chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 10-MAY-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L027432, expiration date: 22-JUL-2017, (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Patient complained of itchy throat and slight cough during post-vaccine observation period. No SOB, no angioedema noted, lung sounds clear. Skin warm and dry, no rash or mottling noted. Pt continued to have occasional cough and was medicated with 10 mg Zyrtec. Patient reported improvement after taking the Zyrtec and drinking water. Pt completed 30 min observation period and was dismissed from clinic in stable condition.
Fever of 100-100.8, body aches, chills, headache, upset stomach. Side effects began at 4 AM and have persisted till 6:30 PM same day. Have not taken any over the counter medications in an effort to not impact my immune response.
Patients reports a baseball-sized welt and localized reaction at the injection site. He has had fever x 3days and has not felt well. This was his first pneumonia vaccine.
Patients mother stated child developed a fever approximately 6 hours after administration of vaccine what was a maximum of 104F upon checking at home.  Patient was given ibuprofen at home, then taken to the emergency room to be treated for the fever.  Patient is still recovering at this time.
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 38-year-old female patient who received MENVEO (batch number A15069, expiry date September 2016). Co-suspect products included TWINRIX adult. Concomitant products included TWINRIX adult, citalopram and Oral Contraceptives. On 11th May 2016, the patient received MENVEO (intramuscular) .5 ml. On 22nd June 2016, the patient received the 2nd dose of TWINRIX adult. On 12th May 2016, 1 days after receiving MENVEO and TWINRIX adult and not applicable after receiving TWINRIX adult, the patient experienced injection site swelling. On 22nd June 2016, the patient experienced drug dose administration interval too long. In May 2016, the outcome of the injection site swelling was recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the injection site swelling to be related to MENVEO. Additional details were provided as follows: The reporter stated that, the patient experienced swelling under her right arm after receiving MENVEO and TWINRIX vaccines. The swelling was under the right arm where MENVEO was administered. TWINRIX was administered in the opposite arm (left arm). In May 2016, the swelling resolved after one week. The patient did not have to seek medical attention. At the time of reporting, the patient received 2nd dose of TWINRIX adult later than recommended interval, which is more than 7 days after the one month mark of 12th June 2016. This led to lengthening of vaccination schedule.
He was a little warm Wednesday morning 99F and a little fussy. Thursday his fever had reached 102F, we alternated between Tylenol and Motrin he was good until the medication wore off. On Friday the fever was 102F sometimes up to 103F, some coughing but not a lot. He did not want to eat much at all. We called his Pediatrician who told us what to watch for advised us to take him to the emergency room if his fever got up to 104F or higher. Told us to keep him hydrated and to continue with the Tylenol and Motrin. He started to feel better on Sunday by Monday he was his normal self.
PATIENT'S WIFE CALLED AN 1 HOUR AFTER RECEIVING VACCINE CLAIMING HER HUSBAND EXPERIENCED AN ADVERSE EVENT FROM THE BOOSTRIX VACCINE.  CLAIMED HE WAS VERY DIZZY,LIGHTHEADED AND HAD PINS AND NEEDLES IN HIS ARM AFTER GETTING THE VACCINE.  AS OF THIS REPORT I HAVE YET TO SPEAK TO PATIENT HIMSELF.  MESSAGE WAS LEFT FOR PATIENT TO HEAR INFORMATION FIRST HAND
headache; bloating; mood swings; lethargy; started an abnormal length of spotting (breakthrough bleeding); feel tired; feverish; brought on my period when I haven't had one previously since being on Nexplanon in Jan/ altered menstrual cycle after 2nd dose; I am spotting between my period; Dose Number: 1 # Date of start of drug: 28Apr2021/ Dose Number: 2 # Date of start of drug: 15May2021; anxiety; depression; uncertainty; My cramps ere unusual compared to my normal cycle; This is a spontaneous report from a contactable consumer (Patient). A 29-year-old Non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0173), intramuscular, administered in Arm Left on 15May2021 10:30 (at age of 29 years old) as single dose for COVID-19 immunisation. Medical history included Asthma from 1993 and ongoing, PCOS (Polycystic ovarian syndrome) from Jun2021 and ongoing, Known allergies: Raw Apples, Known allergies: Sulfa drugs. There were no concomitant medications. No other vaccine in four weeks. COVID prior vaccination. No COVID tested post vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0170), Intramuscular at left arm on 28Apr2021 01:30 PM (at age of 29 years old) as single dose for COVID-19 immunisation, and The 1st dose made patient feel extremely fatigued with 101 fever & no appetite & head/body aches. The patient had Nexplanon inserted 28Jan2021.The 2nd dose made patient feel tired & feverish, it also brought on patient's period when haven't had one previously since being on Nexplanon in Jan/altered menstrual cycle after 2nd dose (Seriousness criteria: Not Serious). Since my 2nd vaccination, patient was spotting between period. All above events started on 21May2021 07:00 AM. No treatment for above events. Period started a week earlier, lasting a few days longer than normal; start 21May, end 26May. Nine days later (24May2021) started an abnormal length of spotting (breakthrough bleeding). Spotting started on 05Jun and ended 28Jun with a brief day of spotting on 03Jul. During these weeks of spotting patient (Jun2021) experienced headache, bloating, mood swings, and lethargy. In 2021, There were periods of strong anxiety, depression and uncertainty. Patient's cramps were unusual compared to normal cycle. Altered menstrual cycle after 2nd dose had Physician office visit. The outcome of the events feel tired & feverish, spotting between my period was Not recovered, for brought on my period when I haven't had one previously since being on Nexplanon in Jan/altered menstrual cycle after 2nd dose was recovering, for other events was unknown.  No follow-up attempts are possible. No further information is expected.
She got her vaccine, she had no reaction to anything, and then later that evening she went to bed, then she realized about 2 1/2 hours later she had not fallen to sleep.  She drank some sleepy time tea, some herbal remedies to try to relax her to sleep and nothing helped.  She has not been able to nap, her eyes do not want to stay open, she's tired and exhausted and if she goes to sleep she sleeps for a few hours, and the other night she did sleep for 5 hours, but otherwise sparse sleeping.  She went to UC today who had not heard of the symptoms being related to the vaccine, but she did read about it online, and she was given a prescription for sleeping pills.  She wants to know if this is going to be something she has forever or is it going to go away.
On 04/10/2023, I had a respiratory infection  and on 04/13/2023 I developed a Shingles rash. On 04/16/2023, I developed a high fever, extreme pain and nausea. I had a tele visit and was diagnosed with Shingles. I was prescribed an anti-viral.  I went to urgent care for pain medication. Fever and pain continued and I began to not be able to communicate well.  I went to the urgent care and was diagnosed with VZV Encephalitis. I was started on IV Antivirals and was admitted to the hospital. I was dismissed on 04/21/2023. I am still recovering from Shingles.
Patient received Pfizer Covid-19 vaccine dose # 2 after BUD-expiration date.  Doctor recommended for dose to be repeated. patient's parents were informed of the adverse event, they reported no symptoms or signs related to this adverse event. patients was offered to be revaccinated.
Loss of appetite, diarrhea, vomiting, runny nose all of which happened on and off for two weeks. I thought about taking her to the doctor but knew I would be sent home as these are considered "normal". However, I disagree.
On 2/20/2021 participant went into Urgent Care for routine ultrasound for the liver due to being on Strattera medication. The ultrasound also found a blood clot in the inferior vena cava right above the liver superior hepatic.  Participant was sent to the ER  for CT scan to confirm the ultrasound findings.  Participant was put on blood thinners (Enoxaprin injection  twice a day for 1 week).  Participant was switch to oral blood thinner Pradaxa 150mg twice a day. Participant is currently still on Pradaxa.  She has a CT scan schedule for this Friday to conclude to clot and decide to continue medication.
I received the  vaccine on 1/19 and it is not 1/26. I had no severe side effects except for minor headache and soreness in the arm. However yester day I noticed the injection site had become red and raised. It is a bit hard and very warm. When I woke up today it was even bigger, about the size of a quarter.
THE PATIENT HAD A VAGAL RESPONSE DURING THE ADMINISTRATION OF THE VACCINE. SHE BEGAN TO FEEL CLAMMY AND AS IF THOUGH SHE MIGHT PASS OUT. SHE REQUESTED A COOL, WET CLOTH. HER BLOOD PRESSURE DROPPED TO 97/61. (SHE MENTIONED SHE HAD A SIMILAR REACTION WHEN BLOOD WAS DRAWN FOR LABS BEFORE.)
skip eruption, redness and itching all over, including head, it comes and goes in different parts of the body, there is always one active and its been like this since the third day of the second shot, so its been 18 days today
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.
pt noted to be pale, limp, drowsy w/little movement on stimulating;pt was @ fair-went to medics tent given 02 then went by amb to ER
Patient presented to ER with C/O Pain, swelling and warmth to injection site. Pneumonia Vaccine administered today approximately 1100 by PCP office, unknown administrator/Lot/Exp date as it is not charted in system at this time. Patient to be seen by ER Physician for further treatment Care at this time. Patient did NOT take TYLENOL/IBUPROFEN PTA.
Fatigue, Stomatitis and swelling of hand (injected side) the morning following the injection of bivalent dose. Resolved without treatment after one day.
Patient died at home of an apparent heart attack, was not rescesitated and did not make it to hospital
11 yo autistic child had 5 days of uncontrolled motor tics (head jerking). On 5th day it decreased to approximately one an hour.
This spontaneous report was received from nurse refer to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. It was reported that third patient was vaccinated on 13-JUL-2016 with improperly stored doses of VARIVAX with lot # L048462, expiry date: 02-DEC-2017 (route, dose and frequency not reported). The vaccine was exposed to temperature of -3.3 Celsius for 2 hours. The vaccine had previous temperature excursion on 20.3 Celsius for 27 hours and 8 Celsius for 30 hours. No adverse effects were reported. No further information provided. A phone was placed to the licensed practical nurse on 07-SEP-2016. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested.
Inadvertent vaccination with Pfizer vaccine who's "good for Use' date was 10 days expired. Vaccine itself was still within expiration date.
User Error.   A new syringe type was used by administrator, and first attempt, provided patient with only (predominantly) air from syringe without vaccine which was not properly drawn up. This was noted and rectified and the patient was then provided with opportunity to receive 2nd dose of COVID 19 Pfizer vaccine L3247 (3ml)  half an hour later. He stayed for 30 minutes post both doses. No adverse sequelae noted
Information has been received from a consumer concerning her 19 year old daughter with no pertinent medical history and no prior drug reactions who on 22-AUG-2007, was vaccinated with her first dose of Gardasil.  There was no concomitant medication.  On 22-AUG-2007, a few hours after receiving the dose, the patient developed fever, loss of appetite, chills and loss of energy.  As of 28-AUG-2007, the patient's fever, loss of appetite, chills and loss of energy persisted.  The patient sought medical attention with a physician.  Additional information has been requested.
Patient with Severe sepsis -Possibly from colitis.  Blood cultures no growth to date -We will continue short course of Augmentin to complete 5 days. -Lactic acid has normalized after sepsis bundle initiated -Continue fluids -Advance diet ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
06/01   Scratchy throat from coughing also I had the knowledge that my wife tested positive either on this day or the day before. I did a at home test, and it was negative.  06/02 I tested positive for COVID-19 I made a video appointment for later in the day. The NP prescribed Paxlovid for me which I did start.  I had reduce symptoms throughout the next four days but they were all minor.
This is a spontaneous report received from Pfizer regarding a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 05Mar202, the patient experienced a headache. Clinical outcome of the event of headache was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pain at injection,Sore, red arm area 2 1/2" diameter, chills, fever , achy, interfered with sleep and work continuing. The severity of the shot will be a factor as to whether I go to get the second shot. Also as an aside, the shots are expensive and not much covered by primary or my secondary. Into second day and not recovered.
Patient was given the Moderna vaccine for her 2nd Covid-vaccine and was originally given the Pfizer vaccine for her first dose.   At this time no adverse effects have been reported
Information has been received from a registered nurse, via a company representative, concerning a female patient (age not reported) who was vaccinated in the right arm with a first dose of Gardasil (date unspecified), followed by a second dose of Gardasil (date unspecified). Subsequently, after the first vaccination the patient developed swelling of two fingers on her left hand. Following the second vaccination, the patient had a recurrence of the swelling in her fingers on her left hand. The nurse indicated that the swelling had improved. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) prevously submitted on 4/13/2007. The MA reported that 12 hours after the first vaccination was administered, the patient developed swelling with redness and pain in two fingers, the middle and fith digit, on her right hand (previously identified as left hand), confirmed as the opposite arm of the vaccination. The swelling lasted approximately 2-3 days. Following the second dose, again 12 hours after the vaccination was administered, the patient had a recurrence of the swelling with pain and redness, in the same fingers of the same hand. The MA stated the recurrent symptoms lasted 1 to 1 1/2 days, and indicated the patient had full recovered. The patient sought unspecified medical attention. No further information is expected.
Neck pain, severed headaches, sudden onset headaches with blurred vision, anxiety, nausea, clamminess, low grade fever.  Currently awaiting an MRI and is under the care of a physical therapist.
Fever started 10/16/15, arm (L) began to swell evening of 10/16/15, 10/17/15 (L) arm red, warm to touch, area is swollen but no lump, area not uncomfortable to child and is not bothering her. No streaking.
for a cold he was experiencing both before and after the second dose; This is a spontaneous report from a contactable consumer or other non-health professional. An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 Immunisation. Patient medical history and concomitant medications were not reported. It was reported that on unspecified date patient states he received his second dose of the Pfizer Covid vaccine but was given prednisone to take for a cold he was experiencing both before and after the second dose. Patient clarified that had a cold prior to receiving the second COVID-19 Vaccine. Patient enquired got a little bit of a cold. Patient enquired to know if it hurts anything to take Prednisone. He wants to know if this lessened the effectiveness. The Outcome of the event was unknown.  No follow-up attempts are possible; informationabout lot/batch number cannot be obtained.
The day after I received the vaccine, there was some redness to the site.  Today, there is increased redness and some swelling at the site of injection.  The swelling is approximately 2 inches long and 1 inch wide.
Loud persistent ringing in left ear (tinnitus) occurred early the next morning in combination with chills, aches, pain throughout the night; Loud persistent ringing in left ear (tinnitus) occurred early the next morning in combination with chills, aches, pain throughout the night.; Loud persistent ringing in left ear (tinnitus) occurred early the next morning in combination with chills, aches, pain throughout the night.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 04:00, the patient experienced loud persistent ringing in left ear (tinnitus) occurred early the next morning in combination with chills, aches, pain throughout the night. Ringing has continued for several weeks and shows no sign of subsiding. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events loud persistent ringing in left ear (tinnitus) occurred early the next morning in combination with chills, aches, pain throughout the night were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
after receiving vaccine and waiting during 15 observation period patient stated that her left cheek felt slightly numb, we advised patient to wait 15 more minutes for observation and after that time the patient stated that the numbness was gone
10 Y O MALE W/4 CM X 5 CM CELLULITIS @ INJECTION SITE N 20 HR P INJECTION. TREATED W KEFLEX 500 MG QID X 5 D.
Initial case was received on 03 November 2010 from a healthcare professional. A 36 year old male patient received on 22 October 2010 an intramuscular left deltoid injection of FLUZONE SV 2010-2011 (lot number U3742AA). On 23 October 2010 he experienced redness, warmth, pain and itching at the vaccination site. He was seen at a clinic and diagnosed with cellulitis that measured 17 cm by 20 cm. The patient had no illness at the time of the vaccination. He had no pre-existing medical conditions and no concomitant medications. He had a penicillin allergy. The adverse event resolved (date not reported). Documents held by sender: None.
SHAKY; FEELING PALE; SWEATING; BODYACHE; HEADACHE; FEELING WEAK; FEVER; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lupus - low grade, and osteoporosis. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the patient experienced shaky. On 11-APR-2021, the patient experienced feeling pale. On 11-APR-2021, the patient experienced sweating. On 11-APR-2021, the patient experienced bodyache. On 11-APR-2021, the patient experienced headache. On 11-APR-2021, the patient experienced feeling weak. On 11-APR-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 100. The action taken with covid-19 vaccine was not applicable. The patient recovered from shaky, feeling pale, sweating, bodyache, headache, feeling weak, and fever on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210842894.
Body aches; Headache; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 21st April 2022, the patient received Menveo. On 21st April 2022, less than a day after receiving Menveo, the patient experienced general body pain and headache. On an unknown date, the outcome of the general body pain and headache were recovered/resolved.   It was unknown if the reporter considered the general body pain and headache to be related to Menveo.     Additional Information: GSK receipt date: 21-Apr-2022 Reporter's comment: The patient self reported this case. The patient stated that he received Menveo vaccine on the date of reporting (today) and had body aches and headaches since receiving the vaccine.   The patient stated that he was okay and he was fine. The patient did not wish to provide further details. Did not consent to follow-up.