chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered GARDASIL 9 and then had a seizure for 30 seconds with his eyes rolling into the back of head; Patient was administered GARDASIL 9 and then had a seizure for 30 seconds with his eyes rolling into the back of head; This spontaneous report was received from a certified medical assistant referring to a male patient of unknown age. The patient had not concurrent conditions, pertinent medical history, and drug reactions/allergies. Concomitant therapies were reported as "other unspecified medication".  On 24-NOV-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, 0.5 milliliter, lot #T036812, expiration date: 28-APR-2023, administered intramuscularly as human papilloma virus (HPV) prevention.   On 15-FEB-2022, the patient was vaccinated with another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage regimen, route of administration, lot# and expiration date were not reported), and then had a seizure for 30 seconds with his eyes rolling into the back of head; however, the patient remembered what was happening and stated that has never had a seizure before, and she also ate before coming to the clinic. No treatment was given for the events, and laboratories (unspecified) were performed (results not provided). At the time of the report, the outcome of the event was unknown.  The causal relationship between the events of seizure, eyes movement disorder, and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.  Upon internal review, the event of seizure was determined to be medically significant.
Pt. stated, she had been working all day to get herself ready for the shot. The shot was given at 2:30pm. She said, she did not even feel it. Then as she was getting her stuff together, she said, "Is it unusually for my arm to feel weird?" When asked what she meant by weird, she could not explain it. This writer asked if she was dizzy/light headed. She said, "no." PHN walked her to the monitoring room. She said, she did not need to lay on the cot and sat down on the chair. A minute later an usher came to get another PHN stating that pt. was feeling lightheaded. When PHN arrived pt. was hyperventilating and grabbing at her neck and chest. PHN asked pt. if she was okay,
Headache, body aches, , cramping , a 101-degree fever that lasted 24 hours.   Sweating profusely, chest/lung pain,  72 hours. Chills 48 hours. Did not seek treatment
Right after receiving the vaccine (approximately 5 minutes after), patient said they were feeling light-headed. I went to go get patient water and a granola bar since he hadn't eaten breakfast and patient passed out. Patient was resting after receiving the 1st dose of the vaccine, and was propped against the wall in the corner on a chair, so he was just leaned up against the wall (didn't fall to the ground). Several patients helped me move the patient to the ground so he was lying horizontal and he woke up almost immediately (max 10 seconds). He wasn't quite oriented to what had just happened but knew he was on the ground. Within 1 minute, patient knew where he was, was feeling fine and wanted to sit back on the chair. He was carrying on a full conversation and did not feel feverish, sweating, tired, faint, or have a headache, just embarrassed. Patient stayed for a full 30 minutes and wanted to drive himself home because he felt completely back to normal. Vaccine administrator calling to check up on patient during next available break.
Uncontrollable itching in the breast area, breast swelling with redness and pain; breast area would not stop growing;  resulted in emergency surgery October 18th, 2021 with over 10 follow-up appointments, four types of antibiotics for bacterial infection,  two shots of Rocephin, one drainage procedure and surgery
10 days after Moderna COVID-19 booster shot, I began presenting with itching hives (pruritic urticaria). These would present anywhere my skin felt friction -- from clothing, from the casual brushing against objects, etc. If scratched, they would spread from that area, since scratching stimulated new hives in adjacent patches of skin. This covers my entire body if I continue scratching, covering me from head to toe, literally. If I resist scratching and take care to not stimulate the skin where urticaria presents, the hives and itching sensation fade over approximately 20 minutes. I have never had hives in my life before now. This has been ongoing for 10 days now, 24/7, with no sign whatsoever of improvement.  My initial reaction to the vaccine shots (all 3) included only the typical symptoms of sore arm at injection site, body aches/fatigue, headache, etc., all of which faded (each time) within 3 days of injection.  This delayed reaction is the first I have had to any of the 3 shots.  I will be seeking professional care from a dermatologist or similar.
my arm was sore; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ XR) taken for an unspecified indication, start and stop date were not reported. The patient experienced my arm was sore on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
DIARRHEA; LEFT ARM DISCOMFORT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 25-MAY-2021) dose was not reported, administered at 13:00, in left arm on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced left arm discomfort. On 23-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 23-MAR-2021, and left arm discomfort on 22-MAR-2021. This report was non-serious.
Pt rec'd Td #3 approx 11AM. Clinic rec'd call from valley med center (ER) approx 4pm. Pt there with fever.
Developed induration, hard, warm at site. Redness was the size of a tennis ball. Next day, redness covered most of upper arm, warm/hot to touch, blister formation on the hard induration that would be center of injection site.
Shot11 AM  Sat .Sun morning bad headache upset stomach in bed all day Mon better kind of weak but much better
Systemic: Nausea-Mild, Additional Details: After 10 minutes from administration, patient started to feel a little nauseous.
My throat started to feel funny. Then it felt like it was closing and my tongue and lips went numb. I received 50mg of Benadryl and was watched carefully for the next several hours after receiving the employee mandatory flu shot.
weakness; Chills; Headache; A little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (A little fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure. Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) 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 25-Jan-2021, the patient experienced ASTHENIA (weakness), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (A little fatigue). On 25-Jan-2021, CHILLS (Chills), HEADACHE (Headache) and FATIGUE (A little fatigue) had resolved. At the time of the report, ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs included for blood pressure and blood thinner.  Treatment drug included Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No new information added.
3.12 to 3/18/06: Fatigue, intense. 3/20/06-macular rash/macular papular abdomen. 3/22/06-Pain in ankles, knees, hands with swelling.
Fine pinpoint vesicular rash in bilateral anterior thighs, where vaccines were administered. Resolved in 1 week with steroid ointment.
One day after receiving first Moderna immunization, I awaken with diffuse, painful  myalgias, dizzy, freezing, blurred vision, profound fatigue, loose stools, very thirsty, generalized weakness but afebrile. Never  developed fever during this episode. Symptoms lasted from 02/18 to  02//21/2021. Diffuse weakness lasted for an additional 4 days.   March 17 2021, I received my second Moderna immunization. Was fine the first day. The next morning, awaken  unable to move due to diffuse muscle  pain. This time, my knees hurt L> R (I have hx of L arthroscopy). Took mixture of Advil and Tylenol which helped markedly but about 7 hours later, pain/weakness, dizziness, thirst, profound fatigue began again. Today, it is day 3, and I feel better but weakness, fatigue continues.
administered before recommended age for Shingrix; Shingrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered before recommended age for Shingrix) and incomplete course of vaccination (Verbatim: Shingrix late second dose). The outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   Additional Information: GSK receipt date: 29-JUN-2023 and 30-JUN-2023 The reporter mentioned patient was mid 40 years old but no exact age was reported. The pharmacist reported that patient had a first dose of Shingrix in approximately in 2020 and had not received a second dose yet. No exact details were reported about initials, vaccination date or vaccine information.  The reporter did not mentioned if patient was immunocompromised or not and a callback attempt was made being unable to contact hcp. The patient received 1st dose of Shingrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
extreme neck stiffness, soreness on complete neck - all the way around and inflamed glands - hurts to turn or tilt head - sore to touch and affecting swallowing and voice - raspiness and cracking - dryness of throat
night of Client complained of chills. Following day, "Bad acid taste in mouth" but, no chills.
Site red, warm to touch, redness runs from site to approx. 4 inches down arm, arm very sore to move. Reported low grade fever & fatigue. Started evening of injection 9-13, symptoms remained until the evening of 9-16-11. Reported feeling much better on 9-17-11.
Dizziness, diaphoresis lasting 1 hour 40 minutes. Div. Med. Director notified. Placed in donor chair, legs elevated, ice packs, water.
PATIENT ADMINISTERED IMMUNIZATION IN LEFT ARM (INTRAMUSCULAR), NO SIGNIFICANT BLEEDING, PATIENT RETURNED TO PHARMACY ABOUT 1.5 HOURS LATER COMPLAINING OF NUMBNESS OF THROAT AND TONGUE ON LEFT SIDE. SHE ALSO COMPLAINED OF HER EAR FEELING "STRANGE". SHE WAS ABLE TO SWALLOW AND DRINK WATER WITHOUT PROBLEM OR ANY FEELING OF SWELLING OR TIGHTNESS. TONGUE WAS NOT SWOLLEN, HOWEVER, PHARMACIST RECOMMENDED PATIENT GO TO URGENT CARE
Vaccine was placed in fridge on 8/19, and therefore expired 9/18. Date was not marked appropriately on the box, and was administered to the patient past it's beyond use date. I contacted patient. She stated she experienced chills, sweating, vomiting, headache, fever and dizziness. I explained what happened and recommended repeating her dose. Patient declined, she felt as though she had adequate response to the vaccine.
Almost immediately after receiving the vaccine the patient started feeling nauseous. Patient's mother then reported that she experiences the same side effects from blood draws from the doctors office. Patient then started to become pale and was clammy. The pharmacist then took action to lay the patient on the floor and prop up feet on chair and took the patient's BP 127/81 HR 97. No epinephrine was given or indicated. The patient had some vomiting about 15 minutes following the vaccine. Patient stated that she did not have any food or fluids prior to receiving vaccine. Fluids and food was not given to the patient. The patient's color returned at 25 minute post vaccination. At 30 minutes patient was feeling much better and was escorted by the pharmacist to the car to ensure safety and no other events or side effects occurred.
Headache, throat closing up, chest heavy and tight, hives, pins and needles feeling, uncontrollable coughing, runny nose, watery eyes, SOB, got shot at 11 am, s/s at 2pm. Ambulance called, went to ER, received benadryl and prednisone.
Patient was given initial dose in left deltoid in which the vaccine leaked out and down the arm. The patient verbalized and understood the situation then gave consent for full dose to be given, in which a full dose of 0.3 mL was given to the patient in their right deltoid, per CDC guidelines. Patient's left arm was evaluated in which the patient denied pain, swelling, or bleeding.
PATIENT WOKE UP AT 4:00 AM ON 08/25/18 WITH THE FOLLOWING SYMPTOMS: FEVER (103F), GENERAL MYALGIA (PAIN: 10 OF 10), CHILLS & SHIVERING, SEVERE PAIN AT INJECTION SITE, SEVERE NAUSEA, MILD DIARRHEA, HEADACHE, & FEELING HEAT ON HANDS. PATIENT CLAIMS THAT THE PAIN HAS SUBSIDED SINCE SATURDAY, HOWEVER, SHE IS NOW EXPERIENCING BILATERAL NUMBNESS, ESPECIALLY WHEN LYING DOWN.
Patient contacted provider the day following vaccination to report a red area approximately 6 inches at the injection site. Area was raised with a few welts around injection site and under the arm. No red streaks reported. Area was also warm to the touch.
Patient reports she had pain at site immediately, but over the next 9 hours, the swelling and circumference grew to larger than the size of a quarter and height of 3 stacked quarters. She took APAP 325 mg and ice compression for relief. On 5-6, still some pain to the touch, but feels recovered.
FLUSHED, RED FACE.  RED WARM RASH ON NECK, TORSO, BACK.  BENADRYL 50MG IM ADMINISTERED
Patient was in with her 2 daughters to get her booster and they were getting first pedi dose. I administered her vaccine and she was waiting in the post imz area for about 5 minutes. She then came to help her daughter who sat in her lap and as I  was ready she looked pale and faint. We called 911. I gave and an ice pack and applied to her face and neck. Paramedics  took her BP which was low and said it was orthostatic hypotension. She had not eaten all day
Positive with coronavirus 10 days after 1st dose; It's been 36 days and did not receive 2nd dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive with coronavirus 10 days after 1st dose) and PRODUCT DOSE OMISSION ISSUE (It's been 36 days and did not receive 2nd dose of vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive with coronavirus 10 days after 1st dose) and PRODUCT DOSE OMISSION ISSUE (It's been 36 days and did not receive 2nd dose of vaccine). At the time of the report, COVID-19 (Positive with coronavirus 10 days after 1st dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (It's been 36 days and did not receive 2nd dose of vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive with coronavirus 10 days after 1st dose.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported. Treatment medication were not reported.
Approximately 10 minutes post receipt of vaccine, chills long lasted of feeling cold. Then tired, became pale, diaphoretic, slight cyanosis HR decreased to 68. Child was confused. Improved in color and mental status after Epinephrine SQ. Hospitalized for observation for 24 hrs. No recurrence.
Right upper arm area of induration and erythema 156 mm X 75mm.  Right upper arm circumference 7 1/8 "and left is 6 1/2".  T-99.9 area hot to touch and painfully.  Mild lethargy and temp.  of 100.1 - F yesterday.
ADMINISTERED 0.3 ML OF UNDILUTED COVID BIVALENT VACCINE, EQUIVALENT TO 30 MCG DOSE. THIS IS IDENTICAL TO THE DOSE THE PATIENT SHOULD HAVE RECEIVED BUT WAS WITHDRAWN FROM THE INCORRECT VACCINE VIAL
trivial deltoid soreness starting about 4-6h later (maybe lasted a bit longer then 36 hours); not sore enough to limit use of the arm even a little bit.; This is a spontaneous report from a contactable physician (patient).  This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EH9899), via an unspecified route of administration in left arm, on 18Dec2020 at 10:00 AM at single dose for COVID-19 immunisation. The patient was vaccinated at hospital, age at vaccination was 57-years-old. No other vaccine was received in four weeks. Patient's known allergies: latex (rash, occ. mild bronchospasm); dysphoria c valium; innumerable food reactions - dairy & eggs, nuts/seeds/grains, fish, latex associated foods, nightshades, meat -but none anaphylactic (occ. debilitating headache, very occ. mild bronchospasm; mostly cholinergic urticaria / joint pain / diarrhea). Other medical history included atopic incl. Raynauds; parox. atrial tach (after ablation for PA-fib.); almost-asx'tic asthma; endometriosis c small bowel resection (terminal ileum). Concomitant medication included metoprolol and a very long list of supplements.  On an unknown date, the patient experienced trivial deltoid soreness starting about 4-6h later (maybe lasted a bit longer then 36 hours); not sore enough to limit use of the arm even a little bit. No treatment was received for the event. Outcome was recovered on an unknown date.
This pt & 3 other pts exp "minor reactions ranging from swelling @ inject site to aches" following the administration of Typhoid vax;
Administered expired vaccine to patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Expiration Date for the lot 048C21A was reported as 09-Nov-2021 with total of 168 doses.  The date in which the vial was initially stored in the refrigerator was unknown  The vial did not undergo any temperature excursions.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
This spontaneous report as received from a physician refers to a not pregnant 25 year old female patient with allergy to food colouring Allura Red, which was breaking out in a rash. The patient had no pertinent medical history. On 23-SEP-2015, the patient was vaccinated intramuscularly with 0.5 ml dose of GARDASIL 9 (lot # L013429, expiry date 21-JUL-2017). Concomitant therapies included PORTIA for birth control. On 28-SEP-2015, the patient experienced swelling of the lymph node. The patient sought medical attention and, on 29-SEP-2015, she presented to the physician's office with a painful supraclavicular lymph node on the left side, which was the same side as the injection was given on. The physician recommended treatment with unspecified nonsteroidal anti-inflammatory drugs (NSAIDs) and BENADRYL. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
soreness in left arm, numbness down the arm early after the shot. Fever and tiredness overnight to next morning. Feeling consistently dehydrating.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jul2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound 3 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: the patient was treated with Paxlovid from 30Jun2023 to 05Jul2023 for Covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient. On 03-JUN-2014 the patient was vaccinated with ZOSTAVAX lot # J013449, 0.65 ml, subcutaneous in the left arm. Dose number was not reported. Concomitant medication, pertinent medical history and drug reactions/allergies were unspecified by the reporter. In June 2014 (date not specified) the patient left arm at the injection site was red, hot to touch and raised area 3 inches by 2 inches. No rash. The pharmacist reported that the patient told her that the raised area at the injection site was getting bigger each day. Pharmacist reported that the patient was treating herself with Hydrocortisone cream. On 10-JUN-2014, the patient sought medical attention (pharmacist). No lab diagnostics studies performed. The patient would follow up with her primary health care provider for follow up. The outcome of her left arm at the injection site is red, injection site raised area 3 inches by 2 inches and injection site hot to touch was reported as not recovered/not resolved. Reporter causality assessment was not reported. Additional information has been requested.