chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First dose was on 15-Apr-2021 and second on 31-May-2021; body aches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), PYREXIA (low grade fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was on 15-Apr-2021 and second on 31-May-2021) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was on 15-Apr-2021 and second on 31-May-2021). On an unknown date, the patient experienced MYALGIA (body aches) and PYREXIA (low grade fever). On 31-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was on 15-Apr-2021 and second on 31-May-2021) had resolved. At the time of the report, MYALGIA (body aches) and PYREXIA (low grade fever) had resolved.            Concomitant medication details were not reported by the reporter.  Patient took treatment drug as Antihistamines daily.   This case was linked to MOD-2021-435507, MOD-2021-435537 (Patient Link).
Medication administration error: Pt received 0.3mL of Bivalent Moderna instead of 0.5mL. No known adverse reaction.
generalized exantham occurring 10 days after primary vaccinia (right deltoid) involving trunk and back and arms consistent with generalized vaccinia
right arm was starting to hurt more at bedtime (10pm). I slept restlessly and at 3pm woke up with severe upper right arm pain and could not raise my arm. tried icing arm, eventually was able to go back to sleep. when I woke up around 8 am, my arm still hurt badly and I could not fully use it. I had to have my husband wash my hair and comb it and help me get dressed (this is not normal). I took some aleve and within a few hours I could move it some and the pain was less but I still could not do normal daily activities with it without pain and still could not raise my arm above shoulder height. I also was quite tired and took a nap mid afternoon (also not normal). My arm was still sore when I went to bed that night but not as bad. When I woke up the next morning, it was sore but I could do all of my normal activities on my own with minimal discomfort. I still feel like I have limited ROM and weakness in my right arm. I had my son help me with dinner because I could not lift a heavy skillet or roll out some dough.  I had normal amounts of fatigue today.
Initially numbness in arm within minutes. Headache, swollen lymph nodes in neck and armpits, chills, fever, and body aches started about 1-2 hrs after injection.  Three hours after injection I took two ibuprofen. Around that time, neck and arm pain and stiffness began.
Cold hands and feet, blood pooling in hands, blurred vision, loss of appetite, palpitations, excessive urination, and pain around left shoulder blade area of back.
site of injection was stiff; discomfort at the site; eyes felt so gritty; left eye very painful; beyond normal dry eyes both eyes; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOMFORT (discomfort at the site), FOREIGN BODY SENSATION IN EYES (eyes felt so gritty), EYE PAIN (left eye very painful), DRY EYE (beyond normal dry eyes both eyes) and INJECTION SITE INDURATION (site of injection was stiff) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE DISCOMFORT (discomfort at the site), FOREIGN BODY SENSATION IN EYES (eyes felt so gritty), EYE PAIN (left eye very painful) and DRY EYE (beyond normal dry eyes both eyes). On 18-Mar-2021, the patient experienced INJECTION SITE INDURATION (site of injection was stiff). The patient was treated with MACROGOL 400, PROPYLENE GLYCOL (SYSTANE LUBRICANT) (ophthalmic) at an unspecified dose and frequency. At the time of the report, INJECTION SITE DISCOMFORT (discomfort at the site), FOREIGN BODY SENSATION IN EYES (eyes felt so gritty), EYE PAIN (left eye very painful), DRY EYE (beyond normal dry eyes both eyes) and INJECTION SITE INDURATION (site of injection was stiff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
17 Oct 08, Pt developed acute onset of substernal chest pressure at rest.  Pressure became a sharp pain that worsened with deep breathing and also radiated down the left arm.
I had no trouble at all with the first shot.  I had the second shot at about 3:30 in the afternoon. I woke up at 6:00 the next morning with wicked chills. I solved that with a heating pad and raising the room temp a couple of degrees. Didn?t last long. But I was dragging all day and had a very mild headache (I think). I do not get headaches. That night at about 7:00 I decided to take my temp and it was 100.  The next day I was perfectly fine with a waking temp of about 98.1 (which is actually a slight temp for me). And I was perfectly fine after that.
No other AE information; patient was given RECOMBIVAX HB that was recalled; incorrect product storage; Information has been received from a nurse reporting on a 11-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 23-OCT-2020, the patient was vaccinated with a recalled, improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) ) thimerosal free, 0.5 mL, lot# T007984 has been verified to be a valid lot number, expiration date 01-NOV-2022 for prophylaxis (route of administration and anatomical location were not reported). No other AE information was given at this time.
8 days, post vax, developed sore throat swollen, nodes in neck, joint pain especially in legs, achy, fever which lasted 2 days. No SOB.
47 year old male presented to the ER with chest pain and dyspnea. D-Dimer elevated at 20. CTA chest shows no PE, but does show hemopericardium. Diagnosed with pericardial effusion and pericarditis.
Patient sweating; throwing up and fainted. We gave her a EpiPen and she left with the emergency department.
This spontaneous report was received from a healthcare business professional and refers to a non dialysis adult patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB dialysis formulation, injection (thimerosal status, route of administration, lot # and expiration date were not reported). There was no adverse event reported.
The following day of the first vaccine I stared having difficulties. I couldn't lift my left leg, it felt as if I severely pulled a muscle in my groin area. The following day my left wrist hand and fingers started. It's a very painful crippling feeling and I could not bend my wrist or fingers. Every day since the first vaccine I have had a different part of my body experience the same painful crippling like feelings on both the left and right sides of my body. From wrists, hands, fingers, toes, knee, groin area, neck, and jaw areas. I've been to see my doctor where she drew blood work to see what is going on. It was discovered that inflammation and rheumatoid arthritis levels were extremely elevated. I've never had or experienced these symptoms before.  My doctor referred me to a rheumatoid arthritis doctor. Over a virtual visit on 4/28/2021 @ 2:15pm I discussed my issues and she order more blood work and a chest x-ray. She also put me on additional medication. Results are pending.
Patient reports being diagnosed with Herpes Zoster at her PCP three weeks after this vaccination.
The pt felt hot on the way home from the physicians office, then developed a macular papular rash on 3/17 and on the following day 3/18 experienced hives and swelling in the neck. The pt also experienced injection site redness, hardness and warmth to the touch. Saw physician on 3/18 and still had rash on arms, trunk and legs.
Shingles after months of 2nd dose administration; shingles; rash on neck and shoulder; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th August 2021, between 8 and 10 months after receiving Shingrix, 370 days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in the left arm. In approximately November 2020, the patient received 2nd dose of Shingrix in in the left arm. The patient stated that her rash started on the left side of her neck and left shoulder. The patient stated she was diagnosed with shingles on 1st September 2021. The patient stated, health care professional started her Valacyclovir 1gm, three times a day for 7 days. The reporter did not consent to follow-up.
Left arm swollen, red, hot to touch 24 hours after receiving ADPT. Left arm measured 21.5cm and right arm 15.5. Started on augmentin to r/o cellulitis.
patient collapsed in the parking lot on the way to car; Initial information received on 17-Dec-2020 regarding an unsolicited valid serious social media case from consumer (patient) via social media .  This case involves a patient with unknown demographic who collapsed in the parking lot on his/her way to the car (syncope), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient collapsed in the parking lot on his/her way to the car (syncope) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant as per Important Medical Event (IME) list. Reporter stated could get a bad reaction, no more shots for him/her.  Details of laboratory data was not 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.; Sender's Comments: This case concerns a patient with unknown demographic who presented with syncope after vaccination with  INFLUENZA VACCINE produced by unknown manufacturer. The time to onset was unknown. However, patient's medical condition at the time of vaccination, Concomitant medication and laboratory tests were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Started with problems with buzzing and indescribable issues in the head. Felt like someone was pulling a string around my head and pulling it out.  I also have a sensitivity to sound and I startle easy.  I also have tingling/numbing sensations in my legs, feet , toes and both right and and left arms and fingers. Finally, my blood pressure shot up to 187/112. It is under control with medication however the other symptoms have not gone away.
COVID-19 / received monoclonal antibodies after first dose of shingrix; This case was reported by a other health professional via call center representative and described the occurrence of covid-19 in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced covid-19. The patient was treated with monoclonal antibody (nos) (Monoclonal Antibody), casirivimab and imdevimab. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The case was reported by pharmacist students. The age at vaccination was not reported. The patient had received first dose of shingrix and developed COVID-19. The patient experienced COVID 19 infection and received monoclonal antibodies, casirivimab and imdevimab for COVID-19 infection on 10th February 2021 as a treatment. No other information was reported.
throat itching and coughing, had to take more benadryl and eventually took prednisone. symptoms started within 20 minutes of injection. continued to take benadryl for 4 days then took prednisone for 3 days
Mother returned with child to clinic on 4/05/2019 at 1:30 pm.  Childs right upper arm swollen and war to touch.  No tenderness, no pain. Mother denies child had any fever, irritability, nor loss of appetite.  Mother states she gave oral Benadryl to child to help with swelling but did not see any improvement.  Recommended mother to start cold compresses multiple times a day to help with swelling. Compresses were not previously as recommended during visit. Contacted mother via telephone on 4/08/19 at 9:08 am; she reports that child is "doing better" and the swelling is gone.
Injection site pain, redness, and swelling. Fever for two days following. As of 8/23/12 still red and sore, no fever and not as painful.
Expired dose administration; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 43-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 14th February 2023, the patient received Havrix. On 14th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.    Additional Information: GSK receipt date: 17-Feb-2023 Reporter's comment:  Nurse reported the patient received an expired dose of Havrix, expiry date 30th January 2023 on 14th February 2023. Reporter consented to follow up. Additional supportive information: As patient received expired vaccine, which led to expired vaccine used.
This spontaneous report was received from a 64 year old female patient regarding herself (who is presently 70 years old). On an unknown date, at 58 years of age the patient was vaccinated with dose 1 of PNEUMOVAX 23 and a second dose of PNEUMOVAX 23 at the age of 64 years old. No adverse effect reported. This is 1 of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to a 54 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On 16-DEC-2016, the patient was vaccinated with a dose of PROQUAD (strength, dose, route, lot # and expiration date were not reported) for prophylaxis; instead of M-M-R II. No adverse symptoms were reported. Additional information has been requested.
I started feeling a little tired on 01/10/2023 but I thought I just needed sleep. On 01/11/2023, I started feeling a little irritated. The back wall of my nasal cavity was inflamed. My wife tested positive for COVID-19 while I tested negative. On 01/12/2023, I went to work, but by around 01:00 or 02:00PM I started having headache, body aches, more irritation in my nasal cavity, and a bit of chills. I finished my workday and picked up my son from school and tested myself again for COVID-19 and was positive. On 01/13/2023, I reached out for a telehealth visit where I was prescribed PAXLOVID in case I needed it. On 01/14/2023, I woke up and felt really tired, but I had been resting and rehydrating quite a bit. The symptoms began to gradually improve on their own without the PAXLOVID. On 01/15/2023 I began to feel a bit more normal and today, I'm feeling a lot better with no body aches or chills.
Rash and swelling at injection site. It's more irritated today and kind of itchy. It started  two days ago and two full weeks after getting the vaccine.
Admitted to hospital after syncopal event after COVID-19 vaccination. Patient with prior history of syncope. Evaluated in hospital with low potassium (3.1). Possible history of orthostatic  hypotension. Referred for further outpatient cardiology work-up for syncope.
Pfizer 4/12/21, 5/3/21. Positive on 1/30/22
Approx. 12-15min after getting flu shot having difficluty breathing, tightness in throat, numbness in arm, nausea and dizziness.
DC from hospital for COVID day prior to arrival, hypoxia at home. Treated with remdesivir, Vit-c, aspirin, zithromax, Vit-D, steroids, singulair, O2. Weaned to RA and discharged home.  Hospital Course: patient is a 66 y.o. female who presented to the hospital with complaint of shortness of breath and fever.  Patient was found to have covid pneumonia and associated acute hypoxic respiratory failure.  She improved with decadron, remdesivir, and supportive care.  She was then discharged home for outpatient follow up.   Disposition: She will be discharged 9/13/21 to home
This spontaneous report as received from a pharmacist refers to a 62 year old male patient with penicillin allergy. On 30-NOV-2014 the patient was vaccinated with 0.65 ml ZOSTAVAX (lot # J014809, exp 20-FEB-2015) subcutaneous in an unspecified arm. On 01-DEC-2014, the patient developed a rash on that also developed into bubble-like lesions on 02-DEC-2014. The patient reported this rash via telephone and this was not assessed by the pharmacist. No treatment given to the events. No lab diagnostics studies performed. The patient did not seek medical attention. The outcome of the events was unknown. No PQC (Production Quality Control) involved. Additional information has been requested.
Information has been received from a medical assistant concerning a patient who on 13-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# 658673/0990U). Subsequently the patient experienced injection site pain and swelling. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of the multiple patient report from the same source. Additional information has been requested.
Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with MMR II (lot# not reported). It was reported that the patient had titers for only measles and rubella and did not have titers for mumps. No other adverse effects reported to the patient. Unspecified date medical attention was sought. No further information is available.
11/2 2:30 got up, dizziness, weakness. Rested for a couple hours. Had HA when got up took Tylenol and HA gone after 1/2 hour. Slight HA today. Normally dose not have HA.
received vaccine at 1635; 1648 rash noted on neck, right chest. Benadryl 50 mg IVP given 1652 c/o lightheadedness and palpitations  Initial bp was 123/87-105 pulse and 20 respirations. At 1652 bp 151/79-128-20;  1720 nausea palpitations intermittently. 1725 134/72-104-20  and feeling fine.
A 22-year-old male subject with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 25 March 2010 (also with a reported date of 01 April 2010) an elevated central laboratory Troponin level of 0.13 ng/ml and on 13 April 2010 a central laboratory Troponin level of <0.10 ng/ml. The date of recovery was reported as 13 April 2010. The subject had a rapid Troponin I level on 25 March 2010 that was within normal limits (negative). On 13 April 2010, the subject had a normal ECG reading. On 13 March 2010 (also with a reported date of 25 March 2010), the subject experienced AEs including intermittent fevers (recovered 15 March 2010), soreness on right smallpox site (ongoing), acid reflux (recovered 24 March 2010), and painful joints left and right legs "both legs" (ongoing). The subject's concomitant medications included ALEVE and TUMS. No further information was available at the time of the report. The subject's outcome was not recovered. According to the Investigator, the event of elevated central lab Troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. List of docs held by sender: medical records.
Information has been received on 20-NOV-2017 from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 21-DEC-2012, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-SEP-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient has been prescribed Acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
a patient who is 47 years old who brought in a prescription to receive GARDASIL 9; No additional AE reported; he has a patient who is 47 years old who brought in a prescription to receive GARDASIL 9; This spontaneous report was received from a pharmacist via a company representative referring to a 47 years old female patient. No information was provided regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies.  On an unknown date, the patient was prescribed with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product prescribing issue). On approximately 29-APR-2021 (reported as about 1 week ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). It was unknown if the patient completed the series or is just starting. No additional adverse event was reported.
I gave the Moderna vaccine to this patient and she is not 18 yet.  She will turn 18 on 4/8/2021.  Cheif Pharmacist contacted the Moderna company and was advised to continue with Moderna for 2nd dose.