chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNTech COVID-19 Vaccine EUA first dose administered approximately 2:52pm. Reaction started approximately 2:57pm after seated in observation area; sense of feeling "not right" then heart started racing, chest felt tight, vision got strange and I couldn't really move. Once this episode passed I got up and told a volunteer I thought I was having a reaction. Moved to secondary observation area, hooked up to machine that tracked heart rate and blood pressure. Next episode occurred at approximately 3:10pm; heart rate shot up to 160 (unsure of BP), same feelings of immobility accompanied with urge to pee/poop. These episodes continued for 4-5 rounds until approximately 4pm and lasted multiple minutes each time.
A nurse reported that a female pt received an injection of flu shield on 11/13/2001. Immediately post vaccination, the pt developed tingling at the injection site with extended to her fingertips. She also developed aching and was treated with Tylenol. She recovered the next day. This is 1 of 4 pts from this facility who has an adverse experience following receipt of flu shield.
Information has been received from a registered nurse concerning a currently 8 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot #: M033906 with expiration date: 28-JUL-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 15°F but less than 46 °F  (15.5 °F) for 30 minutes and at temperature greater than 6 °F but less than 14 °F (10.1 °F) for 1.5 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001065: US-009507513-1703USA012554: US-009507513-1704USA001067: US-009507513-1704USA001068: US-009507513-1704USA001069: US-009507513-1704USA001064: US-009507513-1704USA001066.
Within 2 hrs of vaccination, Pt developed "big knot" at the injection site, and the site turned blue.  Heart rate became elevated.  She had bad headache that evening.  The next day, injection site was red and warm, heart rate normal.  Arm remained bruised and tender for 3 weeks.
After 1st injection, Afib at 4:00am after 6 years of no Afib due to ablation. Rapid heartbeat, Afib lasted 6 hours. Rapid heart beat for week and High blood pressure jumped 50 points bothy systolic and diastolic. Over a month and blood pressure improoving but has sporadic spike.Hx of Sjogrens Syndrome-no issues for several years -symptoms of very dry nouth came back 3 days after injection and still persist. increased left tinnitus and bilatera neuropathy.   After 2nd injection: High Blood pressure increased for several days averaging 180/90. Symptoms from first injections had not fully resolved. High blood pressure not as frequent today.
He collapsed and was hyperventilating. When he came around, he had all over paralysis. When his voice and upper body returned, his legs remained paralyzed. He was released from ER
Not sure when it began. I noticed a warm red blotch (size of an apple) at the injection site a week after the injection. It's slightly itchy. Feels like an allergic reaction.
Child was unresponsive. Limp. Did not respond to loud verbal or physical commands. Catatonic like state. Child doused with cold water and remained unresponsive. Child eventually regained consciousness approximately 10 minutes later.
Information has been received from a consumer concerning her 4 year old son with no pertinent medical history reported and no known drug allergies, who on 18-NOV-2005 was vaccinated with first 0.5mL dose of MMR II (route and lot number not reported) and secondary suspect RECOMBIVAX (manufacturer unknown) (dose, route and lot number not reported). Concomitant therapy included polio vaccine (manufacturer unknown). The patient's mother stated that on the same date, 18-NOV-2005, the patient experienced hives, fever, lethargy, vomiting and dehydration. The patient recovered from the events within 36-48 hours after symptoms staring. No lab studies were performed. It was noted that the patient had a similar experienced after receiving DTaP(manufacturer unknown) on 4-FEB-2005. The patient sought unspecified medical attention. Additional information has been requested.
Patient has experienced persistent trouble breathing 1 hour after vaccination. He reported difficulty breathing @ 5:25PM 10/21/09.
This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On unknown dates, the patients were vaccinated with GARDASIL 9 (lot # K026246, expiration date 28-JAN-2017, exact dates and route of administration were not reported). It was reported that the administered doses were exposed to temperatures outside of the recommended range. No adverse experience was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Patient stated she has had a permanent migraine ever since she got the Moderna booster on 10/26/2021.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Near the injection sites on the right arm, from mid of the arm to above elbow was swelling and warm to the touch as indicated by the patient. Pharmacist on duty advised patient to put ice pack to help reduce swelling and take Benadryl and monitor symptoms; if the site is still swollen in the next couple of days or if symptoms get worse to contact her doctor or seek medical help.
Acute onset of urticaria within ten minutes of administration of vaccine. Epipen given by parent, along with benadryl.Seen in office again within 25 minutes and started on prednisone 2mg/kg for 5 days.
I ended up with Shingles 13 days after the first vaccine.  I have not gotten the 2nd vaccine as of yet.
Swelling, redness, pain 2 1/2 x 2 1/2" within 48 hr of injection.
One hour after vaccination his left shoulder started to hurt.  The pain is mild if he does not move his  left arm.  The pain is 7/10 or 8/10  on a 0-10 pain scale if he moves his left arm.   He was seen at the facility on 1/12/2021 by RN and second RN.   Facility nursing staff advised him to take Ibuprofen and to ice the painful injection area with an icepack for 10-15 min an hour for several hours.  He was  advised  to call his PCP today and to   follow up with his PCP regarding his injection site pain.
Large area of inflammation on his arm; Red area of inflammation on his arm; Area is hot to the touch; This case was reported by a pharmacist via call center representative and described the occurrence of inflammation in a 88-year-old male patient who received Herpes zoster (Shingrix) (batch number 2437H, expiry date 28th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inflammation, erythema of extremities and feeling hot. On an unknown date, the outcome of the inflammation, erythema of extremities and feeling hot were unknown.   It was unknown if the reporter considered the inflammation, erythema of extremities and feeling hot to be related to Shingrix.  Additional information was provided as follows: The reporter was a pharmacist reporting on behalf of a consumer. The patient had a large, red area of inflammation on his arm and that area was hot to the touch. The area of redness on the arm was greater than 5 inches. Till the time of reporting the patient had not received the second dose. This case is linked with US2020019142, reported by same reporter.
Provider ordered Pfizer bivalent booster.  Pfizer monovalent booster was administered.  Lot FR2583, exp 07/2023.
pt felt dizzy and sinus pressure a few days after receiving vaccine, the symptoms were resolved within 30 minutes
Breakthrough COVID-19 Case: I received my 2nd booster on April 14th. I had no immediate symptoms. I first started noticing symptoms on Saturday, April 30th. runny nose and cough. On Monday morning, I saw a doctor and she recommended Flonase and Zyrtec, on Tuesday morning, it tested positive for COVID-19. She prescribed Paxlovid in addition to Mucinex DM, Zyrtec. I feel weak, disoriented, fatigued and sleepy. I assume it has to do with the Mucinex DM, Flonase, and runny nose.
Presented to the ER via EMS with dyspnea.  Patient reports waking to a smothering sensation without chest pain.  Felt extremely short of breath even with his home 2 L oxygen.  He called EMS.  He was found to be satting 82% on his home O2 by EMS.  He was noted to be cyanotic with mottling and tripoding.  EMS brought him in emergently on their positive pressure ventilation.  In the ER rapid Covid test is positive.  Chest x-ray with findings of right basilar pulmonary infiltrate.  He is dyspneic with minimal conversation.  He is alert and oriented x3.  He reports a several day history of progressive shortness of breath.  He was seen by his primary pulmonologist last week and was started on a NEW medication, although he is unable to recall name of the medication.  He states he was unable to afford the prescription and has never started on the medication.  Patient reports a several day history of feeling "hot."  He did not take his temperature.  He reports a new productive cough of yellow sputum.  He reports having Covid-19 last year, and following infection he  received 2 doses of Pfizer COVID-19 vaccine. Patient is in A. fib with RVR.  Heart rates ranging 110-124. He denies any CP.  He received bolus of IV Cardizem in the ER.  Initiated Cardizem drip at 10MG/h and vancomycin.   Assessment:  Acute on chronic hypoxic/hypercapnic respiratory failure, on 2 L nasal cannula at home with history of astral use Right-sided PNA/pulmonary infiltrate A. fib with RVR Hypotension COVID-19 pneumonia Elevated lactate Elevated troponin, likely type II MI 2/2 demand ischemia in setting of acute respiratory failure, A. fib with RVR, and pneumonia Mild AKI  COVID-19: Steroids, remdesevir started. Supplemental O2 given. convalescent plasma given. empiric antibiotics for pneumonia.  9/7/2021: O2 titrated down to 3LPM and cardizem drip stopped and transitioned to oral cardizem Patient still admitted at time of report.
LVN administered flu vaccine prior to PCP visit, developed rashy itchy traveling up arm injection site to left chest; no acute dyspnea or tachycardia.
Information has been received from a physician concerning a teenager female who was vaccinated with the first dose of GARDASIL in April 2007 and second dose in August 2007. There was no concomitant medication and medical history. In November 2007, the patient started experiencing vertigo. Unspecified lab diagnostic studies had been performed. The patient had sought unspecified medical attention. It was reported that therapy with GARDASIL was discontinued. At time of reporting, the patient was not recovered. Additional information has been requested.
Vertigo and stomach cramps beginning ~24 hours after injection and lasting for ~2 hours. Second bout of vertigo ~72 hours after injection, which is still continuing.
Patient presented with extremely swollen upper left (immunized) arm. The swelling is more so at the bicep area compared to deltoid when the immunization would normally be given at. The whole area is red and hard to touch. Pt was unable to stretch his arm into a normal position as it cause him a lot of pain if he tried.
12/26/2020  WOKE UP, STOMACH HURTING, DIARRHEA. MALAISE. CYCLE BETWEEN BOTH, ALL DAY. WENT TO ER SAME DAY; EVENING. COULD NOT GET A STOOL SAMPLE. VITALS WERE GOOD. ADMINISTERED IV FLUIDS.  12/27 STOMACH STILL HURTING BUT NOT AS SEVERE.
Redness at injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comment:  This case was reported via (Shingrix GSK) interactive digital media. The reporter wanted to know how long did the redness at injection site commonly last. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
2nd episode of extreme facial adema. Swelling of lips, cheeks, the exterior of throat to up to 10X normal size. Feeling of tightness in the middle of lungs. Persisted for over 24 hours, with minor swelling up to a week later.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 19-NOV-2012 was vaccinated with an improperly stored dose of PROQUAD (merck) (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Allergies and asthma flare up; Allergies and asthma flare up; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Allergies and asthma flare up) and ALLERGY TO VACCINE (Allergies and asthma flare up) in an adult 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 albuterol inhaler for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHMA (Allergies and asthma flare up) and ALLERGY TO VACCINE (Allergies and asthma flare up). The patient was treated with albuterol inhaler at an unspecified dose and frequency. At the time of the report, ASTHMA (Allergies and asthma flare up) and ALLERGY TO VACCINE (Allergies and asthma flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-162612 (Patient Link).
On 12/21/2022, I woke up with aches and pains. I had a fever, cough, and runny nose as well. I also ended up developing vertigo. I tested myself for COVID-19 and it was positive. I informed my doctor of my positive status but did not seek medical attention. I treated my symptoms with over-the-counter medication. My symptoms last around 5 or 6 days, with the exception of the vertigo which lasted around 45 days.
Significant redness, swelling and warmth of entire left thigh. Swelled > 1 inch. Compassed to right thigh. No few or significant systemic symptoms occurred.
I saw a doctor because I wasn't producing much saliva so I called a telehealth service. He thought I had thrush and recommended some mouthwash techniques and prescribed me tablets to suck on to help try to get rid of the thrush bacteria; but the prescription wasn't helping. I took all of them and nothing came of it. So I'm going to visit my doctor later this month to see a further and better diagnosis.
This spontaneous report was received from a medical assistant concerning, multiple, unspecified patients' of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (lot number: M017983, expiration date: 30-MAY-2018) (dose and route of administration were not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning her daughter who 02-FEB-2009 was vaccinated with her third dose of GARDASIL (lot number, route and site not reported). Concomitant therapy included Allegra. The dates of the first two doses of GARDASIL were unknown. 2 weeks after receiving the first dose. The patient began having pain that has been "on and off ever since". On 02-FEB-2009 the patient had a transvaginal ultrasound that was negative. The patient's pain was so serve that on the night of 10-APR-2009. On Friday night she was seen in the emergency room due to the lower right quadrant pain. The patient had a computed tomography scan completed that were both negative. The patient was discharged home from the emergency room. At the time of reporting she was recovering. Additional information was received a nurse practitioner concerning the 25 year old patient who on 01-AUG-2008, 03-OCT-2008 and 02-FEB-2009 was vaccinated with the first (lot number 660553/0070X), second (lot number 660618/0572X) and third (661764/0650X) dose of GARDASIL (route and site not reported). Concomitant therapy included hormonal contraceptives (unspecified). The patient had no complaints following the first dose. On 17-OCT-2008 the patient complained of lower abdominal pain since the second dose of vaccination. The Nurse Practitioner felt the event was unrelated to GARDASIL. The patient had normal bowel movements and an ultrasound was performed that showed a few cysts on the ovaries but nothing else. The patient had apparently started birth control pills, not prescribed by the nurse practitioner, in December 2008 and stopped them at the end of January 2009. She was not aware the patient had recently been to the emergency room and had a CT scan which showed kidney stones. The nurse practitioner will try to find out where the patient was treated and obtain additional patient details. Additional information has been requested.
Really having trouble breathing had second shot yesterday; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Really having trouble breathing had second shot yesterday) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Really having trouble breathing had second shot yesterday). At the time of the report, DYSPNOEA (Really having trouble breathing had second shot yesterday) outcome was unknown.            No concomitant information was provided. Treatment information was not provided.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies and no past medical history was provided. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 12-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211129928.
This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-OCT-2016, the patient received improperly stored ZOSTAVAX 19400 PFU, lot# M028798 with expiry date: 18-AUG-2017 (dosing details not reported). No adverse effects reported. Temperature/time frame: 18 F for 48 hours. No previous excursions. No data logger involved. No product quality complaint involved. Additional information has been requested.
pt recv vax 10JUN97 & 27JUN97 pt exp joint pain in both knees, paresthesia, malaise, fever, & rash;pt was seen by primary care on 3JUL97;f/u reported that numbness was persistent in the pt first three fingers & joint pain migratory;
lightheadedness and dizziness; This is a spontaneous report from a non-contactable consumer for a female patient (consumer's mother) received via a Pfizer-sponsored program, SUPPORT. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, on 11Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced lightheadedness and dizziness on 12Feb2021. The patient went to the emergency room and was prescribed with meclizine. The outcome of events lightheadedness and dizziness was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
burning sensation; burn; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (burning sensation) and THERMAL BURN (burn) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (burning sensation) and THERMAL BURN (burn). At the time of the report, BURNING SENSATION (burning sensation) and THERMAL BURN (burn) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Information has been received from a licensed practical nurse and a healthcare worker referring to unspecified patients of unknown age and gender. In June 2015 (also reported as since 15-JUN-2015), the patients were vaccinated with doses of RECOMBIVAX HB (lot # K010535, expiration date: 27-AUG-2016, dose and route were unknown) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a company representative concerning a male pt who received several vaccination, the same day of the vaccination the pt experienced seizures, presented to a MD and was hospitalized for 4 - 5 days. Per the pt's mother on 11/8/99,the pt had a normal EEg and MRI and was "doing fine." Additional information has been requested.
Patient seen 10/15/14 and given IPV, TWINRIX, MMR, VZV, MCV4 and HPV4. She denied having intercourse since LMP of 9/24/14. She returned for shelter services 3/22/16 - at which time I needed to give her daughter born her one year vaccines. (Let me know if I need to complete VAERS on her).
approx 1-2 hr p/vax pt exp severe chills; weakness; nausea; unable to lift lt arm