chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Temperature of 101.3; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Temperature of 101.3) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (Body aches), PYREXIA (Temperature of 101.3) and HEADACHE (Headache). At the time of the report, PAIN (Body aches), PYREXIA (Temperature of 101.3) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (Inconclusive) temperature of 101.3.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications were not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-022474, US-MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested US-MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018102) US-MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018102)
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 23-JUN-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2014) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. Addtional information has been requested.
NUMBNESS IN LEFT CHECK ON HIS FACE  RESOLVED AFTER 5 TO 10 MINUTES PATIENT OBSERVED FOR 30 MINUTES NO RESPIRATORY OR AIRWAY SYMPTOMS
SHORTNESS OF BREATH      PT bibm c/o sob, per medics new afib rvr with elevated respirations and low et02 and bp. patient had a recent covid vaccine last week.  Chest x-ray is normal but her BNP is elevated which may be related to her underlying ischemia
09/01/2021 I had a sore throat and a headache and body ache, I took an Advil and went to sleep for 5 hours. I had a fever fever of 102.8 for 4 days.
In the morning I woke up having trouble breathing like I had an asthma attack. I had a fever between 103 and 104 degrees. I waited till morning and called urgent care. On 10/20/2021 I went to the urgent care closest to my house. I was given a steroid shot there and steroids to take home. I was also prescribed an inhaler. Doctors seen inflammation in my lungs. It took about a month for the inflammation in my lungs to come down. It flares up occasionally and has settled down now. I missed work for 2 days. The fever had came down by the end of Sunday. I did get exposed to forest fire smoke on the Thursday before the vaccine. My doctor thought the vaccine may have activated my asthma. My asthma was managed before receiving the vaccine, and I rarely ever had any asthma attacks. I do still get short of breath when exercising or doing physical activities.
This spontaneous report was received from a 65-year-old female patient referring to herself. No medical history, concurrent conditions, concomitant medications or past drugs were reported. On 12-MAR-2018, the patient was vaccinated with a dose of PNEUMOVAX 23, via intramuscular route (exact dose, lot# and expiry date were not reported) as a vaccine for pneumonia. On 15-MAR-2018, the patient experienced high blood pressure and was diagnosed with pink eye. The patient received Lisinopril (manufacturer unknown) as a treatment for high blood pressure. No treatment was given for pink eye. Diagnostic and laboratory tests were not provided. The outcome of both events was reported as not recovered. The causality assessment between the events and PNEUMOVAX was not provided.
At approx 13:45 client was given immunization with in about 20-25 min clients face was red and swollen with welts and indurated covered her entire buttocks down her legs all the way down, face was also covered. No SOB.
Woke up morning after vaccination with large erythema area at injection site. (+) itch-measure 10 cm x 10 cm erythema with center wheal measure 40mm in diameter Rx Benadryl by mouth every 6 hours x 48 hr for prn; cool compress on site 250/5 4ml by mouth every day x 10 days.
Information has been received from a nurse concerning a 10 year old female with an allergy to Vantin who on 11-MAY-1999 was vaccinated with a dose varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed a rash 2 weeks after vaccination, on approximately 24 MAY 1999. The nurse did not see the rash but the patient's mother said the rash was like chicken pox like sores and itchy. Medical attention was sought. The patient recovered on an unspecified date. No product quality complaint was involved. No further information is available.
Upset stomach; Headache; Fatigue; Sleepiness; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Sleepiness), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Headache) and FATIGUE (Fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine, Pfizer vaccine (Patient received 3 doses of Pfizer vaccine) and Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 20-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022, the patient experienced SOMNOLENCE (Sleepiness), HEADACHE (Headache) and FATIGUE (Fatigue). On 21-May-2022, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleepiness), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.            No relevant concomitant medications were reported. It was reported that, 3-3.5 hours after receiving a booster dose of the vaccine patient started to experience fatigue, sleepiness, and headache. The next day he had an upset stomach, and his fatigue started to become more off and on. His symptoms have continued nonstop ever since.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Flu trivalent vaccine for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, between 1 and 3 months after receiving Flu trivalent vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, Guillain Barre syndrome (serious criteria GSK medically significant), tingling of extremity and neurological symptom. Flu trivalent vaccine was discontinued. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza, Guillain Barre syndrome, tingling of extremity and neurological symptom were recovered/resolved. It was unknown if the reporter considered the vaccination failure, influenza, Guillain Barre syndrome, tingling of extremity and neurological symptom to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. In October approximately 20 years before the date of reporting, the patient stated that she received a flu vaccine (unknown manufacturer). In December, between 1 and 3 months after receiving the flu vaccine (unknown manufacturer), the patient developed the flu. The patient stated that shortly after the flu resolved, she started having neurological symptoms such as tingling in her arm and trouble moving her fingers on the computer. These symptoms started in January of the following year (3 months after receiving the flu vaccine). The patient stated that she saw a neurologist and the neurologist informed her that she might have a mild case of Guillain Barre Syndrome. The neurological symptoms and Guillain Barre Syndrome resolved 3 to 4 months later. The patient stated that she no longer got the flu vaccine. The patient had denied permission to contact their physician. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule and lab test confirmation for targeted disease was unknown.
tired first thing in morning; first shot--arthritis felt kind of better, which was odd; First shot--arthritis symptoms came back; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient reported for herself she received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3246, NDC number and Expiry date: unknown) via an unspecified route of administration, administered to left shoulder area/ bicep/ tricep area (as reported) on 20Jan2021 (patient age at time of vaccination was 59 years) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history includes thyroid issues and taking medicines for that and regular vitamins and concomitant medication were not reported. The patient didn't know if Pfizer if recording positive effects of the Covid vaccine, but patient wanted to report that. The patient first shot a couple weeks ago and right afterwards was like "wow", on 21Jan2021, her arthritis feels kind of better, which was odd. This lasted about 3-4 days and she felt pretty good. Wonders if the Covid shot had anything to do with it. Then the arthritis symptoms came back on an unspecified date in Jan2021, with the first dose the arthritis was better she noticed the day afterwards. Then they came back probably around the 25th or 26th of Jan2021 and she wanted to see if it came on the second shot. Pfizer maybe onto something for people with arthritis. This would pretty much be undocumented trial with the effects from it. Had no other effects. Outcome of the event arthritis was not recovered, and other events were unknown.  Follow-up attempts completed. No further information expected.
Severe abdominal pain and congestion,  chills, lower extremity tingling, constipation, burping. approximately 3-4 weeks post Johnson and Johnson vaccination.  Taken to ER at hospital.
Patient reports experiencing tremors from vaccine. Tremors were not seen or observed on subsequent office visit and physical exam but patient described it as being significant and requested it to be reported.
headache; fever 102.7; Chills; vomiting; arm pain; body aches; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular on 18Dec2020 15:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma and diagnosed with COVID-19 prior to vaccination. Patient has unspecified allergies. Unspecified concomitant medication were taken (List of any other medications the patient received within 2 weeks of vaccination: Yes). The patient experienced fever 102.7, Chills, vomiting, arm pain body aches and headache on 19Dec2020 03:00. No treatment received for the events. The outcome of the events was recovered with sequelae (Recovered with lasting effects). The events were considered as non-serious. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular on 08Jan2021 at a single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date.
itchy hives-round blotches on stomach & back, some under arm pits & behind knees was given DPH s/@ noc when sleeping until Tuesday 15APR97;
Patient experienced rash 2 days after ZOSTAVAX vaccine given. Rash went down her left arm & appeared on right arm, abdomen & back as itchy areas. Patient was treated by her Dr with a MEDROL dose pak on 12/20/11.
Injection 11/10/2006 received a tetanus and diphtheria booster.  2 weeks later complained of pain at site. no treatment.
This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a physician concerning a 13 years old premenarchal female student with no drug allergies, "constitutional growth delay", bumpy/itchy rash on anterior chest wall after showering (that resolved after drying self), and warts on an unspecified date, was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. Subsequently, on an unspecified date, the patient felt dizzy and fainted. It was noted that the patient received at least one other vaccine on the same date as when Gardasil was administered. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The patient recovered on the same day as when the injection was given. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
pain in my arm like shooting pain; nausea; 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 (pain in my arm like shooting pain) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    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 PAIN IN EXTREMITY (pain in my arm like shooting pain) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (pain in my arm like shooting pain) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Headache, Myalgia, Arthralgia & Fever Narrative:  In the evening after receiving the vaccine, the patient reported experiencing a head ache, body aches, and pain at the injection site. He also reported a fever of 101.9 (F). He took one dose each of ibuprofen 400mg and acetaminophen 1000mg.  Other Relevant History:
Presented with SOB, cough, fever x5 days; tested Covid-19 + PTA at PCP office; admit with Covid-19 PNA; TX with steroids, vitamin C, Maxipime, doxycycline, Zinc, and supplemental low dose O2. Patient overall improved, inflammatory markers improved, oxygen requirements improved. Patient is currently on 2 L oxygen which is almost close to his baseline, patient is feeling significantly improved, comfortable in going home, patient is discharged with dexamethasone, doxycycline for the next 5 days.
Case number PHEH2014US024346, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to a 78 year old female patient. Past medical history and concomitant medication were not reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
I started feeling tired with flu-like symptoms the afternoon after I had Moderna vaccine , first dose. I went to bed and tried to rest to improve symptoms.  Later, I noticed my heart was skipping beats and causing a fluttering feeling in my chest at times.  I later visited a Cardiologist, for a heart evaluation., and I reported to him that the irregular heart beats started after the Moderna vaccine first dose.    My cardiac  stress test was abnormal and he offered medication, but said as long as my symptoms were mild at this point, I would have to weigh the side effects of heart medication, against tolerating mild skips in my heart.  I chose to exercise more, and try to improve my health naturally, rather than start on heart medication that can cause side effects.
mistakenly received DAPTACEL in the office on 26AUG2021 instead of ADACEL (with no reported adverse event); Initial information received on 26-Aug-2021 regarding an unsolicited valid  non-serious case from a other health professional and consumer/non healthcare professional via Medical Information (under reference number 00741869).  This case involves an 11 years old female patient who mistakenly received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Prophylactic vaccination; and HPV VACCINE (HPV VACCINE) for Prophylactic vaccination.  On 26-Aug-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5774AA, expiry date- 18-Sep-2022 via intramuscular route in the right deltoid for Prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  It was a case of an actual medication error due to wrong product administered (latency same day)  It was reported, Caller asked what they needed to do at this point. Caller asked to receive information related to this occurrence.  At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I discontinued Xeljanz the day of the vaccine per recommendation from rheumatology websites and stayed off for one week to ensure that my immune system would work properly for the vaccine.  I had intense muscle pain in the left arm that was injected that evening and the muscle soreness spread to my whole body the next day, lasting 5 days.  I also began having more intense pain in my lower back, which I believed was related to my psoriatic arthritis, but it continue to worsen.  It brought on a full pain crisis episode of inflammation, causing intense nerve pain at an intensity of 10/10.  I contacted my rheumatologist who prescribed prednisone to bring down the inflammation, though I am still in pain 3 weeks above my normal pain level prior to getting the COVID vaccine.   I also have skin lesions or marks on my left arm near the injection site that have not yet cleared.
Lump at injection site, pain 2/5/18 - swelling in arm 2/6/18, given in (L) arm.
03/05/2021: Arm soreness (mild), itch, slight redness. 03/06/2021: raised temperature at injection site, raised "knot" at injection site, blood sugar increase to over 200, swollen lymph nodes to the armpit of inoculated arm
Patient presented to the pharmacy on 6/27/19 for his second and final dose of his shingles vaccine. Prior to administration of the second dose, the pharmacist questioned how the patient did with the first dose of Shingrix on 3/9/19. The patient mentioned that his arm had swelled down past his elbow and became very red, itchy, and warm to the touch. He stated the symptoms only lasted about 3-5 days and that he medicated with Tylenol during this time which seemed to help. As the patient was being prepped with an alcohol swab on his deltoid muscle, he mentioned that he had not received his first dose in that part of his arm, rather the pharmacist had given it to him in the back, lower part of his arm, indicative of a subcutaneous injection. After contacting our supervisor, it was determined that the first dose, although administered incorrectly, was still effective. After further discussion of the reaction, the patient decided he still wanted to continue with his second dose. A follow up phone call was made 7/12/19 for second dose. Patient did better with this dose in terms of injection site reaction, mild muscle pain for 3-5 days. He experienced more flu-like symptoms with the second dose and medicated with Tylenol. Patient is doing well at this time.
Immediately felt abnormal. Later, left hip pain, feeling bad, sleeplessness, headache all night (severe), feeling hot and cold, difficulty walking, chills, shaking, hot flashes, painful left arm, teeth chattering, fatigue
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On 19-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (dose: 0.5 ml, subcutaneous, lot#, expiration date, anatomical location not reported) that had been exposed to a temperature of 10 degrees Fahrenheit (F) for possibly 15 hours. Concomitant medications were not reported. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
03/13/2021: The patient was admitted after she suffered fracture of the right lower leg as a result of fall attributed to an episode of vertigo. The patient required surgical intervention for her right lower leg. Multiple thyroid nodules with associated calcification reported in CT imaging studies of the brain and cervical spine during this hospitalization.  Review of the patient's record confirms that the nodules were previously reported in thyroid ultrasound studies in 10/2013 and 05/2011.
He had a fever and felt bad the day after the vaccine and then had a rash come up and was diagnosed with Shingles.
Patient was inadvertently immunized earlier then recommended at 22 days instead of the recommended 28
Rash, bruising, throbbing pain, unable to lay on side, unable to put clothes on without arm hurting, clindamycin 300mg 3x's day, steroid injection, Medrol pack, on second round of Medrol pack.