chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown gender and ages. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were inadvertently administered with GARDASIL 9 (lot # L016429, expiry date: 09-AUG-2017; lot # L018351, expiry date: 11-AUG-2017) that had not been improperly stored at a temperature of 34.5 F for 5 hours. The outcome of the excursion was reported as supported. No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
given pnemovax IM in L delt, #2 which was more than 5 years after date of #1, #1 was given before the pt was age 65 years.  Pt reported extreme swelling in tenderness in the L arm the next day.  Afrebrile, without other symptoms.  Pt came into clinic the next day. Noted swelling on bicep, pink, 6 inches in diameter.
Disseminated rash/whole body rash; This is a spontaneous report from a contactable nurse. This nurse reported for a 50-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 19Feb2021 (at age of 50-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included ovarian cancer from an unknown date and unknown if ongoing, had ongoing chemotherapy. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on an unspecified date for COVID-19 immunization. On 22Feb2021 it was reported that, patient was undergoing chemotherapy (chemotherapy not captured as suspect) but patient got COVID vaccine it was the Pfizer vaccine and did end up with rash it was disseminated rash; had whole body rash. Therapeutic measures were taken as a result of disseminated rash/whole body rash as patient had received Benadryl. The patient underwent lab tests and procedures which included blood count: unknown results on 22Feb2021. The outcome of event was unknown. When probed for causality, nurse stated; she got the injection on that Friday and then on that following Monday that was the 22nd and she had a whole body rash.  No follow up attempts are needed; Information about Lot and batch number could not be obtained. No further information is expected.
Patient was given the Moderna vaccine in assumption that it expired on 04/06/2023. When it was being documented after the vaccine was given it was found that it actually expired on 03/11/2023 - 2 days prior to it being given. The expiration date was for the date that it was expired from being stored in the refrigerator instead of the actual expiration date of the vaccine. Saw patient on 03/27/2023 for further catch up vaccines and he was doing fine. No problems from Moderna vaccine that he received that was expired.
Clinical impression: Dizziness. ED Physician Note; Chief Complaint: Patient presents with Dizziness. History of Present Illness: Patient is a 69 y.o. male with hx of hypertension, anxiety, presenting to the ED with reports of dizziness which began upon waking up this morning.  Patient states that he was recently diagnosed with COVID-19 viral infection on 3/19/2021.  He states he was primarily tested secondary to a family member having confirmed infection.  He states he has not had any significant cough, shortness of breath, fevers, chest pain, or difficulty breathing over the past few days.  He additionally denies any dizziness or difficulty ambulating until this morning.  He states this morning when he woke up he felt as though he was having an unsteady gait, reports "feeling like I am drunk".  He denies any sided weakness, numbness/tingling, changes to his speech, or additional symptoms at this time.  He additionally is denying any urinary symptoms, changes to bowel movements, or black/bloody appearing stool.  He denies any prior history of vertigo or dizziness in the past. Exposure to COVID-19 virus.
Photo available.  Hot, red, swollen , severe itching aprox 3in x5 in around injection site.  Very much resembled cellulitis.
I did not have a reaction to the vaccine. On 11/23/2022, I woke up with facial paralysis. I had an appointment with my doctor and was prescribed an antiviral medication for one week and prednisone for two weeks. On my own, I went to an acupuncturist for my symptoms. I went to the emergency room to be evaluated for a stroke. I was admitted for one night and it was determined that I was not having a stroke. I was diagnosed with Bell's Palsy. As of today, I am symptom free.
This spontaneous report as received from a physician refers to a 7 months old male patient with a history of being a premature baby who on 26-JUL-2012, was vaccinated with the first dose of ROTATEQ (dose and lot number not reported). The physician stated that since child was born preemie at 31 weeks, the usual childhood vaccinations, unspecified, were given, today on 26-JUL-2012. No adverse effects were reported. Additional information is not expected.
Pt stated that she had a developed a hard warm patch on her arm the day after the injection. Area is about 2x2" has not worsen over time. Pt stated redness was a couple inches below site of injection.
Patient fainted after receiving  Janssen Covid 19 vaccination  while sitted for the mandatory 15 minutes observation time.  Patient slumped on the chair. Patient was helped to the floor, wet paper towel placed on his head and he became conscious. We immediately  dialed 911 for emergency help. Ambulance arrived shortly after and he was transported to the hospital .
Ached after vaccine as one would expect. Radiated up whole arm. Limited range of motion. Pain with movement continues and has worsened now almost four months later. Still with limited range of motion and significant discomfort.
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 17-year-old female patient who received BEXSERO. On 28th July 2017, the patient received BEXSERO. In July 2017, less than a week after receiving BEXSERO, the pateint experienced injection site erythema, injection site swelling, injection site warmth, tingling of extremity and general body pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, tingling of extremity and general body pain were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, tingling of extremity and general body pain to be related to BEXSERO. Additional details were provided as follows: The sales representative received the information from the pharmacist as well. On 31st July 2017, the patient returned the office with tingling in arms down to hand and up to her neck. The patient was also having body aches and the injection site was red with a large bump and warm to touch. The adverse events had been reported through VAERS.
around 12:30am 1/21/21 patient experienced shivers/chills. self resolved by 5:30am. Awoke 1/24/21 around 8am with slight headache,  feeling "off", joint & muscle pain.  Woke up Monday 1/25/21 feeling worse.  Advised to obtain flu/covid tests by primary provider. Both tests were negative. 1/28/21 patient noticed swelling in the right ankle mostly, slight swelling in left ankle. Patient has been icing/elevating joint.
internal bleeding; had shingles before getting the vaccine /recovered but after getting the vaccine "I've broken out again"/breakout again of Shingles; This is a spontaneous report received from a contactable consumer reporting for herself   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 15Mar2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included Shingles. Concomitant medications were not reported. On 15Mar202 after the vaccination the patient was hospitalized for internal bleeding. It was informed patient  has been out of the hospital for a week and a half. The patient also reported she had shingles on an unspecified date before getting the vaccine that was recovered,  but after vaccination she had broken out again"/breakout again of Shingles. At the time of the reporting events outcome was unknown. The patient was scheduled for second dose of vaccine on 05Apr2021.    Information on the lot/batch number has been requested.
broke out in hives; Need to clear throat; This case was reported by a physician via call center representative and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date unknown) for prophylaxis.   Previously administered products included pennicillin with an associated reaction of anaphylactic reaction (anaphylaxis after receiving pennicillin, cephalosporins, propofol and also a severe case of  angioedema after lisinopril), lisinopril with an associated reaction of angioedema, propofol with an associated reaction of anaphylactic reaction and cephalosporins with an associated reaction of anaphylactic reaction. Concurrent medical conditions included anaphylaxis.   On 4th September 2019, the patient received the 1st dose of Shingrix. On 4th September 2019, immediately after receiving Shingrix, the patient experienced hives and throat discomfort. On an unknown date, the outcome of the hives and throat discomfort were recovered/resolved.   It was unknown if the reporter considered the hives and throat discomfort to be related to Shingrix.   Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient with a history of history of anaphylaxis after receiving penicillin, Cephalosporins, Propofol and also a severe case of angioedema after lisinopril. Immediately after receiving the 1st dose of Shingrix the patient broke out in hives and had to clear throat.  The symptoms passed with no treatment after a few hours.  The reporter did not consent to follow up.
extreme body aches all over body, raise blood vessel in back of left hand and sharp pain in the area
suspected Vaccination failure; Got a light case of shingles a year later / got shingles after my second COVID shot; Still itchy; This case was reported by a consumer via facebook interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis, COVID 19 VACCINE for prophylaxis and COVID 19 VACCINE for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine, the 2nd dose of COVID 19 VACCINE and the 1st dose of COVID 19 VACCINE. On an unknown date, 1 year after receiving Shingles vaccine and more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient got both doses of the vaccine and got a light case of shingles a year later and it was still itchy. The patient got shingles after second COVID shot. The patient asked if this was related. It was unknown if the reporter considered the shingles and pruritus to be related to Covid 19 vaccine. The case was considered, as suspected vaccination failure since the details regarding laboratory confirmation was not provided.
Information has been received from a physician concerning a female with no known medical history, who on 15-OCT-2008, was vaccinated with a dose of ZOSTER vaccine. The physician that on 17-OCT-2008, the patient experienced a severe injection site reaction, after received ZOSTER vaccine. The patient had 48 hours of extreme pain on the injection site, and then three days of red patch on her arm. The patch was red, itchy, painful, swollen and hot to the touch. The patch extended to the most of the upper arm. The patient sought medical attention and saw a physician. At the time of the report the patient was recovering. Additional information has been requested.
LOSS OF VISION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the patient had symptoms of loosing vision. and at 19:30, she experienced loss of vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of vision. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210349284-COVID-19 VACCINE AD26.COV2.s-loss of vision. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
leg pain; Sleeping is difficult due to pain in calves; So Much Pain in Calves of Both Legs; Warmth in Calves; swelling in the calves of the legs; difficult to get on my feet to walk; Calves feel Hardened; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 11:00 (Lot number: EN6198, Expiration Date: 30Jun2021) at the age of 80 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL taken for blood pressure abnormal (ongoing); BENAZEPRIL taken for blood pressure abnormal (ongoing); CRESTOR taken for blood cholesterol abnormal (ongoing). Vaccination history included: Bnt162b2 (First vaccine dose, LOT: EN6201 Left Arm), administration date: 11Feb2021, for Covid-19 immunisation; Prevnar (No NDC, Prevnar Lot: PAA135492, No expiration. 0.5 dose, Left Arm.), administration date: Oct2020, reaction(s): "temperature", "red, hot, swollen down to elbow and hand", "red, hot, swollen down to elbow and hand", "effected her movement of her hand", "swelling in her left arm", "rash"; Prevnar (No NDC, Prevnar Lot: PAA135492, No expiration. 0.5 dose, Left Arm.), administration date: Oct2020, for chills; Infuenza vaccine. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "leg pain"; PERIPHERAL SWELLING (non-serious) with onset 05Mar2021, outcome "not recovered", described as "swelling in the calves of the legs"; GAIT DISTURBANCE (non-serious) with onset 05Mar2021, outcome "not recovered", described as "difficult to get on my feet to walk"; MUSCLE SPASMS (non-serious) with onset 05Mar2021, outcome "not recovered", described as "Calves feel Hardened"; INSOMNIA (non-serious) with onset 07Mar2021, outcome "not recovered", described as "Sleeping is difficult due to pain in calves"; PAIN IN EXTREMITY (non-serious) with onset 05Mar2021, outcome "not recovered", described as "So Much Pain in Calves of Both Legs"; FEELING HOT (non-serious) with onset 05Mar2021, outcome "not recovered", described as "Warmth in Calves". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling, gait disturbance, muscle spasms, insomnia, pain in extremity, feeling hot.  Additional information: Treatment: No treatment; she states to be perfectly honest, she considered going to the Emergency Room that was how uncomfortable she was. She was very active and played pickleball a few days ago and never has leg problems of any kind. She clarifies that the pain was there if sitting or standing. Her calves feel hardened (firm), swollen and warm. She has been up and about and it has been painful before but not as bad as today and the swelling was acute today.  No follow-up attempts are possible. No further information is expected.
30 minutes after injection started shaking and had chills.  Had "hourglass hives" on face.  Next morning tongue was swollen and developed hives all over body.  Throat and mouth was "beet red" saw family MD on 10/09/2003, was given Prednisone 20 mg one time a day for 1 week and Benadryl 25mg, `1 tab every 4 hours.  Had chills again today 10/13/2003 "right knee is swollen since 2 days after injection".  History of right knee surgery, history of breast cancer.
On the 15th of May I began to feel sick having congestions, and ear ache.  The next few days I had a sore throat along with a great deal of chest and nasal congestion.  On May 18th, I tested using an at home test, negative.  Every day until the 24th, I tested this way, all negative.  On May 24th, I had a PRC test, also negative.  I began to feel better by the 20th of June.  Simbacort was prescribed by the doctor to treat symptoms.  Not very effective.
About an hour or so later her arm started to hurt from the shoulder down to the wrist area.  She began to feel weak.  Pt thought having an MI.  Went to ER and put on monitors.  All tests came back normal but ER doc felt like was possibly a reaction to the vaccination.
During return appt 3/29/11 c/o ache (R) forearm 1 week after admin of TWINRIX (R) deltoid.  Pain not resolved. Referred to clinic for f.u. & eval.  Vaccine given at STD clinic.
A report has been received from a Health Professional concerning an 11 year old, Male subject, who had been received Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 04-Dec-2014. The patient was administered by expired FLUMISTT which started on 04-Dec-2014. The outcome of the event of EXPIRED FLUMIST ADMINISTERED TO A PATIENT is unknown. The report was considered to be non-serious.
pt recv vax & exp chickenpox & a rash w/about 50mauclopapular lesions w/a few of them starting to be small vesicular shaped especially in back;MD noted pt exp no fever, no itching;
Information has been received from a third party claims administrator on behalf of a pharmacy concerning a female patient who was vaccinated with ZOSTAVAX (date of administration not provided) and sustained an adverse reaction to the vaccine (not further specified) on 24DEC2012. Additional information has been requested.
Swollen lymph nodes under chin, swollen injection site, numb middle toes on right foot
Dizziness, Myalgia, CHILLS, FATIGUE, L ARM SORE AT INJECTION SITE, RED AND TENDER Narrative:
Soreness in arm; Headache; Swelling; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), PAIN (Soreness), PAIN IN EXTREMITY (Soreness in arm) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced SWELLING (Swelling), PAIN (Soreness) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 26-Jan-2021, SWELLING (Swelling), PAIN (Soreness) and HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Soreness in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: New Event (Pain in extremity) was added.
2 hives at injection site, 1 in left groin and 1 on left leg appeared Monday 4/27/15.
Dizziness, vertigo with room spinning, difficulty walking without assitance. Nausea and severe vomiting. Nausea and tired for 2 days
Staff  in to room with mom and staff reviewed vaccines to be given  mom in agreement with vaccines being given. vaccines explained and given per staff. when staff went to complete orders in chart  noted that. vaccines had changed  in review, Notified doctor of  incident, child was  still to get the vaccines that were  given on a  different catch up schedule, so orders were changed again to the  match the vaccine administered today.
Facial Paralysis of the left side, including the forehead of acute onset that occurred two days after receiving the vaccine; moderate to severe pain on the left side of the back of the neck and head.; moderate to severe pain on the left side of the back of the neck and head.; This is a spontaneous report from a contactable consumer (patient).  This 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL3247) at the age of 66 years via an unspecified route of administration at single dose in the left arm on 28Jan2021 05:30 for COVID-19 immunisation. Medical history included appendicectomy, prediabetes, aortic valve calcification, allergy to Sulfa. Concomitant medication included pantoprazole. The vaccine was administered at Clinic. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient previously took codeine and experienced allergy. On 30Jan2021 07:00, the patient experienced facial paralysis of the left side, including the forehead of acute onset that occurred two days after receiving the vaccine (medically significant), moderate to severe pain on the left side of the back of the neck and head. Primary Care physician prescribed Prednisone 20 mg BID (twice a day) for 5 days with improvement of neck pain but no improvement on facial paralysis. Facial paralysis has improved in 60%, still with some degree of compromise. The outcome of the events was recovering.
Pt came to ER c/o fever, chills, cough, mild headache for the last few days.
Received dose 1 of moderna.  Now experiencing vertigo, tingling of pins and needles all over my body, hands going numb, headaches prolonged.  No sign of symptoms getting better.  Going on 5 days went to urgent care.  Nothing really given for help.
This spontaneous report as received from a health worker refers to an unspecified amount of patients of unknown age and gender. The health worker reported that PNEUMOVAX23 (lot #, dose, route not reported) that underwent a temperature excursion had been administered to these unspecified amount of patients on an unknown date. Concomitant therapies were not reported. No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
Beginning on the second day after the patient first vaccine she began experiencing fever up to 102.5, body aches, headache, profound fatigue, chills and nausea. She came to my clinic as this is her 9th (ninth) day of experiencing fevers and fatigue. The other symptoms have resolved.