chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was given a third full dose of Moderna. He did not qualify for a booster yet.
First one head ache and fever. Second one Muscle and Joint pain, head ache, nausea, vomiting, fever. Missed work.
Pt states at 10 minutes into observation period she began to feel clammy. She states that her blood glucose levels dropped into the 70's w/first Moderna vaccine. She associated clammy feeling to drop in blood glucose. Pt was given cold, wet paper towels. Pt also reports face and lips tingling. Pt was given candy and 1 tablet of 4 mg Truplus Glucose tablets at 10:48am. Pt does have Medtronix 67EG blood glucose monitor. Readings are as follows: 10:00am: 97, 10:30am 90, 10:47am: 71, 10:50am87 (after tablet was taken) , 11:15am: 88, 11:21am:91. Pt denies: SOB, difficulty trouble breathing or swallowing, swelling. Base line vital signs: BP: 114/72, T: 97.7, P71 then dropped to 55, O2: 97% r:12. nurse evaluated pt, will kept pt an additional 30 minutes for observation. 11:21 pt states her face is not tingling anymore, only the outside of her lips. @nd round of vitals signs: BP: 108/69, T:97.9, P:51, O2:97% R:12. blood glucose reading of 105 at 11:29am, 11:30 am blood glucose now stabilized, Benadryl given to pt, to help with lip tingling. ! tablet of 25mg. Final set of vital signs 11:42am: Blood glucose reading: 122, Bp: 109/73, P:52, O2: 98, T:97.4, R:12. Pt is and feels stabilized. Notified her she can go ahead and leave office, If she feels any tingling, numbness, itching rash she is to contact us. Any SOB, difficulty breathing go to ER. Pt verbalized understanding.
Received vaccine before lunch and by 4:00 pm was having chills, low grade temp, coughing and became hoarse, headache, and sore throat. Took Tylenol, continued to have symptoms for 36 hours and then all symptoms subsided.
every 5-10 minutes, ending at 77. It stayed there for 5 minutes of "restful" sleep but then from 7:15-7:55 it went disrupted(HR 72), light, deep, disrupted, light, deep (HRs 71-74). From 7:55-9:40 was light sleep, HR 75-71 until 8:35 when HR spiked 79,78,80, ending at 76. 9:40-10:10 was disrupted, HR 73-71. The last hour of "sleep" was light,deep, light with the same HRs but spiking 77 when I woke up to stay up.)  I took 1000mg of Tylenol shortly after waking up but felt achy and pretty tired all day, like I was recovering from the flu. I felt somewhat better by evening and had no issues sleeping that night. The next day was much better but still spells of fatigue; sore arm mostly dimished. The next day just a little residual tiredness, no arm soreness.
Redness and swelling to injection site (RLT). 2 or more fluid-filled papules at site after 7 days post injection. Papules resolved, pt's mother did not notice scabbing to area, but area remains discolored - scar-like appearance. Lump to area remained x 1 mo., but did resolve.
Information has been received from a physician via medical records concerning a 9 month old male who on 07-DEC-1998 was vaccinated with a first dose of RECOMBIVAX HB (route lot number, and site of injection unspecified). On 09-FEB-1999, the patient was vaccinated with a second dose of RECOMBIVAX HB (route unspecified and lot number: 11904) in the left thigh. On 07-SEP-1999, the patient received the third dose of RECOMBIVAX HB (route lot umber, and site of injection unspecified) and a dose of tuberculin purified protein derivative. The patient's vaccination history also included: On 09-FEB-2009, the patient was vaccinated with the following vaccines: a first dose of ACEL-IMUNE (Lot number: 0970140), a first dose of ORIMUNE in the right thigh (lot number:NO597) and a first dose of HIBTITER (lot number:3615026) in the left thigh. On 13-MAR-1999, the patient received the following vaccines: a second dose of ACEL-IMUNE (Lot number:0984570) in the left arm, a second dose of HIBTITER (lot number:0303A) in the right thigh and a second dose of ORIMUNE in the right thigh (lot number:NO724) in the right thigh. On 14-JUN-1999, the patient received the following vaccines: a third dose of ACEL-IMUNE (Lot number:0984570), and a third dose of HIBTITER (lot number:423203A) in the left thigh. On 12-JAN-2000, the patient was vaccinated with the following vaccines: a first dose of MMR II (lot number: 632457/1084J) HAS, a first dose of VARIVAX (Merck). On 23-JUN-2000, a fourth dose of ACEL-IMUNE, a fourth dose of ORIMUNE in the right thigh. On 21-JAN-2004, the patient received a fifth dose of ACEL-IMUNE, a fourth dose of ORIMUNE and a second dose of MMR II (manufacturer unspecified). On 27-JAN-2004, the patient was vaccinated with a dose of tuberculin purified protein derivative. On 28-JAN-2008, the patient received the first dose of MENACTRA. On 18-AUG-2008, received the second dose of MENACTRA (lot numberU3011AA). On 03-AUG-2010, the patient was vaccinated with a second dose of VARIVAX (Merck). On 25-AUG-2010, the patient's serum hepatitis B surface antibody screen showed a value of <5, it was reported that he was no longer immune per blood test titers. At the time of the report the patient's present status was unknown. Additional information is not expected.
Dizziness, drowsiness resulting in sleeping for approximately 12-18 hours, "hot" feeling at injection site.
Worst headache imaginable, terrible fatigue, joint pain, pain and swelling at injection site, fever over 101 accompanied by chills for 48 hours. All symptoms started 24 hours after administration and all but fever/chills continue now, 4 full days after.
Do not know if this was related to the vaccine.  A few weeks after shot noticed palpitations, recorded slow heart rate several times while resting.  Halter monitor results: The baseline rhythm was sinus rhythm . The minimum heart rate was 42 bpm, the average heart rate was 75 bpm, and the maximum heart rate was 127 bpm. There were occasional premature ventricular beats, as well as very rare premature atrial beats, very rare ventricular couplets, and very rare up to 6 beat nonsustained runs of ventricular tachycardia . No patient diary was returned with the report to correlate with symptoms. No sustained arrhythmias or pauses were seen.    Treatment One 25 mg metoprolol per day, ordered echo on 10/28/2021 with follow up with Dr.
Pain on side of torso of mid abdomem near lower last rib starting on Saturday, 5/8.  Felt like a side stitch similar to a long run but much more intense.  Pain steadily increased as to Monday, 5/17, in the AM went to urgent care.  They misdiagnosed and said I must have twisted wrong.  Went to primary care phisician Wednesday, 5/18, and was diagnosed with, Shingles, Herpes Zoster.  Prescribed anti-viral Valacyclovir 1000mg 3x daily, Naproxen 500Mb 2x daily and lidocaine cream as needed.
Patient received the first dose on 19Apr2021 and took the second dose today; vomiting profusely; headache; nausea; dizziness; sweating; pale; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (dizziness), HYPERHIDROSIS (sweating), PALLOR (pale), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first dose on 19Apr2021 and took the second dose today) and VOMITING (vomiting profusely) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced DIZZINESS (dizziness), HYPERHIDROSIS (sweating), PALLOR (pale), VOMITING (vomiting profusely), HEADACHE (headache) and NAUSEA (nausea). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first dose on 19Apr2021 and took the second dose today). At the time of the report, DIZZINESS (dizziness), HYPERHIDROSIS (sweating), PALLOR (pale), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first dose on 19Apr2021 and took the second dose today), VOMITING (vomiting profusely), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment included Advil.  Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Patient was given 0.25mcg of Moderna Bivalent Booster and was to be given 0.5mcg. Wrong dosage given.
Approximately 30 min post vaccination administration patient demonstrated SOB and anxiousness. Assessed at time of event: Heart sounds normal, Lung sounds clear. Vitals within normal limits for patient. O2 91% on 3 liters NC Continuous flow.   2 consecutive nebulized albuterol treatments were administered. At approximately 1.5 hours post reaction, patients' SOB and anxiousness had subsided and the patient stated that they were feel "much better".
Pt had normal afternoon after vaccine without complications, went to bed. The patient passed away in the middle of the night. ER report indicates cardiac arrest
No reaction to the vaccination. Tested positive for COVID 12/06/2021 also had double pneumonia. Difficult to breath, they thought it was a sinus infection. Lost her sense of smell. Stayed at the hospital ER for about 6-7 hours and rested. Felt bad for about two weeks but total 6 weeks
Minor hives, tired, runny nose, chills for about 12 hours starting approximately 3 hours after vaccine.
Headache, body stiffness, body aches, fatigue, Pain at injection site.
He began to experience profuse sweating, extreme anxiety, pain/discomfort from shoulders to pelvis front and back, severe restlessness especially in legs.
I started getting hives on the left side of my neck at 9A on Monday, 4/26/2021. The hives spread to the back of my neck and torso by 12p. By 5:30p the hives spread to my hips and upper thighs. I woke up the following morning, Tuesday, 4/27/2021 with pain in my chest when swallowing saliva and started getting more hives. By 8a my upper left lip started swelling and I decided to go to the hospital.
26MAR92 seen @ hosp ER dx sterile abscess, cellulitis of lt arm; tx sling, warm compresses, Keflex; resolved 31MAR92;
induration-swollen-lt arm 6 1/2 x 5 1/2cm reddened area; deltoid area; DTAP area; no apparent discomfort;
Patient recieved dose one of the Pfizer Covid 19 Vaccine.  Within ten minutes scratchy throat started.  Patient was monitored for 30 minutes and throat irritation became worse. Transferred to urgent care for follow up. Received a dose of diphenhyramine, symptoms lessened, and was able to leave urgent care for home.
Steadily rising blood pressure and heart rate throughout a day, leading to an ER visit. Symptoms resolved after a high BP episode. No hospital admission, no drug treatment, heart attack ruled out but heart monitor assigned for two weeks.
9/15/17 weakness, headache, nausea, decreased appetite started in evening. 9/16/17 Fever 102 degrees, back discomfort, redness and swelling right upper arm about 3 1/2" wide band extending from outer arm, inner arm to right axillary and over breast area. Some confusion with fever for 48 hours. Redness and swelling improving by 9/19/17.
No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse regarding a 4 year old female patient with birth weight of 8 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).  Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h.    On 08-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T017682, expiration date 21-MAY-2022, subcutaneous in the left arm, for prophylaxis, on a private doctor's office/hospital with private funds.  This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments:  US-009507513-2101USA011364:Original Case : 2101USA011364
Child was very tired for a week after vaccines, also got very large, hard, red bumps where they were injected that stayed for two weeks.
I had very minor reaction to the vaccine with a sore arm and fatique. On 07/07/22, I tested positive for COVID-19 with a home test. Symptoms: - really tired and sore muscles. I contacted my doctor through the patient portal and scheduled a telehealth. I was prescribed Paxlovid. It has helped with my symptoms. I continue to have the cough as of today.
On 12/27/2021 I woke up with tiredness and cold like symptoms, 12/30/2021 I went to the doctor and they gave me a COVID and Flu test. Three days later my COVID test came back positive (breakthrough) and I was told to quarantine for at least ten days, I took cough syrup to help with my throat and that helped me. I then started back to feel my normal self about a week later and back to my normal daily activities.
Patient received her 2nd dose of Moderna COVID-19 vaccine at 16:14 and felt faint, dizzy and diaphoretic at 16:20.  She reported that she had none of these symptoms after her first dose of COVID vaccine 4 weeks prior.  PHN took VS at 16:24 BP- 73/41, P-56, R-18, O2-96%; 16:27 BP-78/42, P-59, R-18, O2- 96%; at this point EMS/911 was notified and PHN had epinephrine auto-injector at the ready but did not administer.  Patient was able to talk to nurse while symptomatic and did not report any tightness in her chest or throat, but did report a history of fainting after blood draws. 16:29 BP- 105/68, P- 76, R-20, O2- 93%; 16:32 BP- 125/69, P-90, R-16, O2- 94% at this point EMS arrived and took report from clinic nurse; completed 2 set of VS and patient felt symptoms improved and refused medical transport, denied need for further medical attention.  She was driven home by her husband and left clinic at 16:50
she knew/heard someone past away (die) due to inflammation of the heart; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Program. This consumer reported for two patients. This is the second of two reports. A female patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter would like to know if inflammation of the heart was a commonly reported side effect post-vaccination of the COMIRNATY vaccine and if there had been a lot of reports about it. The reporter stated that she knew/heard someone past away (die) due to inflammation of the heart (onset date not reported) as an AE post-vaccination. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) :PFIZER INC-202101132810 Same reporter/drug, different patient/AE; Reported Cause(s) of Death: she knew/heard someone past away (die) due to inflammation of the heart
pt recv vax 21NOV95 @ approx 10AM;the next day mom called to report pt c/o n/v w/fever the noc of receiving vax "OK" am until 930 when mom  went to school to pick pt up c/o fever w/n/v x1;to MD t102, c/o sore throat;MD felt rxn to vax
got some product in his eye; got some product in his eye; This case was reported by a other health professional via call center representative and described the occurrence of occupational exposure while preparing product for administration in a 44-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th April 2022, the patient received Shingrix. On 27th April 2022, unknown after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown.   Linked case(s) involving the same patient:  US2022AMR072582   Additional Information: GSK Receipt Date: 29-APR-2022 Reporter's Comment: The patient self-reported this case. The patient stated that as he was withdrawing Shngrix, he inadvertently got some product in his eye.  He also stated that he flushed his eyes and started Valtrex prophylactically. The reporter consented to follow-up. Additional supportive information: As the patient was withdrawing Shngrix, he inadvertently got some product in his eye, which led to occupational exposure while preparing product for administration and exposure via eye contact.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR072582:Same Reporter/Same Patient
No adverse event; two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior) 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 (two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior).    No concomitant medication was reported. It was reported that Monovalent vaccine was given as a second dose to two individuals under the age of 18. HCP stated that two patients received their second dose from a Moderna monovalent vaccine lot that had already expired a day prior. The patients had not reported any adverse reactions to this dose. Vial size was reported as 2.5 mL. It was reported that the vial was initially stored in the refrigerator on 21-MAR-2023. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720581 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Live follow up received contains nonsignificant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720581:
pins and needles in my hands; very strong and painful left shoulder and it went up my shoulder blade and up to my neck then; headache in the back of my head and it was going down my neck; chills the first two days; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (pins and needles in my hands), ARTHRALGIA (very strong and painful left shoulder and it went up my shoulder blade and up to my neck then), HEADACHE (headache in the back of my head and it was going down my neck) and CHILLS (chills the first two days) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced CHILLS (chills the first two days). On 27-Mar-2021, the patient experienced ARTHRALGIA (very strong and painful left shoulder and it went up my shoulder blade and up to my neck then) and HEADACHE (headache in the back of my head and it was going down my neck). On 28-Mar-2021, the patient experienced PARAESTHESIA (pins and needles in my hands). At the time of the report, PARAESTHESIA (pins and needles in my hands), ARTHRALGIA (very strong and painful left shoulder and it went up my shoulder blade and up to my neck then), HEADACHE (headache in the back of my head and it was going down my neck) and CHILLS (chills the first two days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Post vaccine fever. Temperature elevation began 4-5 h after vaccine administration. Duration approx. 30 h. Tmax 104 F (rectal). Appetite decreased, increased fussiness, but no change in mental status, no lethargy, no N/V/D, no cardiac sxs. TYLENOL was only treatment.
I had wisdom tooth surgery on Saturday, 5/15 to remove the right upper wisdom tooth. On Tuesday, 5/18, the clot became loose and shortly thereafter fell out. Unusually, another one nearly immediately formed but was also nearly immediately loose. The dentist removed it and mentioned that he and especially his wife have been seeing a lot of this lately, and his first question was whether I'd had the vaccine.
FELT LUMP WHERE RECEIVED VACCINE/VACCINATION SITE LUMP; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced felt lump where received vaccine/vaccination site lump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt lump where received vaccine/vaccination site lump. This report was non-serious.
expired dose Menactra administered to patient; Initial information received on 03-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Quality manager).  This case involves a 25 years old female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patients past medical history and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B (MENINGOCOCCAL VACCINE B) and MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) on unknown date.  On 30-May-2019, the patient received a 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5833AA, expiry date 25-Feb-2019 via intramuscular route in the left deltoid.  It was an actual medication error due to expired vaccine used.  It was reported that expired dose Menactra administered to patient.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Patient was given Moderna Bivalent Booster 0.25mcg, was to be given 0.5mcg. Wrong dose given.