chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild local redness, tenderness, warmth at injection site; Mild local redness, tenderness, warmth at injection site; Mild local redness, tenderness, warmth at injection site; This spontaneous report was received from a nurse practitioner via other company; referring to a female patient of unknown age. The patient's current conditions, historical conditions, allergies and drug reactions could not be determined.  On an unspecified date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (strength, dose number, dose, frequency, route and anatomical location of administration, lot numbers and expiration date were not provided) administered as prophylaxis.  On an unspecified date, the patient experienced an allergy to the vaccine, consisting of mild local redness, tenderness, warmth at the injection site (vaccination site erythema, vaccination site pain and vaccination site warmth). The outcome of the events was not provided.  The action taken with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) regarding vaccination site erythema, vaccination site pain and vaccination site warmth was not applicable.  The causal relationship of the vaccine was assessed as related to the events.
ON 09/04/2021, CLIENT ARRIVED AT CLINIC TO RECEIVE PFIZER VACCINE SECOND DOSE ALTHOUGH SHE STATES ON HER CONSENT AND VERBALLY TO NURSE AT CLINIC THAT SHE HAD AN ALLERGIC REACTION CONSISTING OF HIVES AFTER HER FIRST DOSE. SHE ALSO VOLUNTEERED THAT SHE HAD A "CERTIFICATE OF EXEMPTION" NOTE FROM HER PCP THAT SHE IS EXEMPT FROM RECEIVING THE COVID-19 VACCINE/THAT SHE CANNOT RECEIVE THE COVID VACCINE.   SHE STATES THAT SHE WOULD LIKE TO HAVE IT ANYWAY AND EVEN TOOK BENADRYL PRIOR TO  COMING TO VACCINE CLINIC AND CARRIES AN EPI PEN.  SHE LATER STATED THAT THE CERTIFICATE OF EXEMPTION WAS FOR THE FLU VACCINE.  SHE STATED THAT HER DOCTOR DID NOT KNWO SHE WAS THERE. THE NURSE CONSULTED WITH DR. WHO RECOMMENDED SHE GO ELSEWHERE FOR THE VACCINE SINCE HERS WAS A "COMPLEX SITUATION".  SHE DID NOT RECEIVE A COVID VACCINE THIS DATE.
This case was reported by a nurse via sales rep and described the occurrence of rash in a 4-year-old male patient who received KINRIX (batch number GM7X3, expiry date 13th November 2017). Concomitant products included PROQUAD. On 1st June 2016, the patient received the 1st dose of KINRIX. On 1st June 2016, immediately after receiving KINRIX, the patient experienced rash and hives. The patient was treated with BENADRYL. On 1st June 2016, the outcome of the rash and hives were recovered/resolved. It was unknown if the reporter considered the rash and hives to be related to KINRIX. Additional details were provided as follows: The patient received the 1st dose of KINRIX concomitantly with PROQUAD and immediately after receiving both vaccines, the patient experienced a rash and hives beginning on his abdomen, and then it got spread to both arms, growing area, face and jaw. The patient was treated with Benadryl and was monitored in the office. The patient would follow up with an allergist. The reported batch number of KINRIX (UM7X3) did not exist and was updated to GM7X3 as per sales database.
EXTREMELY TIRED; UNABLE TO STAY AWAKE; WOBBLINESS; SHORTNESS OF BREATH; PAIN AT INJECTION SITE; NOSEBLEED; LETHARGIC; This spontaneous report received from a patient concerned a 77 year male. The patient's height, and weight were not reported. The patient's concurrent conditions included Chronic obstructive pulmonary disease (COPD). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: Unknown) dose was not reported, 1 total dose, administered on 06-APR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported.  On 06-APR-2021 (evening), the patient experienced extremely tired and lethargic. On 07-APR-2021 (the day after), he developed nosebleeds. For a long period of time, he felt extremely tired, and he was unable to stay awake. Later, he developed wobbliness. On 17-APR-2021, he was taken to emergency room (ER) and was admitted to the hospital for couple of days. His all tests and assessments were performed which came out clear. He also experienced shortness of breath, and pain at injection site. On an unspecified date, he experienced shortness of breath, and pain at injection site. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nosebleed, had not recovered from extremely tired, wobbliness, lethargic, and unable to stay awake, and the outcome of shortness of breath and pain at injection site was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 2021506688-Covid 19 Vaccine-Unable to stay awake, Wobbliness. 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). 2021506688-Covid 19 Vaccine-Extremely tired. This event is labeled per RSI and is therefore considered potentially related.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and genders. Medical history and drug reactions/allergies were not reported. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored PROQUAD (lot, dose, frequency and route not reported). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source (1405USA000349 and 1405USA001550). Additional information is not expected.
pt recvd vax; devel hives,swollen face,throat closed;p/ 2nd dose devel sxs; as of 26oct93 is still on prednisone;when trying to be weaned from steroids,still gets sxs;now seen allergist;
Discharge Physician: DO Primary Care Physician: DO  Date of Admission: 12/26/2022 Discharge Date: 12/28/2022 COVID positive 12/26/2022 PRESENTING PROBLEM: Ketosis (HCC) [E88.89] DKA, type 2, not at goal (HCC) [E11.10] Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus (HCC) [E11.10] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 73yo male who presented to hospital with euglycemic DKA, believed to be secondary to his initiation of Jardiance a month prior plus decreased oral intake secondary to covid. He was also found to be COVID positive but was asymptomatic from this, with no cough or fever, an no hypoxia. He was started on D5 and insulin drips and admitted to the ICU with frequent electrolyte monitoring.    CT imaging, obtained for PE ruleout in the setting of elevated D Dimer, did show diffuse ground glass opacities suggestive of viral pneumonia, but no pulmonary embolism.    His labs corrected and he was able to come off of the insuline drip and transitioned to basal bolus insulin. He tolerated a diet and was viewed as medically stable for discharge to home.   He has been instructed to remain off Jardiance at this time, he is to resume metformin and actos.   Electrolytes were monitored and repleted PRN throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP as scheduled on 12/30. Patient voiced understanding was agreeable with plan of care discharge.
first dose of the Pfizer Biontech COVID19 vaccine (purple cap) on 06Oct2021 and her second dose was administered on 15Oct2021 which is only 9 days apart; body was really achy, like she had aches and pains; was hard to move around; was a little stuffy; 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 31 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 (Lot number: FF2588) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot Number: FF8839 , Anatomical Location: left arm, unknown expiry date), administration date: 06Oct2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Oct2021, outcome "unknown", described as "first dose of the Pfizer Biontech COVID19 vaccine (purple cap) on 06Oct2021 and her second dose was administered on 15Oct2021 which is only 9 days apart"; PAIN (non-serious) with onset 15Oct2021, outcome "recovered" (18Oct2021), described as "body was really achy, like she had aches and pains"; MOVEMENT DISORDER (non-serious) with onset 15Oct2021, outcome "recovered" (18Oct2021), described as "was hard to move around"; FEELING ABNORMAL (non-serious) with onset 15Oct2021, outcome "recovered" (18Oct2021), described as "was a little stuffy".  Additional information: Reporter Subtype: Pharmacist. Caller was a pharmacy technician calling for herself. Caller had her first dose of the Pfizer Biontech COVID19 vaccine (purple cap) on 06Oct2021 and her second dose was administered on 15Oct2021 which is only 9 days apart. Caller was asking for information regarding re-vaccination. She did have an adverse reaction from the 2nd dose that let her out of work for 2 days. Her body was really achy, like she had aches and pains, it was hard to move around and she was a little stuffy as well. The body aches was the major thing. It began that night of her vaccination, 15Oct2021 and it ended on 18Oct2021. No prior Vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Tingling on tip of tongue about 30 minutes after dose. Lasted several hours and ended. Did not interfere with any functions. At first dose experienced a more subtle version of light tingling and tongue swelling, though so mild, dismissed as anxiety. More dominant tingling after 2nd dose. Had not heard of this side effect so felt worth reporting. No action was taken since it did not interfere with breathing, eating and went away after a few hours.
Patient received her first pfizer vaccine in her left arm. She waited around for about 15 before driving home. While driving she had to pull over because her whole right side of her body, from head to toe went numb. It was like her right said had fallen asleep but could still feel it. She said it felt like her right said was moving slower than it should have been. She was also dizzy and light headed. She called me about two hours after the event. She was still light headed/dizzy and numb but the numbess was better. I called her the next day to check on her and she said the symptoms lasted about another 30 minutes after talking to me. So about 2.5 hours total and she was fine the next morning with no issues.
Information has been received from a medical assistant referring to multiple unspecified patients. On multiple unspecified dates the patients were vaccinated for prophylaxis with ROTATEQ (lot # L035510, expiration date 13-MAY-2017), which was improperly stored at 61.03 F for 3 hours 38 minutes. The temperatures were not logged with a data logger and there were no previous excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA004271: US-009507513-1612USA006817: US-009507513-1612USA006815.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Case contains information regarding patient 14 out of 190 reported.  Concomitant products were not reported.  It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
Inserted needle via Intramuscular in patients left arm when pushing the syringe to inject the medication the needle came out of the patients arm and the medication sprayed all over. I called the office supervisor and she told to me to call another staff member to report it to him.
At approximately 10 hours after receiving my second injection of the Covid19 vaccine, I started noticing nausea, headache and a neck ache. Within 5 minutes of these symptoms, my tongue felt swollen and my speech was slowed and slurred. Within ten minutes of these symptoms occurring, my nausea went away as well as my swollen tongue and speech problems. The neck ache and headache progressed into a migraine. I took Tylenol and went to sleep. I woke four hours later with abdominal pain, nausea, head ache and neck ache as well as pain at the injection site. Again I took Tylenol. I experienced fatigue, migraine, neck and back ache, night sweats and axillary adenopathy over the next 5 days. Today is day 6 and I haven't gone a day without neck pain and headache yet. It usually occurs in the afternoon. I continue to take Tylenol and it feels better.
autoimmune hepatitis; This spontaneous report was received from a nurse and refers to about 18-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, lot# and expiration date were nor reported) for vaccination.  On an unknown date, the patient was diagnosed with autoimmune hepatitis. The patient was told that she would be lucky if her liver would last for another 10 years.At the time of the report, the patient was still receiving unspecified infusion as a treatment for the autoimmune hepatitis at unspecified hospital. The outcome of autoimmune hepatitis was reported as not recovered/not resolved. The reporter considered autoimmune hepatitis to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).  Upon internal review, the event of autoimmune hepatitis was considered to be medically significant.
Muscle problem; Joint problem; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (Muscle problem) and ARTHRALGIA (Joint problem) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LORATADINE (CLARITIN [LORATADINE]) and FUROSEMIDE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle problem) and ARTHRALGIA (Joint problem). At the time of the report, MYALGIA (Muscle problem) and ARTHRALGIA (Joint problem) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment provided included extra strength acetaminophen 500 mg and prednisone 10 mg for 5 days.    Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter contact information updated.
migraine headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine headache.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MIGRAINE (migraine headache). The patient was treated with SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine headache, at an unspecified dose and frequency. On 09-Mar-2021, MIGRAINE (migraine headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.
Pt with immediate pain with injection. Continues with shoulder pain and limited range of motion. Seen by primary care.
headache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EN5318), via an unspecified route of administration at the left arm on 29Jan2021 at single dose for covid-19 immunization. She doesn't really have any other health problems or take many medications. On 31Jan2021, the patient experienced headache. They are not just little small headaches. She has taken Tylenol/ Acetaminophen for it. She will get more. The outcome of the event was not recovered.
Immediately after my shot (while I was sitting the the waiting area) my entire right arm started to feel heavy and  numb. I told the nurse and she said it's a common symptom. I felt the right side of my face feel tingly and numb too. It's now day 5 and I still feel these symptoms. Today (day 5) my arm feels better than yesterday. Yesterday I could barely type. My right arm felt heavy and hurt a lot for 4 days. My right arm and right side of my face still feels different than my left (numb feeling).  On Monday (day 4) I got a nosebleed for no apparent reason. I never get nosebleeds. On Tuesday I got another nosebleed. I also accidentaly knicked my wrist and noticed it bled right away.
Prolonged seizure fever (approximately 30 minutes) associated with a very high fever (>104 degrees).
The day of vaccination I was extremely lethargic and developed nausea and diarrhea. The day after, I experienced an intense pounding headache for at least 8 hours that OTC pain medication did not help with. I experienced nausea and diarrhea as well as exhaustion. Extreme pain at injection site and unable to do much with that arm.
This spontaneous reprot was received from a licensed vocational nurse regarding two patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 21-JUL-2015, the patients were vaccinated with a dose of an improperly stored PROQUAD (Merck), lot number L007230, expiration date 03-SEP-2016, (dose and route were not reported). No adverse effects were reported. There was no concomitant medication reported. This is one of several reports from the same source. Lot number L007230 has been verified to be a valid lot number for PROQUAD (Merck). Additional information has been requested.
I started feeling poorly at the end of the day on 12/26/2021. I received a text the same day that my grandson had tested positive for COVID19. On Tuesday (12/28/2021), I made it to the Medical Center and got tested and I was positive for COVID19.
My symptoms started on October 16,2021 when I got COVID.  I coughed so hard developed a hernia, nausea,  fever and dizziness. I went to the hospital had Regeneron infusion within a week of having COVID. My symptoms lasted for about two months.
Information has been received from a physician concerning a 13 month old female patient with no pertinent medical history who on 25-FEB-2008 was vaccinated with a third dose of ROTATEQ. The first dose was administrated on 01-OCT-2007 and the second dose on 21-DEC-2007. On 08-SEP-2008 the patient developed diarrhea. The patient was seen by the physician on 18-SEP-2008 and a stool culture was obtained. The stool culture came back positive for rotavirus. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Fever (up to 101.6), body aches, nausea and headache peaking between 12-18 hours after dose, mostly resolved by 30 hours. Nausea, and headache persisted until about 30 hours (took Tylenol Extra Strength at 24 hours). Pain at injection site, could not sleep on that side.  Gradually developed and peaked 12-18 hours after dosing.  Still slightly sore at 30 hours.
About 24 hours after 1st vaccine noticed mild red skin rash across stomach and back. Back is slightly itchy, while stomach rash is not.  Still evident 48 hours later.
mild icky feeling; felt achy; injection site left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (mild icky feeling), PAIN (felt achy) and VACCINATION SITE PAIN (injection site left arm was sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Palpitations.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced FEELING ABNORMAL (mild icky feeling), PAIN (felt achy) and VACCINATION SITE PAIN (injection site left arm was sore). On 23-Feb-2021, FEELING ABNORMAL (mild icky feeling) and PAIN (felt achy) had resolved. At the time of the report, VACCINATION SITE PAIN (injection site left arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.   This case was linked to MOD-2022-447964, MOD-2022-447985 (Patient Link).