chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"moderna covid-19 vaccine eua" Abdominal pain lasting about 1 hr. Slight chills (not serious)
OCTOBER 10, 2007:  Patient completes a routine physical examination from Dr.  Patient is not experiencing any health problems and none are found during this examination.  Dr. recommends patient receive two vaccines due to her age: (1) Meningitis vaccine  (2) Cervical cancer vaccine series.  After discussion with Dr., we decide to receive only the Meningitis Vaccine at this time. One shot of Menactra was administered at this time.  NOVEMBER 18, 2007:  Patient informs me of a small raised bump on the back top of her head approximately 1" in diameter.  I told her to let me know if this bump doesn't go away. JANUARY 24, 2008: My wife is sitting on our couch rubbing patient head when she feels a large mass approximately 4" in diameter contouring to the top back of patient's skull.  Patient said it felt like part of her head when she was washing her hair.  I immediately took patient to Hospital to be examined.  An X-Ray showed a large bone distortion at the site of the mass, and we were advised to seek medical attention promptly at  Hospital in downtown.  An appointment was scheduled with neuro-surgeon on 1-25-08.  January 25, 2008:  Patient sees Dr., who examines patient, and orders a series of tests and scans.  The tests and scans indicate a lesion has developed in the meninges area of her skull, and is destroying a large portion of the skull bone in this area.  Dr. recommends surgery as soon as possible to remove the infected bone and area. FEBRUARY 5, 2008:  Patient has surgery at Hospital in downtown.  A large 4" section of her skull bone is cut out, and replaced with a temporary metal plate. FEBRUARY 25, 2008:  Patient has appointment with Dr. to evaluate her recovery.  Scan performed to size opening in patient's skull for fitting a permanent plastic covering for this area.  Surgery scheduled for May 2008, to insert plastic covering into opening. MAY 5, 2008:  Patient's pre-op work at Hospital. MAY 13, 2008: Patient has skull reconstruction surgery completed.  She will need to be seen annaully for evaluations.  1/20/09 Reviewed hospital medical records of 5/13-5/14/2008 & additional clinic records of 1/24-5/27/2008. FINAL DX: intraosseous calavarial meningioma, s/p cranioplasty Records revela patient experienced bony & scalp occipital lump.  Had been initially noted appro 3 mos earlier & thought to be secondary to trauma.  Thought to be resolved until 1/24/08.  Seen in Urgent Care.  Suspicious for osteosarcoma & referred to Heme/Onc clinic.  Seen in clinic 1/25/08 & sent for neurosurgery eval.  Craniectomy for mass excision done 2/5/08 & the resulting calavarial defect was repaired 5/13/08. Follow-up: Meninges lining shows abnormalities and has affected over laying skull bone. Surgical removed of this bone was necessary (cranioplasty) in 2008. See pictures a large plastic implant has replaced skull bone, however the meninge lining could not be removed.
Pt was given 23 valent pneumococcal vaccine as well as high-dose influenza vaccine in left deltoid on 1/31/17. On 2/2/17, pt presented to PCP office c/o injection site tenderness, redness, and hardness. Stated he had no previous reactions or issues with these vaccines but it was the first time for them in same arm. Pt instructed to use ice packs, elevate are, and take diphenhydramine OTC as needed.
7-10 days after vaccine, left shoulder pain, posterior to injection site, along tendon began hurting. Limited ROM, unable to sleep on Lt side. Lasted around 1 week, gone after using heating pad x 2 days. Pain returned around 3 weeks later 11/29/10, limited ROM & unable to sleep on Lt side. Worse in am. No nodule or swelling. Pain better 4 days later, still present, though after heating pad.
pt vax w/double dose of vax;p/vax pt devel a red inflamed arm & became irritable;48hr later pt devel viral infect & lost 2 pounds;sx persisted;2wk p/vax pt treated w/med;pt taken to ER;CXR was done @ pt treated w/med;adm to hosp;60 day follow-up received on 10/25/00 states that the pt has recovered.
Dizziness, NauseaVomiting, HYPOtension, lightheaded Narrative:
Within day to 2 days following vaccination, developed severe paresthesia of hands and feet bilaterally, and several months later in July 2021, EMG and nerve conduction test identified severe neuropathy with axonal and demyelinating qualities.
Information has been received from a physician concerning a patient (demographics unknown) who on 09/03/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 640576/0923L).  On 09/11/2002, it was reported that the patient experienced a severe reaction, which consisted of swelling of the entire arm and fever.  Unspecified medical attention was sought.  The reporter expressed a concern with the lot.  The records of testing prior to release of this lot have been rechecked by GMP compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.
Fast heartbeat (95-108 bpm), normally 56 when resting. Fluttering/palpitations. Headache, body aches, chills, fever.
About 2 and a half hours after the vaccination, I started to have pain in the body, I was shaking, headache, tired, chills. During the course of about 4-5 hours after the vaccination, I had other symptoms such as an urge to urinate, accompanied by pain and burning. Pain in the ribs, back, left arm, diarrhea, felt like inflamed lungs and shortness of breath. Today and 3 days later I still have diarrhea, headache, fatigue and pain when urinating.
SEVERE MUSCLE PAIN in arm shoulder weakness numbness on left side where vaccine injected SEVERE MUSCLE SPASMS
No adverse event; Received expired vaccine beyond 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture).    The 3 adult patients who received the vaccine on 08-Aug-2022.  No concomitant medications information was reported.  It was reported that date when the vial was initially stored in the refrigerator was unknown and the vial was first punctured on  08 Aug 2022.  It was unknown how the vial was stored post puncture. It was unknown whether vial undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree C which was equal to 46 degree to 77 degree F was unknown.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-627652 (Linked Report). This case was linked to MOD-2022-627652, MOD-2022-627637 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-627652:case for patient 2
Conjunctivitis like eye inflammation; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8724) via an unspecified route of administration in the left arm on 10Apr2021 at 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 14Apr2021, the patient experienced conjunctivitis like eye inflammation. 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 any treatment for the event. On 15Apr2021, the patient underwent SARS COV-2 Test (Nasal swab) and the result was negative. The clinical outcome of the event conjunctivitis like eye inflammation was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
ache: joints balance: dizzy upon standing blood pressure: varies cold and flu-like symptoms cough Cramps leg energy: low levels fatigue headaches Nervousness (anxiety) verbal skills: trouble finding words vision: tunnel vision sleep: too much sleeping
Pt was inadvertently given 0.5ml of purified protein derivative IM in Left deltoid at the same time received Dtap injection 0.5ml in right deltoid. Pt waited 10-15min post vaccination for monitoring. No adverse effect were reported at that time. IPV on a pt. When I went to go draw the vaccine I noticed the difference of size and shape of the vials. I automatically advised the pediatrician about the incident.
ACUTE ST ELEVATION MI, UNSPECIFIED 3/17/2023 ASHD NATIVE CORONARY ARTERY W/O ANGINA PECTORIS
Had the shot, got shingles/ suspected vaccination failure; shingles in eyes; shingles; numbness above eye; tingling in head; This case was reported by a consumer via 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, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, eye numbness and tingling. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and shingles were unknown and the outcome of the eye numbness and tingling were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, eye numbness and tingling to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had the shot 4 years ago and got shingles on left side of face, in eye and head this spring. The patient still had numbness above eye and tingling in head. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.
Shortness of breath, elevated heart rate, elevated blood pressure, dizzy, diaphoresis.  Still had episodes of tachycardia and  diaphoresis at 8pm. Following day headache and fatigue.
12 days after immunization, onset of painful gum lesions with purulent exudate, still present at OV 7/14/08.  Treated with penicillin and Periogard for acute periodontitis.  No previous history of similar symptoms, good dental hygiene.
One syringe out of the box reported to me that it had a large white clump of material. Upon shaking it would disperse, but quickly coalesced again
raised, red rash to lt lower leg;viral cult taken, DPH, calamine lotion;T97, P124;
pt in Health and Rehab; on hospice; pt had a positive COVID test on 7/8/22; pt gradually declined with increase in congestion; poor oral intake; pt passed away in the facility
This is a spontaneous report from a contactable pharmacist. A contactable pharmacist reported a 67-year-old female patient started to receive PREVNAR 13, (lot number: N05077, expiry date: 30Sep2017), intramuscular on 28Sep2016 12:15 at single dose for immunisation and influenza vaccine, via an unspecified route of administration on 28Sep2016 at unknown dose for immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient's arm bubbled up where at the point of vaccination on 28Sep2016 with outcome of recovered.  The action taken in response to the event for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and influenza vaccine was not applicable.  Therapeutic measures were taken as a result of patient's arm blew up like it swelled up really bad.
No additional AE; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 29-JUL-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliters (ml), once, as prophylaxis (lot number 1879870 has been verified to be valid; expiration date not reported but upon internal validation established as 16-OCT-2023) (strength, vaccination scheme, route of administration, and anatomical location were not provided). The administered dose of the vaccine was stored at a temperature of 34.5 degrees Fahrenheit (F), during a time frame of 1 hour 7 minutes and 0 seconds. There was a previous temperature excursion reported as 66.7 F for 13 hours 52 minutes and 0 seconds. There was no adverse effect reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA005936: US-009507513-2210USA005937: US-009507513-2210USA005929: US-009507513-2210USA005979: US-009507513-2210USA005916: US-009507513-2210USA005624: US-009507513-2210USA005942: US-009507513-2210USA005994: US-009507513-2210USA005996: US-009507513-2210USA006007:
intussusception, reduced via air contrast enema.  5/21/07 Received hospital medical records which reveal patient experienced fever, inconsolable fussiness, loose stools.  Exam revealed abdominal tenderness & distention.  Admitted 5/19-5/20/07 for overnight observation after contrast enema revealed no IS, probable spontaneous resolution.  Continued to have fever but abdomen was benign & was able to tolerate oral feeds at d/c to home. FINAL DX: Reduced intussusception & fever.
Fever & chills started on 6/14/20 evening, continued for 2 nights Chest pain started on 6/21/20, went to Emergency Room at the Hospital and diagnosed with acute pericarditis, discharged from hospital on 6/23/20 after 3 days & 2 nights of inpatient treatment
pt recv vax & devel fever & chills for 8hr during the day p/vax;
Immediately after administering the vaccine, the patient experienced near-syncope: pallor, diaphoresis, hypotension and bradycardia.  This lasted over 1.5 hours until she was transported by EMS to the ED.  Her BP baseline was 125/75 with pulse 108, but during the event BP was 80's/50's with pulse in the 50's.  Standing caused dropping of BP and pulse and diaphoresis and near-syncope.  7/7/09 ER records received DOS 5/22/09. Assessment: Vasovagal Syncope. Patient instantly developed lightheadedness and had syncopal episode. Presented with low blood pressure and pulse.
The evening of 2/25/21, my injection site was tender and sore.  At 2:00am, I woke up in pain from my arm and just felt achy with a slight fever. I had trouble sleeping due to the pain from my arm, I slept all day on 2/26/2021 and took 2 doses of tylenol which helped alleviate some of my arm pain. On 2/27/21, I woke up feeling about 90% better but my arm still hurts when I move it in certain directions.
Frustrated; could not focus after getting vaccine shot; Patient reported taking Tylenol at time of having vaccine.; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. The reporter stated that an individual said she was frustrated because could not focus after getting vaccine shot, implied this was due to vaccine. The patient reported taking Tylenol at time of having vaccine (This would imply that they potentially had side effects.) No other information was provided. Seriousness of the events was reported as non-serious. The outcome of events was recovered.  No follow up attempts are needed. No further information is expected.
patient felt sick next day with fatigue and body ache and then her arm swelled up with redness at injection site. I advised her to seek medical attention and to get it evaluated for possible site infection.
Severe worsening of mild tinnitus to high pitch 'screaming' in both ears. About 30 min after shot. It continues unabated
Received vaccinations around 12:30 p.m. and started feeling ill around 8:30 p.m. Fever of 103, stiff neck and neck pain, back pain, headache and body aches with chills. Fever lasted for 24 hours off and on. Went to the doctor, and I was told to take to the ER if symptoms get worse or any new symptoms occur. Still complaining of headache and neck stiffness, 3 days later.
given both Infanrix doses by mistake; This non-serious case was reported by a physician via sales rep and described the occurrence of accidental overdose in a 18-month-old male patient who received DTPa (Infanrix) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (INFANRIX).   On an unknown date, the patient received the 4th dose of Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced accidental overdose (Verbatim: given both Infanrix doses by mistake). The outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-APR-2023 The reporter stated that Twins (18 months) had a visit and Infanrix and Havrix were on a tray 1 of each for each patient (baby).  An immunocompetant patient was given both Infanrix doses by mistaken because of an interruption in their protocol by the patient's father.  Provider called Poison Control and was given guidance.   The reporter agreed to follow up from GlaxoSmithKline (GSK). The patient received 2 doses of Infanrix mistakenly, which led to accidental overdose
Patient presented to the Emergency Room for a concussion associated with abrasion of the forehead. This was treated with local wound care and the ER attending administered a tetanus shot. Relatively suddenly, the patient started to develop hives on her axillary area and then started to spread on arms and toward the belly. She started to develop nausea. Tongue swelling reported. (anaphylaxis angioedema hives).  Vaccine Lot #C4114AA from Sanofi Pasteur
Pain in left arm: unable to lift arm past shoulder : started next day 1/21 in the am and subsided 1/22 am Body Aches: started next day 1/21 in the am and subsided 1/22 am
Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Mild, Additional Details: Patient received injection and got up from chair. After standing for a few minutes he fainted and lost conciousness. His mom and I got him to the floor and he regained conciousness within a minute. He said he felt thirsty and nauseated. His mom gave him water. He laid on the floor for 20 minutes and then sat up for a few minutes. Then he walked out of the dressing room and left the store.
Vaccine was exposed to 34.7 degree Fahrenheit for 5 hours and 36 minutes/ no AE; Initial information was received on 10-Sep-2021 regarding an unsolicited valid non-serious case received from an Other health professional via Medical Information (Reference number- 00763952) and transmitted to Sanofi on 10-Sep-2021.  This case involves a five-year-old female patient reported that DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] was exposed to 34.7-degree Fahrenheit for 5 hours and 36 minutes with no adverse event (Product storage error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 ml (total) dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5772BA and expiry date 17-Sep-2022] via intramuscular route in the right deltoid for prophylactic vaccination.  It was reported, "They had a temperature excursion of unknown cause. Caller stated it was a total of 5 hours and 36 minutes. Caller stated the refrigerator temperature reached 34.7 degrees Fahrenheit. Caller also stated 5 children received vaccines after the excursion occurred."  Product used: Used. First time product used: Yes. Still using product: No. HCP can be contacted Yes/No: No.  It was a case of actual medication error due to incorrect product storage (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initial healthcare professional report received on 28 May 2010: The patient was vaccinated with FLUVIRIN (batch number: 97844p1), 0.5 ml, intramuscularly, on 18 Sep 2009. An hour later, on the same day, the patient experienced numbness at injection site (date not specified). On 28 May 2010, the patient called back, stating that, these symptoms were escalated to pain and fluttering at the injection site on an unspecified date. The pain was ongoing and not resolved yet. The outcome of events were not reported. Follow up pharmacist report received on 05 Jun 2010: After vaccination, the patient experienced "fluttering or pricking sensation" in the arm and upper body. As corrective measure, the patient was instructed by pharmacist to take BENADRYL and advised to consult with doctor in case of persistence of symptoms. On 19 May 2010, the patient informed to pharmacy about "on and off numbness" in the shoulder area occurring 2-3 times per hour. This occurred more often during raising of arm above the shoulder. Final outcome of the events was reported as condition unchanged. The reported assessed the events as medically significant. Causality was assessed as suspected.