chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 4 was still feeling fatigue so took a nap 1.5 hour. Developed a fever (99.7F) around 6:30.; Yesterday around 1 pm I started feeling fatigued; Chilled, but no fever; My oxygen was 93-95, which is low for me usually 97-99.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 12Apr2021 at 13:30(at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic back pain, fibromyalgia, osteoarthritis, osteopenia, myofascial syndrome, high blood pressure, basal cell carcinoma, spinal stenosis and known allergies to ACE inhibitors. The patient previously took tramadol hydrochloride (ULTRAM) and prednisone (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cyclobenzaprine (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN); both for an unknown indication from unknown date and unknown if ongoing. On 19Apr2021 at 13:00, the patient experienced started feeling fatigued and chilled, but no fever around 13:00 and she went for a 2-minute walk around 14:30. Around 16:00, the patient still felt fatigue so took a nap 1.5 hour.  She developed a fever (99.7F) around at 18:30.  She took 2 Tylenol.  The patient oxygen was 93-95, which was low for her usually 97-99.  Fever and oxygen returned to normal by 22:00.  The patient went to bed as normal and woke up fine the next morning. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of fever, chills and included treatment with two paracetamol (TYNELOL) . On 19Apr2021, the patient had body temperature test and the result was 99.7 degrees Fahrenheit. On 19Apr2021, the patient underwent Oxygen saturation test and the result was 93-95 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 99.7 Fahrenheit and oxygen was 93-95, which was low for her usually 97-99 was recovered on 19Apr2021 at 22:00 whereas the events feeling fatigued and chilled on an unknown date at Apr2021.  No follow-up attempts are needed. No further information is expected.
Flu-like symptoms for two days.  Bad stomach cramps.   All joints ached.
No additional adverse events reported; MMRII was expired on 08-JAN-2022; This spontaneous report was received from a Medical Assistance referring to a 16 year old patient (patient's gender not reported). The patient's concurrent conditions and medical history were not reported.   On 25-JAN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (0.5 ml once, lot number T000889, which expired on 08-JAN-2022) for prophylaxis. Concomitant product included the sterile diluent used: (0.5 ml, lot number U013279, expiration date: 15-SEP-2023). There was no temperature excursion for the components administered. No adverse event was reported.
Temperature of 102, aches and pains, chills lasting from 7 pm through night.  Upon waking, some better but still hot.  Haven't taken temperature yet this morning, but can feel fever.  Aches and pains gone.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium
pt recv vax & 2 days later devel 2.5inch by 5 inch area of redness, warmth & swelling of rt arm;rxn extended from shoulder to elbow; A 40mm papule formed @ the site of vax;pt recovered;this is 1 of 4 pt from this site to devel inj site rxn
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Apr2023 at 10:00 as dose 5 (booster), single (Lot number: GJ2524), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Apr2021 at 10:00 as dose 1, single (Lot number: ER8732), in left arm, on 26Apr2021 at 12:00 as dose 2, single (Lot number: EW0167), in left arm, on 23Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 04Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient thought had "Rebound COVID" with runny nose, muscle aches, cough, lethargic 6 days after finished last dose of Paxlovid. Paxlovid did reduce initial symptoms 2 days after starting treatment though.
Syncopal event after flu vaccine. About 1 min after receiving shot, patient was standing & waiting for his mom to get her shot. He said "I don't feel well", took a few steps and fell to floor. Arms were flexed & stiff but no clonus. He soon started crying. Entire episode lasted about 1 minute. No incontinence or postictal-like phase.
Extreme fatigue for a couple of weeks; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue for a couple of weeks) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 014M20A) for COVID-19 vaccination.     Previously administered products included for Flu: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Food allergy (Onion), Food allergy (garlic), Food allergy (spices), Drug allergy (anastazole), Allergy to metals (pyridium), Non-Hodgkin's lymphoma (CLL-SLL x 7 years) and Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced FATIGUE (Extreme fatigue for a couple of weeks). At the time of the report, FATIGUE (Extreme fatigue for a couple of weeks) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2021, SARS-CoV-2 antibody test: negative negative (Negative) Sars Cov 2 serology ab IGG/IGM/ IA- negative.         Patient had similar symptoms when she had a flu shot. No concomitant information was reported. No treatment information was reported. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received and contains non-significant information(AE contact information).
Severe flu like symptoms, weakness, nausea, vomiting, muscle aches, dry throat, difficulty swallowing, 102 temperature
Approx 12 noon patient called to say she is experiencing "severe" neck pain radiating to head a few minutes after injection-advised ER assess as primary MD not available. 12:15 seen at ER. Pulse 103, BP 119/85, R 16. Also c/o lightheadedness, L arm discomfort. "Acute anxiety reaction. Mild reaction to H1N1".
I got a lump several weeks after taking the moderna shot at which time is was also feeling sick and the lump turned out to be cancer
Temp 103.9 to 105.0 on 4/10/03. Temp on 4/9/03 began of 103, fussy, mom gives Tylenol q 4 hrs, mom concern very fussy since 4/9/03. Child received 6 mos old shots on 4/8/03 of DTaP, HIb, Hep B and Prevnar.
Received 4 yr vaccines. Emesis after dinner. Went to sleep, woke screaming, said room was shaking & wanting to be held. Rhythmic jerking of both legs, respiratory rate 45/min. Sleepy. No pain. Total of 5 episodes between 3:30 & 5:30. History of febrile seizures. Pt knows when seizure coming on unsure if fever.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was severe sepsis with septic shock.
She was sent to emergency room Feb 2, 2021 by her PCP after calling him with headache, found elevated BP by school nurse, 163/95, vomited x3, left hand numbness but resolved upon arrival, decreased vision brief right visual disturbance. denies fever nasal congestion, sore throat, cough, chest pain. EKG NSR 95, head CT-no acute intracranial abnormality, UA and blood work completed
Chills, fever, skin sensitivity/pain when touched, nausea, diarrhea, migraines, no appetite, fatigue, cough on the first evening for a few hours.
Patient states that she developed a persistent rash on her breasts, stomach, back, legs, and arms.  The rash presented on the same day as the 1st Pfizer Covid vaccination within a couple hours after receiving the vaccination. It has not gone away. Patient states that it does not itch or hurt. I recommended that the patient contact their primary care physician.
Headache, Sedation, Myalgia, CoughWheeze, Chills, Swollen lymph nodes Narrative:  Other Relevant History:
Acute headache on right side of head and eye. Today after one week I still have severe headaches daily.
parents reported pt was 1 day late w/period on 28APR98;has had no period since;awaiting initial appointment w/OB=gyn MD;
Systemic: Dizziness / Lightheadness-Severe, Additional Details: The pt passed out for few minutes after recieving the vaccine, He indicated he was very lightheaded and nervous.
Patient had ER visit for anxiety and suicidal thoughts. Admitted to Inpatient Behavioral Health. This visit was within 6 weeks of receiving vaccine.
Pain at injection site, swelling, warmth, fever, muscle aches, headache, dizziness, nausea, difficulty breathing for 1/2 day.
This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received her booster dose as 0.5ml instead of 0.25ml) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Patient received her booster dose as 0.5ml instead of 0.25ml). At the time of the report, ACCIDENTAL OVERDOSE (Patient received her booster dose as 0.5ml instead of 0.25ml) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant product information was not provided.Treatment information was not provided.Most recent FOLLOW-UP information incorporated above includes:On 18-Nov-2021: Follow up received and contains No New Information.
Fine maculo-papular, pink blanching rash over left wrist and left knee, no swelling no erythema, no past abnormalities. Right shoulder area, erythematous patch.
Patients states 2 hours after receiving her initial dose on 9/29/2017, she began feeling a "tightness" or "discomfort" in her chest with some SOB. This lasted consistently and "started to go away" on Sunday 10/1/2017. She returned to the same hospital on 10/2/17 and received RABAVERT dose #2; lot number 564011A given IM in left deltoid. She stated again after 2 hours she felt the same symptoms.
Large local inflammatory reaction on arm of vaccine started on Day 9 after 1st dose of Moderna vaccine
swollen lymph nodes under each arm / armpit for several weeks.  tender/slight pain for at least 6 months after the shots.
Pt had not eaten today, stated that he is affraid of injections. Felt like he wanted to vomit, had nothing in his stomach, looked pale
Found down by mother at home while sleeping the next morning after well visit. Was dead on arrival to ER. Last known normal about 2-3 hours prior to being found unresponsive. Was reportedly found in unsafe sleeping position (co-sleeping with another caregiver with blanket covering the infant).
10 minutes after flu vaccination, experienced throat tightness, coughing, and difficulty breathing. Treated in the ER at facility where she was working.
Patient's eyes burned immediately and shortly thereafter developed a sore throat, coughing, and nasal discharge.  Early a.m. on 11-11-05, the day following vaccine, patient noticed she was severely hoarse and is still completely hoarse today 11-15-05.
Vaccine was administered to a patient subcutaneously and not intramuscularly; A spontaneous report was received from a pharmacist concerning a patient, of an unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine was administered to the patient subcutaneously and not intramuscularly.  The patient's medical history and concomitant medications were not provided by the reporter.  On 11 Mar 2021, the patient received their planned doses of mRNA-1273 (Lot number: unknown) subcutaneously for prophylaxis of COVID-19 infection.  The event was categorized as a medication error and the anatomical location of vaccine administration was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of event, vaccine administered subcutaneously and not intramuscularly, was considered resolved on 11 Mar 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.
Fever 101.7 3-14-13, headache, muscle pain, bruise/redness on injection site.
Headache, Arthralgia, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE,  BODY ACHE Narrative:
about 25min p/vax pt noticed trouble swallowing a little SOB 7 a mild h/a about the temples;BP 132/72, T99.9, P96;pulse ox 98 peak flow 520;
1st dose of Shingrix and broke out.; This case was reported by a consumer via interactive digital media and described the occurrence of skin breakout in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin breakout. On an unknown date, the outcome of the skin breakout was unknown.   It was unknown if the reporter considered the skin breakout to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient received the dose of Shingrix and broke out.
After 2nd dose fatigue for 2 weeks; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (01Mar2021), this case now contains all required information to be considered valid.    This is a spontaneous report from a contactable consumer (patient).  A 70-year-old male patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 on 06Jan2021.He reported they told him to go back on 03Feb2021. He got his first shot 06Jan2021 and it's more than 21 days. After 2nd dose fatigue, the patient experienced fatigue for 2 weeks. He did not received treatment for the event and was not admitted to hospitalization for this event. The outcome of the event was recovered on an unspecified date.  Information about lot/batch number has been requested.
BLACKING OUT; LIGHT HEADEDNESS; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 in APR-2021, and concurrent conditions included: celiac disease, and gluten allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: Unknown) dose was not reported, 1 total,  administered on left arm on 03-DEC-2021 for prophylactic vaccination (dose number series is 1). No concomitant medications were reported.  On 03-DEC-2021, after the injection, the patient experienced light headedness. On 04-DEC-2021, in the morning while in kitchen, the patient started to black out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blacking out, and light headedness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211212231-covid-19 vaccine ad26.cov2.s- Blacking out. This event(s) is considered unassessable. The event(s) has a compatible/ suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Insomnia that night. Very significant swelling of left upper arm. This spread to the left forearm a couple of days later. Fever on 1st night. Passed out on 11/29/2001 in AM for a few minutes.
Initially severe shivering initiated suddenly and without prior symptoms about 12 hours after injection; severe episode lasting about 1.5 hours then tapered off slowly; general malaise, lethargy and difficulty focusing; area around injection site very sore and touch sensitive; slight swelling and tingling of hand on injection (left) arm. Next morning (24 hours after injection) I noticed a marked decrease in smell and taste senses but that resolved over the subsequent day.  All symptoms resolved within 48 hours after injection;
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No Concomitant medication was reported. Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No patient information or product information available. Consent provided for safety follow-up. No treatment medication was reported.
Had pain and soreness in both arms and back beginning 2 days after the shot.  Took Advil to relieve pain which gradually got better until was gone 3 weeks after shot.
Pain, redness & swelling in Rt. deltoid. Went to ER on 4/13/13 due to pain. Given pain meds there. Has been icing and taking Ibuprofen since.
Nausea, body aches, pain at injection site, fever and headache. Just in general sever flu symptoms.
Pt recvd vax 10AUG92 & approx 2 1/2 hrs following vax pt devel swelling in rt eyelid; 1 hr later devel swelling in lt eyelid & face, itching, SOB, fine rash; pt seen in ER & treated w/adrenalin, DPH, & oxygen; 11AUG92 devel hives;
Acute Erythema Multiforme; This literature-non-study case was reported in a literature article and describes the occurrence of ERYTHEMA MULTIFORME (Acute Erythema Multiforme) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.       No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA MULTIFORME (Acute Erythema Multiforme) (seriousness criterion medically significant). At the time of the report, ERYTHEMA MULTIFORME (Acute Erythema Multiforme) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient had not experienced any adverse reactions with first two doses. The diagnosis was made clinically, and the patient course was followed for 8 weeks without complete resolution.  Company Comment: This is a literature non-study case concerning a 39-year-old, of unknown gender patient with no reported medical history, who experienced the serious (due to medically significant) expected AESI ERYTHEMA MULTIFORME. The event occurred 10 days after receiving the third dose of mRNA-1273 vaccine. It was reported that the patient had not experienced any adverse reactions with first two doses. The diagnosis was made clinically, and the patient course was followed for 8 weeks without complete resolution. The outcome of the event was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
mom stated elevated temp of 103 for several days-mom did not bring pt back for evaluation;
Moderna COVID-19 Vaccine EUA: Case of COVID-19 that resulted in Hospitalization post vaccination. Patient received Moderna COVID Vaccinations on January 14, and February 11, 2021. On May 17th patient requested a Telemedicine visit for chest congestion, painful cough, tightness in chest since May 14th - diagnosed with acute bronchitis and provided prescriptions for prednisone BID, Doxycycline BID, and Benzonatate  Q6H prn cough. On May 18th the patient presented to the ED for evaluation of confusion upon waking. Upon arrival patient was febrile (102), CRP was 224. Evaluation was significant for acute respiratory failure with hypoxia secondary to COVID pneumonia. CT scan demonstrated multifocal  pneumonia consistent with COVID. He was started on 2L oxygen via NC, dextamethasone, remdesivir (2 doses given), & Duo Neb treatments. He initially did well on 2L. On the 20th, he began to decompensate. He went from 2L to Airvo 55L 70% at 11am. Procalcitonin went from 0.26 to 0.96. Ceftriaxone & doxycycline was initiated. He maintained saturations on the Airvo, & was even weaned down to 55%. On May 21st, he has decompensated further, with saturations quickly dropping to the upper 80's with minimal activity. RR has been 28-32. Airvo settings were increased to 60L/95%. Saturations are now 88-93%. ABG was 7.45-38-60-27-92%. He was given an additional IV dextamethasone. Patient will be transferred to Medical center for a higher level of care. Patient was treated with tocilizumab on May 21st.