started to experience a burning sensation as he urinated and now he has a UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (started to experience a burning sensation as he urinated and now he has a UTI) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013m20a and 032l20a) for COVID-19 vaccination.     Concurrent medical conditions included UTI and Bladder cancer. Concomitant products included MONTELUKAST, OMEPRAZOLE (OMEPRAZOL 1 A PHARMA), ROSUVASTATIN CALCIUM (CRESTOR) and Presidon for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced URINARY TRACT INFECTION (started to experience a burning sensation as he urinated and now he has a UTI). At the time of the report, URINARY TRACT INFECTION (started to experience a burning sensation as he urinated and now he has a UTI) outcome was unknown.            No treatment details was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional info-1
Initial unsolicited report received from a physician on 05-JUN-2017. This case involves a nine months old male patient who was vaccinated with a first dose of YF VAX (batch number UI266ab, expiry date, dose and route of administartion was not reported) at left thigh on 30-May-2017. Patient's medical history reported as none. Concomitant medications included as vaccination with HEPATITIS B VACCINE (Heb B) and with MEASLES, MUMPS AND RUBELLA VACCINE (MMR) on unspecified date. On 05-Jun-2017, six days following the vaccination, the patient experienced a welt like lump over the vaccination site, a bullseye type ring on his left thigh with a dark redddish spot in the center and measured it to be 2 cm by 1cm with no heat but bruising noted at the center. It was reported that the patient required emergency room/doctor visit. Laboratory investigations was reported as none. Patient received no corrective treatment. It was reported that patient did not recovered from the events. List of documents held by sender: none.
Severe stomach nausea, cramping 101 -102 fever, joint pain and whole body muscle aches, severe dehydration,  4/9/-4/20/2021
This case was reported by a physician via sales rep and described the occurrence of reactogenicity event in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (more than 5 years prior to vaccination with SHINGRIX). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced reactogenicity event. On an unknown date, the outcome of the reactogenicity event was unknown. It was unknown if the reporter considered the reactogenicity event to be related to SHINGRIX. Additional details were reported as follows: At medical booth, the health care professional (HCP) asked about whether there were are higher rates of reactogenicity when SHINGRIX were administered in someone having had ZOSTAVAX in the past. The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient was not hospitalized. No additional details were provided. The reporter did not agree to follow up from GlakoSmithKline (GSK). This case was linked with case US2018GSK186137, reported by the same reporter. This.
10 month old had felt warm in afternoon after his shots.  Mom had him in her bed and he started having a seizure, showed lethargy.  Brought into ER.  She did give him Motrin earlier in evening.  He was given O2 in ER along with IV fluids, Tylenol suppository and Motrin.  Rectal temp 104.6 upon arrival and decreased to 100 after fluids, suppository.  Was observed for few hours and released.
Left thigh erythema & swelling extending 3 cm inferior to lower shot & 1/2 cm above upper injection site - supportive care ZYRTEC 1/2 tsp daily prn - Allergic Rx to vaccine.
Hives/ welts/ hives on arms and leg/ hives on left upper arm; Bumps; Itchiness/ itching/ back of right knee seemed itchy/ "The more I itched it, the itchier it got"; Red spots on back of leg and on back of other leg; Burning; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives/ welts/ hives on arms and leg/ hives on left upper arm), SWELLING (Bumps), PRURITUS (Itchiness/ itching/ back of right knee seemed itchy/ "The more I itched it, the itchier it got"), ERYTHEMA (Red spots on back of leg and on back of other leg) and BURNING SENSATION (Burning) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZ1A) for COVID-19 vaccination.     The patient's past medical history included Shingles in January 2021 and Surgery (Surgery in shoulder) in 2020. Previously administered products included for Shingles: Shingles vaccine in January 2021. Past adverse reactions to the above products included No adverse event with Shingles vaccine. Concurrent medical conditions included Allergy to arthropod bite (Reacting to bug bites severely- usually swell up and get itchy and hives). Concomitant products included CORTISONE and PREDNISOLONE for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced URTICARIA (Hives/ welts/ hives on arms and leg/ hives on left upper arm), SWELLING (Bumps), PRURITUS (Itchiness/ itching/ back of right knee seemed itchy/ "The more I itched it, the itchier it got"), ERYTHEMA (Red spots on back of leg and on back of other leg) and BURNING SENSATION (Burning). The patient was treated with HYDROCORTISONE (topical) for Hives, at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives/ welts/ hives on arms and leg/ hives on left upper arm), SWELLING (Bumps), PRURITUS (Itchiness/ itching/ back of right knee seemed itchy/ "The more I itched it, the itchier it got"), ERYTHEMA (Red spots on back of leg and on back of other leg) and BURNING SENSATION (Burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Medical history includes 30 days prior to vaccine, had shingles. 6 days prior to vaccination, completed cortisone patch.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received on 21-Jul-2021 contains Non significant information AE Contact information Updated.
Arm got the injection in is stiff; Felt weak; Arm got the injection in is sore; A spontaneous report was received from a consumer concerning a 77 years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm got the injection in is sore, arm got the injection in is stiff, and felt weak.   The patient's medical history was not reported. Concomitant product use included unspecified blood thinner.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 042L20A) on 26 Jan 2021.  On 23 Feb 2021, approximately one day prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 022M20A) in the left arm for prophylaxis of COVID-19 infection.   On 24 Feb 2021, the patient reported the arm which got the injection was sore & stiff and the patient felt weak the same morning. Patient reported forgetting to inform that patient was taking a blood thinner.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events arm got the injection in is sore, arm got the injection in is stiff, and felt weak is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
PATIENT FELT DIZZY AND LIGHTHEADED .  THEN HER KIDNEYS STARTED HURTING SEVERELY.  THE KIDNEY PAIN SUBSIDED IN A FEW MINUTES AND THEN PATIENT FELT WEAK AND SHAKEY.   HER BLOOD PRESSURE WAS 154/96 & PULSE 86 AND THEN LATER 154/90 & PULSE 89.  PATIENT FELT WEAK BUT WAS WELL ENOUGH TO WALK TO HER CAR.
I had the worse sore throat ever. Swallowing was very difficult & painful as I was unable to sleep. I also had sinus congestion & postnasal drip.
1 week after the vaccine: same arm as vaccination was sore.  started around 1pm.  raised area (like a bump).  throughout day and evening, same symptom.  Woke up on Friday 1/15/21 with very red area, raised, sore and hot to the touch.
Information has been received from a health professional concerning a female with a history of rubella who in 1976 was vaccinated with MMR vaccine. Subsequently the pt had a titer drawn which showed non immunity to rubella. She was then given a second dose of MMR vaccine. Additional info has been requested.
Pt had a syncopal episode 1-2 minutes after vaccination. He denies any prior hx of syncope or near syncope. Initial BP 90/60 and HR 46, SP02 99%. Repeat BP 100/68, HR 64. Pt recovered after 20-30 minutes of observation and was driven home.
Caller stated now her daughter is working on a cancer floor and had titers done which showed again no immunity; Her daughter had the VARIVAX booster in 2015 and in 2020 due to not having any titers for the vaccine/ 2015 where she had to have titers done that showed no immunity/ In 2020 where she had titers done again which showed no immunity again; Her daughter had the VARIVAX booster in 2015 and in 2020 due to not having any titers for the vaccine/ 2015 where she had to have titers done that showed no immunity/ In 2020 where she had titers done again which showed no immunity again; This spontaneous report has been received from a consumer, regarding a female patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On unspecified dates (reports as "as a child"), the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) two shots as prophylaxis (doses, routes and anatomical locations of administration, lot numbers and expiration dates were not reported)  On an unspecified date in 2015, the patient was tested for titers which showed no immunity (Antibody test negative), therefore she had to receive a booster of varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (dose, route and anatomical location of administration, lot number and expiration date were not reported). On an unspecified date in 2020, the patient had titers done which showed again no immunity (Antibody test negative), therefore she received a fourth booster of varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (dose, route and anatomical location of administration, lot number and expiration date were not reported). On an unspecified date in 2022 (reported as now), the patient got titers test again and no immunity was found again Antibody (Antibody test negative). Reporter stated the patient was not sure if she should get another booster since each time, she has shown no immunity to the vaccine and by the time of the report she has gotten four doses of varicella virus vaccine live (Oka/Merck) (VARIVAX). The outcome of Antibody test negative was not reported.  The causal relationship between Antibody test negative and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
I was driving to my job after 45 mins. Hot and chill flashes. Bones felt very cold. Layered up and then 5 mins later I was very hot, had to take it off. Chest tightness, hard to breathe. Called the doctor the next day and  went to the clinic. They said it was an initial reaction. The reaction lessen and by day 3, I was fine.
Rash on face, neck, abdomen, groin. Swollen lymph nodes.
Extremely uncomfortable; Difficult to sleep; Joints became painful; Stiff joint; Inflamed joints; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 03Apr2021 at 00:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included sore joints since caught COVID in Mar2020 and COVID-19 in Mar2020. The patient had no known allergies to medications, food, or other products. Concomitant medications included fish oil (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and cannabidiol (CBD OIL); all taken for unknown indication from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 14:00, the patient experienced most of the joints became painful, stiff and inflamed all night, making it difficult to sleep. On 04Apr2021, 22 hours after getting first vaccine shot, the patient was extremely uncomfortable. After the patient took the vaccine, her joints felt notably far more painful, more like they felt last spring and summer at their worst. The patient stated her joint problem was likely a COVID long-hauler condition. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events most of the joints became painful, stiff and inflamed all night, making it difficult to sleep and extremely uncomfortable was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. No concurrent condition, medical history or concomitant therapy was reported. Since 02-SEP-2015 or after the date, the patients were vaccinated with doses of improperly stored ROTATEQ (lot # K019370 with expiration date of 16-JUL-2016, dose unknown) orally. The excursion was reported as temperature at 47 F for 23 hours and no previous temperature excursion was reported. No adverse effect  was reported. This is one of several reports received from the same reporter. Additional information has been requested.
No further adverse effect reported; Medical assistant called to report that on 2/25/2020 patient received a dose of improperly stored ROTATEQ; This spontaneous report has been received from a medical assistant, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was not provided.  On 25-FEB-2020, the patient received the first dose of an improperly stored (product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot number S014947 and expiration date 10-DEC-2020 for prophylaxis (strength, frequency, route of administration and anatomical location were not reported).  The vaccine was stored at a temperature below 36 degree Fahrenheit (34 Fahrenheit) for a timeframe of 27 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No adverse reactions were reported.; Sender's Comments:  US-009507513-2002USA010005: US-009507513-2002USA009991:
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine. Additional details were provided are as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient got both Shingles vaccine shots and he still got shingles on his lower back. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
My Arm got a huge red swelling in the muscle, lots of inflammation, hurts, the pain goes up my arm into my neck.
c/o fever, chills, clammy and vomiting and fainted. Felt like she had been hit by a truck
I inadvertently administered the dose SQ instead of IM.  I advised the patient what happened and signs and symptoms to expect with SQ dosing.  No reaction at time of administration.
Expired Heplisav-B Dose Administered; Initial Report Received on 11-Jun-2021  A pharmacist reported that a 28 year-old male (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No relevant medical history was reported.  No relevant concomitant medications were reported.  On 11-Jun-2021, the patient received a dose of HEPLISAV-B (Lot # 933841, expiration date 06-Jun-2021, NDC # unknown, serial number 699727536567) in the left deltoid from a nurse. At the time of reporting, no site reactions or other adverse symptoms were reported.   No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Developed serum sickness on 11/30/15. Of note she was on her 10th day of CEFDINIR. Treated with ORAPRED. CEFDINIR discontinued.
Muscle pain, high fever 101,body pain,chills,headaches.  Swollen, red,hot shoulder for 5 days. Stomach pain due hight does of Tylenol and Ibuprofen Still taking Omeprozole
Mother reports that daughter developed patches of rash on lower abd, rt thigh & rt lower leg and black discoloration on the middle finger of both hands.
Intense itch at injection site. After adnibistration 1st dose second dose intense pain, fever see she body aches for 4 days missed work. July 21 2021 diagnosis pnuemonia been on falling health since
redness came back , size of coin; Redness in arm; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in arm), PAIN IN EXTREMITY (Soreness in arm) and ERYTHEMA (redness came back , size of coin) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ERYTHEMA (Redness in arm) and PAIN IN EXTREMITY (Soreness in arm). On 02-Feb-2021, the patient experienced ERYTHEMA (redness came back , size of coin). On 29-Jan-2021, ERYTHEMA (Redness in arm) had resolved with sequelae, PAIN IN EXTREMITY (Soreness in arm) had resolved. At the time of the report, ERYTHEMA (redness came back , size of coin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.
Patient fainted in the waiting room approximately 5 to 7 minutes after receiving Janssen COVID-19  vaccine. He was caught by his father and a bystander (preventing fall). Upon regaining consciousness, he began to experience loss of color, sweating and disorientation. I removed his hat and jacket and kept him upright with support to keep him from falling. He fainted/loss consciousness an additional 2 times (time between unknown). I was unable to get a BP reading on an automatic BP machine. I administered 0.3mg of epinephrine. Patient reported approximately 30-45 seconds later he was beginning to feel better. Diaphoresis improved and he began to regain color. EMTs arrived and took over care.
On 8/7/01, the pt complained of pain, redness in right upper leg after sliding on mat on large slide at the fair. Pt had 12" X 7" of redness on right upper leg and a blotchy rash on both legs. Afebrile. Admitted to hospital on 8/7/00 with apparent cellulitis at right upper leg. Discharge on 8/8/01.
Information was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. The patient's healthcare provider(s), recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 04-APR-2007, a healthcare provider at medical office administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On 03-FEB-2011, the patient was treated by her healthcare provider at a medical office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
bilat wrist pain and swelling started ~2 weeks after 1st dose, recurred 1-2 days after second dose with more prominent symptoms in wrists and also pain and swelling in ankles.