chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 9:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The age of patient was provided as 61.29.  On 14-Feb-2021, Excursion time was 09 AM, 10 AM, 11 AM, 2PM, 3PM temperature was 32 and 35, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Severe headaches lasting a couple days at a time with a constant headache ever since the shot, severe ringing in the ears nonstop since the shot, severe fatigue since the shot
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L026553, expiration date: 16-JUL-2017, (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree 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 reporter. Additional information has been requested.
4pm- tiredness  7pm-tiredness,nausea and chills 11pm- stomach cramping, tiredness, nausea, chills 1/29 @1am- nausea, vomiting, severe chills, shaking, body aches, tiredness. 1/29- bodyaches continue through day.
Initial report received from a health care professional on 01 September 2009, at which time only non-serious listed events were reported. Follow-up information was received on 16 September 2009 which added an unlisted event; this narrative incorporates information from both versions. An 11-year0old male patient, with no reported medical history, received a right arm injection of MENACTRA lot number U3014AA) on 24 August 2009. Within 24 hours of vaccination, he developed an urticarial rash, redness, and swelling of the whole upper arm. He subsequently experienced blotchy urticaria on back and behind his ears, and also developed an upper respiratory infection. No cough or rhinorrhea were noted. The patient was seen by his physician, and treatment included Zyrtec and topical Benadryl. The events recovered on 01 September 2009.
It was progressive weakness, I went from being able to walk fine and by January I had to use a walker. At the end of April I went to take out the garbage pout and my legs turned into Jello and fell backward and broke my left ankle in four places. I ended up in the hospital and a rehab facility for a month. I think the weakness might be better but I am just now getting back to weight bearing. I was referred to a neurologist and I am scheduled for a brain MRI, lumbar spine MRI in the next couple of weeks.
Local reaction to Dtap (given on 03/30/09), right arm swollen and red (4cm). Pt. came back to office on 04/01/09.
lt arm is swollen, inflammed also red hard & tender to touch & pain w/movement;
Sibling had chicken pox two weeks ago, also vaccinated. On Amoxicillin for strep 12/03/2001. Six marks on trunk and face. Started 12/06/2001. Diagnosis: chicken pox. Pt has allergy to peanuts and cashews.
When diluting the Covid 19 vaccine with NS, it appears that instead of 1.8ml, it was less.  I drew up 3 X 0.3ml doses and then noticed that there was not enough for a 4th dose in the vial.  That was not consistent with any of the previous vials that we had prepared.  We immediately tried to retrieve the doses that had been given to the nursing staff, 2 of the 3 dose had been administered.  This is one of the 2 patients that received a dose that may have been diluted incorrectly.  No immediate reaction was observed and he was notified of the potential error.
interchange of vaccine products; Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "heart issues" (unspecified if ongoing), notes: I have heart issues and am taking several drugs for the heart issues." (Further not clarified.). Concomitant medication(s) included: FLU VACCINE VII. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: Last blood test: Unknown Results, notes: Last blood test I think I had was in Jun; Weight: Unknown Results, notes: about 146 (pounds), 147 (pounds).  Clinical course: Other conditions was reported as yes and investigations was reported as no. He received paxlovid treatment for COVID-19. He stated, he was 83 plus years of age he had got most serious health problems (Intent History). He had all his Pfizer and Moderna vaccine and all that stuff and the booster shots and flu shot and everything but he came down with Covid19 recently which he understand you can get. So, he went to patient health in city and they diagnosed that you do have Covid-19 and they gave him one of your drug Paxlovid and he have been taking this drug and this was his second day and he do not know how to say this but it feels like miracle taking place. He had been suffering for years with a throat thing. He have got a valve in his throat that did not work right and when he eat he choked sometimes and he have been having blowing nose and cough and all these concept and that has really subsided and he was just wondering if this drug, these effects were from Covid or what because he cannot figure if it cured the other things." When clarified the concern, consumer stated, "because it do things for other than Covid-19 because he have had a problem and it seems to have cured that." He was type 2 diabetic, no medication for that and he have heart issues and he was taking several drugs for the heart issues." No lab work. Last blood test he think he had was in Jun." Consumer stated, "he was very pleased with the product. It was doing what they are supposed to do but he was thinking it had any, like some of these drugs you take all through the year and it takes forever for them to cure those problems."    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Chills, malaise 16th, 17th and 18th. Hives developed in the region of the vaccine site 12/20/14.
Headaches; Nausea; Fatigue (more then normal); This is a spontaneous report from a contactable consumer. A 45-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in left arm on 25Feb2021 12:45 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient received dose 1 of BNT162B2 on 04Feb2021 02:00 PM. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced headaches, nausea, fatigue on 26Feb2021 07:00. The patient received treatment of Tylenol. The events assessed as non-serious. Outcome of the events was recovering.
The very next day I woke up with itchy eyes, as if something was inside, but then progressed during the day to both eyes very red and itchy. I woke up better the next day. (today)  A swollen spot about 2.5" x 3' on top of my feet. Skin was darker and hurt. Next day (today) a bit better but still there. I did not had any injury.  Sore where the shot was given.
Fever over 103F, intense chills, extreme muscle aches, tingling in hands and feet for 6 hours.  Severe headache for 24 hours.  Extreme night sweats for 2 night.  Fatigue for 24.hours.
Less than 1 mo following injection pt developed DVT RLE. He presented with rt foot/ankle pain 3/29. The pain improved then around 4/10 he developed significant pain/swelling to rt calf. Venous US confirmed DVT. Pt started on Eliquis. Pt has h/o superficial thrombosis, not h/o DVT.
Employee started to feel a "dry itch" in her throat, described as mild.  Refused EMS, refused to go to the emergency department.  after speaking to medical director, benedryl 50 mg PO given with relief after 30 minutes.  no hives, no rash, no itching to skin, no visible swelling, vitals are stable, 114/62, hr 72, saturations 98% on room air, respiratory rate 18
Ringing in ears. Began in left ear and then in both. Non stop since 3 days after second dose.
On 10/11/2023 another Tdap was inadvertently given as a result of an electronic uploading error. Tdap (Boostrix - GlaxoSmithKline) 9HR72 IM R. Delt.
3-5 minutes after vaccine injection I noticed a strange feeling in mouth, tongue and throat.  Felt as if it might be swelling or a little numb though there was no swelling. Also felt a burning in my chest for about a minute or two.  The feeling in my mouth, tongue and throat persisted for another 45 minutes or so without getting worse.  I was taken to the medical portion of the building and assessed by a physicians assistant approximately 10-15 minutes after injection.  Was given 25 mg of oral Benadryl and watched for approximately an hour at which time the symptoms had improved though still slightly noticeable.  Was very tired that evening likely from the Benadryl and fell asleep early.  The next day the mouth still felt a little strange till mid day.  Overall felt a little shaky or weak that day, had a sore arm nothing more than I would get with a flu shot. The second  day following the vaccine had a couple of episodes of diarrhea but otherwise no complaints.
Pt received injection on Friday later that night pt had localized redness and swelling that resolved on Sunday. Pt was given steroid.
Reporting an allergic reaction to the bivalent booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Reporting an allergic reaction to the bivalent booster".  Additional information: Description of Event Outcome: Hello please provide information for reporting an allergic reaction to the bivalent booster. I want to report this for science.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Nausea and weakness after receiving shot-redness and swelling on neck.  12/08-noon.  Red, rash and swelling on shoulders, neck and arms 12/09.  Red, rash and swelling on stomach and legs.   12/10 dizzy, shortness of breath, nausea, choking 12/11: ER slept rest of 12/11, all of 12/12-12/13 very weak, just ate some and slept.  Weak and wobbly 12/14, 12/15, 12/16.
Sharp stabbing pain from top of arm down to ventral forearm of left arm; dull ache in left posterior shoulder; limited range of motion due to pain; brief red streaks down arm.
This is a spontaneous report from a contactable Pfizer employee. A 1-year-old female patient received PREVNAR 13, on an unspecified date, in 2013, at 0.5 ml, single dose. Medical history included chronic ear infection. There were no concomitant medications. The patient had a blood work to confirm her antibodies and to determine that her vaccine did not build up the antibodies (in 2013), so she would need a booster shot. No hospitalization was required. Subsequently, a booster shot was administered. The outcome of the event was recovered at time of this report. Follow-up (23May2016): New information received from a contactable consumer includes: suspect drug details and reaction data. Follow-up attempts completed. No further information expected.
Shot initially hurt at injection time, unlike 1st injection.  By 2pm, could not lift arm without severe pain.  Around 6pm, developed serious chill and could not get warm. So cold did not take off clothes and put two heavy robes over clothes and covered with heated blanket.  Remained cold until around 5 am and was burning up at that time.  Temp was 101.3.  Had headache from hell and my body felt as if it had been beaten with worse pain in shoulders, upper and mid back and left knee.  Interesting because shoulders have been previously injured and are in poor shape and recently had injured left knee.  Don't know if relevant or if existing pain was amplified by effects of virus. With tylenol and aspirin, got temperature to 100 to 1.  Felt bad all day Saturday and only got up to go to bathroom and eat bowl of soup.  Pushed fluids.  By Sunday morning, temp running 99.8 to 100.5 with meds.  Pain and h/a continued with slight improvent in h/a.  Today, Monday, I feel about 50% better.  Temp 98.8 to 99.5.  Headache at about 50% of previous level  with body aches only slightly improved.  Hopefully, I am coming to the end of this reaction
A few hours after injection, I started experiencing headaches, shortly afterwards was chills and finally a fever of 99.4 F. This lasted between Thursday 2/25 and Friday 2/26.
tired; nauseous; my arm was sore to the touch; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE, FATIGUE, NAUSEA, and MYALGIA in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE. On 11-Mar-2021, the patient experienced FATIGUE, NAUSEA, and MYALGIA. At the time of the report, HEADACHE, FATIGUE, NAUSEA, and MYALGIA outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-403033, MOD-2021-403058 (Patient Link).
Initial report received from a healthcare professional (nurse) on 09 October 2014. A female patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (batch number, expiration date, route, site of vaccination and dose in series not reported) on 09 October 2014. The patient had experienced chest tightness immediately after vaccination on 09 October 2014. The patient's illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were unknown. The patient required emergency room or doctor visit. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the events was unknown. List of documents held by sender: none. Follow-up information received from the healthcare professional (nurse) on 11 May 2015. FLUZONE vaccine lot number reported as UI188AB. List of the documents held by sender: none.
pt recv vax SEP95 & LMP 5NOV95 & became pregnant;AUG96 delivered an infant who devel sleep apnea & reflux;
PATIENT DID NOT HAVE AN ADVERSE REACTION SHE JUST CAME IN TOO EARLY. HER FIRST DOSE WAS ON 05/14 AND WAS DUE ON THE 11TH. SHE RECIEVED HER DOSE ON 06/02/2021. PER GUIDLINES IT STATES DO NOT REPEAT VACCINE. PATIENT HAS BEEN NOTIFIED
Cellulitis treated with Keflex unsuccessfully area of redness reached 12.5 x7.5cm resolved with Augmentin ES.
sore arm (briefer than with #1); malaise; fatigue; Pulsing tinnitus, eased off now; bad headache (prexisisting but markedly amplified-still; chills (no fever, 3 days for real, now fading); mild nausea/loss of appetite (largely resolved.); mild nausea/loss of appetite (largely resolved.); This is a spontaneous report from a contactable Physician reported for herself. This 57-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 09Jan2021 09:00 AM on Arm left at single dose (Lot # EK9231) for covid-19 immunisation. Medical history included Pacemaker, Insomnia, and some preexisting hearing loss, due to effusion. No known allergies. No covid prior vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 16:45 PM on Left arm at single dose (Lot # EH9899) for covid-19 immunisation. Covid test after #1 (December) due to sore arm, chills, aches and malaise. Was negative. No other vaccine in four weeks. Concomitant medications included other medications in two weeks. The patient experienced pulsing tinnitus, eased off now, also sore arm (briefer than with #1), malaise/fatigue (still but better), bad headache (persisting but markedly amplified-still, chills (no fever, 3 days for real, now fading), mild nausea/loss of appetite (largely resolved.) Events all on 10Jan2021 06:00 AM. Lab data included covid test (Nasal Swab) on 22Dec2020: negative. No treatments were received for the events. Outcome of events mild nausea/loss of appetite, malaise, fatigue was recovering.  Outcome of the event chills (no fever, 3 days for real, now fading) was recovered. Outcome of the events was unknown.
Patient received GARDASIL vaccine and was observed in office. After checking out pt fainted/fell and hit head on a column in the waiting room. She suffered a skull fracture with ongoing treatment.
feeling tired; muscle pain; chills; sore arm; difficulty lifting arm; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced tiredness, muscle pain, chills, pain in arm and movement disorder. On an unknown date, the outcome of the tiredness, muscle pain, chills, pain in arm and movement disorder were recovered/resolved.   It was unknown if the reporter considered the tiredness, muscle pain, chills, pain in arm and movement disorder to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix about 4 months ago and experienced feeling tired, muscle pain, chills and sore arm, difficulty lifting her arm.   The caller reported that issues resolved within one day except for arm issues which took about 3 days to resolve. The reporter consented to follow up.
Oblong patch with increased color (Pink) without erythema, ecchymosis, or induration, non blanching 2cm width at the superior aspect surrounding the site of injection extends down the arm 9cm widens to 4 cm
Patient had a fever, rash and was extremely irritable following all of his immunizations. Later developed autism.  11/16/07 Reviewed medical records from pcp which reveal patient experienced good growth & development until approx 9 mos of age when parent expressed concern.  PCP felt he was WNL for his corrected age except for speech delay.  Started speech tx 9/2006 & early intervention 10/2006.  Dx w/autism 2/2007 along w/his twin brother. Placed in intensive program & started dairy & gluten free diet w/some improvement. 1/4/08 Reviewed vax record which provided vax brand info but no lot #s.  VAERS database updated w/same.
Swelling in left axilla, could not put my arm down- would lose feeling in left arm.
No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 07-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
As of Disease Investigation date 7/27/21 Case reported onset of symptoms as 7/23/21 which included runny nose, muscle aches, headache, sore throat, loss of smell and fatigue.
COVID arm. Hot, swollen, hard,, red, itchy, sensitive to touch.   9 days later had sore back, that worsened and became  like a kidney stone/ infection.
6AUG92 pt recvd DTP/OPV/HIB mom called 7AUG92 stating pt sleeping all day, won't wake up well, eating poorly-seen by MD 7AUG92; devel crying & screaming which was different from usual crying & persisted 3 hrs;pale, lethargic;
It started as a mild headache then i became nauseous and threw up during the night and then developed a fever and the headache got worse