chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/29/09 DAD REPORTS BY PHONE TEMP OF 102.6, HEADACHE, BODY ACHES, CONGESTED COUGH.TYLENOL FOR FEVER, PRO-AIR INHALER FOR CHEST C/O. 3 P.M. 10/20/09 TEMP.103.1 WITH TYLENOL,PRO-AIR HELPED COUGH, USES ADVAIR 100/50 BID. ADVISED TRY MOTRIN FOR FEVER. KEEP FLUID INTAKE UP.
Thirty minutes, post vax, the pt experienced injection site soreness then numbness and tightness of her chest, which was not associated with angina or left sided arm pain. Because of the tight feeling in her chest, the pt had a difficult time catching her breath. She also experienced shakiness and mottled skin. The pt was seen by a Dr. who felt that she may have had an allergic reaction and treated the pt with Allegra. The pt was sent home with Allegra for the evening and has recovered. Upon internal review, the pt's experience was determined to be an Other Medical Event. Additional information has been requested.
Extreme fatigue, headache, and chills. Temperature hovering just below 101 F. By far the most sever flu-like symptoms I've ever felt.
rash on left arm, fever for three days, dizziness, no energy, diarrhea three days, coughing, phlem,
Arm is swollen, red and hot to the touch. Also have a painful lump at the base of my neck on left side. Have a painful lump on top of my collarbone left side. Neck and collar bone lumps are also red, and hot.
Left arm soreness after first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Mar2021 14:00 (Lot number: EP7534) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Atherosclerosis" (unspecified if ongoing), notes: Atherosclerosis Diagnosed 4-5 years ago; "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities (including diabetes)" (unspecified if ongoing); "endocrine abnormalities (including diabetes)" (unspecified if ongoing), notes: obesity: none. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Mar2021, outcome "recovering", described as "Left arm soreness after first dose".  Additional information: Left arm soreness took a number of hours before it started to get sore. It was probably 18:00-19:00. It was not excessive where she could not use arm and was much improved by the morning. No ER (emergency room) or physician's office required. Patient had no family medical history and other Products was provided as no. No relevant tests were provided. The Vaccination facility type was hospital not a military facility. As per her, it was explained and answered by the doctors in the facility what happened. When asked about medical conditions, she said she was kind of old and probably has a few things but she does not know of anything.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse concerning a 6 month old patient who on 28-OCT-2008 was vaccinated with dose 1 of ROTATEQ.  No symptoms reported.  No product quality complaint.  Additional information has been requested.
About 4-5 hours following injection, started to feel tired and achy.  Went home to bed, slept for several hours.  Woke up, went to sleep again.  Woke in the middle of the night feeling urgent pressure to urinate.  Rose to go to bathroom, became dizzy, fell and lost bladder control.  Returned to bed with help from spouse.  Measured  fever of 100.2.  Awoke in the morning feeling some better.  By  mid morning was sitting up in  house.  Fever and aches were dissipating.  By evening felt normal except for fatigue.
Felt ill - thought I was going to throw up - upchucked small amount followed by dry heaves - also started having diahrhea. Cold sweats.  Lasted several hours - finally able to settle down and go to sleep - stayed on liquid diet most of following day - was fine the following day.  Never had any reaction in previous years from flu shot.  Delayed reporting as I had misplaced my receipts - was handled as a medicare billing at pharmacy.
Information has been received from a physician concerning a 11 year old female with a history of blood in urine -cause unknown who on 30-JUN-2008 was vaccinated intramuscularly with 0.5 ml first dose of GARDASIL in her arm (not specified). There was no concomitant medication. On 30-JUn-2008, within one minute of vaccination, the patient developed a red, raised and warm rash on her left arm, and spread to her face, trunk and other limbs in physician's office. No laboratory diagnostics studies were performed. The patient was treated with BENADRYL. On 30-JUN-2008 the patient recovered. Additional information has been requested.
Type II diabetes mellitus; Sever tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TYPE 2 DIABETES MELLITUS (Type II diabetes mellitus) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TYPE 2 DIABETES MELLITUS (Type II diabetes mellitus) (seriousness criterion medically significant) and TINNITUS (Sever tinnitus). At the time of the report, TYPE 2 DIABETES MELLITUS (Type II diabetes mellitus) and TINNITUS (Sever tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.  This case concerns a 42-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of type 2 diabetes mellitus. The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 42-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of type 2 diabetes mellitus. The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
LARGE RED CIRCULAR MARK THAT HURTS TO TOUCH-LASTED 4 DAYS.
1st dose 2019, no 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in year 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not consent to follow up.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Severe
Dead arm. Sore and hard  Between elbow and shoulder.  Can?t raise arm over head or behind my back.  If arm is moved to quickly get a stabbing pain in injection site.   Didn?t start until 6 months after 3 rd shot and still continuous today.
Narrative: COVID infection following COVID vaccine series 02/26, Pfizer dose #1 03/19, Pfizer dose #2 09/11 CXR Impression: No focal airspace consolidation. 09/11 COVID swab, result: detected 09/11 pt cc: exposure: unknown 09/11 PT/INR 13.3/1.19 09/11 DDIMER: 0.93 09/11 CRP: 0.175 09/11 pt admit to medicine cc: N/V, po intolerance dx: recurrent hyperemesis likely secundary to diabetic gastroparesis and asymptomatic COVID-19 infection (no PNA/pneumonitis) LOS: 4 days 09/12 FIBRINOGEN: 317 09/12 DDIMER: 0.73 09/12 ESR: 39 09/13 FIBRINOGEN: 312 09/13 DDIMER: 0.44 09/13 ESR: 45 09/14 FIBRINOGEN: 304 09/14 DDIMER: 0.46 09/14 ESR: 39 10/08 COVID swab, result: NOT detected 10/09 CXR impression: No acute cardiopulmonary abnormality 10/26 COVID swab, result: NOT detected
12/28 started having fever , chills cough, body aches, HA, went to ED 12/29, symptoms resolved 29th
This spontaneous report as received from a registered nurse refers to five patients of unknown demographics. Pertinent medical history and concomitant therapies were not reported. The nurse reported that patients received improperly stored (Merck) PROQUAD (lot number L008353, expiry date 11-SEP-2016, 0.5 ml, subcutaneously). Four doses were administered on 17-AUG-2015 and one dose was administered on 20-AUG-2015. No adverse effects were reported. Follow up information has been received on 02-OCT-2015 that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received from the nurse on 08-OCT-2015. The nurse reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from the reporting nurse on 08-OCT-2015 and refers to a 4 year old patient of unknown gender. On 20-AUG-2015, the patient was vaccinated with the dose of improperly stored (Merck) PROQUAD. Temperature excursion had place on 09-AUG-2015. This is one of several reports received from the same reporter. Additional information has been requested. The patient details and narrative was updated.
I wanted to report that I am experiencing an unusual reaction to the COVID-19 vaccination. When I first received the vaccine on 1/6/21 I experienced redness, heat, pain and, golf ball sized  induration localized to the injection site. Over the next 3 to 4 days those symptoms subsided into a small amount of induration (1.5 cm) at the injection site. Last night 1/13/20 the injection site the injection site began to itch and I noticed a small welt forming. I refrained from scratching. This morning injection site again is red, hot, tender not painful, and 4.5cm sized  induration has occurred. I do not experiencing any systemic reactions yet except for possibly more sinus congestion.   Ibuprofen, warm compresses. Keflex prescribed If needed, but not yet taken.
Expiration date for this lot number was 5/20/2023. The HCP mentioned that this vaccine was administered to a patient on 5/26/2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received HAB (Twinrix) (batch number J477Y, expiry date 20-MAY-2023) for prophylaxis.   On 26-MAY-2023, the patient received Twinrix. On 26-MAY-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expiration date for this lot number was 5/20/2023. The HCP mentioned that this vaccine was administered to a patient on 5/26/2023). The outcome of the expired vaccine used 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: 31-May-2023 The health care professional asked that if the dose was considered valid. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received an expired dose of Twinrix, which led to expired vaccine used.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/30/2022 ATRIAL FLUTTER, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/30/2022 CARDIAC AMYLOIDOSIS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/30/2022 AMYLOIDOSIS, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/30/2022 SYSTOLIC HEART FAILURE, ACUTE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/30/2022 NONTRAUMATIC INTRACEREBRAL HEMORRHAGE, UNSPECIFIED
Injection site red and itchy with a ard, swollen center area about the size of a quarter.  The overall affected area is about 1.5 inches by 4 inches.  Since first observed, about 55 hours ago, there has been no change.
pt recvd vax & exp numbness & soreness radiating into Lt neck area; exp v; pounding heart; sob & was extremely tired; MD informed pt should not have anymore td booster;apap & benadryl recommended;Lt Arm reveals 30 mm of erythema & swelling;
Body aches, fatigue, headache within 7 hours with complete resolution 7 hours after onset.
Parosmia- meat smells like rotten chemicals, bodily functions smell like chemicals, very acrid. Eggs, broccoli, smell like burning chemicals.
Could not sleep secondary to Headaches; Terrible Headaches mostly on the back of the head close to the left ear; a little congested; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep secondary to Headaches), HEADACHE (Terrible Headaches mostly on the back of the head close to the left ear) and NASAL CONGESTION (a little congested) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 28-Jan-2021, the patient experienced INSOMNIA (Could not sleep secondary to Headaches), HEADACHE (Terrible Headaches mostly on the back of the head close to the left ear) and NASAL CONGESTION (a little congested). The patient was treated with MUSCLE RELAXANTS for Sleep problem, at an unspecified dose and frequency; IBUPROFEN for Headache, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Nasal congestion, at an unspecified dose and frequency.   At the time of the report, INSOMNIA (Could not sleep secondary to Headaches), HEADACHE (Terrible Headaches mostly on the back of the head close to the left ear) and NASAL CONGESTION (a little congested) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
PT IS 12 YEARS OLD AND RECEIVED ADULT PFIZER COVID-19, 0.3 ML AS THE FIRST DOSE BUT RECEIVED THE "PED PFIZER 5-11 YO, 0.2ML" BY ERROR FOR THE SECOND DOSE. NO ADVERSE REACTION WAS REPORTED AND NO ADDITIONAL DOSE WAS GIVEN TO PT FOLLOWING CDC GUIDELINES
Within an hour sore arm at the injection site. It appeared that day - some 3 days later and some later. I experienced severe fatigue about 5-7 days after vaccine. The fatigue may also be tied to my sleep apnea - both of these have complicated the fatigue. It is impossible for me to function normally. Tonight I have a study for sleep rates for a new CPAP machine. About two weeks after the vaccine, I got extreme chills that were so bad that my chest was having difficulty breathing - I thought I was going to go into shock. I have never ever had that before - it was out of the blue. I developed low grade fevers - started about five days afterwards - 100.5 - it would come on a day or two and then it would go away; it came and went without taking anything for it;  body/muscle aches, joint pains and my wife who got Moderna had these, too.  After the vaccinations, I have not been able to exercise and I have felt very bad since. Symptoms have snowballed. I'm on conflicting thoughts on whether I should get the booster. We've been isolating through all of this time - stay out of stores and get curbside pick up etc. My back has been hurting back since the injection (I have degenerative disc disease). They say it's my hip - my family doctor may do diagnostic testing on that. I have been so fatigued that I can hardly do anything. I have had a couple of times where I almost passed out with my blood pressure dropping severely. It was extremely low. I took coffee/caffiene and I laid down - it came back up. That's not normal for me as I have high blood pressure.
Patient had localized redness and swelling. Mother advised to apply warm compresses and to notify Dr. of any further selling or pain. Mother has not called us back. Two messages left for Mother to call back with update on status of child.
blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, shortness of breath, extreme blood pressure immediately upon injection for 1 hour. Continued reactions 48 hours, extreme fatigue, blood pressure, dizziness, metal and bitter taste in the mouth, migraine, stomach upset, red polka dots on hands, itchiness underarms, cough, sore throat, and fever
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 3:18 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 3:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 19.97   Concomitant products were not provided.  On 12-Feb-2021, Excursion time was 09 AM,10 AM and 11 AM, temp was 29, 35, 35, total doses given for the day was 55, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 12-Feb-2021. 3 vial was moved to clinic. Vaccine BUD date was 10-Mar-2021.  Vial was stored on cooler 1, on 12-Feb-2021, Excursion duration At 9 AM: 29, 10 AM: 35, 11 AM: 35, 12 AM: 39, 1PM : 42, 2 PM : 43, 3 PM: 40, 4 PM: 39.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Inappropriate age vaccine given. Client 2 yrs. Received FLUZONE 0.5 ml instead of FLUZONE 0.25ml. No adverse effects noted.
Hospitalized chest pain and headache normal cardiac testing runny nose dry cough exposed to sick child.
I got the vaccine at 3:50. I got a sore arm within about 3 hours.  I woke up I at 1am with a sore throat
No additional AE information provided.; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted. HCP states that the person administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted. HCP states that the person administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering; This spontaneous report was received from a registered nurse and referred to a 15-month-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-SEP-2022, the patient was going to receive the 15-month booster dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #W002453, expiration date: 24-JUN-2024, strength, dose, frequency and route were unknown) for prophylaxis. During the preparation, the vaccine was diluted with sodium chloride (NORMAL SALINE) 0.5 milliliter (ml) (strength, lot #, expiry date, route of administration, and indication were not provided) and then drawn up 0.5 ml of the mixed solution and administered it to this patient (vaccine preparation error, accidental underdose). No additional adverse events were reported.
Palpitations, "HEAVY CHEST" , TINGLING LIPS Narrative: Immediately after 2nd in series COVID-19 vaccine developed palpatations, "heavy chest" , tingling lips (all mild). V/s 134/85, 100% RA, 84 BPM, 18 RR. Employee requested ER evaluation and was taken from vaccine clinic to PAD ER by wheelchair.
Information has been received from a registered nurse referring to a 15 year (also reported as 16 year) old patient of unknown gender. No concurrent condition and medical hisotry was reported. On 10-MAR-2015, the patient was vaccinated with full dose of improperly stored GARDASIL Lot# K006117, expiry datet: 14-JAN-2017, intramuscularly in the Left arm. No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
This case reference number 2000004140-1, is a spontaneous report from a physician referring to a 29 year old male. Allergies are unspecified. The patient has dysuria and received Bactrim starting on 12/31/99. On 12/29/99, the patient, received his first IM dose of Engerix-B for Prophylaxis of Hepatitis B. Post vaccination, on 12/29/99, the patient experienced urticaria. He was seen in the ER twice over a three day period. Then the patient was treated with Benadryl and IM Depo-Medrol 80 mg. Engerix-B was discontinued. Symptoms resolved over "several" days. The most recent information, received on 2/8/00, reports the condition of the patient as resolved.
Soreness and redness at site of injection; headache-soreness and redness has continued for three days, so far.
Swelling of face, lip and uvula. Swelling and tenderness right axilla and lateral chest. Face swelling improved with Allegra.
PATIENT ONLY 16 YEARS 6 MONTHS RECEIVED MODERNA VACCINE APPROVED FOR 18 YEARS OR OLDER
Raised, red, itchy rash at injection site of ~4 inches in diameter, accompanied by deep muscular pain and numbness, as well as subcutaneous pain.
Lot FK9894 was administered after the "beyond use" date of 7/3/2022.  Vaccine was picked up from Health Department on 4/25/2022 and was to be used by 7/3/2022.  Vaccine was administered on 7/14/2022.  Awaiting feedback from Pfizer regarding vaccine viability.