chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 16-APR-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Nausea and faintness with vaccination  Vitals: BP 125/70 HR 95 Resp 18 O2Sat 97 Skin Signs: Warm and dry, Other - pale  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Initial Treatment: Supine on cot, feet elevated. Feeling better already.  7:00 PM  Vitals: BP 118/60 HR 66 Resp 18 O2Sat 99  Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Follow up Treatment: Nausea disappeared. Ready to leave. Home with mother.
This spontaneous report as received from a pharmacist refers to a 72 years old male patient. No allergies listed. The patient was vaccinated with PNEUMOVAX 23 (0.5 ml, intramuscular, left arm, lot # was reported as H009826, expiration date was 11-FEB-2014) on 12-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated a few days after vaccination patient's wife called the pharmacy stating her husband had chills, sweats, his left arm was red, swollen and painful. The pharmacist stated it was recommended that patient contact his doctor for follow up. The pharmacist stated the patient came into the pharmacy yesterday (24-JAN-2013) stating he had to be hospitalized. The patient ended up having his left arm opened up and drained and dead tissue had to be removed. Unspecified what hospital, unspecified how long the patient was in the hospital. The pharmacist stated the patient had fully recovered. The relatedness for events were unknown for PNEUMOVAX 23. The reporter considered one or more of these events to be medically significant. Additional information has been requested.
COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00pm according to the storage guidelines and placed in the refrigerator for 31 days. Our staff did not pull the vail out the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.   There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1,2021. There are 27 vials that were not used and have been set aside to waste.
This spontaneous report was received from a pharmacist via company representative refers to 2 patients less than 20 years of age with unknown gender. Patient medical history and historical conditions were not reported. On an unkonwn date, the 2 patients inadvertently received ZOSTAVAX (dose, lot # were not reported) instead of VARIVAX (Merck) and no adverse effect reported. That was related to a staff error. Concomitant therapy was not reported. No PQC was involved. Outcome of events was unknown. The reporter considered patients inadvertently received ZOSTAVAX instead of VARIVAX (Merck) and no adverse effect to be not related to ZOSTAVAX. This case was linked to MARRS # 1409USA005101 (same patient link). Additional information has been requested.
Resident had immediate elevation of heart rate with discharge heart rate after 15 min monitoring of 135 bpm.
Bilateral redness, swelling, and pain in ankles started a week after getting the vaccine. By 8pm, patient could barely walk so went to the ER.  In the ER, they did blood tests and told patient there was no clotting issues. ER prescribed the patient antibiotics and NSAIDS for inflammation.   As of 04/13/21, patient still experiencing symptoms. Called PCP and ER back and they recommended an ultrasound. She is headed their now
Past lot that had also been expired that was administered to patients.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients.) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 065F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients.).    No concomitant medication information was reported. Patient age reported as 63 Year 4 Month. No treatment information was reported.  The NDC ID was reported as 80777027398.  Person number was reported as Unknown.
Swelling of injection site with both vaccinations, red, hot, painful burning, blister like formations, Charlie horses/ cramping in arm, headache, fever
pain; a decrease in range of motion; should have been IM but was placed into the shoulder joint as opposed to the deltoid muscle; should have been IM but was placed into the shoulder joint as opposed to the deltoid muscle; should have been IM but was placed into the shoulder joint as opposed to the deltoid muscle; This spontaneous report was received from a medical student referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 03-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliters administered into the shoulder joint (joint injection and injected limb mobility decreased) as opposed to the deltoid muscle (strength, route of administration, lot #, and expiration date were not reported) for another health condition.      On the same day, the patient experienced pain (vaccination site pain) and a decrease in range of motion initially, but her status was improving.  It was unknown by the reporter if the patient received any treatment, or if any laboratory diagnostics or studies were performed to the patient due to this event.  The outcome of vaccination site pain, joint injection, injected limb mobility decreased and joint range of motion decreased was reported as resolving.   The causal relationship between the events and pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Feeling lethargic, foggy and has lost her voice almost entirely; Foggy; lost her voice almost entirely; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient that she received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on 09Mar2021 at single dose and second dose on 30Mar2021 at single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Consumer is calling for her boss, who received the first dose of the vaccine on 09Mar2021 and the second dose today, 30Mar2021. Her boss is now feeling lethargic, foggy and has lost her voice almost entirely on an unknown date. She would like to know if this is normal with the vaccine. Consumer declined to be transferred as she has consulted someone else for help. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt stated he received 2nd dose Moderna yesterday, today he has 4+ swollen to his face to the point he can't keep eye opened.  stated took some Allegra and Benadryl.  stated doesn't have any difficulty breathing.  did c/o chill and low grade fever, didn't take temperate.  alert and oriented x3.  stated if will go see doctor or hospital if there is anything life threaten or problems get worse.
I had a bowel movement and lots of blood; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJI686), via an unspecified route of administration in the right arm on 11Jan2021 at 12:45 as a single dose for COVID-19 immunization. Medical history included arthritis and migraines. The patient had no other vaccines within four weeks and did not have COVID prior to the vaccination. Concomitant medications (reported as other medications in two weeks) included fexofenadine hydrochloride (ALLEGRA) and paracetamol (TYLENOL). On 13Jan2021 at 12:00 AM, the patient had a bowel movement and lots of blood and also on 15Jan2021, she had a bowel movement with blood. The patient was not treated for the event. The patient had not tested positive for COVID post vaccination. Outcome of the event was not recovered.
Moderna Covid19 vaccine was administered to this individual age 17 years 4 months. Minimum age is 18 years. Awaiting guidance from Department of Health for follow up.
4 or 5 hrs after vaccination - fever 103 degrees, chills, headache, joint pain lasting 24 hrs.
Arm was red at the injection site; Arm was swollen at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 06Apr2021 at 14:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and women's probiotic (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not 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 16Apr2021 at 16:00, about 10-11 days after the vaccination, the arm of the patient was red and swollen at the injection site. It was not painful. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events arm was red and swollen at the injection site was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Noted to be pale p/nap (several hrs p/vax); Had high pitched cry off & on for several hrs; vomited p/nursing, t100.6;
Extremely swollen lymph nodes -  axillary and supraclavicular including pain in the area
Within three hours after vaccination period type cramping outside of regular period. Twenty-four hours after the following symptoms began. Muscle pain. Chills. Fever. Shortness of breath. Fluid buildup in lungs. Cough. Hives all over body.
Information has been received from a physician concerning a 25 year old female who on 07-AUG-2009 was vaccinated with a dose of GARDASIL (lot# 661766/0652X, dose and route not reported). On 07-AUG-2009, the patient experienced "weakness, numbness and tingling in both of her hands and fingers" after receiving GARDASIL. The physician stated the patient had this reaction "later in the day but on the same day the GARDASIL was given". The patient complained that she was "unable to turn the ignition in her car to start her car". It was unspecified if medical attention was sought. At the time of the report, the patient's status was unknown. Follow up information was received on 17-AUG-2009 from the physician concerning the 25 year old female with no pertinent medical history and no known drug allergies who on 07-AUG-2009 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. No other vaccines were administered on that day. No treatment was sought following the adverse events. The patient called in to office on 10-AUG-2009 to report event. The patient was not recovered as of 10-AUG-2009. The events of "weakness, numbness and tingling in both of her hands and fingers" were considered to be "somewhat" disabling. Additional information has been requested.
Patient initially presented to Advent emergency room with symptoms of swelling in her the left arm worsening over last few days.  She reports that she got Moderna COVID-19 vaccination on April 7th 2020, subsequently few days after she noticed a golf ball-sized induration in the area of injection, however over the next few days it increased to the "size of a baseball" on the 14th of April.  She reports that she went to urgent care, and was advised to continue with Benadryl cream, icing, and ibuprofen, however yesterday the area "doubled in size" expanding beyond the previously marked area.  She denies any chills, fever, night sweats, nausea, vomiting, chest pain, shortness of breath associated with the symptoms.  She cannot think of any specific aggravating factors or relieving factors at this time.  She has not experienced similar symptoms in the past.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 20-OCT-2012 12:35, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2023) Positive; (31Jan2023) Positive; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Clinical course: She have had 5 Pfizer vaccines. She is a physician and a patient who took Paxlovid orally from 26Jan2023 to 30Jan2023 as COVID 19 Treatment. Other medical history many too many to list, given shortage of time. known allergies: she have many drug allergies, but she do not think that she had an allergic reaction to Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after BNT162b2, BNT162b2 omi ba.4-5 immunization is considered ineffective of suspects, and the Company cannot completely exclude the possible causality between the reported events and BNT162b2, BNT162b2 omi ba.4-5 administration.
This spontaneous report as received from a pharmacist refers to a 51 year old female patient with diabetes. On 31-OCT-2014, the patient was vaccinated with PNEUMOVAX 23, 25/0.5 Y, intramuscular in the arm (dose and lot number were not reported). Other suspect therapies included influenza virus vaccine (unspecified) (dose, strength, frequency and route were not reported) on the arm, received on 31-OCT-2014. The pharmacist reported on behalf of his patient that she developed an injection site reaction following administration of PNEUMOVAX 23 and influenza virus vaccine (unspecified). Beginning on unspecified date, patient reported to pharmacist that she experienced redness, swelling and tenderness at injection site. Patient stated that she could barely raised her arm. The outcome of the events ws not reported. Treatment included ibuprofen. The patient did not seek medical attention. Additional information has been requested.
I63.9 - Ischemic stroke (CMS/HCC) I63.9 - Stroke determined by clinical assessment (CMS/HCC)
Patient developed redness, itching, and warmth at the site of vaccination beginning a couple days after receiving vaccination. Itching improved some but red rash remained and a nodule under the skin formed. Patient went to urgent care on 12/17/22 since the nodule had not gone down. Provider prescribed 7 days of antibiotic therapy and patient is currently taking the antibiotic.
pt admitted for removal of a spinal stiumulator and post op found to be COVID positive. has a slight cough no shortness of breath. no treatment
Numbness tingling around mouth, throat, chest tightness.   143/99-78;  resolved
This spontaneous report as received from a registered nurse refers to unknown number of patients with unknown gender and age. The reporter stated that an unknown number of patients were inadvertently administered GARDASIL (lot#, strength, dose, frequency and route unspecified) during March 2014 and April 2014 that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Bell's palsy diagnosis, with symptoms beginning 1 week after the Covid19 Pfizer vaccine.
cried all way home-1hr drive-gave APAP settled down-checked later hands-feet purple-shaking bad;called amb-took to ER;dx febrile seizure,rt dec lobe pneumonia,hyperpyrexia;ER gave cefzil & alternate APAP/Motrin;f/u next day
vision problems (blurriness and sensitivity like a bright light is being shined directly into your eyes).; vision problems (blurriness and sensitivity like a bright light is being shined directly into your eyes).; Vertigo; shaking and twitching (I'm not cold); shaking and twitching (I'm not cold); Pain at the injection sight; mild head ache; fatigue; This is a spontaneous report from a contactable other health professional (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 19Jul2021 18:00 (Lot Number: ER8736; at the age of 40-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included allergy to onion and lavender. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 20Jul2021 07:00, the patient experienced vertigo and vision problems (blurriness and sensitivity like a bright light is being shined directly into your eyes); was shaking and twitching (I'm not cold as reported). The other symptoms were normal side effects like pain at the injection sight, mild head ache, and a little fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. Blurring of vision was considered medically significant. Therapeutic measures were taken as the result of the events which included treatment with Zofran; blood test (to be scheduled). The patient also had Covid-19  test on 21Jul2021 which came negative. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported blurring of vision cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
C/O sweating profusely, nausea and lightheaded. Color looked flushed as well. transferred.
patient had knowingly gotten the janssen(j&j) vaccine a few weeks back but decided to get the 2 series moderna vaccine in addition to the j&j and failed to disclose that he had already been fully vaccinated and stc couldn;t be accessed since it was an offsite event, information on his prior covid immunization was not accertained. as a result he had an additional dose of 1 moderna vaccine plus his previous j& j vaccine he had gotten from a different facility.  patient described not having any adverse events from the 2 vaccines given.  he had no symptoms  to the additional moderna dose gotten. since pt had gotten 2 different doses of covid 19 from 2 different manufactures, its incumbent upon  us to report the incident although patient did not have any adverse events
This spontaneous report as received from a medical assistant refers to 10 unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with the improperly stored does of (Oka/Merck) VARIVAX (lot number L016125 and expiration date 06-MAY-2017)(dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Rapid heart beat 157bpm took about 30-1hr for the heart rate to fully go down ... was wearing a Fitbit watch and it said I was entering cardio.. I was sitting down