chrisvoncsefalvay/vaers-outcomes huggingface dataset:
could not move her arm with second shot; second shot hurt a lot more than the first; This spontaneous case was reported by a physician and describes the occurrence of LIMB DISCOMFORT (could not move her arm with second shot) and PAIN (second shot hurt a lot more than the first) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included OMEPRAZOLE, EMPAGLIFLOZIN (JARDIANCE), METOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN + HIDROCLOROTIAZIDA), ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOTHYROXINE SODIUM (THYROXINE), METFORMIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced LIMB DISCOMFORT (could not move her arm with second shot) and PAIN (second shot hurt a lot more than the first). At the time of the report, LIMB DISCOMFORT (could not move her arm with second shot) and PAIN (second shot hurt a lot more than the first) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.   Action taken with mRNA-1273 in response to the events was not applicable   This case was linked to MOD21-060488, MOD-2021-054449.
Mother reports red spot on a place of on of the injections L side. Not really painful and does not have fever, mother will observe and make sure that spot is not getting bigger, will give patient Benadryl and Tylenol and if no relief will contact office to make appt with Dr. before weekend.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported. The patient had a fever on the first day. No treatment drugs were reported.   This case was linked to MOD-2021-350423 (Patient Link).
All health issues related after receiving vaccine, damage of body, life; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (All health issues related after receiving vaccine, damage of body, life) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (All health issues related after receiving vaccine, damage of body, life). At the time of the report, IMMUNISATION REACTION (All health issues related after receiving vaccine, damage of body, life) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IMMUNISATION REACTION (All health issues related after receiving vaccine, damage of body, life) to be related.    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that patient had medical issues after vaccination.  It was also reported that involved.  Treatment medications were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2023: Live follow up received include no new information.
After second shot (EL9265) left arm got hot and burning sensations began. Within 24-48 hours it became very itchy and tingling feelings took over. The entire arm is itchy from the inside out and burning from the inside out.
skin has become itchy all over; This case was reported by a consumer and described the occurrence of itchy skin in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 days after receiving Shingles vaccine, the patient experienced itchy skin. On an unknown date, the outcome of the itchy skin was unknown.   It was unknown if the reporter considered the itchy skin to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-Nov-2022 The patient self-reported this case. The patient stated that his/her skin had become itchy all over 4 days after receiving the Shingles vaccine. The patient asked was this normal. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Hep A was given to a 2 month  old child instead of a Hep B. Mom was informed of this error. Mom chose to receive Hep B dose when they come back for their next well child exam in Nov.
Patient recieved intial dose of COVID Moderna vaccine on 2/10/21 and on 2/21/2021 developed symptoms of COVID. Tested positive on 2/25/2021. Currently not hospitalized.
Moderna COVID 19 Vaccine EUA PATIENT WAS GIVEN THE VACCINE PASSED 30 DAYS AFTER THAWED.  NO NEGATIVE REACTIONS NOTE
diagnosed with an auto immune disease Hashimotos; Initial information regarding an unsolicited valid serious case was received from a consumer (patient) via the Agency (Reference number- 00395638) and transmitted to Sanofi on 16-Dec-2020. This case involves a female patient age not reported who had been diagnosed with an auto immune disease Hashimoto's (Autoimmune thyroiditis), while she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (batch number and expiration date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date about 2 years ago, the patient had been diagnosed with an auto immune disease Hashimoto's (Autoimmune thyroiditis), unknown latency following the administration of  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Seriousness criteria was assessed as medically significant as per important medical events (IME) list.  Caller wants to know if MENACTRA has pegylated lipid nano particles because she was reading an article about the new Coronavirus disease (COVID) vaccine possibly having the ingredient pegylated and the article said some vaccines have it so she was calling to see if Menactra had this. States she was wondering if this is why she has this disease since she is very young to have it and has not had any other vaccines in the last 2 years.   No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  Information on the batch number was requested for this case.; Sender's Comments: This case concerns an unknown age female patient who had menactra about 2 years ago and since has been diagnosed with an auto immune disease hashimotos (Autoimmune thyroiditis)  after vaccination with MENACTRA. It was unknown if the time to onset is compatible. However, concomitant medications, patient's medical condition and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of vaccine cannot be assessed.
Patient received the vaccine on 09/13/2017 at 945 am tolerated injection well, sent home. Called the clinic around 4 pm that afternoon complaining of sore, swollen arm. Instructed to use ice to area and take pain reliever for the pain and call back in the am with an update. Patient presented to the clinic on 09/14/2017 with a red, swollen, warm painful arm from the injection. Patient was examined by out provider and instructed to use Benadryl and ice and elevation follow up in the am.
Minor rash at injection site, much better than the first dose. Some itching. I would like to add that one symptom I had with the second dose that I did not have with the first dose was pain in my lymph node on my left arm.
Neuropathy (tingling, burning, pins and needles) starting in heels, spread to entire foot - both feet. First at night, then intermittently throughout the day and night, sometimes in other areas of the body such as fingers, hands, lips.
Became real fussy since shots, cranky & moody; Was able to be comforted by being held; This persisted for 4 days; Seen by family MD & was found to be OK; no fever;
74-year-old female presents emergency room complaining of shortness of breath.  EMS reported that initial sats were 50% she was placed on a non-rebreather mask.  She subsequently was placed on BiPAP in the emergency room and her saturations actually decreased therefore she was placed back on a non-rebreather mask.  The patient continued to decline and ultimately required intubation after her initial blood gas revealed her to be extremely acidotic with a pH is 7.19 and pCO2 of 83.  Little is known about the patient's history otherwise I do not know if she has had any fever.  I have been told that the patient has been fully vaccinated for COVID.  She has had a COVID swab returned as positive tonight.  I am unaware of  exposures at this time.  She has other remarkable findings in the emergency room specifically a leukocytosis of 34,000 with left shift.  ProBNP is 11000.  Procalcitonin is elevated at 1.18.  The patient has a history of incarcerated diaphragmatic hernia in 2014.  On chest x-ray tonight it appears that she has stomach in her chest.  On the CT it also appears that she has hiatal hernia with part of the stomach in the chest also part of the colon in the chest through her diaphragmatic hernia.  Question of bowel obstruction is raised but no definitive answer is given on CT.  Patient also has a consolidation of the right upper lobe with possible mass.  CT also reveals bilateral findings consistent with COVID.  No PE.  The patient I believe has a cardiac history and has a history of heart failure with reduced ejection fraction.    DISCHARGE: Patient was a 74-year-old patient, who was admitted after arriving via EMS with respiratory distress.  Apparently, she had been sick for 2 weeks for shortness of breath.  She came to the ER, was emergently intubated with acute hypoxic hypercapnic respiratory failure.  The patient has multiple CTs done, one of the chest revealed a central mass with significant narrowing of the right upper lobe and right middle lobe pulmonary arteries, stenosis of the right upper lobe bronchus.  I thought she probably had a postobstructive pneumonia.  Also, of note, she has some patchy airspace disease, consistent with COVID-19 pneumonia.  The patient did test positive for COVID-19.  The patient was intubated, placed in ICU. Palliative Care was consulted and after discussion with family, it was decided to remove her from the ventilator given her diagnoses.  The patient was extubated and pronounced by Dr. at 05:39 p.m.
expired vaccine was given on 18Nov2021, as two second doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was given on 18Nov2021, as two second doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was given on 18Nov2021, as two second doses). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine was given on 18Nov2021, as two second doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.   Reporter did not allow further contact
Patient received 4 vaccines, 2 in each arm. Patient stood up to put on his jacket and was waiting on paperwork from nurse and fell backwards hitting head on the floor causing his glasses to fly off. Seizure activity noted for less than 30 sec. Knot noted to back of head, ice pk applied and vls. taken B/P=122/70 (R) arm, 58 pulse, 16 resp.
Pain in and around injection site x several days; itching at and around injection site x several days; tired x one week, improving as week progressed; mild stomach upset/abdominal discomfort x several days; unusual clear/milky vaginal discharge x several days
Pink patches developed on upper right arm; vaccinated on right arm. 2 patches were on the outside of right arm, the size of a small egg, and one large patch, on inner right bicep, about 60% of area. I, his brother/caregiver didn't notice until Sept. 08, 2016, when giving my brother a bath.
Both my arms started to swell up which kind of looked like a rash. My neck was red and I had some red marks on both my legs. I was itchy in all these spots.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information provided. no concomitant medications are provided.   This case was linked to MOD-2021-093054 (Patient Link).   Reporter did not allow further contact
101 fever; A spontaneous report was received from a certified nurse assistant concerning a 53 year- old, female patient who received Moderna's COVID-19 vaccine and experienced 101 fever.   There were no medical history and concomitant medications reported.  On 30 Dec 2020, approximately twenty-four hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient woke up with a 101 fever. Treatment for this event included ibuprofen.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, 101 fever was unknown.; Reporter's Comments: This case concerns a 53 year-old female patient, who experienced a non-serious expected event of Pyrexia. The event of Pyrexia occurred approximately one day after first dose of mRNA-1273, lot # 025J20A.  Treatment included ibuprofen. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Temperature greater than 105 degrees for 12 hours. Unconsolable for 12 hours.
Narrative:  Patient received three doses of COVID 19 vaccine (Feb/Mar 21 and Sep 21). The patient tested positive for COVID 19 on 14 October 2021 and was admitted with COVID pneumonia, sepsis, hyponatremia, hypokalemia, and respiratory failure. The patient was discharged on 23 Oct with some improvement, but was readmitted on 31 Oct 21 for long COVID pneumonia. Reported per EUA.
None at time of shot except tenderness in injection area and arm soreness. About 40 hours later, swelling of face (lips) and hands, high histamine.
This spontaneous report was received from a medical assistant referring to a 51 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB with lot # reported as M046376 and expiration date 04-NOV-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning RECOMBIVAX HB with lot # reported as M046376. On 11-MAY-2017 at 12:24, the time in the range 32° Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32° F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009217 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009217 is being deleted from our files and the case is consolidated into case # 1711USA003950 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Upon rising from the chair, the client fell backwards and complained of being dizzy and nauseous.  Client went very pale and allowed to lay on a cot for about 20 mins, given water to drink.  Vitals were all WNL  Temp. = 97.5, pulse = 65, bp = 105/62.  Client was fully recovered after 20 mins and left clinic area.
Information has been received from the pregnancy registry for GARDASIL from a nurse concerning an 18 year old female with pertinent medical history reported as none and no known drug reactions or allergies who on 17-APR-2007 was vaccinated with the first dose of GARDASIL (lot # 657621/0387U) 0.5ml, IM. The second dose of GARDASIL (lot # 657736/0389U0), 0.5 ml, IM was given on 15-JUN-2007. Concomitant therapy included prenatal vitamins (unspecified) and ferrous sulfate (unspecified). The third dose of GARDASIL (lot # 659055/1522U), 0.5 ml, IM was given on 26-DEC-2007. Subsequently the patient became pregnant. She sought medical attention via an office visit. Her last menstrual period was reported as 29-NOV-2007. Her estimated delivery date was 04-SEP-2008. No adverse event was reported. Follow-up information was received from a licensed practical nurse which reported that on 14-AUG-2008 the patient gave vaginal birth to a liveborn male weighing 5 lbs. 12.3 oz, APGAR= 9/10. She was 37 weeks from her last menstrual period. The infant was reported to be normal and there were no congenital anomalies of complications. On an unspecified date the baby developed jaundice. The baby was seen on 19-AUG-2008 at which time it was reported that the baby was feeding on demand. Laboratory values from 16-AUG-08 were all within normal limits and on 19-AUG the baby had gained 5 ounces and the jaundice had resolved. The baby was rechecked on 10-22-08 with no further mention of jaundice. Follow-up information was received from a licensed practical nurse which reported that on 14-AUG-2008 the patient gave birth to a liveborn male weighing 5 lbs. 12.3 oz, APGAR= 10/10 (previously reported as 9/10), length 19 inch. The infant was reported to be normal and there were no congenital anomalies or other complications. The patient's concomitant therapy included prenatal vitamins daily, TANDEM daily for low iron and globulin, RHOGAM at 28 week gestation. Additional information is not expected. The mother's AE has been captured in WAES # 0806USA02842B1B1.
Grandmother broke out with rash on 8/5/05 chest, arms, abd. after grandchild received varicella on 7/27/05. States are itchy. Denies fever, nausea on malaise. Her Dr Did not confirm. Varicella disease at this time.
Lymphadenopathy and mild rash. Patient had also received influenza vaccine on 10/23/18 and had some malaise.
itching, rash, hivey bumps, scratching on both legs from the knees down to ankles on the shin from on legs.  Once it got to the ankles it started spreading around the ankles and up the back of my legs.   tried creams and lotions.  washed legs with T-gel.  Finally called doctor in June 21.  Gave me clindamyacin and famotidine and ?.  Went back July 12, gave me clindamyacin again along with hydroxyzine and Clotrimazole and Betamethasone dipropionate.  deep oozing sores are gone.  looking better.  But skin looking very dry and flaky
THE INTENDED VACCINE WAS SHINGRIX.  THE ADMINISTERED VACCINE WAS COVID-19.  NO SYMPTOMS WERE EXPERIENCED AND NO TREATMENT WAS NECESSARY.
Pfizer-BioNTech COVID-19 Vaccine  Diaphoretic, SOB, Sudden Heat, BP 90/56, 98% O2 Room Air, HR 75 Pt states - likely due to anxiety from vaccine, will continue with 2nd dose in 21 days.
I felt dizzy light headed & had a horrible headache. I basically just laid in bed all day 7 had very bad muscle aches.
Pt passed out in vehicle after vaccine. Pt had excessive sweating and trembling. Said she felt lightheaded and dizzy. 20 post vaccine pt felt "normal" again.
6 maculo-papular erythematous lesions surrounding site of inj;no vesicles noted;eruption started 5-6 days p/shot given;
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Date the vial was initially stored in the refrigerator 08-NOV-2021.No concomitant medications are provided.No treatment medications are provided.