chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with body aches and soreness followed by chills in the evening. Woke up around 2 AM with fever of 102.5. Took Advil and water but fever kept rising to 103.5 by morning. Called DR, went in, he put me on Tylenol and a five day course of Prednisone. Arm remained red and sore from elbow to shoulder for 5-6 days.  Still somewhat stiff today.
pt recv vax; 7mar95, broke out w/ hives;genl on trunk,back,legs;to MD;on antihistamine,seldane;cleared up in 4 days;rash reoccurred;cleared up later in 3 days;
16 year old got vaccinated with both doses of Moderna; Product administered to patient of inappropriate age; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got vaccinated with both doses of Moderna) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got vaccinated with both doses of Moderna) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got vaccinated with both doses of Moderna) had resolved and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant products was reported.  No treatment information was reported.  No lab data information was reported. Action taken in response to mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up document was attached on 01JUNE2021. No other new information was reported.; 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.
Bloodshot left eye for four days before contacting the doctors office. Doctor diagnosed left eye as episcleritis and prescribed Ketorolac drops and Predinisolone drops 4x's daily for 14 days. Redness of the eye resolved within that timespan.
Muscular pain, more than just aches.  It was as if all of the muscles in my legs had shortened.  It wasn't like a sudden cramp that just went away after a few minutes. Nothing I did seemed to help, walking around, stretching,.  It got progressively worse.  This started around 9 pm.  I took three (200 mg) ibuprofen at about 10:30  p.m.. That didn't help much, unable to lay down and sleep,  too uncomfortable in any position. . Finally around midnight I took a muscle relaxant, and that  worked. When I woke up this morning, I felt fine.  No muscle pain or aches.
Redness near injection site that traveled to L chest and down L arm stopping at the elbow.
In a lot of pain currently; Vomited this morning; After receiving the second booster dose he had 2 bad fevers that finally broke; Back issues; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (In a lot of pain currently), MUSCULOSKELETAL DISCOMFORT (Back issues), CHILLS (Chills), VOMITING (Vomited this morning) and PYREXIA (After receiving the second booster dose he had 2 bad fevers that finally broke) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 024C21A, 045H21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2022, the patient experienced MUSCULOSKELETAL DISCOMFORT (Back issues), CHILLS (Chills) and PYREXIA (After receiving the second booster dose he had 2 bad fevers that finally broke). On 29-Apr-2022, the patient experienced PAIN (In a lot of pain currently) and VOMITING (Vomited this morning). The patient was treated with IBUPROFEN on 28-Apr-2022 at an unspecified dose and frequency and PARACETAMOL (TYLENOL) on 28-Apr-2022 at an unspecified dose and frequency. In April 2022, PYREXIA (After receiving the second booster dose he had 2 bad fevers that finally broke) had resolved. At the time of the report, PAIN (In a lot of pain currently) had not resolved and MUSCULOSKELETAL DISCOMFORT (Back issues), CHILLS (Chills) and VOMITING (Vomited this morning) outcome was unknown.            Concomitant medication list was not provided. The patient received the second booster dose on 28-Apr-2022. As per the narrative, the patient was in a lot of pain and vomited on 29-Apr-2022, the next day after the second booster dose.   This case was linked to MOD-2022-554854, MOD-2022-554862, MOD-2022-554863 (Patient Link).
Patient with 2 Pfizer COVID vaccinations, last dose 05/15/21 who admitted with COVID complications.  Provider discharge summary below:  "Patient came in with Acute respiratory failure secondary to COVID.  She had symptoms for 10 days already.  Procal as well as CTA was negative for a PE and secondary pneumonia.  Patient was given remdesivir as well as decadron with some improvement.  She continued to require a little oxygen with activity.  She was given vitamins as well as zinc.  The decadron increased her BS so she needed higher doses of lantus and humalog.  Patient was on lantus already.  She wasn't well controlled prior to the steroids.  Humalog was added.  She was given instructions on adjusting her Insulin at home.  The patient continued to be weak but clinically stable so was discharged home.  She has follow up with her PCP.  She should take an aspirin a day for a few weeks to decrease risk of thromboembolism  She is encouraged to do deep breathing exorcizes."
fever 102.7; myalgia; fatigue; This is a spontaneous report from a non-contactable physician.   A patient of unspecified age and gender started received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on an unspecified date single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever 102.7 after 24 hours, and myalgia, fatigue both on an unspecified date. The events outcome was recovered.   No follow-up attempts are possible; information on lot/batch number cannot be obtained.
disorientated; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disorientated) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Previously administered products included for an unreported indication: ASPIRIN (E.C.).    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 DISORIENTATION (disorientated). At the time of the report, DISORIENTATION (disorientated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. Concomitant information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Additional information include no new information.
Information has been received on 12-OCT-2016 and from a certified medical assistant referring to 2 patients of unknown age and gender. The patients' medical history and concomitant therapy were not reported. On 12-OCT-2016, two patients were vaccinated with ROTATEQ lot # M019707, expiration 25-OCT-2016, (dose and route not reported). The patients experienced lip swelling with redness around the mouth on 12-OCT-2016 immediately following the administration of ROTATEQ. The primary reporter stated that the two patients were also administered other vaccines during the vaccination session on 12-OCT-2016, however, the reaction occurred following the ROTATEQ and not following the administration of PEDVAXHIB, PREVNAR 13 and PEDIARIX on 12-OCT-2016. The primary reporter stated that the two patients were then observed in the office for 15 to 20 minutes and the symptoms that consisted of lip swelling with redness around the mouth resolved without treatment on 12-OCT-2016. No further information was provided. Additional information has been received on 18-OCT-2016 from a nurse. The primary reporter is requesting a Lot check concerning ROTATEQ lot # M019707, expiration 25-OCT-2016. No further information was provided. Additional information has been requested.
body aches, chills, fever, abdominal cramps, nausea and vomiting
per death certificate, pt died at home of COVID and ARF; doctor who signed death certificate states he does not have any records pertaining to COVID 19
pt recv vax 1215PM on 22AUG94; 430PM same day went limp & pale; did not stop breathing or have convuls; MD visit-BP 80/50, Blood Glucose 120, fever 101.6, pale & soreness @ Tetramune inj site; dx hypotensive episode lasting 5 mins;
Injection site pain days 1 & 2, dizzy days 2 &6, fatigue day 4 Narrative:
Develop extreme body aches to the point of crying due to extreme pain all over, fever of 101.5, and hallucinations. Develop strange sensation of internal heat coming out from the eyes, mouth, nose, ears; but also had an external sensation of cold. Extreme shivering. Also had a headache but that was mild. Felt really thirsty but even drinking water was painful. Heard noise in my head and talk gibberish.
I gave a first dose of the Pfizer vaccine to a patient this morning and about 5 minutes after I gave it to him, he was feeling light headed and having blurry vision. I got him a water and he asked to lay down. He never passed out and his symptoms cleared in 10 minutes. I continued to monitor him for another 15-20 minutes. He was able to get ahold of his wife to let her know he was not feeling well. After 30 minutes, he was felt comfortable leaving and all of his symptoms were cleared. I checked back in with him several hours later and he is feeling better and not having any more symptoms.
Pt returned to STD clinic, appeared anxious, stating upper lip "quivering" at times. NP examined pt, noted upper lip intermittent twitching. Gave Benadryl 50mg oral dose. Sx subsided. Pt given instructions to take Benadryl 25mg orally every 6 hours for 24 hours. Sx resolved.
24 hours later, at about 2:00 PM,  I began to run a fever which reached 102 by about 6:00 PM.  It began to subside about 10:00 PM and temperature was normal the next day. Five days after the injection a raised red rash with some itchiness, developed around the injection site.  It's almost gone now, the next day.  I have some mild itchiness persisting and I have some random, infrequent pin prick sensations on some recurrent sites of my body.
The patient experienced fever, blisters (multiple vesicular lesions) on his hand, trunk and scalp.
STOMACH CRAMPS; BODY ACHES; HEART RATE HIGH; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced stomach cramps. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced heart rate high. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Laboratory data included: Heart rate (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, stomach cramps, body aches, nausea and heart rate high was not reported. This report was non-serious.
Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; This non-serious spontaneous safety report with reference number 02125895 was received by a partner on 10-MAR-2022 and forwarded to Agency on 14-MAR-2022 from a health care professional.  The causal relationship between Vaxelis and the reported event of "On 10-Feb-2022, patient was administered both improperly stored ROTATEQ, and improperly stored VAXELIS (product temperature excursion happened on 05-Feb-2022)" is assessed as not applicable due to the nature of the event.  Further information is expected.
Moderna COVID-19 Vaccine EUA seven days after my injection I had a large four in circle with itchy rash and soreness  around the injection area. I understand it?s called Covid arm and I?ve been putting  Benadryl gel to decrease the itching.
Pt. was sitting in the waiting area, as she had been asked to do after getting her shot.  She C/O not being able to see well.  She turned pale, her eyes rolled back, she stiffened and her arms flexed, hands drew into fists, hands shook quickly 2-3 times.  She relaxed, and her eyes opened.  We laid her on a cot with her feet elevated.  When she started to get some color in her face and responded well, she was given a glass of fruit drink through a straw.  She left with her mother, when she felt better.  Her mother was called later in the day.  She reported that pt. was "doing fine".  She further said that when they got home, pt. said, "Wow, I don't even feel wierd or anything."
approx 1 hr p/inject pt devel fever 102, h/a, dizziness, nausea;
Fever and chills with nausea reportedly started around 5:45pm on March 12, 2021. Ibuprofen taken that night around 8pm which seemed to help the chills and fever. Hives developed around 8pm March 13, 2021. Hives have continued into March 15, 2021.
Patient received Pediarix on 07/13/2005. Baby became febrile during the night as high as 104 degrees.  He became extremely irritable and had bulging fontanel by AM 07/14/2005.  Baby examined at office and sent immediately to Emergency Room for LP tap.  No signs of meningitis. Baby continues to be monitored.
Vaccinees rec'd (deltoid) a 3 dose series of Engerix-B and/or "Recomivax." 21% ("approximately 17 employees") were non-responders; re-vaccination planned;
Extreme left arm pain; This is a spontaneous report from a contactable consumer. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Mar2021, at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient did not have  any known allergies. It was unknown if the patient received any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021, at 09:30, the patient experienced extreme left arm pain. It was reported that the patient nearly went to emergency room secondary to the extent of pain. The event did not result in a visit to the doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme left arm pain was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Exhaustion, chills, body aches, headache - no stomach issues. Lasted all day, the day after the vaccine. Symptoms gone the following day, except for some tiredness.
edema & redness of rt arm from the elbow to deltoid the next day p/vax;tx cephalexin;
Dizziness - lasted 2-3 hours. Body aches with feeling of fever but normal body temperature - lasted 12 hours. Pain at injection site - lasted 3 days.
I had a runny nose and a cough but I did not have any fever. I contacted my doctor who prescribed Paxlovid for me.
FEW MINUTES AFTER RECEIVING THE VACCINES, THE PATIENT FAINT FOR SEVERAL MINUTES. STARTED SHAKING AND PRESENTED DIFFICULT BREATHING. SHE WAS EVALUATED BY DRA., WHO ORDERED 09 NSS AND OXYGEN, AND OBSERVATION.  PATIENT RECOVERED AND MD ORDERED CBC AND CHEMISTRY.
Chills, fever, body soreness, excessive urination, unable to sleep for longer than a few hours, all appeared hours after vaccine administration and were lessened but not resolved by the next morning.
Patient Name: Date: 2/24/21 Vaccine:Moderna  The response was to which dose?First  Approximately how long after the administration the reaction started? 23min  Major signs and symptoms: ill-appearing with drooped posture, tingling lips, throat hives  Medication(s) given: 50mg PO Benadryl  Vitals: 11:35pm HR99, O2 98% 11:37pm BP 128/107, HR78, RR18. 50mg PO Benadryl given 11:41pm lungs clear to auscultation. O2 98%, BP 126/79, HR79 11:46pm 120/73, HR72, O2 sat 98%, RR16. Hives visibly improving, tingling of lips resolving.  11:52pm 127/78, RR16, HR76, O2 99% 11:57pm good affect, hives/tingling nearly fully resolved.   Other Interventions: water   Outcome: Patient discharged with mother to home.
tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, 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 experienced FATIGUE (tiredness). At the time of the report, FATIGUE (tiredness) outcome was unknown.            Upon internal review on 04-Aug-2021, the age was corrected to 65 years.
This is a spontaneous report from a contactable physician communicated to a sales representative for two patients, this case is for the second patient. A female patient in her 80's of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at 0.5ml single dose in arm on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received PNEUMOVAX over one year before. The patient experienced arthus with redness of upper arm 3-4 days later on an unspecified date with outcome of unknown. Sender's Comments: The events arthus with redness cannot be excluded due to the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate. Linked Report(s): US-PFIZER INC-2017188145 same reporter drug event different patient.
cold sweats; a red hot spot the size of a golf ball appeared over the injection site; This is a spontaneous report from a contactable consumer (the patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 31Mar2021, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. It was stated that (tonight, as reported) on 08Apr2021, the patient experienced a red hot spot the size of a golf ball appeared over the injection site and cold sweats. The outcome of the events was unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
NORMAL REACTION; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced normal reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of normal reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20210854866.
muscle/body ache, bad headache, pain, redness, and swelling at injection site approximately the size of a grapefruit, nauseated, neck swelling.
pt recvd vax & lab eval in AUG89 revealed neg rubella titer & was vaxed w/rubella vax live; pt devel acute arthropathy;
This case was reported by a healthcare professional and described the occurrence of red spot at injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (.5 ml, unknown route and site). At an unspecified time after vaccination with FLULAVAL, the subject experienced red spot at injection site and itching. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 5 out of 70 subjects who received FLULAVAL experienced the events as noted. The facility used a single dose syringe vaccine last year and did not have any complaints of this nature. This is case 2 of 5 (see case IDs A0885547A, A0885965A - A0885967A for the other reports).
On Jan 22  I had fever, body aches and headache. Woke up on Jan23 and felt fine, no symptoms.  At around 2:30 on Jan 23 I had an argument with someone and felt my heart race for a minute and then chest pain radiating to my back. Went to the hospital at 7pm and was being ruled out for an MI.
Sudden onset of syncope and fall with finding of subarachnoid hemorrhage and subdural hematoma without significant head trauma found, findings inconclusive for reason of the syncope. Negative CTA head and neck.
A nurse reported that a 45 year old female received the Flu Shield on 10/13/99 and subsequently developed a low grade fever and an injection site reaction characterized by swelling, redness and itching. On 10/15/99, the pt was seen by the physician. Additional information received 11/11/99 from the physician indicated that as of 11/5/99, the pt's symptoms resolved, however, she subsequently developed a lump the size of a pea at the injection site.