chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upset stomach; Swatting a lot almost her bedsheet was wait; Tempera100.2C; Joint pain; Extreme headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), HYPERHIDROSIS (Swatting a lot almost her bedsheet was wait), PYREXIA (Tempera100.2C), ARTHRALGIA (Joint pain) and HEADACHE (Extreme headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), HYPERHIDROSIS (Swatting a lot almost her bedsheet was wait), PYREXIA (Tempera100.2C), ARTHRALGIA (Joint pain) and HEADACHE (Extreme headache). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), HYPERHIDROSIS (Swatting a lot almost her bedsheet was wait), PYREXIA (Tempera100.2C), ARTHRALGIA (Joint pain) and HEADACHE (Extreme headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 100.2 (Inconclusive) 100.2.         Action taken with mRNA-1273 in response to the events was not applicable.
Got 2nd dose of Pfizer 3/31 3 days later SOB 1 week after vax admitted for CHF exacerbation, vomiting and diarrhea
Suspected vaccination failure; Bad shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Bad shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient's friend via interactive digital media. The reporter stated that the shingle shot gave the patient bad shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Patient is having some range of motion and mobility issues with his shoulder 1 month after the injection. Patient states he has a hard time lifting his arm over his head. Patient did not need to seek medical treatment.
Hospital admission 9/13/2020 to 10/8/2020 On date of receipt of vaccine, 9/11/2020 parents noted mild fussiness. On 09/12/2020 he was more tired and did not drink as much as usual. On 9/13/2020 noted to be lethargic, poor color , not drinking and difficulty breathing.  Admitted to Hospital 9/13/2020, 2 days after receiving routine 2 month immunizations of Pentacel, Rotavirus, and PCV with severe anemia (Hgb 2.5), respiratory failure, shock , hypothermia and metabolic acidosis. Intubated and admitted directly to PICU.  Received massive transfusion protocol as well as respiratory and hemodynamic support.  Initial blood smear suspicious for Donath Landsteiner hemolytic anemia.  Able to be extubated within 48 hours, but required sequential multiple transfusions as hemolysis was ongoing.  Further evaluation did not confirm Donath Landsteiner but diagnosis of cold agglutin anemia, unknown etiology. During hospitalization noted to have high pitched cry, with increased right upper extremity tone - Neurology consulted and will follow for possible watershed infarct or ischemic encephalopathy.
3RD DOSE OF MODERNA COVID VACCINE GIVEN 11/12/2021, LOT #020F21A. 4TH DOSE OF MODERNA COVID VACCINE GIVEN 06/17/2022, LOT #059A22A. pt in SNF; had a positive COVID test on 7/26/22; on O2; DNR with limited intervention; family desired pt to not be hospitalized, but kept comfortable in the facility; seen by Hospice in the facility; pt passed away in the facility
This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on an unspecified date, for tolerance see case US2018GSK159755). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter asked if the chemical composition of the first dose of SHINGRIX identical to the second dose because his wife (patient) had a sore arm for 2 days after 1st shot (for tolerance see case US2018GSK159755), but got really sick after 2nd shot.
patient received FLUBLOK on 24SEP2021/then again on 05NOV2021 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via the Agency (Reference number- 00853841) and transmitted to Sanofi on 11-Nov-2021.  This case involves a 67 years old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] two times.  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 05-Nov-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2154 expiry date 30-05-22 and on 24-Sep-2021 he also received a 0.5 mL dose of the same vaccine lot QFAA2108 expiry date 30-05-22 via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered.  It was reported "a patient received a FLUBLOK vaccine in their office. HCP staff later discovered that the patient had already received a FLUBLOK vaccine somewhere else. HCP states that it was an accidental discovery, when she contacted the patient, he was not aware that he had gotten the same vaccine twice. She states that the language spoke is not his first language, so that may have contributed to the mix-up."  No adverse events have been reported.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
HPV vaccine given. Pt was sitting on exam table. MA was talking to MA when he fell forward onto floor and hit face. Pt had syncopal episode.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 12-Aug-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported  Date of vaccine refrigerated -05 July 2021.   This case was linked to MOD-2021-364986 (Patient Link).
Hives within days at injection site then systemically x weeks 0 Anaphylaxis
Dizziness, nausea, fatigue, few episodes vomiting x 3 - 4 d.
pt said the day after she had the covid shot she started seeing an increased amount of bleeding.  She said she was about 6 weeks postpartum and she was bleeding normally but increased after shot., no blood clots though just an increased amount. She had as must rest as she could and drank plenty of fluids and water.   She talked to md at 6 week appointment, which was shortly thereafter, and he examined her and told her to drink plenty of fluids and rest. He just told her to monitor the bleeding for increased amounts and if need be call him. The doctor said was beneficial to get second shot she seems ok now and said she has what is normal bleeding now. she said she has regularly bleeding to me now when I asked is it back to normal she told me yes. She opted to get another vaccine shot knowing all this.
Patient came in for 2nd dose of Pfizer covid vaccine.  After he received the vaccine, he stepped to the side, while his brother was being vaccinated.  After the brother received his vaccine,  patient fainted and fell to the floor.  His mother broke the fall.  He did not hit his head or sustain any injury.  After about 2 seconds,  he regained consciousness.  I called 911 and the EMS came right away.  He was not transported away.
On 4/25/08 patient received GARDASIL #2. Within 50 minutes - onset of vomiting x 6 hours and fever 102. Twin sister - same symptoms. On 2/18/08 - Gardasil #1. Onset of vomiting, fever 3 days later.
My body temoature dropped and I started uncontrollably convulsing for 1 full hour starting at 1AM.  Followed with heart palpitations so intense I thought i was going to have a heart attack. I could not get my heart to stop pounding, I then became dizzy and felt like waves we're surging through my body and head. I almost passed out while trying to stay awake so I could call 911 if needed. This is my first covid vaccine ever. I caught covid 3-4 months ago and recovered. The vaccine caused a severe reaction I never experienced with the natural virus.
about 1 1/2-2 hrs p/vax turned grey color & pale, listless; pt fussy-grey in color; eye rolled back but immed responded to & had a sl weaker cry than nl; tired;t101, thrush rash, pulse oximetry 95%
Suffered from ischemic optic neuropathy/optic neuritis - having seizure disorders - heavy metal poisoning due to influenza vaccine.
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The office manager reported that the patients received unspecified doses of M-M-R II (lot# M004305 with expiration date: 25-JAN-2018, lot# L039613 with expiration date: 08-OCT-2017 and lot# M015930 with expiration date: 29-MAR-2018) that were improperly stored (freezer: temperature of 31F for 5 hours; refrigerator: temperature of 54F for 7 hours; there was a data logger in combination with manual monitoring system). Route of administration was not reported. Vaccinations occurred between 15-SEP-2016 and 16-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
2 inch x 2.5 inch reddened area on L deltoid area. Rash nonelevated, no temperature change to area. Denies pain. States "it itches if you touch it".
Lethargy; My reaction fits the symptons you describe abovee; My reaction fits the symptons you describe abovee/ chills; My reaction fits the symptons you describe abovee; My reaction fits the symptons you describe abovee; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 82-year-old patient who received Herpes zoster (Zoster vaccine) for prophylaxis.   Concomitant products included pyridostigmine bromide (Mestinon).   In January 2020, the patient received the 1st dose of Zoster vaccine. In January 2020, less than a week after receiving Zoster vaccine, the patient experienced lethargy, headache, shivering, myalgia and fatigue. On an unknown date, the outcome of the lethargy, headache, shivering, myalgia and fatigue were unknown.   It was unknown if the reporter considered the lethargy, headache, shivering, myalgia and fatigue to be related to Zoster vaccine.  Additional details were reported as follows: The patient received vaccine and experienced lethargy, headache, shivering, myalgia and fatigue. The patient would check with primary care physician. The reporter wanted to know what would be the recommendation to get 2nd zoster shot
seizure; cardiac arrest; nauseous; dizzy; This is a spontaneous report from a contactable consumer (parent) reported for patient (son). A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Jun2021 as dose 2, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. He has had no prior health issues. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in May2021 at age of 16-years-old for COVID-19 immunization. On 19Jul2021 upon arriving to a friend's house, the patient suffered a seizure than cardiac arrest. He was resuscitated 3x prior to arriving at the hospital, thankfully getting his pulse back. If he was not where he was reporter would be writing you a very different email as thankfully the house he was at was able to administer CPR. He was airlifted to a hospital where testing began to try to find out what happen. It was ruled his event was cardiac related, not neurological. Prior to the event he was nauseous, and dizzy. He was tested for myocarditis which came back negative. A defibrillator was now in his chest, and her son will never play sports again. For a 14-year-old (as reported), this was a huge hit mentally. She read so much about the effect of the vaccine. The nausea, the dizziness, the cardiac arrest. All signs point to that a child wouls have had chest pains, and that these symptoms occur a certain amount of time ater vaccination. The fact that he was working out after the vaccine too, and an athelet by nature, just make her even more curious. With her son, it happened about 5 weeks post vaccination and no myocarditis that thay have seen to date. The signs and symptoms are so spot on for what happened to him. He could have died, in fact on paer, he did and was resuscitated. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Father called today at 11:45am and reported that patient woke up at approximately 8:00AM and vomited two separate times.  Reported that patient had a headache and temperature was 99 F.   Patient had not vomited since 8am and headache subsided.
Erythema, diffuse swelling and induration of upper arm from shoulder to above elbow. Started the day after the vaccine and spread to involve upper arm by 2 days after the vaccine. Mild splitting of the skin on upper outer arm, vs excoriations from scratching. Tenderness with moving the arm.
No adverse reaction noted.  Pt was under the age of 18 at the time of the vaccination (17 years and 9 months old).
As per site director, It appears that a 6mo pt at Medical center returned to clinic today for their 2nd dose primary series of pfizer but when evaluating the Lot# of their 1st dose primary series it was found to be for a pfizer pediatric bivalent booster rather than primary series pfizer pediatric monovalent.
pt recv vax OCT94 & in NOV94 pt devel pneumonia;pt recovered;SEP95 devel pneumonia again;MD reported that testing of blood & sputum revealed no evidence of pneumococcus;
Heavy cramping of internal stomach organs early AM (2AM) of second day. Nausea second and 3rd day.  Regurgetated 3rd day.
pt says on 4/17/21 she developed a rash on her face under her eyes.  On 4/18/21 she noticed some bruising on her right eye.  She had started having a headache that kept getting worse and worse and it was only on the right side of her head.  Pt has only taken aspirin for pain every 4 hours.  She contacted her PCP and was instructed to contact vax administrator to let them know.  Patient says her symptoms are better.
She reports symptoms of Other: Immediately after injection patient reports feeling dizzy and "hotflashes".  Denies nausea, heart racing, shortness of breath or throat swelling.   I have observed: Patient shaking arms.  Eyes closed.   Complains of tongue and throat pain.  Describes it as "a sinking feeling".  Denies nausea, heart racing, shortness of breath or throat swelling.  Able to swallow.  Drinking water and talking without difficulty.
Fever as high as 104 for 12 hours, chills, diarrhea for 3 days, sweats.
The patient was sweating and feeling hot. Called EMS at the patient's request and the patient's was checked at the scene and released with no issues.
sore arm with the first one (First shot); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Mar2021 (Lot number: EN6204) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm with the first one (First shot)".  Therapeutic measures were taken as a result of pain in extremity.  Additional Information: "Motrin." Dosage of Motrin: The patient took two of them. They are 200 milligrams and the patient took two of them. The patient was not hospitalized.  No follow up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 27, via an unspecified route of administration, in the left arm, on Apr 14, 2021, at 19:00, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On Apr 19, 2021, at 19:30, patient had a severe migraine with aura. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures taken as a result of the event and included treatment with ibuprofen 800mg. Since the vaccination, patient has not tested for COVID-19. The outcome of severe migraine with aura resolved with sequelae on an unknown date in Apr 2021. No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.
Soreness; Achiness; the plunger broke halfway through the shot; received the full booster dose or not as some of the vaccine ran onto his arm; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (the plunger broke halfway through the shot), ACCIDENTAL UNDERDOSE (received the full booster dose or not as some of the vaccine ran onto his arm), MYALGIA (Soreness) and PAIN (Achiness) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 016M20A and 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CITALOPRAM for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (the plunger broke halfway through the shot) and ACCIDENTAL UNDERDOSE (received the full booster dose or not as some of the vaccine ran onto his arm). On an unknown date, the patient experienced MYALGIA (Soreness) and PAIN (Achiness). On 04-Nov-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (the plunger broke halfway through the shot) and ACCIDENTAL UNDERDOSE (received the full booster dose or not as some of the vaccine ran onto his arm) had resolved. At the time of the report, MYALGIA (Soreness) and PAIN (Achiness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-418844, MOD-2021-418848 (Patient Link).
Developed eczema 3 days after shot. Started mild and has turned in to severe eczema. Lost her hair. Stopped sleeping at night. Developed food allergies.
Two nights after the vaccine on the site, it was the size of a pimple on 04/30/2021. After that day everyday I woke and it grew, inflamed, it was firm lump to about inch and half near injection site, and grew overnight larger it was red, swollen and painful. Called my dr on 05/02/2021 and did not hear back from him at all. The lump ended up being the size of my hand, I placed iced on it, and it has went down. Each day since, I have iced it and it  has gone down each day. During this time, my period it was very heavy flow for  8 days, then it stopped then began again 9 days later and lasted 7 days heavy flow again.
Tightening in my chest.  Swollen airway, tongue swollen.  Nasal passages swollen.  Extreme difficulty in breathing.  Coughing up sputum and wheezing.  Pain in left chest cavity.  Tingling and numbness in both arms and hands.  I feel like there has been a vice grip on my chest for the past week.  I am having a lot of difficulty in breathing.  This has been daily but at night it has happened to the extreme twice.  It was bad enough for a hospital visit but the hospitals are full.  I called a cardiologist this morning.  I am seeing an immunologist tomorrow. My O2 SAT was 88 and heart rate of 48 steady during these extreme episodes at night.
SPORADIC ITCHING AND RASH - TRUNK, BACKSIDE, BACK OF NECK, ABDOMEN TAKING BENADRYL AND USING HYDROCORTISONE CREAM IF UNRESOLVED WILL SE PRIMARY PHYSICIAN
I'm wanted to inform the CDC. I exp right shoulder pain and right shoulder discomfort. Then after the 2nd dose the symptoms worsened with severe right shoulder, decreased mobility and market right hip tightness discomfort especially in the morning. Which caused decreased walking ability, hard to apply socks. The Celebrex, ice/heat didn't help my symptoms. Around 4/5 I had a steroid injection in right shoulder which made my shoulder/hips better for 2 days. Then the symptoms came back. On 4/15 I started Dexamethasone 6 mg daily within 24 hrs my shoulder and hips symptoms was 80% improved. At that point my suspected Polymyalgia Rheumatica based on my symptoms of shoulder pain and hip pain, rapid response from the Dexamethasone. Since that date I have been on Prednisone still currently taking today. Also the lowest of Prednisone I have got to is 7mg that's why I got to 10mg cause of the pain. My diagnosis have been confirmed by 2 visits to Rheumatologist and 1 visit to family physician.