chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 8:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 8:40 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 76.05.  No concomitant medications were reported.  Batch number 031L20A administered on 17-Feb-2021 underwent temperature excursion with temperature range 20 degrees Fahrenheit at 08:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 17-Feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Vaccine mixed with incorrect diluent (sterile water instead of normal saline).  Pt reports no adverse reactions. Pt informed of error and offered revaccination.
Congestion, body aches, sore throat, cough, headache which is gotten progressively worse over the past week since receiving the vaccine that is required by employer.
Complained of discomfort in left upper arm after injection given.  Trouble with pain when moves arm in certain ways.  Pain still persists.  I puke with my nurse (unable to read). 11/16 no discomfort.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles at the time of reporting. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
The day after the vaccine I had bad joint pain, heavy fatigue and fever. I also had a cluster headache  for one day. The joint pain lasted 4-5 days. For two weeks I felt inflamed and fatigued for two full weeks after that day. I felt very poorly like I had a low grade fever. Two to three weeks after the vaccine I noticed spot on my upper lip that was raw and hot. It is across my whole upper lip at the same time. It is red but not swollen and most noticeable when it becomes dry. Cold seems to help and some balm helps when it is at the dry stage.  After it settles down it gets really dry and then it heals up.  I keep getting the spots on my upper lips. It cycles for a 5-6 day period and it gets better and it returns and repeats the cycle. I always have a feeling that my lip is twitching before it comes up. It has been eight weeks and I have had the condition with my lip cycle six times since the vaccine. I have never had anything like this before. It is always the same and has not improved any with each cycle. The last time it was dormant for longer (10 days) but it seems to be worse with a bigger gap.
immed p/vax pt exp swelling & itching @ injs ite;this event resolved in less than 12hr;this is 1 of 6 pt from this site to have an adverse exp following vax w/lot# 4968173;
day after vaccine, the lymph-node under my left arm was  extremely swollen and stayed that way for 4-5 days. After the swelling went down I could tell the other lymph-nodes stated getting swollen but they seem to go down after a few days. Then the lymph node behind my right knee became swollen about 10 days after vaccination, and has stayed swollen and sore ever since. It has become worse and more painful over time to the point I am going to go get a CT scan since it has been going on for over 3 months. About 30 to 45 days after my vaccine I developed tinnitus in both ears, and both ears also get quite a bit of pressure that lasts for a day or two, and then when the pressure leaves the tinnitus comes right back.
Adverse effects began within 5 minutes post-vaccination. Pt experienced sensations of nausea and dizziness; pt became pale. Mother was with pt. Had pt lay on floor and elevated legs. Pt was fanned and a cold pack was used to keep pt cool. Cold water was offered to pt if needed. Pt recovered about 20 minutes later.
Seasonal Flu mist given instead of H1N1 mist (dispensed by pharmacy - packaging very similar)
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 54-year-old, adult patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 10-Oct-2018, the patient was administered FLUAD (TIV) which underwent temperature excursion [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. The reported batch number (250802), dose not match FLUCELVAX QIV batch numbers, however, the batch number was mapped to FLUAD (TIV). Hence, the suspect vaccine was coded as FLUAD (TIV). At the time of this report, no adverse event was reported. This case 201805504 was crossed linked to original case 201804863 due to same reporter.
This case was reported by a healthcare professional and described the occurrence of mild hives in a female subject aged 40 and 29 years old who was vaccinated with TWINRIX (GlaxoSmithKline), Polio vaccine, DTAP and Typhoid injection. There were no concurrent medications. In June 2008 the subject received 1st dose of TWINRIX at 1.0 ml in an unknown arm. On the same day, the subject also received unspecified dose of Polio vaccine (unknown), unspecified dose of DTAP (unknown), unspecified dose of Typhoid injection (unknown). One day after receiving TWINRIX and other vaccines, the subject developed mild hives. She treated herself with BENADRYL and the hives resolved right away (the same day).
Patient exhibited hives difficulty breathing and felt like her throat was closing up greater than a hour after receiving vaccinations. Pt went to facility and recieved Benadryl, Solumedrol and epinephrine and albuterol nebulizer and IV Fluids.
Mom claims child's left thigh became very swollen (twice normal size)  Took child to ER and was told it was a reaction to the immunization.  Was given antibiotics.
Patient reported to clinic 1+ hour post vaccination with complaints of itchiness and swelling to face. Patient denied any discomfort of the throat or tongue. Vital signs were within normal limits. Consulted with Pediatric Dr. who consented the administration of a 25 mg oral capsule of Benadryl.  Patient began to feel slight discomfort swallowing. Oxygen levels remained within normal limits. Consulted with Dr. and per his assessment patient stable and no need for further intervention. Patient was observed for a total of 30 minutes following administration of medication. After 30 minutes patient reported that her symptoms were resolved.
ELEVATED BLOOD PRESSURE; FELT A HEAVY PRESSURE IN CHEST; NOT FEELING WELL; FELT TIRED; FEVER; ELEVATED D-DIMER; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included: mild covid 19, and concurrent conditions included: alcoholic, non smoker, and inactive thyroid, and other pre-existing medical conditions included: The patient was very healthy and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, and expiry: 27-APR-2022) dose was not reported, administered on 12-DEC-2021 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride for drug used for unknown indication, probiotics nos for drug used for unknown indication, and vitamins nos for drug used for unknown indication.  On SEP-2021, Laboratory data included: Antibody test (NR: not provided) COVID Antibodies level was good. On DEC-2021, the patient experienced elevated d-dimer. Laboratory data included: Blood pressure (NR: 60 - 110) 110/60 mmHg, Blood pressure (NR: not provided) High (Elevated), Blood test (NR: not provided) Not reported, CT scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, EKG (NR: not provided) Not reported, Normal, and Fibrin D dimer (NR: not provided) Elevated. On 13-DEC-2021, the patient experienced felt tired, and fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 14-DEC-2021, the patient experienced elevated blood pressure, felt a heavy pressure in chest, and not feeling well. Laboratory data included: Blood pressure (NR: 92 - 138) 138/92 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt tired, and fever, had not recovered from elevated blood pressure, and the outcome of felt a heavy pressure in chest, not feeling well and elevated d-dimer was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Got the vaccine around 9:20-9:30 am, experienced a sore arm and headache a few hours later and some body aches. Woke up in the middle of the night with chills- fever Of 101, nausea, dizziness, headache, sore arm, and body aches
I thought this booster would be a breeze, as the only reaction to my second Moderna vaccine was, besides a sore arm for a few days, a slight headache and tiredness, that was alleviated with Tylenol and only lasted about 24 hrs. I was fine with the Moderna booster until approximately 6 hrs later, I felt ill, had extreme chills, muscle and joint aches. The spasms from chills tightened my back and chest muscles for minutes at a time. The spasms, joint and muscle aches were intermittent and lasted for more than 24 hrs.  I felt ill all the next day but didn't vomit and took Tylenol, drank lots of liquids and rested. That night I awoke and was drenched in sweat, to the point of getting up, changing my nightgown, putting a towel down on the wet sheets and sleeping again. I was still felt tired on waking, but felt a little better. Drank fluids, took Tylenol at intervals,some soups, and rested. I just felt tired with a headache the next day and today I feel well this morning. I had a similar reaction to the second shingles shot I received, with spasms, dizziness, and chills, but it only lasted about 6hrs and was fine after that. Hope this report helps others.
Pain in my toes, more on the right foot, and especially the middle three toes. It was surprisinlgy painful and difficult to walk!  And, I noticed that my balance was off.  Also, I developed TMJ on the left side of my jaw.   The pain in my toes and my balance improved after a few days.  The pain in my jaw continues.  All of these symptoms were new, never in my life had these issues before.
This spontaneous report was received from a medical assistant regarding a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 06-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Upset stomach; General feeling of unwell ness; Extreme headache; Extremely swollen and painful lymph node above collar bone; Extremely swollen and painful lymph node above collar bone; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Aug2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included graves' disease and allergy to latex, gluten and sulfa based drugs. 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 COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received ciprofloxacin (CIPRO) and experienced drug allergy. On 22Aug2021, the patient experienced extreme headache 4 days after receiving shot. On 23Aug2021, the patient had upset stomach 5 days after shot. On 19Aug2021, the patient experienced extremely swollen and painful lymph node above collar bone. On 23Aug2021, the patient experienced general feeling of unwell ness 5 days after receiving shot. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events extreme headache, upset stomach, extremely swollen and painful lymph node above collar bone, general feeling of unwell ness were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 11-year-old male patient who received MENVEO (batch number M16172, expiry date 30th October 2018). Concomitant products included BOOSTRIX. On 2nd October 2017 14:30, the patient received MENVEO (intramuscular) .5 ml. In October 2017, less than a week after receiving MENVEO, the patient experienced extensive swelling of vaccinated limb, rash and skin warm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, rash and skin warm were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, rash and skin warm to be related to MENVEO. Additional details were provided as follows: The case was reported by an office manager. At 14:30 hours, the patient received MENVEO in right arm. The patient experienced a severe rash with swelling down the entire arm where the injection was administered that was hot to the touch. The office manager did not have access to the full records at the time of reporting. She did not indicate filing a quality assurance, so no quality assurance was completed at the time of reporting. The reporter indicated this had already been called in by a Medical Science Liaison, so this event had been marked as a follow up. This case had been linked with case US2017GSK154366, reported by the same reporter.
Wed 5/5 - 10am - cluster headaches Sat 5/8 - 7am - cluster headaches
Vaccine given in am and pt developed symptoms that evening of the typical sore arm with some fatigue.  By day 2 she had pain in left shoulder to trapezius and left headache, face and eye pain.  Symptoms persist now for 8 days
I came down with severe itching all over my body at about 9:30PM on 6/14/2022.  By the morning of 6/15/2022 hives started to appear and the itching continued.  At this time I also experienced severe fatigue and chills.  This has continued throughout the day and evening on 6/16/2022.
A non-serious spontaneous report of "7 patients were inadvertently administered expired H1N1" was received from a health professional concerning a five-year-old male out of seven patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. On 01-Feb-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
Doctor diagnosed me with pityriasis rosea this week, and the rash has been there since January 24th, 20 days after my first vaccination dose. The herald patch of pityriasis rosea appears 1-20 days before the rash, and I don't know when it appeared since it was not itchy and on my back, but I did have some mild symptoms such as a mild sore throat that can be early signs of this disease.
Headache, nausea, and vomiting starting about 2 hours after vaccine and got worse overnight. Patient reported intractable vomiting the next morning an feeling week so she called EMS in the evening. She developed sudden onset of right lower extremity paralysis and numbness.  In ED, stroke was called and Alteplase was given on 3/13/21
Pain at the injection site; Swelling in his lymph nodes; Fatigue; This is a spontaneous report from a contactable consumer. A male patient (reporter's father) of an unspecified age (Age: 65; Unit: unknown) received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 05Jan2021 for COVID -19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Covid-19 vaccine last Tuesday. On 06Jan2021, the day after the injection, he developed pain at the injection site that quickly resolved, and he felt great. He recently developed swelling in his lymph nodes and fatigue and the caller would like to know if that is normal to have this delayed reaction 5-6 days later. The patient recovered from the pain at the injection site on an unspecified date in Jan2021. Outcome of other events was unknown.  Information on the lot/batch number has been requested.
Got Pfizer-BioNTech COVID-19  Vaccine EUA about 5:55 pm on Thursday April 8th. Started to feel sorness after 10 minutes at the shot site. 3 hours after got like a whoosh sounds in ears. Sore left arm. Went to bed. Woke up with a headache and feeling drowsy. took acetaminophen at 9am. Headache is gone. Still drowsy. It is 2:15 pm on Friday april 9th. And whoosh sounds in ears came back like 30 minutes ago.
Adverse Event occurred when vaccine diluted with 1.3mL, instead of recommended 2.2mL. Pt. received dosing of 4.7mcg. No current adverse reaction at this time, but will continue to monitor.
Gave immunization 12/8/11 - called me 12/14/11 stated she had 3 red welts on her arm & tenderness into the arm pit - hard to lift arm for awhile.
Patient received 1st dose at other facility on 06/11/21.Due to travel to other country did not able to get 2nd dose with in manufacture recommended time line. Patient received 2nd dose 65 days after the 1st dose.
This case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a child patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.  On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the paralysis was unknown. It was unknown if the reporter considered the paralysis to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported that receiving second vaccine left a patient temporarily paralyzed a couple weeks before the date of reporting. It was also listed on GlaxoSmithKline website that was no safety or effectiveness testing. The reporter stated to let her sign right up and keep her fingers crossed so that she should not end up with some serious side effect.
No adverse effects reported.; one patient was inadvertently administered PROQUAD and VARIVAX; This spontaneous report was received from a licensed practical nurse concerning a 14 months old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medication were not provided.    Simultaneously on 30-AUG-2019, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S012472; expiration date 20-OCT-2020) (dose, frequency and indication were not provided) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S015459; expiration date 20-MAY-2021) (dose, frequency and indication were not provided).   No adverse effects reported.
Generalized hives improved with Benadryl. Sent to allergist for further evaluation.
Patient developed a blistery rash on different areas of the body the day to a couple days after the 2nd dose of Moderna Covid-19 vaccine,  She went to see a doctor about the rash in outpatient setting and was prescribed glucocorticoids to treat the rash.
At 3:30 am after receiving the vaccine the day before at about 11 am, woke up with chills, low-grade fever (99.4 when normal temperature is in low 97s).  Also had a fairly bad headache, a fast heartbeat of up to 111, hips and legs ached, and felt a bit nauseated.  At about 9 am took 1 extra-strenghth Tylenol, with little help.  At 1 pm took 2nd Tylenol and all symptoms were pretty much gone by 3 pm in the afternoon.
high fever beginning overnight, 103-104 Fever continues to persist at 101-102 the next day despite treatment with Motrin
Sore arm.  From half a day after vaccination for a day and a half my whole arm was inflamed.  Also felt queasy for that night and through next day.    These didn't stop me from doing anything but I did decline a glass of wine the day after vaccination because I felt uneasy.  So I gardened, hauled firewood, transferred stuff between trucks and cleaned house.  I ate normal meals.  Not all that bad just discomfort.
Extreme muscle pain, chills, headache over right eye, fatigue, nausea, arm soreness at injection x 24 hours