chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature Excursion; Initial Report Received on 11-Jan-2023  A registered nurse reported that a patient (Patient 6) (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11 Mar 2023 or Lot # 938794, expiration date 09-Oct-2023). The NDC #, injection site, and route of administration were unknown. These two HEPLISAV-B Lot #s affected by the temperature excursion occurred between 22-Aug to 15-Nov (year not reported). For 97% of the time, the temperature was between 8°C - 12.31°C.   No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient received Pediatric Pfizer Dose 0.3ml diluted with 1.8ml Sodium Chloride (Normal Saline).
The patient should have gotten the bivalent.  I contacted her mother to explain the error, that she got another monovalent.  I enquired if the child is experiencing any adverse reactions such as apprehension, flushing and or skin edema, palpitations, numbness or tingling, itching, localized or generalized urticaria (rash, welts), seizure activity, choking sensation, any coughing, hoarseness or wheezing, difficulty breathing, nausea and vomiting, severe hypotension, vasomotor collapse or loss of consciousness to which mom responded no.  Mom states she is feeling fine.  Mom is encouraged to continue to monitor the patient for any of the above signs and symptoms and to notify the clinic or 911 for any of the above s/s.  Understanding verbalized.  Mom is further advised to bring the child back in 2 months for the pfizer bivalent vaccine understanding also verbalized.
Was awoken early ~ 16 hours after shot with severe nausea, back pain, hot and and cold chills. Initially also only able to breathe shallowly, (has since resolved). Unusual sensation in bladder/ genital area. Repeated urge to urinate but unable to, also felt painfully swollen/ engorged in genital area, but no actual redness or swelling. Symptoms are still ongoing at about the same level 48 hours after the shot. Still disinterested in food and feels dehydrated despite trying to ingest fluids.
Information has been received from a registered nurse concerning a 15 year old female who on 31-JUL-2007 was vaccinated with a dose of Gardasil (lot # 658488/0930U). On 31-JUL-2007, the patient fainted for 30 seconds to 1 minute after she was given Gardasil. The patient complained that her ear "felt funny" and left fingers were tingling. On 31-JUL-2007, the patient recovered. Additional information has been requested.
achiness; headache; pain in injection site arm that persists after 18 hrs; Chills overnight; fatigue; joint aches; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 12:30PM as DOSE 1,SINGLE for covid-19 immunisation (At the age 47 years). Medical history included hypothyroidism and depression from an unknown date and unknown if ongoing. Concomitant medication(s) included liraglutide (SAXENDA), levothyroxine 50mcg and liothyronine 5 taken for an unspecified indication, start and stop date were not reported. On 26Mar2021 20:00 the patient experienced achiness, headache, pain in injection site arm that persists after 18 hrs, chills overnight, fatigue, joint aches. Patient received no treatment for the event. The patient had not received any other vaccine within 4 weeks. Patient received no treatment for the event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The clinical outcome of the event was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
The day after the injection there was a very large, very warm raised rash. It was the size of my forearm. The injection was on a Monday and is still there today which is Thursday. It's still warm and red, but getting better.
I have very regular and reliable menstruation patterns and had finished my menstruation bleeding 8 days before this injection and was beginning to shed the mucous lining that traditionally follows all blood products. Today, April 15, I have begun spotting again and passing small clots. I feel fine otherwise with the exception of standard injection site discomfort.
This case was reported by a healthcare professional and described the occurrence of shingles in a 51 year old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. Medical history included arrhythmia. the subject dose not use alcohol or tobacco. Concurrent medications included Atenolol for an unspecified medical condition. On 2/10/2005 the subject received the first dose of Engerix B (lot number not provided). Within 7 to 10 days after vaccination with the first dose of Engerix B, on an unspecified date in Feb 2005, the subject experienced shingles on her back. the shingles resolved four weeks after the outbreak, in an unspecified date in march 2005. On March 24 2005, the subject received the second dose of Engerix B (lot AHBVB052AA. This is longer the recommended interval of one month between the first and second doses of Engerix B. Approximately two weeks or more following vaccination with the second dose of Engerix , on an unspecified date in April 2005, the subject again experienced shingles on the opposite side of her back. The shingles resolved three weeks after the outbreak, on an unspecified date in either April or May 2005. The healthcare professional considered both occurrence of shingles to possibly be related to vaccination with Engerix B. Follow up to this case was received on Sept 20 2005 from the subject. The subject is a nurse. She reported that she was seen at a physicians office as a result of the shingles. She was treated with valacyclovir (Valtrex) and lidocaine patches. The events resolved on an unspecified date. She considered the shingles outbreaks to possibly be related to vaccination with Engerix B.
He developed redness to left leg after vaccines. He was also admitted to hospital 2 days later, but that may be unrelated to vaccines.
Redness at injection site. 1st 24 hr, then spread down left arm to fingertips, pain in arm, tingling left index 3rd finger. Took Benadryl 50mg every 6 hrs without relief.
This spontaneous report was received from a registered nurse and refers to a 5 year and 2 months old male patient. The patient medical history and concurrent conditions were not reported. On 17-SEP-2012, the patient was vaccinated with a dose of M-M-R II (route of administration, dose, lot number and expiry date were not reported) and VARIVAX (route of administration, dose, lot number and expiry date were not reported). Subsequently, on 06-MAY-2016, the patient was vaccinated with a dose of PROQUAD (subcutaneously, dose, lot number and expiry date were not reported). On an unknown date in May 2016, a couple of days ago, the patient developed vesicles on his legs, arms, chest, back and face. The patient sought medical attention, presented to the reporting nurse at the office. No treatment was given for the adverse event and no laboratory test diagnostic was performed. At the time of the report, the patient did not recover from vesicles on his legs, arms, chest, back and face. The relatedness between the adverse event of vesicles on his legs, arms, chest, back and face and vaccination with M-M-R II , VARIVAX and PROQUAD was not reported. Additional information has been requested.
Narrative:  Patient tested positive for Covid-19 and was hospitalized despite of full vaccination ( Pfizer 1 and 2) and one booster with Pfizer on 1/28/2022.
Moderna COVID-19 Vaccine EUA Received vaccine dose #2 at 14:10 on 1/20/21. Left work around 4pm, exercised from 4:30pm-5:30pm. During exercise, started to feel chills/hot flashes. Arm was also sore. Arm soreness progressed throughout evening. Took acetaminophen preventatively at 1800 and again at 2200 before going to bed. Woke up with chills and arm soreness at 0400 1/21/21. Took more acetaminophen and went back to sleep until 0515. Got up, went to work at hospital pharmacy at 0700. Had arm soreness, full body aches, nausea, and chills that worsened upon movement at that time. Left work at 1130 due to progression in symptoms. Went home, napped on and off. Developed fever around 1600 (to 100.4 F), chills continued, nausea continued, aches continued. Fever increased to 101.3 around 1830 that evening. Went to bed around 2100, taking more acetaminophen at that time. Completely soaked sheets and shirt with sweat by 2200, fever appeared to break, then return. Awoke around 0300 1/22/21 with full body chills to the point of teeth chattering, got up, called out for work, took more acetaminophen, returned to bed. Continued to have bed soaking sweats until around 0500. Intractable headache upon waking at 0600 - could not remain vertical. Also transitioned from chills to full body sweats without fever. Sweats resolved around 0800. Took acetaminophen every 6 hours 1/22/21. Headache did not resolve until 1/23/21 upon waking at 0730.
Information has been received from a nurse referring to an unspecified number of unspecified patients. On unspecified dates in 2015, since 06-AUG-2015 the patients were vaccinated with an unspecified number of improperly stored doses of (Oka/Merck) VARIVAX (lot # L008272, expiration ate in 11-MAR-2017) (dose and route unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Nerve pain running from fingers up through shoulder to base of neck after injection. Pain was really bad for at least a week. I still have residual pain in my hands and forearm from the shot.
PT STATED THEY WERE 65 HOWEVER AFTER SHE LEFT I REALIZED HER BIRTHDAY WAS NEXT WEEK PT WAS STILL 64 AT THE TIME
No adverse effects but no protection for the omicron strand of Covid-19 variant. Patient may get revaccinated two months from wrong dose given.
The patient got very sick/Patient was in bed sick; Achy; Diarrhea; Headache; Chills; Feverish; Vomited; Nausea; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (The patient got very sick/Patient was in bed sick), PAIN (Achy), DIARRHOEA (Diarrhea), HEADACHE (Headache) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 012M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (The patient got very sick/Patient was in bed sick), PAIN (Achy), DIARRHOEA (Diarrhea), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Feverish), VOMITING (Vomited) and NAUSEA (Nausea). At the time of the report, ILLNESS (The patient got very sick/Patient was in bed sick), PAIN (Achy), DIARRHOEA (Diarrhea), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Feverish), VOMITING (Vomited) and NAUSEA (Nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-734507 (Patient Link).
Developed a headache within 30 minutes of immunization that lasted for 31/2 days; Body aches upon arising 10/04, 20 hours after immunization. Felt as if she had been hit in the back with a baseball bat.   Joints were painful, fingers, knees, elbows and face were swollen. Four days after immunization, swelling is gone, joints in hands and knees; and back still stiff and sore but improving.  Denies fever or any respiratory symptoms.  Tongue did not swell.  No vomitting; did have diarrhea following immunization on 10/3 and 10/4.  This was the first flu immunization patient has ever gotten.  Allergies:  Demerol, Morphine, oral constast solution, Nubain, feathers and strawberries.  Does not take any medication. Patient called her physician who told her to rest, take Ibuprophen, and call if symptoms got worse or did not improve by 10/6/08. Patient admits to taking Excedrin, Ibuprophen, and Tylenol for the headache and body aches.
Received H1N1 LAIV although asthma marked on consent. Spoke with mom next day when error noted. No untoward effects.
Received recommended shingles vaccine. Have been in pain with limited mobility of left arm ever since.
This study case was received from the investigator in a trial on 22 October 2013. A 21-year-old male subject with no reported past medical history had received an injection of ACAM2000 (lot number, route and site not reported), an injection of Anthrax Vaccine (manufacturer, lot number, route and site not reported) and an injection of Typhoid Vaccine (manufacturer, lot number, route and site not reported) on 10 January 2011. Eight days later on 18 January 2011, the subject had an elevated Troponin I level of 0.12 ng/mL. Troponin I recheck on 20 January 2011 was <0.10 ng/mL and ECG was normal. The subject was asymptomatic. Outcome was recovered on 20 January 2011. According to the Investigator, the event of elevated troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
Tinnitus - in both ears - started about 4 days after the fist dose, progressively got worse.  Watching TV, listening to the radio was brutal as was nighttime.   This condition started to subside then got worse again after my second dose on 9/26/21 - i waited to get the second dose because of the ear ringing.    It took weeks to finally stop and only after I went to an acupuncturist/herbalist for assistance.  I still have random times when the ringing returns, but it is not as horrible as after the shots.
I got the vaccine at 10 AM, at 5 AM I had a stiff neck. At 8 PM I had chills and fever. At 12 AM my upper body was throbbing, and my temperature was 99.6, it should be noted my temperature is 97.4. At 4 AM my wrists were burning. At 5 my shoulders, hips and knees were sore. At 8 AM the fever broke, and at 1 PM my left arm was still in pain. I have continued limiting movement in my shoulders. My shoulders, hips and knees. I have continuing flushes every 2-3 hours every night. My fever continues to go up to 99.8 and I have fatigue. I have also lost weight. On 11/17 I saw my doctor and they prescribed me prednisone. My symptoms are still continuing.
Patient experienced redness and swelling of upper left thigh following vaccination. Symptoms started the morning after. F/U with Dr. on 3/16, given BENADRYL liquid and Fluocinolone Acetonide topical oil.
cellulitis on hand, clinic visit 6/16, ED 6/17, clinic again 6/17, clinic 6/18, outpatient IV antibiotics on 6/18, transfer to town on 6/18.
Got shot then felt light headed drank water then passed for 30 sec then woke up and drank more water and waited to stand. No medications given by EMS.
Information has been received from a physician concerning a 11 year old (also reported as 9 year old) female patient who on 26-APR-2001 and 29-JUL-2002 was vaccinated with the first and second dose of MMR II respectively. On 02-JAN-2010 the patient experienced mumps. On 03-JAN-2010, the patient was diagnosed. The patient was afebrile and had left parotitis. At the time of the report, the outcome was unknown. No further information is available.
Dry heaves; Chills; Headache; This is a spontaneous report from a contactable consumer. A 66-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: E90955) via an unspecified route of administration in the left arm, on 26Mar2021 at 11:00 (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa (sulfonamide allergy). Concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 at 11:30 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 28Mar2021 at 18:00, the patient experienced chills, dry heaves and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of chills, dry heaves and headache were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Swollen arm at injection site, redness and ringing in arm down to fingers. Pain in lymph nodes in left arm.
Patient received Moderna (lot number 025J20-2A, left arm, on 12/29/2020). She came for a 2nd dose today and received Pfizer (lot number EL1283, left arm, on 1/19/2021). No adverse effects at this time.
I missed my period following the second injection. My period is very regular- and I?ve never missed one completely- I missed my period in March and only got my period the following month.
9:15 AM  PATIENT RECEIVED HEP A, THEN MENACTRA. THE MEDICAL ASSISTANT SAID SHE NOTICED THE PATIENT SLUMP FORWARD AND SHE THOUGHT THE PATIENT WAS STARTING TO CRY. SHE ASKED HER IF SHE WAS OK AND THE PATIENT STATED SHE WAS FINE SO THE MEDICAL ASSISTANT THEN GAVE THE TRUMENBA. THE PATIENT STOOD UP AND STARTED TO COLLAPSE SO THE MEDICAL ASSISTANT HELPED THE PATIENT TO SIT DOWN. PATIENT FAINTED FOR A FEW SECONDS AND CAME TO. SHE STATED SHE HAD NOT EATEN BREAKFAST. SHE DRANK A GATORAID AND AFTER 1/2 HOUR REST SHE STATED SHE FELT FINE AND LEFT THE OFFICE.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hyperventilation-Severe
This spontaneous report was received from a registered nurse via a company representative reporting on unspecified number of unknown patients. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot# L037562, expiration date 29-SEP-2017; lot# L012038, expiration date 07-APR-2017 lot# L021215, expiration date 10-JUN-2017; lot# L004655, expiration date 11-FEB-2017; lot#L035124, expiration date 04-FEB-2017; lot# M004326, expiration date 25-JAN-2018; lot# L043624, expiration date 03-NOV-2017 (dose and route of administration were not reported). The administered VARIVAX with lot# L037562, expiration date 29-SEP-2017 and lot# L012038, expiration date 07-APR-2017 was exposed to three separate temperature excursions (dates unspecified): one lasting for 24 hours and 30 minutes with the lowest recorded temperature of - 14 degrees Celsius, the second lasting for 24 hours and 15 minutes with the lowest recorded temperature of -12.7 degrees Celsius and the third lasting for 14 hours with the lowest recorded temperature of -13.7 degrees Celsius. The administered VARIVAX with lot# L021215, expiration date 10-JUN-2017; lot# L004655, expiration date 11-FEB-2017 and lot# L035124, expiration date 04-FEB-2017 was exposed to one temperature excursion (date unspecified) lasting for 32 hours and 30 minutes with the lowest recorded temperature of -13.3 degrees Celsius. The administered VARIVAX with lot# L043624, expiration date 03-NOV-2017 was exposed to one temperature excursion (date unspecified) lasting for 24 hours and 30 minutes with the lowest recorded temperature of -14 degrees Celsius. The administered VARIVAX with lot# M004326, expiration date 25-JAN-2018 was was exposed to two separate temperature excursions (dates unspecified): one lasting for 24 hours and 15 minutes with the lowest recorded temperature of -12.7 degrees Celsius and the second lasting for 14 hours with the lowest recorded temperature of -13.7 degrees Celsius. No adverse event was reported. This is one of two reports from the same reporter. Additional information has been reported.
Inflamed eyes, neck, spasms, felt like a strong blast in brain from back to front side of head (primarily on right side for 2 minutes), both knees began to hurt and ache along with inflamed lower back.
PATIENT RECEIVED VACCINE THREE WEEKS AND TODAY REPORTED THAT SHE HAS HAD JOINT AND MUSCULAR PAIN IN HER LEFT ARM PAIN THAT HAS NOT RESOLVED SINCE RECEIVING THE VACCINE.  FURTHERMORE, MOVEMENT CAUSES UNBEARABLE AND REVERBERATING PAIN IN HER LEFT ARM.  SHE REPORTED NO FEVER, JUST A GREAT DEAL OF DISCOMFORT.
Sunday April 11th around 2 p.m., tongue numbness and pain behind left ear going down the neck Monday April 12th 715 a.m. left side of face paralysis  Monday April 12th 740 a.m. went to e.r. and went through tests for stroke or bell's palsey and was determined it was bell's palsey, also had a CT scan and was determined to be ok, was prescribed 5 days worth of prednisone and 7 days worth of antiviral valacyclovir
On 09/27/2021 you noticed a lump in my left arm, it was the size of a kiwi.  It was very uncomfortable, the lump is still there but it is going down.
Pt received Pfizer vaccine 2nd dose on 1/11/2021.  On 1/12/2021, pt had severe lower back seen her PCP and lower back pain progressed on 1/18/2021. Employee went to ER and was discharge. She continued to have back pain and went ER on 1/24/2021, she was admitted and doctor related her symptoms/neuropathy to the COVID vaccine, per employee.   On 1/24/2021, admitted to Hospital for treatment included CT scan, MRI scan, medication such as morphine, dulaudid, Norco and gabapentin. Current using a walker for stability.