chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No event/No adverse effects; Indicate at which point in the process the medication error occurred? Storage in clinical practice/Temperature excursion - vaccine not viable according to manufacturer; This spontaneous report has been received from a physician and refers to a 4-year-old female patient. Her pertinent medical history, current conditions and previous drug reactions or allergies were not provided. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL), multivitamins (unspecified) and levocetirizine dihydrochloride (ZYZAL). Historical vaccines included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP vaccine), influenza vaccine, HIB vaccine, hepatitis B vaccine, measles vaccine (+) mumps vaccine (+) rubella vaccine (MMR vaccine), diphtheria vaccine toxoid (+) hepatitis b vaccine rhbsag (yeast) (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (PEDIARIX), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13) and rotavirus vaccine live reassort oral 5v (ROTATEQ).  On an unknown date, a temperature excursion of improperly storage vaccines occurred in a clinical practice; therefore, according to the manufacturer, the vaccines were not viable; however, on 01-JUN-2023, at the private doctor's office/hospital, one of those vaccines, a hepatitis A vaccine, inactivated (manufacturer unknown) intramuscular injection, was administered to the patient in her right arm, as prophylaxis (lot number X003791 has been verified to be valid, expiration date 01-JUN-2024; strength, dose and route of administration were not provided) (product storage error). The vaccine was purchased with public funds. There was not required a drug treatment prescription for that experience. Additionally, there was a Data Logger involved; it was believed to be due to sensory issues. Subsequently, a monitoring of temperatures with back up logger was performed, and the temperature was in range; a new data logger was in use at the reporting time (also reported as now). It was reported that the suspect vaccines were returned to manufacturer and the waste was in progress. No adverse events reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA010113: US-009507513-2307USA011295: US-009507513-2306USA013096:
No AE, however, the syringe was faulty and the dose leaked down the patient's Left arm when the RN administered it which the patient and RN both observed.  I discussed this with our RN supervisor and called his boss.  Considering that there was no way to determine if he got the full dose our RN supervisor consulted his boss to see how they have handled this at our main campus at the medical center and she mentioned that they have given another dose which I had the RN give him another dose in the R arm.  The patient preferred this and was on board with this plan.  I was also ok with this plan as I wanted to ensure that patient that he received the second dose and is fully vaccinated.
Following vaccination, the patient experienced altered sensation in the left deltoid muscle radiating into the left face with occasional muscle fasciculations of the left deltoid. Over the course of several weeks, symptoms progressed to the patient experiencing altered sensation in lower extremities, perceived weakness in lower extremities, and diffuse muscle fasciculations throughout the body to include head, upper and lower extremities, back, and abdomen. As symptoms progressed, the patient began experiencing significant anxiety and sought mental health services, and was prescribed an SSRI to manage anxiety from the adverse event. There has been no course of treatment to alleviate physical symptoms.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 12-MAR-2016, the patient was inadvertently vaccinated with a dose of expired PNEUMOVAX 23 injection, lot # K010522, expiration date 25-FEB-2016 (strength, dose, route and site of administration were not reported). No adverse effect was reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Patient is a 27-year-old female with no significant past medical history who describes an adverse reaction to her anthrax vaccine received on 9 January 2014 (Manufacturer Emergent Biodefense Operations; Lot # FAV328A, Left Arm, Intramuscularly). Specifically, patient described receiving the vaccine and almost immediately developed pain to the left arm. This pain progressed to develop swelling that extended almost to her wrist and lasted for greater than one week. She denied any weakness, numbness, paresthesias or systemic symptoms. She specifically denied any lip swelling, tongue swelling, throat tightness, or any airway or vascular compromise. She denied any skin lesions or rash at other sites noncontiguous with the vaccine site. Patient stated the pain and swelling was so extensive she was unable to perform her normal duties, or social activities for more than one week. She stated her range of motion was extremely limited and pain was severe. Patient stated she did seek medical attention in the emergency department and was treated with BENADRYL and anti-inflammatories with slow improvement. She denied any long-term sequelae or permanent symptoms from this adverse reaction.
SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side effects. This report was non-serious.
Patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported
I had a severe headache lasting about 3 weeks.  On March 27, I had a CAT scan, COVID-19 test, flu test, all Negative.  3/29 I went to the ER and had blood work done, also negative.  Doctor currently thinks this is Tri genital neuralgia, but follow ups are scheduled to try to verify.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Hypertension-Medium, Systemic: Shakiness-Medium
This spontaneous report as received from a physician via company representative refers to a female pediatric patient of unknown age. On an unknown date, the patient was vaccinated with first dose of VARIVAX (merck) (strength, dose number, lot number and expiry date unknown). On an unknown date patient received second dose of VARIVAX (merck) (strength, dose number, lot number and expiry date unknown). Approximately in 1994 (20 years ago), patient developed shingles after receiving 2 doses of VARIVAX (merck). The outcome of shingles was unknown. This case # 1402USA010748 was linked to case # 1402USA007533 via same reporter link. Additional information has been requested.
Myalgia, arthralgia, night sweats and chills, elevated temperature, fatigue for 2 days.
Within 1 minute of vaccine being injected. I started to feel dizzy. I was wheeled in wheelchair to observation area. I kept feeling more dizzy and started to feel tingly in my fingers and legs (both sides equally) After 15 minute observation time was over, I tried to stand up and immediately sat down again as a wave of dizziness  hit me. Doctor in observation area saw me and came over. I told him how I felt. He put his fingers to my wrist and felt my pulse. It was initially between 40 and 90, then steadied off around 90-100. He called for EMTs on duty to come over with a stretcher because he thought I should be laid flat. The EMT took my blood pressure and it was 155/94. The doctor said at one point my pulse was thready. By this point the dizziness was stronger and I felt tingly in my teeth as well as other areas. I was asked about my breathing and I said that it was okay. An ambulance was called for and arrived. I don't remember the exact time. The moved me from the wheelchair to a stretcher. I could not stand up on my own and lurched toward the stretcher. I am grateful strong people were there to get me on stretcher and strapped in. All throughout this my normally barely noticeable Atrial Fibrillation was quite apparent and more erratic. This was a major reason for ambulance call. Some of the stroke protocol was done including gripping EMT's fingers equally and following his finger with my eyes. I was very cold throughout. I was brought to the waiting ambulance outside and driven to Medical Center. The EMT took an EKG which showed atrial fibrillation and a line was put into my arm.  When we got to the hospital, I was brought into the triage area and had all my vitals taken. Blood pressure was high, so was pulse then for a half hour, I was very hot and sweated a lot after being cold.
Mild fever; Body ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever) and MYALGIA (Body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Mild fever) and MYALGIA (Body ache). At the time of the report, PYREXIA (Mild fever) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received on 21 Jul 2021 contains no significant information
Information has been received from a medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided.   On an known date, the patient was vaccinated with a dose of improperly stored PROQUAD (lot# M039448, expiration date 20-MAR-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for PROQUAD was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA011638: US-009507513-1706USA000481: US-009507513-1706USA000482: US-009507513-1703USA002284: US-009507513-1706USA000487: US-009507513-1706USA000488: US-009507513-1706USA000489: US-009507513-1706USA000490: US-009507513-1706USA000491: US-009507513-1706USA000492:
pt recvd vax;exp fever of 100, n, chills/sweating;area around inject site red & warm to touch;seen in ofc w/ bruise (qtr size), swelling at inject site; area red/tender/warm; md recommended tx w/ heat
My appointment was at 3:15 pm but I did not receive the 2nd shot until around 4:30 pm. I drove home and felt fine until I became very tired and went to bed at 7:00 pm. I slept straight through until 7:00 am and woke with a headache, (something that I get around once every year or two). I slept most of the day, (was up around eight hours), and then slept through Saturday night and woke around 9:00 am and felt like my old self. The headache was severe enough to take ibuprofen but only took it the one time in the morning.
Red, swollen area approximately the size of an orange on the left deltoid, also tender to touch.
COVID (MRNA) Vaccine- not stated which one  Reaction: Angioedema, high
I experienced a shooting pain under my breast, fatigue, fever, dull pain in my lower back and abdominal pain.
Caused me a visit to the emergency room, chest pain; Caused me a visit to the emergency room / difficulty breathing; This case was reported by a consumer and described the occurrence of chest pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on unknown date for further tolerance refer case US2021AMR043055).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chest pain and difficulty breathing. On an unknown date, the outcome of the chest pain and difficulty breathing were unknown.   It was unknown if the reporter considered the chest pain and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The age group was not reported but was captured as adult as per vaccine indication. The patient received the dose of Shingrix and experienced chest pain and difficulty breathing. The patient stated that the shot caused a visit to the emergency room. The patient wanted to find out the ingredients of the vaccine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR043055:Same reporter.
Headache, Fever, fatigue, arm soreness Narrative:  employee states: 1st dose: arm soreness that lasted about 24 hours @nd dose: fever (temp 100.4 F) headache, fatigue, arm soreness . all lasted about 24 hours
(R) deltoid red, warm to touch. Black and blue, also "hard as a rock", "very swollen". To ER - oral antibiotics.
I received the Pfizer covid booster at 10:00 a.m. Friday morning, 11/12/2021. At 8:00 pm, I became nauseated and had a slight headache. Around 9:00 pm, I began having episodes of seizure like activity with dystonia and semi paralysis of my diaphram muscle about every 4 minutes. These episodes lasted for 15-30 seconds each time. Also was severe contracture of the pelvic floor muscles. This continued for about one hour. Around 10 pm, the episodes seem to subside and I was able to go to sleep, although I had begun to have a slight headache. Upon awakening around 3:15 Saturday morning, the headache was more severe and I began to have flu like symptoms of fatigue, body aches and joint pain. This worsened until about 7:00 am. Around 3 pm, I began to feel better and by 6:00 pm I was fine, and it was as if nothing had ever happened.
Shortness of breath and hospitalization within 30 hours, post vax. Developed chills, aches, etc. Reports subnormal temperature. Treated with IV's, steroids and antibiotics by pt history. "Reaction to Flu shot".
Very sore muscles starting halfway down the left arm, up to the shoulder, across to the middle of the shoulder and down to the middle of the trapezius.
BUD for vaccine was 12/18, vaccine was administered on 12/19. expiration date on vial was 02/2022
Patient given vaccine that was incorrectly diluted.  Nurse diluted with 0.8mL instead of 1.8mL. No known adverse reactions at this time.
PAIN IN RIGHT UPPER ARM WORSENING  WITH RANGE OF MOTION EACH DAY AND  WHEN LAYING DOWN SO SEVERE THAT I HAD TO USE LEFT HAND TO LIFT RIGHT ARM
This is a spontaneous report from a Pfizer-sponsored program. A contactable health care professional reported that a patient received PREVNAR 13 on an unknown date at single dose for immunization. Medical history and concomitant medication were not reported. The patient had gotten redness around the injection site with outcome unknown.
Employee came to clinic on campus to get 2nd Pfizer vaccine.  Employee didn't bring his vaccine card with documentation of 1st vaccine.  Employee received his 1st Pfizer Covid vaccine on 12/21/2020.   The recall window for his 2nd vaccine was between 1/7/2021- 1/15/2021.  RN gave Employee his 2nd Pfizer Covid vaccine on 1/5/2021 at 1802 in his left arm.  She didn't check the administration date of first vaccine.
48 hrs p/vax pt who was initially doing well devel cough, dyspnea, CXR-LUL inflitrate; afebrile; sputum cult-no growth;
stiff arm; This case was reported by a consumer via call center representative and described the occurrence of limbs stiffness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2023, the patient received Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced limbs stiffness. On an unknown date, the outcome of the limbs stiffness was unknown.   It was unknown if the reporter considered the limbs stiffness to be related to Shingrix.     Additional Information: GSK receipt date: 23-FEB-2023 Reporter's comment: The reporter was the patient's wife.  The reporter stated that the patient received a dose of Shingrix and experienced a stiff arm. The reporter did not consent to follow up. Additional Supportive Information: The case had been linked with US2023030460 reported by same reporter.; Sender's Comments:  US-GSK-US2023030460:same reporter
Pt was transferred from facility with a left trimalleolar ankle fracture.  Pt was tested on 2/9 for COVID pre-operatively and found to be positive.
That evening, developed swelling of lt half of her head, face and eye which also extended from the left side of her neck to her collar bone. She had confusion in thinking, mispronouncing of words, insomnia & each day had "terrific" migraine
On 2/29/00 approximately ten hours post vax, the pt experienced an itchy urticarial rash over the arms, back, abdomen, hands, and legs. The pt visited the physicians office the next morning. Most of the itchiness had subsided. She was put on loratidine for four days. The rash resolved that day without any complications. She had no respiratory symptoms. No further information is available.
Patient presented to Hospital on 01/08/2022 with an unwitnessed cardiac arrest onset just PTA. EMS reports that the patient was found unresponsive, pulseless V-tach.  EMS gave patient 2 rounds of Epinephrine and 1 round of sodium bicarbonate en route to the ED, at which point the patient went into asystole. CPR was continued upon EMS arrival to the ED. Multiple rounds of ACLS were continued. Eventually a very bradycardic pulse was obtained and despite giving atropine, patient became asystole again. Patient had been resuscitated for over an hour and time of death was called.  To note, patient tested positive for Covid-19 on 01/03/2022.
starting the day after 2nd shot I had nosebleeds on and off all day and night for 10 days.; This is a spontaneous report from a contactable consumer (patient herself). A 67-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection. Lot Number: ER8732) via an unspecified route of administration, administered in Arm Left on 30Mar2021 08:30 as dose 2, single (at the age of 67-years-old) as dose 2, single for COVID-19 immunization. Medical history included allergic to asprin sulfa barium and cancer. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection. Lot Number EN6202) via an unspecified route of administration, administered in Arm Left on 09Mar2021 08:30 as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior the vaccination patient did not diagnosed with COVID-19. The patient experienced starting the day after second shot she had nosebleeds on and off all day and night for 10 days on 31Mar2021 06:00. The adverse event result in Emergency room visits and doctor or other healthcare professional office/clinic visit. Therapeutic measures cauterized and given afrin spray were taken as a result of nosebleeds. Since the vaccination patient did not diagnosed with COVID-19. The outcome of the event reported as unknown.  No follow-up attempts are possible. No further information is expected
After the first dose I had a headache and chest pain, but it went away quickly; After the first dose I had a headache and chest pain, but it went away quickly; This is a spontaneous report from a contactable consumer (patient). The patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). This is the case for dose 1. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, after receiving the first dose the patient had headache and chest pain, but it went away quickly. The outcome of the events was recovered.   No follow-up attempts are needed; Information related to batch/Lot number could not be obtained.
Systemic: felt not herself and had stomach bloating-Mild, Additional Details: Patient came the pharmacy reporting having a reaction from her vaccines (recieved second dose of Shingrix and Fluzone). Said she was having bloating and didn't feel herself. Told her she could take benadryl if she felt she was having a reaction. Checked with the other RPh on duty who also hadn't heard of bloating as a reaction and added to make sure she hydrates and eats well. Patient then went to the front store to say we refused to help her. Told her to contact PCP if symptoms progress.
pt recv vax 1PM & began to c/o h/a around 7PM w/irritability & nervousness, low backache, T38.5C, pain, joint aches & pains, nausea, vomited x2;
Pt received live virus while pregnant - EDC 5/2/2011 (about 16 weeks).
Pt received Pfizer COVID-19 vaccination at a COVID Vaccine Clinic held at Hospital on 6/12/21.  She received the vaccine approx 9 am and had c/o of L arm pain but didn't notice bruising welts/rash until approximately noon same day.  She presented to ER same day.  Photos of rash were taken in ER.  Swelling, tenderness, joint pain and rash noted to left upper extremity (LUE).  Parent reports 5-6 "bruised welts" to LUE were noted prior to ER visit.   Pt took cetirizine for rash and Tylenol for pain.