chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Five minutes after the vaccine was given, the patient became diaphoretic and her skin appeared dusky and gray. Patient stated she had a history of passing out. She was moved by wheel chair to a recovery pod where she lost consciousness. She became cyanotic and no pulse could be felt. She was moved to the gurney and extensive sternal rubs were used. When patient gain consciousness again, she was confused and tearful. Nurse called 911. She was assessed by EMTs Refused to go to hospital .
Sudden complete hearing loss in left ear. Severe leg cramping (both right and left thighs).
This spontaneous case reported by a consumer, describes the occurrence of a bad headache in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date,  patient had a bad headache. At the time of the report, bad headache outcome: unknown. No concomitant medication provided.
Fever above 39C Chills Muscle ache Serious throbbing headache Joint pain   Acetaminophen does not help. Ibuprofen works.
Covid bivalent administered to my 90 year old mother on 10/13/2022 in healthcare setting and by 10/16/2022 she was vomiting and became unresponsive. IV started for hydration. Placed on hospice 10/19/2022. She is awake but continues to be declining since the COVID bivalent. She had been eating and drinking without difficulty prior but now barely drinking and not able to eat except for few bites of pureed food. She had received all prior boosters without incident. Since she is now on hospice, we have not gotten any blood work or additional testing. She turned 91. I would not recommend this bivalent to anyone with any underlying conditions. At 91, she was in good condition but had progressing renal failure and memory loss. The renal failure due to no intake has to be much worse. No meds able to be swallowed at this point so BP elevated.
Dec. 4   experiencing sharp pain and some swelling of his both antecubital fossa, bicep and tricep areas.    Dec. 21 initial pain and swelling returned starting to experience generalized weakness (difficulty standing from a chair, holding his arms over his head).   FP-labs were ordered immediately and an  Physical exam was consistent with symptoms, despite labs values, his EKG/Chest X-ray were within normal limits. As Muscle Injury and Liver lab values were elevated, the decision was made to treat with a Medrol Dose Pak starting 12/22/2021 and concluding 1/2/2022.  1/6/2022 Less than 48 hours after concluding steroids, symptoms were back with a vengeance with increased pain in thighs and difficulty swallowing. Worked in with our FP for acute onset of symptoms.  During appointment with FP taken for immediate consultation with a rheumatologist. Multiple labs were ordered. Preliminary Working Diagnosis was either Polymyalgia Rheumatica or Polymyositis.  Labs, once resulted would help fine tune a diagnosis. 1/6/2022  Dr. called and identified that based on preliminary labs patient was to start taking Prednisone 60 mg. and that further review would occur during Dad's next office appointment scheduled 1/14/2022. 1/14/2022  Dr. identified that his primary working diagnosis is now Polymyositis.
After receiving the moderna booster shot, I noticed that my heart rate felt faster than normal.  I could feel my heart beating faster than normal.  I did not think anything of it.  I had a dental appointment and a blood pressure check is required to do the appointment. I was told I couldn?t be seen due to high blood pressure. I went to a Doctor and was diagnosed with hypertension.  I was prescribed medication for it.
I woke up with a headache, chills, body aches, and incredibly tired. I experienced that for about a week. And then the same thing happened the following week, but every other day. And that lasted for a week. And then the next week, every 2 days. It was the same thing all the time, but it became less frequent and less intense.  They completely stopped after almost 4 months.
Chills, fatigue, hallucinations, nausea, vertigo, generalized weakness, extreme headache.
patient was given expired vaccine. patient reported nausea, vomiting, chills and arm pain patient was prescribed Zofran 8mg taking one tab po TID prn x 2 days, use ice on arm and rest
Left thigh moderate erythema 4x3" firm with edema, not painful with palpation. Instructed antihistamines use as directed.
"Right bicep swelled up" evening after vaccine (10/28/08 evening). Called MD who instructed to apply ice. Pt did so with resolution.
This spontaneous report as received from a physician via a company representative refers to a 11 year old male patient. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (lot#, expiration date, dose and route of administration were not reported). On an unknown date, a week after receiving the first dose of GARDASIL 9, the patient came to the doctor's office experiencing lost of balance. The patient had also diplopia and symptoms consistent with Guillain-Barre Syndrome (onset dates of all events were unknown). No treatment was given, but the patient was scheduled for a spinal tap on 23-NOV-2016. There was no product quality complaint involved. At the time of the report, the patient did not recover from the events. The relationship between the events and GARDASIL 9 was not reported. Upon internal review, the event of symptoms consistent with Guillain-Barre Syndrome was considered as medically significant event. Additional information has been requested.
Patient had a local reaction to the Kinrix. He had a red swollen, warm area around the injection site. He was instructed to use a cold compress.
First as expected arm sore apx 5 hrs post, at 930 pm extreme upper abdominal pain (similar to pancreatitis), followed by continuous nausea, vomiting for 1.5 days eased finallyby Zofran. On day 2 my lips began to swell and were itchy, by day 3 they were very swollen, took benadryl every 8 hrs and by day 5 today they are fairly normal but still sore. My arm also swelled and spread to arm pit and was very hot and red. The redness has mostly gone, the swelling has lessened but not gone. Still sore and itchy. Still pretty run down and no energy. My cousin and I live together and were vaccinated at the same time and both had these symptoms except the lips swelling.
Patient began her menstrual cycle on normal schedule April 16th 2021. The flow was much lighter than normal in the beginning then after a few days it was normal flow. Her periods have always been 4 to 7 days long. Her period has been ongoing since 4/16/21 and has fluctuated In flow.
Red patches and dots on face after vaccines, no shortness of breath, no swelling or difficulty swallowing, observed for another 35 minutes post vaccines, client happy and talking, redness and dots diminishing, mom aware to go to ER if symptoms change.
6 Hours after the patient had received his 2nd  COVID Vaccine, the patient had suddenly experienced symptoms of sudden hearing loss, tinniutis, and vertigo  out of his Left Ear
brainstem lesions are reported in pt who recvd fluogen vax; also had diplopia, ataxia w/wide based gait; pt's MRI showed 2 brainstem lesions;
Pt reports 3 hours after injection given - 102 degree fever, rapid heart rate, nausea, stomach & chest pain. Resolving as of evening of 8/3 when reported.
Diarrhea, NauseaVomiting, muscle spasms, severe vomiting X10 hours and then resolved Narrative:  Doctor visit to see if should receive vaccine #2; had just had COVID-19 about 1 month prior
Patient contracted the full chicken pox disease as a result of receiving the vaccination.  She received this vaccination along with four others: Hib, inactivated flu, MMR, and pneumococcal conjugate, and was also running a mild fever of 99.9 degrees from a cold.  She developed a high fever about a week after the vaccination and developed raised spots a few days after that.  She is still sick at this time.
Headache, Fever, NauseaVomiting, PAIN AT INJECTION SITE; CHILLS; SEVERE BONE PAIN
Janssen COVID-19 Vaccine EUA 12 hours after receiving the vaccine (4/1/21 at 3am), I fainted and collapsed at home. Hit my head and landed on back. Had about a  2 second warning that I was going to faint. I felt perfectly fine prior to fainting.  After fainting where I was unconscious for 15 seconds, I was dizzy.  Today (4/4/21) - I am very tired and weak and have lower neck pain due to fall.
Severe left shoulder pain with raising my arm forward, diagonally forward or laterally. The pain was muscular at first but now feels like rotator cuff pain. It could be left shoulder bursitis. I had no issues with my left shoulder prior to the series of 2 injections. It was much more severe after the second injection, and has not resolved 5 months later.
I drove over two hours to get the vaccine.  About 1.5 hours into the drive I get a bad head rush.  I had to pull over on the freeway.; This is a spontaneous report from a contactable consumer or other non-health care professional. A 54-Year-old female non-pregnant patient started to receive first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EN6199 and Expiration date: Unknown) via an unspecified route of administration and administered in right arm on 06Mar2021 15:00 as 1st dose, single dose for COVID-19 immunization. The patient medical history included high cholesterol. The patient's concomitant medications were not reported. There was no known allergies and did not experience Covid-19 before vaccination. The patient experienced drove over two hours to get the vaccine. About 1.5 hours into the drive the patient had a bad head rush and to pull over on the freeway on 06Mar2021 (at16:45). The patient was not tested for Covid-19 on post vaccination. The patient didn't receive any treatment as a result of event. The outcome of event was considered as recovered.  No follow-up attempts are possible. No further information is expected
Information has been received from a Registered Nurse (R.N) concerning a 23 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 08-OCT-2009 was vaccinated with the first dose of GARDASIL. There was no concomitant medication reported. It was reported that "after October 2009" the patient has had lighter periods. The patient received the second dose of GARDASIL on 11-DEC-2009 and the third dose of GARDASIL on 04-MAY-2010. There were no laboratory diagnostic tests performed. The patient sought medical attention with a visit to the nurse. It was reported that the patient recovered on an unknown date. Additional information has been requested.
Psoriasis and psoriatic arthritis flare up, began sometime in July, saw my rheumatologist in August, prescribed long taper steroids with significant improvement, after stopping, symptoms returned, began taking Methotrexate and Folic Acid in October.
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All    COVID VACCINE CLINIC 12/22/2020      Date:  12/22/2020                                                                                            Subjective Patient is a 34 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.  She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and confussion.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis.   Pt  Presents with lightlessness and confusion.  Blood sugar on presenting was 74.  She has a history of fibromyalgia and Migraines.  She had a gastric bypass in 2010. She was given a protein bar to eat.  Fingerstick BS done 20 minutes later was 96.  Pt was feeling better after eating.    Review of Systems  Neurological: Positive for light-headedness.  Psychiatric/Behavioral: Positive for confusion.  All other systems reviewed and are negative.        Objective    Vitals Vitals:   12/22/20 1612 12/22/20 1628 12/22/20 1639 BP: (!) 135/92 127/79 128/84 BP Location: Right arm Right arm   Patient Position: Sitting Sitting   Pulse: 98 74 88 SpO2: 98% 98% 98%     Physical Exam Vitals signs and nursing note reviewed.  Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic.     Right Ear: External ear normal.     Left Ear: External ear normal.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are moist.  Eyes:     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     General: Abdomen is flat.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     Mental Status: She is alert.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.         Assessment/Plan  Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.   Pt was released at 4:39 with no symptoms at that time.       APRN Electronically Signed 12/22/2020 4:40 PM       Division of Health       3 of 3
no additional AE reported; patient received a dose of PROQUAD and a dose of VARlVAX concomitantly; patient received a dose of PROQUAD and a dose of VARlVAX concomitantly; This spontaneous report was received from a pharmacist and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-APR-2021, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot # T037955, expiration date: 09-MAY-2022, 0.5 milliliter (formulation, strength, frequency and route of administration were not reported), concomitantly with varicella virus vaccine live (oka/merck)(VARIVAX) lot# T003707, expiration date: 30-JAN-2022, 0.5 milliliter (formulation, strength, frequency and route of administration were not reported), both for prophylaxis. No additional adverse event was reported.
Lightheadedness; This is a spontaneous report from a contactable Other Healthcare professional reporting on behalf of a patient. A 46-year-old Male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot number:EN6205] through an unspecified route of administration and an unspecified anatomical location on 16Mar2021 as a single dose for Covid-19 immunisation. Medical history of the patient was not reported. On 16Mar2021, during his 15 minute waiting period after the injection, the patient began to experience lightheadedness. He denied rash, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, itching, dizziness, facial swelling, lip swelling and tongue swelling. The patient was obese but not ill-appearing. The patient received treatment for lightheadedness which included water and snacks. The follow up response to treatment was good. Patient was stable to go home and follow up with PCP. Clinical outcome of the event lightheadedness was unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
Red spot at the injection site / Got bigger and was raised and puffy; Red spot at the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 44-year-old female patient who received HBV (Engerix B adult) (batch number IMM28 ? and 90746 ?, GSK note the reported batch number did not match with any GSK lot number expiry date unknown, ) for prophylaxis.  Concurrent medical conditions included latex allergy.   On 20th July 2020, the patient received the 1st dose of Engerix B adult (intramuscular). On an unknown date, the dose was an unknown dose. On 21st July 2020, 1 days after receiving Engerix B adult, the patient experienced injection site erythema. On 23rd July 2020, the patient experienced injection site swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injection site swelling was unknown.   The reporter considered the injection site erythema and injection site swelling to be unrelated to Engerix B adult.  Additional details were provided as follows: The reporter was the patient and nursing student.  The patient received Engerix B intramuscularly in her left deltoid and the next day she noticed a red spot at the injection site.   About 3 days later she noticed that it got bigger and bigger and was raised and puffy and red. She took oral Benadryl and it went away and resolved in about one week. The injection was given via pre-filled syringe and was not able to find a VALID lot number on the paperwork.  The reporter stated that they could contact her health care provider to obtain the lot number.  The health care provider indicated that did not think it was a reaction to the shot however the patient did not feel that she should continue the series since it was not anaphylaxis. The reporter consented to follow up.
Headache, muscle aches, upset stomach and fatigue for 24 hours starting about 24 hours after shot. Maculopapular pruritic rash on torso and extremities starting 4 days after shot and lasting 5 days until gradual resolution.
INDIVIDUAL THAT GAVE VACCINE DID NOT MIX IT ACCORDING TO THE MANUFACTURERS GUIDELINES. MENA (ORANGE CAP) WAS NOT MIXED WITH THE MENCYW (GREY CAP) INSTEAD IT WAS MIXED WITH THE LIVE VIRUS DILUENT SO PATIENT DID NOT RECEIVE THE ENTIRE MENVEO DOSE. MOTHER WAS INFORMED THAT THE DOSE IS INVALID AND PATIENT WILL NEED DOSE REPEATED.
sore arm; red splotch on arm at injection site that feels hot; red splotch on arm at injection site that feels hot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INJECTION SITE WARMTH (red splotch on arm at injection site that feels hot) and INJECTION SITE ERYTHEMA (red splotch on arm at injection site that feels hot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), INJECTION SITE WARMTH (red splotch on arm at injection site that feels hot) and INJECTION SITE ERYTHEMA (red splotch on arm at injection site that feels hot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), INJECTION SITE WARMTH (red splotch on arm at injection site that feels hot) and INJECTION SITE ERYTHEMA (red splotch on arm at injection site that feels hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were mentioned.  The second dose was scheduled for 10-May-2021.
Improper storage of product in use; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Improper storage of product in use) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) 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 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (Improper storage of product in use) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Mar-2021, PRODUCT STORAGE ERROR (Improper storage of product in use) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provider by the reporter.  Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-163779 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-163779:Same reporter
Pain and swelling starting last evening at site of PNEUMOVA 23 injection received yesterday 2/1/17. She reports the pain was initially worse , however the red area has spread to the whole upper arm. No trouble breathing, swallowing, rash/hives elsewhere. No hx prior similar reaction.  Apply ice , Benadryl 25-50 q 6-8 hours. If any extension rash, redness, worsening pain, or otherwise worse, to f/u. Will forward note for Dr.'s review.
After 3 days of Vaccine I had 3-4 days of chills, body aches and low grade fever. Now about a week and a half later Im having continuous heart palpitations, heart racing, chest discomfort.