chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe stomach cramping  and diarrhea: Began at 4:30 pm 02.03.2021 - 02.07.2021 required hospital ER visit for iv fluids to treat stomach pain, nausea and dehydration from diarrhea. Sent home with prescription for Dicyclomine 20 mg tablet  anti spasm medication.  Petechiae on back of both hands, wrists and fingers: Began at 4:15 pm 02.05.2021 required hospital ER visit for multiple blood testing to evaluate platelets, etc. Testing clear and ER Dr. noted condition is associated with vaccination reaction and advised to  closely monitor for any change and seek immediate return if continued progression and if so follow-up with hematologist. Foot cramps: Began overnight 02.04.2021, increased fluids and subsided. 99.8 Temperature: Began 02.04.2021 at 9:30 pm - to 11:30 pm and treated with extra strength Tylenol and subsided. Began 02.03.2021 at 10:30 pm -11:30 pm and treated with extra strength Tylenol and subsided. Soreness at injection site: Began 02.04.2021 ongoing treating with extra strength Tylenol.
Initial misuse report received from a healthcare professional on 16 February 2014. A 21-months old patient had received second dose of FLUZONE on an unspecified date when second dose was not indicated. No adverse event was reported. List of documents held by sender: none
Several days later or a week I noticed my arm was really red down to my elbow. I sent a photo to my doctor and was told it was normal.
Information has been received from a physician concerning a 11 year old female who on 13-JUN-2007 was vaccinated with a dose of Gardasil in the left upper arm. Concomitant medication was not reported. On 13-JUN-2007, later in the evening, the patient's left hand became swollen, itchy, red and painful." The patient sought unspecified medical attention. The outcome of the event was not reported. Additional information has been requested.  This is in follow-up to report (s) previously concerning a 12 year old female student (weight 102L - hight 60") who on 14-JUN-2007 was vaccinated with the first dose of GARDASIL vaccine in the left upper arm (also reported as deltoid). Concomitant medication was not reported. No illness was reported at the time of vaccination. On 14-JUN-2007, later in the evening, the patient's left hand ("ipsilateral side") became swollen, itchy, red and painful." The patient sought unspecified medical attention. On 15-JUN-2007 less than 24 hours, the patient recovered from the events. At the time of reporting, there were no further complaints. Additional information is not expected.
Muscle aches (24 hours) Fatigue  (24 hours) Soreness at injection  site (12 hours)
Information has been received from a registered nurse and a father concerning his 18 year old daughter with a history of "something related to irritable bowel syndrome" and "gastrointestinal problems" over the last 10 years who on 24-JUL-2007 was vaccinated IM with a first 0.5 ml dose of Gardasil.  Concomitant therapy included LOESTRIN.  On 10-AUG-2007 the patient experienced severe abdominal pain and diarrhea.  It was reported that she experienced pain when she was "up and moving around" but not when she was laying down.  On 13-AUG-2007 the patient went to the emergency room .  There she received a "gastrointestinal work-up" that was reported as normal.  The patient was not admitted to the hospital.  The patient's severe abdominal pain and diarrhea persisted.  Additional information has been requested.
twisted his back a little bit/strained his back; he is having some muscle pain; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Jan2021 this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) reported that a 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he is in good physical health. The patient stated that he is 79 years old, and received his first dose of the COVID vaccine 48 hours ago, on Monday at noon (11Jan2021). The patient strained his back last night (12Jan2021), and he is having some muscle pain, and he would like to know if it is okay to take Ibuprofen, following having received the vaccine. The patient clearly stated that he has had no side effects and he is fine from the vaccine. He also added that it was while he was in the shower last night, he twisted his back a little bit, and that happens to him now and then and that was normally when this happens to him, it takes a few days to get better. But patient stated that this event is totally unrelated to the COVID vaccine. The patient normally just takes a Motrin, and it clears the pain up, it relieves it. But he was just wondering if it is contraindicated to take Motrin after having had the vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The events back strain and muscle pain were intercurrent conditions and unrelated to BNT162B2 vaccination.
This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine after having two excursion for a total of 29 hours and 30 minutes) and PRODUCT TEMPERATURE EXCURSION ISSUE (The first temperature excursion lasted for 9 hours 45 minutes/The total amount of the excursion is 29 hours 30 minutes.) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 04-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine after having two excursion for a total of 29 hours and 30 minutes). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The first temperature excursion lasted for 9 hours 45 minutes/The total amount of the excursion is 29 hours 30 minutes.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine after having two excursion for a total of 29 hours and 30 minutes) and PRODUCT TEMPERATURE EXCURSION ISSUE (The first temperature excursion lasted for 9 hours 45 minutes/The total amount of the excursion is 29 hours 30 minutes.) outcome was unknown. Concomitant products were not provided. The vial was first punctured on 04-Mar-2022. The vial were not exposed to room temperature. The vial was stored only in freezer. The vial did undergo temperature excursion. The maximum 10.8 degree Fahrenheit and minimum 5.5 degree Fahrenheit were reached. The vial was not moved from freezer to refrigerator. The vial was found to be refrozen in the visual inspection. At least 1 vial was impacted. No previous excursions were seen. Treatment medications were not reported. This case was linked to MOD-2022-592504 (Patient Link).
Muscle ache, Headache, Hip Joint Pain, Shortness of Breath, Neck Pain, swollen glands in neck and throat, Back pain, tingling legs/feet, slight numbness of legs.
2nd shot. Night sweats beginning at 1 or 2 am. Felt very warm. Removed blankets in cold room to achieve comfort. No medications taken. Returned to sleep comfortably and symptoms had resolved with unknown duration by time I awoke in the morning.
fever was 99.3; shaking; tired; fever/ temperature of 101 to 101.5; shivering; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), FATIGUE (tired), PYREXIA (fever/ temperature of 101 to 101.5), CHILLS (shivering) and PYREXIA (fever was 99.3) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (diagnosis of COVID-19 in November) in November 2020.    On 25-Jan-2021 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced TREMOR (shaking), FATIGUE (tired), PYREXIA (fever/ temperature of 101 to 101.5) and CHILLS (shivering). On 27-Jan-2021, the patient experienced PYREXIA (fever was 99.3). At the time of the report, TREMOR (shaking), FATIGUE (tired), PYREXIA (fever/ temperature of 101 to 101.5), CHILLS (shivering) and PYREXIA (fever was 99.3) outcome was unknown.        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.   No treatment information was provided.
gave a booster dose too early to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave a booster dose too early to a patient) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First shot  Lot number: EW0198 Expiration date: Unknown) on 19-Jul-2021 and PFIZER BIONTECH COVID-19 VACCINE (second shot Lot number: FA7484 Expiration date: Unknown) on 09-Aug-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave a booster dose too early to a patient). On 23-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave a booster dose too early to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Arm where vaccine swollen big as round as a grapefruit, dark red, swollen throat to choking, dizziness, fever, disorientation, hives
Sore arm at the site of injection.  Was injected once, then pulled out by medical provider and injected again with same needle.
03/16/21  4:00pm  Nauseous, arm aching, headache  Midnight and all day on 17th  All joints and bones aching,  100.4 fever, exhaustion and headache 03/18/21   7:30 am Headache,  dizzy and exhausted  In bed or recliner since 6pm on March 16th  03/18/21  11:00am Still headache  but much better Took tylenol and ibuprofen  for symptoms
having trouble with his knee, it's been swelling; upper respiratory dryness; little flare ups here and there; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EJ6796, expiration date was not reported), via an unspecified route of administration, on an unspecified date, at dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included tofacitinib citrate (XELJANZ) from Dec2020 and ongoing; acetylsalicylic acid (ASPIRIN (E.C.)) as a BP medication. The patient previously took prednisone and experienced dryness in his throat and respiratory dryness.  After the vaccination, the patient experienced having trouble with his knee, it's been swelling, upper respiratory dryness, little flare ups here and there (described as flare up of arthritis) on an unspecified date. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
nausea started w/in min of inj;approx 2 hr later had blurred vision which lasted 1hr;itching from lt elbow to lt shoulder became hard & red;used DPH lotion;did not resolve;saw MD in ER;ice applied site better but remains discolored;
very low pulse 46; unable to walk; unable to stand; Headache; sore throat; pain on the legs; difficult breathing; chest pain; dizziness; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female non-pregnant received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: FE3592, Expiration date was not reported), via an unspecified route of administration in arm right on 01Oct2021 at 09:30 (at the age of 66-year-old) as a dose 2, single for COVID-19 immunization. Medical history included sleeping apnea, Sulfa allergy, known allergies: Codeine and Sulfa. Past drug event included codeine and experienced allergy. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8736, Expiration date was not reported), via an unspecified route of administration in arm right on 13Sep2021 (at the age of 66-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. No other vaccines received within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as yes. On 07Oct2021, the patient experienced headache, sore throat, unable to stand, unable to walk, pain on the legs, difficult breathing, dizziness, very low pulse 46, chest pain. Most of these symptoms have lasted longer than 30 days. The events resulted in the emergency room visit and physician office visit. The reporter considered this report as serious (medically significant). No prolonged hospitalization was reported. Treatment was not received for the events. The patient underwent lab tests and procedures which included heart rate: 46, low on an unspecified date in Oct2021 and Nasal Swab (SARS-CoV-2 test), resulted as negative on 20Oct2021. The device date was on 06Nov2021. The outcome of the events was recovering.
High fever of 104.5 which lasted for 3-4 days.   It was reported to the pediatrician who advised us to use infant tylenol.  We were not told by the physician that we should not do the next series or do an alternative vaccine schedule.
Vaccine was initially painless. During that a.m., arm & hand became very sore. And for the next 5-8 days; both arms, neck & shoulders were very painfull, could not lift head off of pillow without turning on side. That hand remained very tender to touch for 8-10 days. I have fibromyalgia - curious if there's a connection.
Received a flu shot in my left arm which hurt very much when given. The hurt is still there today. Been to several doctors and therapy, but still have the pain, which all these problems were not there before. I have the lot number and nurse number. The vaccine was out of clinic. I am having alot of problems and was told it was given wrong or something was wrong with the vaccine.  3 others at work are having problems also. I was told by my pharmacist to get in touch with you.  02/27/2007 MR received from consulting neurologist.  3 visits from 01/05/2007 to 02/19/2007 for c/o pain and weakness in the left arm since receiving flu shot 11/17/2007.  PE (+) for left arm pain and difficulty raising left arm against gravity >90'. Impression: Left ulnar neuropathy.  Left arm pain.  AE from Flu shot.  03/05/2007 MR received from PCP for several office visits for c/o left shoulder pain following flu shot.  1st visit 12/04/2006 with pain level 6/10.  F/u 12/21 and 02/01/2007.  Impression:  Left Shoulder Impingement. Ortho consult 01/12/2007 showed discomfort upon forward flexion and slightly decreased external rotation on the left. Ortho did not feel the bone spur evident on the MRI had any bearing on his clinical symptoms.  No DX made although improvement was reported on NSAID and muscle relaxer. Per annual follow up information, recipient has not recovered. Left arm still hurts-deltoid muscle is still affected. Went to doctors, neuro-surgeons, and therapy 8 wks & then additional 8 wks. No one would take the repsonsiblity. I am afraid to get the flu shot again and still paying some of the doctors for the pneumonia one.
Substantial chest pain for nearly two months following initial injection. Told by medical staff it was unrelated to the vaccination, so had my second dose on 4/7/21 at the same site, Pfizer lot #ER8734. Pain continued and has subsided in mid May 2021.
For four days I had frighteningly strong heart palpitations,  racing/pounding heart, shortness of breath while doing normal activities, and a sensation of missed heartbeats/difficulty breathing while falling asleep. This was not a psychological response; I had only a minimal reaction to the first shot, and no fear nor concerns with taking the second shot.
Sore arms; Outbreak of Hives; Sick; Severe muscle aches; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arms), URTICARIA (Outbreak of Hives), ILLNESS (Sick), MYALGIA (Severe muscle aches) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arms), URTICARIA (Outbreak of Hives), ILLNESS (Sick), MYALGIA (Severe muscle aches) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore arms), URTICARIA (Outbreak of Hives), ILLNESS (Sick), MYALGIA (Severe muscle aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details reported.
On 04/25/21, my face felt like I was having an allergic reaction, but wife couldn't understand my speech. So, we rushed to hospital (emergency room) and Dr diagnosed Bell's Palsy. Recommended I see a neurologist. Neurologist confirmed the diagnosis.
COVID Arm; Inflamed Injection Site; Red Rash on the Injection Site; Tender to the touch Injection Site; Red Rash on the Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (COVID Arm), VACCINATION SITE INFLAMMATION (Inflamed Injection Site), VACCINATION SITE ERYTHEMA (Red Rash on the Injection Site), VACCINATION SITE PAIN (Tender to the touch Injection Site) and VACCINATION SITE RASH (Red Rash on the Injection Site) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION COMPLICATION (COVID Arm), VACCINATION SITE INFLAMMATION (Inflamed Injection Site), VACCINATION SITE ERYTHEMA (Red Rash on the Injection Site), VACCINATION SITE PAIN (Tender to the touch Injection Site) and VACCINATION SITE RASH (Red Rash on the Injection Site). At the time of the report, VACCINATION COMPLICATION (COVID Arm), VACCINATION SITE INFLAMMATION (Inflamed Injection Site), VACCINATION SITE ERYTHEMA (Red Rash on the Injection Site), VACCINATION SITE PAIN (Tender to the touch Injection Site) and VACCINATION SITE RASH (Red Rash on the Injection Site) 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.  Treatment information was not provided.
Severe pain with movement after vaccine given since 11/7/16, seen in ER on 11/28/16. Started MEDROL dose pack. Still having pain.
Severe auto immune flare--terrible unrelenting muscle aching all over body--profound weakness and fatigue necessitating bedrest for hours at a time.  This has continued for 4 WEEKS and is just beginning to slightly  let up. My immune system has been in the worst flare I have ever experienced  in all the 20 years I have had auto- immune flares--it just cannot seem to down regulate itself and I have crippled up badly as a result.  Every movement hurts--even my chest hurts every time I take a breath!
This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 53-year-old male patient who received FLUARIX QUADRIVALENT (batch number 34RE5, expiry date 30th June 2018). On 2nd October 2017, the patient received FLUARIX QUADRIVALENT .5 ml. On 9th October 2017, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced sinus pain (serious criteria hospitalization) and ear pain (serious criteria hospitalization). In October 2017, the patient experienced dehydration (serious criteria hospitalization), hearing loss (serious criteria hospitalization and GSK medically significant), nausea (serious criteria hospitalization) and vomiting (serious criteria hospitalization). On 17th October 2017, the patient experienced Ramsay-Hunt syndrome (serious criteria GSK medically significant). On 19th October 2017, the patient experienced shingles (serious criteria hospitalization) and facial paralysis (serious criteria hospitalization and GSK medically significant). The patient was treated with Acyclovir and Steroids. On an unknown date, the outcome of the shingles, Ramsay-Hunt syndrome, hearing loss and facial paralysis were not recovered/not resolved and the outcome of the sinus pain and ear pain were unknown and the outcome of the dehydration, nausea and vomiting were recovered/resolved. The reporter considered the shingles, sinus pain, Ramsay-Hunt syndrome, dehydration, hearing loss, nausea, vomiting, ear pain and facial paralysis to be unrelated to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported to the physician. The concomitant medication included hypertension medication. The patient received FLUARIX QUADRIVALENT in the right deltoid. On 9th October 2017, the patient started to have ear and sinus pain. On 12th October 2017, the patient went on antibiotics. On 15th October 2017, the patient went to the emergency room and the physician increased his antibiotics and steroids. On 17th October 2017, 15 days after receiving FLUARIX QUADRIVALENT, the patient was diagnosed with Ramsay Hunt Syndrome. The patient received intravenous steroids at that time and Acyclovir. From 19th October 2017, 15 days after receiving FLUARIX QUADRIVALENT, the patient was admitted to the emergency room (ER) with facial paralysis and was diagnosed with shingles in his ear and it ran across the nerve across his face which caused facial paralysis and the patient experienced hearing loss as well. In October 2017, less than a month after receiving FLUARIX QUADRIVALENT the patient experienced nausea, vomiting and dehydration at that time which caused him to be admitted. On 23rd October 2017, the patient was discharged. The patient reported that he had the Varicella Titer test and the results were 574. The physician said that the symptoms were unrelated to the flu shot. The patient lost two days of work and was still experiencing 58 percent hearing loss with facial paralysis on the left side of his face. The reporter indicated that the patient had a job and marital stress, which might have contributed to his condition.
Throat became very sore & swollen, hard to swallow. Extreme aches, fever. This lasted about 8 or 9 hours. I did not call 911 or seek treatment, but slept fitfully due to throat swelling. Thought I should report the throat swelling, as it isn't among the most common reactions. I've never had a reaction to a flu shot before.