chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 19-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, albumin status: recombinant human albumin (rHA)). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742.
Vials from the above lot # and expiration date of 10/9/21 (per QR code) were received on 4/13/21 and placed into our refrigerator (2-8degrees C).  This made the use by date of 5/13/21.  The vial used for this patient was the final vial from this supply.  The dose was logged out and expiration date was noted as 10/9/21 instead of the use by expiration of 5/13/21.  The remaining doses were not used and were wasted/discarded appropriately.  The dose was administered to the patient as noted above without incident.  The error was discovered later that day or the next and an incident report was written.  The manufacturer was contacted by  Dr through email.   The recommendation given is to contact the patient and have them get re-immunized with new in-date dose of Moderna vaccine and continue with dosing schedule.
4/2/21 woke up with whole left side without feeling/weakness, to ER, stroke ruled out, sent home, progressively got weaker. Blood pressure and pulse remaining low around 114/58 and 48 despite no longer taking BP meds. Passed out 2am 4/4/21, 911 to hospital. Continued to decline, sent to acute rehab 4/7-4/10. d/c'd home currently wearing heart monitor for 30days, follow up with neuro tomorrow 5/7, f/u with cardio 5/14. Therapy twice a week.
Patient received first GARDASIL vaccination at 430 PM 7/19/07. Five minutes after injection experienced syncope and again experienced syncopy 10 minutes after vaccination.
Myalgia, Fever, Fatigue, Weakness Narrative:  Took Ibuprofen and Tylenol
TOOK COVID VACINE ON MARCH 9TH. APPROXIMATELY ONE WEEK LATER LAID DOWN ON PILLOW ON COUCH WITH RIGHT EAR DOWN AND LEFT EAR UP AND REALIZED A SIGNIFICANT HEARING LOSS. WENT TO DR. HE SCHEDULED ME FOR HEARING TEST. HEARING TESTS SHOWED RIGHT EAR TYPE A TYMPANOGRAM, NORMAL SLOPING TO MODERATELY SEVERE SNHL AND LEFT EAR TYPE A TYMPANOGRAM, NORMAL SLOPING TO SEVERE SNHL.
Upset stomach resulting in three consecutive trips to the bathroom (diarrhea) over about a 15 minute time frame. Upper left arm muscle pain - similar to right arm injection site. Felt like there was a lump in my throat for awhile making it very slightly difficult to breathe.
NAUSEA WHICH WENT AWAY THE NEXT DAY / PAIN, WAS TOLD THAT IT MAY LAST FOR 7 TO 10 DAYS AND TO TAKE TYLENOL/ RASH , WAS TOLD TO USE BENADRYL  CREAM
Adverse effects began immediately on 02/16/2021 after the 1st Pfizer Covid shot at 3.45p.  They included flushing & face really hot & much higher than normal BP.  My BP, usually low, 95/67 pulse  61 that morning rose precipitately to 142 in the parking lot via  a nurse who tested me.  It subsided to 125 within 30 mins.  BUT the next morning, W the 17th,  it again rose precipitately from 99/65 pulse 74 at 9am  to  141/88 pulse dropped to 66, at 10a, it was 150/88 pulse was 73, at 10.30a it was 156/93 pulse 80 and I called the nurse.  Again BP rose to 160/84.  I tested my right arm where I rec.d the shot, it was still sore.  I suggested going to Urgent Care, the nurse advised the ER.  I went to ER & by then my BP lowered to 140 & within an hour I left.  I  notified my doctor bvia a voice mail to her PA and an email today.  Im feeling fine today Feb. 19, 2021 & felt fine yesterday Thursday, Feb 18, 2021. With the unusually high BP I felt shaky.  This high of a BP is something Ive never experienced before in my life.  It was frightening.  My only other near death experience was in 1970 at a Hospital getting a broken tooth repaired bc of a car accident.  They gave me an injection of Demerol & I immediately went into shock, perhaps anaphylactic, was given Epinephrine I believe & survived the ordeal & he was able to repair the cracked tooth.  I was advised to never have Demerol again.  It is such a vivid memory I checked with my doctor prior as I was very concerned about the PEG in the Demerol injection & also in the Pfizer vaccine.  She advised that I was at a very low risk for adverse reactions from the Pfizer shot.  I preferred Moderna after reading it had 1/2 of the Pfizer adverse reactions reported.  I was not so lucky.
Baby was irritable and fussy, site of injection was sore.  Baby got very hot-fever of 103-gave ibuprofen and fever came down-baby was limp, seemed life-less and had fast/short/labored breathing.  Baby would not eat/nurse/drink.  Symptoms lasted for 18 hours at that intensity, but are now low grade fever and moving a little.
Pt received H1N1 vaccine and rapidly developed hives and facial swelling in 15 min. Seen in office and responded well to IM BENADRYL and IM steroids.
Several itchy circles on body, some dime sized, some larger and all have a red outline.; Several itchy circles on body, some dime sized, some larger and all have a red outline.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on  08Apr2021 at 10:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient had no known allergies to medications, food and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER872) via an unspecified route of administration in the left arm on an unknown date  as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 08:00, the patient experienced several itchy circles on body, some dime sized, some larger and all have a red outline.  No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events several itchy circles on body, some dime sized, some larger and all have a red outline was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fever, chills, joint soreness, for 16 hours, treatment of otc analgesic, symptoms subsided without seeking treatment
In February 2023, I went for my annual well visit and we did some blood work.  The results were abnormal for thyroid and A1C.  I was having weight gain and fatigue and general unwell feeling.  I was diagnosed as diabetic.  Before the vaccine, my A1C and sugar levels had always been normal.  We had been keeping good track of my A1C for several months before this diagnosis.
tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No relevant concomitant product were taken. This case concerns a 59-year-old female patient with no medical history, who experienced the unexpected event of COVID-19 virus test positive  6 months and 21 days after the second dose of mRNA-1273 Moderna COVID-19 Vaccine. No additional information is available at the time of this report.  The benefit-risk relationship of mRNA1237 in not affected by this report.; Sender's Comments: This case concerns a 59-year-o ld female patient with no medical history, who experienced the unexpected event of COVID-19 virus test positive  6 months and 21 days after the second dose of mRNA-1273 Moderna  COVID-19 Vaccine. No additional information is available at the time of this report.  The benefit-risk relationship of mRNA1237 in not affected by this report.
arm pain; redness; This is a spontaneous report from a contactable other healthcare professional (patient) and a consumer (husband). A 68-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Dec2020 at a single dose for covid-19 immunization. The patient's medical history included a heart attack 20 years ago; coronary artery disease and autoimmune deficiency (ATS) from an unknown date. Concomitant medication included clopidogrel bisulfate (PLAVIX), warfarin sodium (COUMADIN). The patient experienced arm pain and redness on an unspecified date with outcome of recovered.    Information about lot/batch number has been requested.
Information has been received from a licensed practical nurse concerning an 81 year old white retired male patient with osteoarthritis who on 09/20/2004 at 1:45PM was vaccinated into the deltoid with a second dose of pneumococcal 23v polysaccharide vaccine.  There was no illness at the time of vaccination.  On 09/20/2004 at 07:00PM the patient's arm became stiff and sore for 2 days.  His arm was fevered and swollen.  Subsequently, the patient recovered from his experience on 09/23/2004.  Additional information is not expected.
Administration Error-Repeat dose of COVID-19 Moderna BiValent given on 2/6/2023; Moderns Bivalent given on 10/27/2022.
outbreak of hives; His lips are swelling; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 29Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the first dose of COVID-19 vaccine last 29Mar2021 and scheduled for the second dose on 20Apr2021 (22 days apart). The patient said that he really wanted to get the second dose of vaccine, but he had an outbreak of hives since last week. His lips were swelling as well (closed to anaphylaxis), said that it was breaking out might be because he was worried about getting the second dose but claimed that this was not because of COVID-19 vaccine. The outcome of the events was unknown.  No follow up attempts were possible, Information about lot/batch number could not be obtained.
Pain in left shoulder and upper back muscle; Red circle area at the shot area about the size of a nickel; This is a spontaneous report received from a contactable consumer, the patient. A 67-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration in the left arm on 04Mar2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 Immunisation. The patient medical history included Osteopenia, Osteoarthritis, Nerve pain in legs and occasional bouts of Trigeminal neuralgia, drug allergy (Ibuprofen), allergy to contrast media, food allergy (spicy food). The patient past drug history included Ibuprofen, Iodinated Contrast. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient concomitant medications were not reported. On 04Mar2021 at 13:15 the patient experienced Pain in left shoulder and upper back muscle and red circle area at the shot area about the size of a nickel. It was reported that pain shoulder had never gone away continues still today 18Mar2021.  Around 08Mar2021 patient noticed a red circle area at the shot area about the size of a nickel.  By 16Mar2021 it was 2X2 and oblong.  Patient took photos of it. By 18Mar2021 it was even larger but the middle of the circle was starting to fade and only the edges were dark pink. The patient was not treated for the adverse events. The clinical outcome of the events pain in left shoulder and upper back muscle and red circle area at the shot area about the size of a nickel was not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
Headache, vomiting, confusion, lost ability to speak, hypokalemia, tingling in arm all in evening of 6/12
ATE 50 MINUTES AFTER TAKING THE DOSE; This spontaneous case report was received from a consumer (PVX2019-217) on 23-Jan-2019. The report describes a 19-year-old adult female consumer who "ate 50 minutes after taking the dose". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the first dose of Vivotif on 23-Jan-2019 and accidentally ate 50 minutes after taking it instead of waiting an hour.  The action taken with Vivotif with respect to the event "ate 50 minutes after taking the dose" was not applicable.  The clinical outcome of the event "ate 50 minutes after taking the dose" was unknown.  Company's Comment: The causality of the event "ate 50 minutes after taking the dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "ate 50 minutes after taking the dose" was considered as not applicable.
I am having the common reactions; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th May 2020, the patient received the 2nd dose of Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and had common reaction. The reporter asked how long do these typically last. Any over the counter medication to mitigate the symptoms.
Administered booster dose of Moderna (blue top). Person should have received Moderna Bivalent booster (blue top).  No adverse event occurred,
I have had three heavy periods after receiving the moderna shot. I have a mirena IUD and had not had a period in about 6 months besides spotting once or twice. My IUD is still effective and not near expiration. I have had very heavy periods with nickel to quarter sized blood clots. Cramping is quite painful. Hoping this information is helpful.
Flu-like symptoms (fatigue and achiness) 5 hours after receiving vaccine and lasting 36 hours. Violent diarrhea and vomiting starting 8 hours after vaccine and continuing for 12 hours. Fever of 99+ 8 hours after vaccine and lasting 24 hours.
Information has been received from a pharmacist referring to a 30 year old female patient with asthma and chronic bronchitis. The patient has allergies to penicillin, tramadol and cinnarizine. On 17-AUG-2015 the patient was vaccinated with her first dose of PNEUMOVAX 23 intramuscularly (dose and lot# were not reported). Concomitant therapy included ZANAFLEX. On 18-AUG-2015 the patient developed soreness and swelling at injection site. On 19-AUG-2015, the patient was experiencing tingling in the arm that the PNEUMOVAX 23 was administered as well as redness, soreness, and swelling at injection site. The patient did not seek medical attention. No lab diagnostics studies were performed. Ibuprofen was given for the adverse events. The outcome of all the events was reported as not recovered. The causality was not reported. Additional information has been requested.
Patient experienced macular pruritic skin eruption on chest, abdomen and thighs, approx 6-8 hrs post immunization. Symptoms subsiding with 24 hrs post injection.
Mother reports that child began symptoms on her way home (after administration of vaccine) she reported drooping on one side of face affecting the tongue. Unable to reach mother since her report on 8/20/12 to complete VAERS.
Pt's (R) arm at injection site became red - redness extended approximately 5" long & 2-3 " wide - red, warm & painful.
Three days after receiving the booster, I started to develop more pain in the upper left arm where I received the injection. I also started to develop numbness in the tips of my fingers on the left hand. Over the next few days the numbness progressed to the hand and the arm and now is in my left chest as well. The left arm is also weak and continues to be sore and upper arm has limited range of motion. There is pain if I try to move it too far or too fast.
24 hours after vaccine administration, patient's left deltoid swollen to size of orange, erythematous, hot to touch.
massive headache; All over aches; nausea; severe dizziness; This is a spontaneous report from a contactable consumer, reporting for herself. A 65-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration in right arm on 03Mar2021 01:45PM (at the age of 65-year-old) at single dose for COVID-19 immunisation. The patient had COVID prior to vaccination and known allergies (unspecified). She did not have other vaccine in four weeks and was taking other medications (unspecified) in two weeks. On the day of first dose of vaccine, at about 07:00PM, the patient had severe dizziness, then around 01:00AM on 04Mar2021 massive headache. On 04Mar2021 she felt all over aches, headache and later nausea. On 05Mar2021 she was feeling better but headache persisted. No treatment was received. The patient was not tested for COVID after vaccination. Headache was not resolved, while other events were resolving.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
immed p/vax pt rt deltoid turned red 2 1/2" in diameter;immed p/hep b vax pt lt deltoid turned red 2 1/2" in diameter;
Several hours after flu shot, patient reported severe headache, muscle spasms, temperature of 101°, unsteady gait, abdominal cramping. These symptoms lasted for 3 days.  Symptoms did resolve.
I had migraines, dizziness, nauseous , recurring menstrual cycle, ear congestion and hearing loss in the right ear.
This spontaneous report as received from a registered nurse refers to a 5 year old male patient. No medical history or concurrent conditions were provided. On 03-Mar-2015, the patient was vaccinated with his second dose of (Oka/Merck) VARIVAX (lot number reported as K016127; expiration date not reported), subcutaneously (dose not provided). No co-suspect or concomitant therapies were provided. On 04-MAR-2015, the patient experienced localized redness and swelling, and pyrexia for three days. Approximately on 07-MAR-2015, the patient recovered from pyrexia. At the time od the report, the outcome of the events local swelling and erythema was unknown. The causality was not provided. This case is linked to case MARRS # 1107USA02800 (same reporter link). Additional information has been requested.
1wk p/vax full body rash spots, not raised, t100;2SEP97 no further problems rash gone next day;
Patient received the pediatric dose of Pfizer for his booster shot --- did not receive the adult dose -- no adverse reaction
29JAN96 immed p/vax pt devel large hardened area, marble size;w/in 30-40sec center area blanched approx dime size;pt was closely observed for anaphylactic rxn, which did not occur;area around induration was reddened approx 1cmx2cm;
Pt experienced a painful injection site reaction, musculoskeletal reaction, then subsequent flu starting 2 days later. Flu symptoms were headache, sore throat, cough, muscle and joint soreness and fatigue. Pt reported having much pain in her joints. By 02/01 she experienced an extremely painful upper arm and shoulder with limited movement in shoulder joint. Symptoms disrupted her sleep. Pt took Advil. A physician diagnosed a torn rotator cuff. Pt was instructed to keep her arm in a sling and keep it immobile. Pt was treated with Relafen and Ultram for pain. Subsequent to taking these medications the pt felt nauseous, dizzy and paranoid and began vomiting. She was confused and disoriented.  Advil was substituted for Ultram and Relafen was replaced with Velparon and Diclofen. Pt was treated for pain, inflammation and lingering soreness for a couple of weeks.
10/21/2013 Nausea and headache 7:00 PM - 12 MN. 11/01/2013 Fever, chills, dizziness, headache and nausea 12MN - 6 AM. Dizziness, headache 6:00 AM - 8:00 AM. Lethargy, headache 8:00 AM - 4:00 PM.
COVID test was positive; Chills; low grade fever 100-101F; This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID test was positive), CHILLS (Chills) and PYREXIA (low grade fever 100-101F) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (low grade fever 100-101F). On 18-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID test was positive). On 14-Jan-2021, CHILLS (Chills) and PYREXIA (low grade fever 100-101F) outcome was unknown. At the time of the report, SARS-COV-2 TEST POSITIVE (COVID test was positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Body temperature: 100-101 (Inconclusive) Low grade fever- 100-101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not provided by the reporter.
No symptoms or adverse reactions. Vaccine given to patient out of the 12 hour room temp range. Vaccination coordinator contacted and spoke with Pfizer safety people this morning (Nurse triage & safety person). When speaking to them, they stated the following: A gray top punctured vial should be used before 36 hours at room temperature range of 46 to 84 F.