chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWELLING OF HANDS & FEET-HANDS MORE THAN FEET(UNABLE TO FLEX/BEND FINGERS OR MAKE A FIST)& ITCH WAS OVER ENTIRE AREAS OF HANDS & FEET BILATERALLY BUT >est ON PALMS OF HANDS & TOPS OF FEET. 10/30/09 SWELLING LESS-ABLE TO BEND FINGERS BUT ITCH MORE INTENSE & HAND PALMS & KNUCKLES (ALL) EXHIBITED CONFLUENT ERYTHEMA AND EDEMA AS DID TOPS OF FEET,& LUMBAR SACRAL AREA. ANTERIOR THIGHS ALSO "ITCHED" BUT HANDS MORE THAN OTHER AREAS.
Information has been received from a registered nurse referring to an 11 year old female patient with none pertinent medical history and none drug reactions/allergies. On 20-JUL-2015 the patient was vaccinated with VARIVAX (Merck) (lot # L004652, expiration date: 11-FEB-2017, 0.5 ml/once, subcutaneous). There was none concomitant medication. On 21-JUL-2015, the patient experienced redness, warmth and swelling at the injection site. The patient sought medical attention via office visit. None treatment was given or lab diagnostics studies were performed. The outcome of the events was reported as not recovered/not resolved. The causality was not provided. Additional information has been requested.
Initial dose given was .05 ml instead of the .5 ml dose. Patient came back in to get .45 ml IM within 24 hours of initial dose.
Headache, Myalgia, NauseaVomiting, FEVER 101.3 Narrative:
I now have shingles of the eye from the shot itches, rash, and blood shot. Pressure of my eye very high. I use Timodol, Brimonidine, Latanoprost. Nothing is helping. I don't want to lose my eyesight although vision risk. I may have laser treatment for high pressure. My next eye.
No additional AE/PQC; improperly stored PROQUAD that was inadvertently administered to a patient; This spontaneous report was received from the Registered Nurse, and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 15-JUN-2023, the patient was inadvertently vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) injection, 0.5 milliliter, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, anatomical location and route of administration were not provided) (product storage error). There was no additional adverse event.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date of patients received improperly stored doses of M-M-R II (lot # reported as K001997, expiry date reported as: 10-FEB-2016, therapy type, dosage, route of administration, anatomical location were not reported), which were exposed 8.5C for 15 minutes. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Burning and itching down right arm, then up right side of neck, difficulty breathing, wheezing.
approx 3-3 1/2 hr p/vax pt w/onset of pruritus, emesis & diarrhea resolved p/4-6hr;
First dose: tenderness at injection site.  Swelling on the roof of mouth that lasted three hours. Second dose: immediate severe tenderness at injection site. By 5pm, I could barely raise my arm and could not touch it. At 11pm, I began to have chills with uncontrollable shaking that lasted 2 1/2 hours. Temperature of 104 that only came down to 102.9 in a 15 hour span.  I did alternate Tylenol and Ibuprofen that entire time.  Severe headache, sore throat,  thirst, burning ears, fatigue, no energy, and chest pain.
Pt recvd 1st dose of vax w/no noted problem; pt recvd 2nd dose of vax on 18AUG92 w/in an hr following vax pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; No further details were provided;
Red non raised erythema on right upper arm slightly below injection site. Lasting three days.  No other adverse effects other then minor pain in right shoulder area lasting for 24 hrs.
sick; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involved patient who was sick (illness), while patient received INFLUENZA VACCINE [Flu shot].   The patient's past vaccination(s) included INFLUENZA VACCINE for prophylactic vaccination and had sickness. It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) unknown latency (for duration 1-2 week) following the administration of INFLUENZA VACCINE.  It was reported that, patient asked why should patient get something they just made less than 1 years.  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Injection site pain; Muscle ache; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the right arm on 21Feb2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Feb2021, the patient experienced injection site pain and muscle ache. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain and muscle ache was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
HIVES; HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included occasional alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041a21a, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 at left deltoid for prophylactic vaccination.  No concomitant medications were reported.  On 03-APR-2021, the subject experienced headaches. On 07-APR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, and hives. This report was non-serious.
(Swelling, pain, redness, and heat (warm) from the site. Left deltoid). BP 122/50 Pulse 100 Respirations 20.
Received the third dose of the vaccine even though I am not immunocompromised.; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Received the third dose of the vaccine even though I am not immunocompromised.) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced EXTRA DOSE ADMINISTERED (Received the third dose of the vaccine even though I am not immunocompromised.). At the time of the report, EXTRA DOSE ADMINISTERED (Received the third dose of the vaccine even though I am not immunocompromised.) had resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient reported that they received the third dose of the Moderna COVID-19 vaccine even though they were not immunocompromised. The patient stated that they received the first dose in JAN-2021, exact date, lot, arm, and expiration date was unknown. The patient reported that they were experiencing bad side effects after the first dose and really bad side effects after the second dose. The patient did not specifically mention side effects just referred to them as bad and really bad and the side effects had resolved by the time of the call 19-OCT-2021.   This case was linked to MOD-2021-358998 (Patient Link).
A report has been received from a Health Professional concerning a patient, male subject, height: 43.5 in; weight: 40.0 pounds, who had been receiving FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, once/single administration. The patient's concurrent disease(s) included allergic rhinitis and eczema. The patient received FLUMIST QUADRIVALENT on 16-Nov-2015 after temperature excursion of 34.7 degrees Fahrenheit for 20 hours. FLUMIST QUADRIVALENT (intranasal) was discontinued on 16-Nov-2015. The outcome of the event of consumer received FLUMIST QUADRIVALENT on 16NOV2015 after temperature excursion of 34.7 degrees Fahrenheit for 20 hours is unknown. The reporter's description of the event(s) was as follows: HCP reported that consumer has a past medical history of allergic rhinitis and eczema. The report was considered to be non-serious by company physician.
This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration and administered in the right arm on 05Mar2021 at 11:00 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient had no known allergies. The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. On 06Mar2021 at 09:30 the patient experienced Chills (Freezing), Low grade temperature, Body aches, Headache and Muscle aches. The patient did not receive treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no adverse event; The patient received an improperly stored PROQUAD; This spontaneous report was received from a nurse concerning a 4 year old male patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 12-AUG-2019 and on 13-AUG-2019, the vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) experienced two temperature excursions each date respectively. On 19-AUG-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # R026722, expiration date 17-MAR-2020) or (lot # R023499, expiration date 13-FEB-2020) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported) (product storage error). The vaccine was reconstituted with properly stored sterile diluent (lot # and expiration date were not reported). The administered dose of the vaccine experienced a temperature excursion of -14°C to -10°C (-11.91 C, multiple) for 8 hours, as recorded by a data logger. There was no adverse effect reported.
Within 20 minutes patient's throat was closing up; This case was reported by a physician via sales rep and described the occurrence of throat constriction in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA701A, expiry date February 2023) for prophylaxis.   On 13th July 2022, the patient received Menveo. On 13th July 2022, less than an hour after receiving Menveo, the patient experienced throat constriction. The patient was treated with prednisone and benadryl (nos) (Benadryl). On an unknown date, the outcome of the throat constriction was recovered/resolved.   It was unknown if the reporter considered the throat constriction to be related to Menveo.     Additional Information: GSK Receipt Date: 15-JUL-2022 Reporter's comment: The patient was given Menveo in Doctor office and then within 20 minutes patient's throat was closing up.  It was then after hours so the patient went to urgent care, and was given prednisone and Benadryl.  As per the Doctor the patient was ok as of now.  Doctor originally was seeing patient for well visit when Menveo was given.  The patient originally was healthy with no other symptoms. Menveo was only vaccine given.
Patient reported swelling on upper arm around injection site the day after receiving Pneumovax vaccine. He went to see doctor 3 days after receiving the vaacine and doctor prescribed him Bactrim DS 800-160 mg tab for the reaction
Pfiser-BioNTech Covid 19 vaccine EUA Fever 99.5 , muscle aches, diarrhea & chills lasting approx. 24 hours
Complains of pain radiating from vaccine site up to neck. Woke up with symptoms the day after the flu vaccine. Now complains of increased pain and spreading beyond neck. Still C/O symptoms 11/23/16.
sore arm at injection site; tiredness; This is a spontaneous report from a non-contactable consumer, the parent. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 12Apr2021 at 15:30 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. The patient did not have a history of allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 23Mar2021 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 11:00, the patient experienced sore arm at injection site and tiredness. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event sore arm at injection site and tiredness was recovered in Apr2021.   No follow-up attempts are possible. No further information is expected.
Patient was given both doses of Pfizer under the age of 16. No symptoms or signs reported as of today.
This case was reported by a nurse and described a 21 year old male subject who had a decreased antibody response to the hepatitis B component of immunization of Twinrix. On September 23, 2003, February 20, 2004, and August 03, 2004 the patient received three doses of Twinrix (lots HAB238B6, HAB276A, and HAB306A6) in his arm. Approximately 7 months after the last dose of Twinrix, on March 15, 2006, a hepatitis B surface antibody titer measured less than 8 UI/L. Protection is 10 (mIU/ml).
This is a spontaneous report from Pfizer sponsored program, by a contactable physician. A 71-year-old female patient of an unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced allergies: Statins; PREVNAR 13 on an unspecified date with outcome of unknown.
THIS WAS A SECOND BOOSTER DOSE. HE HAD RECEIVED 3 DOSES OF PFIZER AND THE GOT MODERNA FOR HIS 4TH DOSE. PATIENT WAS FINE DURING THE 15 MINUTE OBSERVATION AFTER VACCINATION. AFTER RETURNING HOME, HE REPORTED THAT HIS WIFE FOUND HIM PASSED OUT IN THE YARD; SHE GOT HIM IN THE HOUSE WHERE HE PROCEEDED TO PASS OUT AGAIN. HE SAID HE HAD PRETTY SEVERE VOMITTING AND FELT UNWELL FOR THE NEXT 24 HOURS.
Headache, NauseaVomiting, Insomnia  Narrative:  Other Relevant History:
Within 1 - 2 minutes post-vaccination patient developed severe shortness of breath & wheezing. She was able to use her own Ventolin-HFA inhaler. Breathing improved and she felt much better after about 10 minutes. She waited in the pharmacy for an additional 20 - 30 minutes for observation, with no additional symptoms.
Abrupt onset cough; This spontaneous case was reported by a physician and describes the occurrence of COUGH (Abrupt onset cough) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ATORVASTATIN and SILDENAFIL CITRATE (VIAGRA) for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced COUGH (Abrupt onset cough). At the time of the report, COUGH (Abrupt onset cough) 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.   No treatment medications provided by the reporter.   This case was linked to MOD-2021-216078 (Patient Link).
2/23/11 PREVNAR 13 given in left upper arm 2/27/11 MOC notified welt & redness of (L) upper arm. Within 24 hrs, rash had spread to 75% of skin surface.
By 7am-22 hours after injection, parent described redness at site with inflammation and heat present.
Patient received their first dose with us at on 5/20/21. Patient came back to get their second dose on 6/10/21  at  a clinic. Patient's parent filled out form stating last immunization was 5/20/21. When we processed second vaccination, their insurance showed they received the vaccination a day earlier on 6/9/21 at a pharmacy. We attempted to contact patient's parents with phone number provided and left several messages but no returns.
Patient developed jerking of all extremities while at school. EMS called and taken to the ER at Hospital. Labs negative. Sent home with Rx for DIASTAT & Neurology referral.
Patient is a 62-year-old, female. Alert, oriented X3, clear speech, able to answer to the questions before being vaccinated. At 3:34 pm, the patient received her first dose of Pfizer, (lot number EW0150, expires on 07/2021) on left deltoid, given by RN. The patient was able to give her verbal consent to receiving the Pfizer vaccine. RN, reports patient sounded "normal" and was responsive to all pre-vaccination questions. Patient reported mild anxiety to RN, immediately after being vaccinated. RN, followed the patient to the EMT observation area and assisted the patient to a zero-gravity chair. At 3:41 pm, while waiting in observation area, patient reported feeling "anxious" and "faint". EMT (Name), EMT (Name), EMT (Name) and RN, responded. At 3:41 pm, the patient became unresponsive to verbal stimulation. Her pupils were fixed and dilated. During this time, EMT took the patients vitals and found her BP to be 132/98 and HR 73 BPM. At 3:41 pm, RN called 9-1-1. The patient continued to be unresponsive for an additional 5 minutes with normal respirations of 17 per minute. At 3:45 pm, the patient jumped up out of the anti-gravity chair, screamed and proceeded to run down the hallway toward the patient restrooms. EMT followed the patient down the hall and RN followed. The patient collapsed to the floor and started to scream and convulse. While on the ground, EMT took the patient's blood pressure which was found to be 209/162 with a HR of 101 BPM. The patient was assisted to her feet by EMT (Name) and EMT (Name) and assisted her back to the anti-gravity chair at 3:47 pm. FD arrived on site at 3:48 pm and took over monitoring the patient's vital signs. The patient was A&Ox1 to self at 3:48 pm. She was unable to follow direction. Medical response assisted the patient to a stretcher chair with her arms and legs strapped to the chair. She left with EMS at 4:02 pm.
A report has been received from a pharmacist concerning a 26 year old, female patient (one of two patients). The patient had been receiving on 28-Dec-2013 FLUMIST QUADRIVALENT (intranasal). The two patients received accidentally expired FLUMIST which started on 28-Dec-2013. The patients had not reported any adverse effects. The outcome of the event of accidentally gave expired FLUMIST was unknown. The report was considered to be non-serious by reporter. Corrected report 10-Jan-2014: case suppressed as medication error.
A few days after getting the vaccine I noticed that my arm started hurting and then went away after I took something for pain. Then the first of May I had a stroke. I was then admitted into the hospital for a month. I was doing rehab to rebuild my strength.
Rash on both arms and upper torso.  Clammy feeling during sleep hours Mostly resolved today 9/27
WARM TO TOUCH; TINGLING A LITTLE; RED RASH MEASURING ABOUT 3 INCHES; This spontaneous report received from a pharmacist concerned a 31 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. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1816022 expiry: 01-JUL-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAY-2021, the subject experienced warm to touch. On 03-MAY-2021, the subject experienced tingling a little. On 03-MAY-2021, the subject experienced red rash measuring about 3 inches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the red rash measuring about 3 inches, warm to touch and tingling a little was not reported. This report was non-serious.
HEADACHE; This spontaneous report received from a patient via a company representative concerned a male 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, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.