chrisvoncsefalvay/vaers-outcomes huggingface dataset:
General lethargy; Joint pain; Achy muscles; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (General lethargy), ARTHRALGIA (Joint pain), MYALGIA (Achy muscles) and PYREXIA (Low grade fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 037L20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Atrial fibrillation and Allergy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, SOTALOL HYDROCHLORIDE (BETAPACE) and ACETYLSALICYLIC ACID (ASPIRIN LOW) for Atrial fibrillation, ENALAPRILAT (VASOTEC [ENALAPRILAT]) for Blood pressure high.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LETHARGY (General lethargy), ARTHRALGIA (Joint pain), MYALGIA (Achy muscles) and PYREXIA (Low grade fever). At the time of the report, LETHARGY (General lethargy), ARTHRALGIA (Joint pain), MYALGIA (Achy muscles) and PYREXIA (Low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2021, SARS-CoV-2 antibody test: 155 (abnormal) 155 for SARS COV2 total antibodies, test type: ECLIA. On 13-Dec-2021, SARS-CoV-2 antibody test: 148 (abnormal) 148 for SARS COV2 total antibodies, test type: ECLIA.         Patient was a part in the COVID care study, where antibodies are monitored every 3 months or 12 weeks. When patient first entered the program, the antibody level was 620 for SARS COV2 total antibody. However, ever since patient received the booster dose of the Moderna COVID-19 vaccine,  antibody levels had dropped 500%. As of test conducted on 07 Sep 2021 antibody level was 620 and test type was ECLIA.  No treatment information were provided.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot years ago and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Breakthrough COVID-19 case with symptom onset 8/27/2021: Subjective fever (felt feverish), Chills,  Muscle or body aches,  New loss of taste or smell,  Runny nose/Congestion,  Sore throat,  Cough (new onset or worsening of chronic cough),  Shortness of breath or difficulty breathing,  Fatigue or tiredness,  Nausea or vomiting, Headache,  Diarrhea (>/=3 loose/looser stools in 24 hr period), memory loss. Hospitalized from 8/30/2021-9/5/2021. Case said he was admitted to hospital for COVID. Case could not breathe, his stats were in the low 70's; he was on oxygen
two weeks after the vaccine for Gardasil I had a cold that lasted a month and a half. Than on 3/20/08 I went to the emergency room because of chest pains shortness of breath dizziness tingling in arms and legs blurred vision. They diagnosed me as having an anxiety attack and they prescribed Xanax. Which I ended up taking to much due to the chest pains i was having I than ended up in the er the next day. After that i went to my doctor for a follow up and saw (P.A) who prescribed cough suppresant and zithromax that I took for 5 days and she told me to go see a cardiologist and a psychiatrist. So then I saw Dr. (Cardiologist) he ran test. He then said my heart was inflammed and gave me trial moblic i had to take for 3 days along with Zantac. I still continued with the chest pains and tingling in arms and legs with the shortness of breath. He then did a 2D echo and had me take a stronger dose of moblic and then had a CT of my chest because he thought I had a pulmonary emboli. Then he gave me motrin 800 mg every 8Hrs as needed for chest pains. I still get the chest pains constantly. Yesterday I started with the shortness of breath and tingling in my arms and legs, the dizziness and blurred vision. I will be calling the cardiologist again on Monday 05/05/08 to see what else I need to do. At that time I will be letting him know that I did recieve the Gardasil injection in January 24,2008, since I had forgotten to tell him. I did not think it was important at the time, but now I am wondering if this is a side effect of Gardasil.I have no problems prior to recieving the shot.
Muscle weakness; This case was reported by a consumer via interactive digital media and described the occurrence of muscle weakness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced muscle weakness. On an unknown date, the outcome of the muscle weakness was unknown.   It was unknown if the reporter considered the muscle weakness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Jul-2022. Reporter's Comments: This case was reported by the patient via interactive digital media. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Information has been received from a physician concerning an unknown number of older adult patients who on an unspecified date were vaccinated with VARIVAX (Merck) (dose and lot number not provided). The patients experienced local injection site reactions. Follow up call information was received from a physician and a registered medical assistant concerning a 70 year old male patient who on 06-MAR-2008 was vaccinated with a dose of VARIVAX (Merck) (lot # 659724/1660U). The patient was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck). This event was not a case of product confusion, but a result of human error. No further information is available. This is one of two reports from the same source.
pt w/prolonged crying beginining immed p/vax; lasted thru noc w/resolution in afternoon next day;
Fainted - vertigo - pallor.  No strida.  No shortness of breath - no rash - no chest pain.
Male patient went to MD office due to swollen left arm, above elbow and fever. MD gave him prescriptions for Keflex 500mg QID #40 and Percocet 10/325mg for pain. He also is running test for cellulitis.
Immediate swelling of face, arms, chest, rash, heart racing, tongue tingling, dizzy.
This spontaneous report as received from a mother refers to her daughter of unknown age. In February 2016 the patient was vaccinated a dose of unidentified Merck HPV vaccine (name and lot number not provided). The vaccine was picked up from a local pharmacy so that eh patient's pediatrician could apply it. In April 2016 (last week), the reporter was informed that vaccine had been in refrigerator that was not functioning properly. As a result the vaccine given to the patient was not effective. The patient would have to take an extra dose of the vaccine. Additional information has been requested.
Chills and aches lasting 24 hours. L arm continues to experience numbness and tingling like my arm was asleep
SOB, Cough, Rash (Diffuse erythema), Pruritis, Urticaria, Mild Tachycardia (122). NS 1,000 sec at wide open rate then 200 sec/hr. Solumedral 125mg IV, Discharge Meds: Prednisone 20mg twice each day for 4 days, Benadryl 50mg ever 6 hr today then if needed. Final diagnosis: allergic reaction to Flu vaccine.
No known adverse reaction, reporting as noticed a tiny fuzz (one single strand of a thread/cotton ball size) on the end of the needle after it came out of his arm after injection.  Nothing noticed before injection therefore likely came from air after removal but cannot be positive.   Assuming nothing was on the needle when injected but reporting as it was noticed afterwards and cannot be sure.  No issue after injection and patient was to come back in 15 minute to inspect arm but did not, so called him to follow up and just make sure no injection site reaction fo any kind.
SLEEPINESS; VERY SLIGHT ACHES IN THE HIPS; SLIGHT FEVER OF 99; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 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 MAY-2021, the subject experienced sleepiness. On MAY-2021, the subject experienced very slight aches in the hips. On MAY-2021, the subject experienced slight fever of 99. Laboratory data included: Body temperature (NR: not provided) 99. The action taken with covid-19 vaccine  was not applicable. The outcome of the slight fever of 99, very slight aches in the hips and sleepiness was not reported. This report was non-serious.
3/10 2pm - immunization administered. 3/11/09 Am - increased redness, swelling at injection sites, ice applied, TYLENOL given. 3/12/09 6pm - seen by MD in office for increased pain, worsening redness and swelling at injection site. Had both KINRIX and MMR boosters put in left arm. On Wednesday started with the swelling which has progressively gotten worse. Mom gave TYLENOL and put ice on it but did not give anything else. Not itchy. No history of adverse reactions before.
Patient was given 3rd dose of Shingrix vaccine upon prescription sent from Dr office. patient had actually finished shingrix series in 2019. 3rd dose not indicated. patient did not report Adverse effects and pharmacist counseled pt to report any symptoms
Got vaccine 12/21/20.@1645. Felt fine until 1500 on 12/23. Started with severe H/A, then started with extreme dizziness. Had to have some drive me 100 yards home from the dog park. Needed my hiking poles to navigate from bed to bathroom. Even had bed spins.
Information has been received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On an unspecified date, the patient was most likely vaccinated with a improperly stored dose of one of the following vaccines that were reconstituted with sterile diluent (manufacturer unknown) (unspecified lot number and expiration date), but is not sure which of the lots the unspecified patient received. Sterile diluent (manufacturer unknown) did not undergo a temperature excursion. The vaccines involved were M-M-R II  lot number # M017346 and expiration date of 06-APR-2018 and lot number # M011667 and expiration date of 08-MAR-2018, or VARIVAX lot # M035142 and expiration date of 03-AUG-2018 (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of -14 Celcius degrees to -10 Celcius degrees for 7 hours. Previous temperature excursion was reported frozen multiple excursion.  No adverse effects were reported. Digital data logger was involved. Additional information has been requested.
Developed blood clots after the second dose; resulted in a stroke; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed blood clots after the second dose) and CEREBROVASCULAR ACCIDENT (resulted in a stroke) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Developed blood clots after the second dose) (seriousness criterion medically significant) and CEREBROVASCULAR ACCIDENT (resulted in a stroke) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Developed blood clots after the second dose) and CEREBROVASCULAR ACCIDENT (resulted in a stroke) outcome was unknown.            Patient states that she knows other women in their 60s who got blood clots after the second shot of Moderna and resulted in a stroke as well.  No concomitant medication was reported. No treatment medication was reported. Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of Thrombosis and Cerebrovascular accident. The events occurred 13 days after administration of second dose of mRNA-1273. There was no information regarding the first dose. It has been reported that 13 days after vaccination, patient woke up with paralysis of her arm, leg and face, has permanent numbness on her face and numbness on her left arm and hand. She experiences easy fatiguability when going up and down the stairs and was unable to go to work. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-566820, MOD-2022-566822, MOD-2022-566828, MOD-2022-566808, MOD-2022-566814, MOD-2022-566821 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2022: Follow-up received with added reporter Information, verbatim for event thrombosis and stroke updated.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of Thrombosis and Cerebrovascular accident. The events occurred 13 days after administration of second dose of mRNA-1273. There was no information regarding the first dose. It has been reported that 13 days after vaccination, patient woke up with paralysis of her arm, leg and face, has permanent numbness on her face and numbness on her left arm and hand. She experiences easy fatiguability when going up and down the stairs and was unable to go to work. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
patient got a flu from the vaccine; patient got a flu shot once and it almost killed patient sick in bed for a month; patient got a flu shot once and it almost killed patient sick in bed for a month; Initial information was received on 09-Oct-2020 and additional information was received on 10-Oct-2020 regarding an unsolicited valid serious case from a consumer/ non-healthcare professional (patient).  This case involves a patient of unknown age and gender who got a flu shot once experienced flu (influenza) it almost killed patient was sick in bed for a month (bedridden due to illness), while patient received INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient who got a flu shot once experienced flu (influenza) it almost killed patient was sick in bed for a month (bedridden due to illness) (latency: unknown) following the administration of INFLUENZA VACCINE. These events were leading to disability (seriousness).  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a patient of unknown age and gender who experienced influenza, was bedridden due to illness (latency: unknown) after vaccination with INFLUENZA VACCINE. The time to onset is not known. There is, however, no information regarding patient's condition at time of vaccination, history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Redness itching, tingling in the left arm at the site of the injection and spreading both up and down arm.
he said I have trigger figure; The night of the first injection I woke up with pain in my right thumb area; My thumb was what I though sticking in a locked position; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 05Apr2021 (at the age of 52-year-old) (Batch/Lot Number: Ew0176) as dose 2, single for covid-19 immunisation. Medical history included known allergies to hormones patch. The patient was not pregnant. The patient's concomitant medications were not reported.  The patient received first dose of bnt162b2 for covid-19 immunisation on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Apr2021, the night of the first injection, the patient woke up with pain in her right thumb area. Her thumb was what she thought sticking in a locked position. She wasn't sure what was going on so she massaged it and went back to sleep and it continued to stick. After a month, she saw her primary doctor who referred her to a hand specialist and he said the patient had a trigger "figure". The events resulted in doctor or other healthcare professional office/clinic visit. Therapy for the events included a cortisone shot in right thumb. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19. The patient underwent a nasal swab (rapid covid) on 15May2021 with negative results. Outcome of events was not recovered.
pt exp an inject site react (red, swollen, hot arm) & serum sickness (myalgias, arthralgias) w/in 36 hrs post-immun; treated w/ATB; steroids were added 3 days later; seen in allergist office 24JUL93; seen in MD office 26JUL93; sx resolved;
PAIN SITE,TIRED,MUSCULAR PAIN,CHILLS,FEVER JOINT PAIN SWELLING ON INJECTION SITE .
Information has been received from a nurse practitioner concerning a female who on 18-SEP-2008 was vaccinated with a dose of GARDASIL. Two days after vaccination, on 20-SEP-2008, the patient had a rash. The reporter stated that the patients rash appeared from the upper arm to the shoulder. The rash lasted for two days. The patient sought medical attention and contacted the nurse practitioner. Additional information has been requested.
Moderna COVID- 19 Vaccine EUA:  patient presents to emergency department (ED) reporting  shortness of breath, headache, nausea, one episode of emesis with breakfast, tingling around lips and both hands, and abdominal pain starting one day after receiving vaccination.  Denies fever, chills, sore throat, runny nose, chest pain, coughing, and diarrhea. Vital signs respiratory rate= 17 breaths per minute, blood pressure 138/81 mmHg, heart rate 104 beats per minute, and rest within normal ranges. Physical exam notable for rales. Administered intravenous fluids, famotidine, lorazepam, and ondasetron and observed. Symptoms resolved and patient discharged to home stable with follow-up in place.
Started Day 10 with redness, at near injection site- slightly below. Warm to touch about 4 cm Day 11 increased in size to about 8.5 cm warm to touch. by evening became slightly swollen. Day 12 redness slightly decreased in the center, but more swollen. Less warm No fever- but feel tired. Arm feels slight achy
Weakness in left arm; Locking of shoulder joint; Worsening pain in left arm at injection site; This is a spontaneous case reported by other health care professional to AGENCY (Case: SEQ19-05359) and initially received on 22-Oct-2019, concerning a female patient in her 30s.  The patient's medical history and concomitant medications were not reported.  On an unspecified day in Sep-2019, reported as last month at the time of the initial report, the patient was administered Afluria Quadrivalent [Influenza Vaccine, dose: 0.5 ml, route of administration: intramuscular, batch number: P100110239, anatomical location: left deltoid, expiration date: not reported) for influenza prophylaxis.  On 15-Oct-2019, three weeks after vaccination, the patient developed worsening pain in left arm at injection site with locking of shoulder joint and weakness in left arm. Patient's treatment measures included lab work and steroids.  The outcome of the events was not recovered/not resolved, at the time of reporting.  This case is linked to 201905416 (same reporter)   The reporter assessed the case as non-serious.  Non-significant follow-up reported by other non-health professional from Agency [reference number: SEQ19-06171] on 26-Nov-2019: Additional Agency reference numbers added. No changes in narrative.  Company comment: The patient developed muscular weakness, periarthritis and vaccination site pain, three weeks after administration of Afluria Quadrivalent. Chronology does not seem plausible. More information regarding patient's medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect vaccine cannot be excluded and it is assessed as possibly related for all events.; Sender's Comments: The patient developed muscular weakness, periarthritis and vaccination site pain, three weeks after administration of Afluria Quadrivalent. Chronology does not seem plausible. More information regarding patient's medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect vaccine cannot be excluded and it is assessed as possibly related for all events.
0.3 ml of Moderna was drawn up by mistake (for a booster dose) and given to this patient. No adverse reactions were observed in the 15 minutes post administration.
REDNESS WITH EDEMA AROUND INJECTION SITE IS LEFT DELTOID APRROX. 5X4 INCHES IN SIZE. CHILD WAS EVALUATED AND TREATED BY MD AT URGENT CARE.  RX FOR AUGMENTIN ISSUED.  NO RESPIRATORY DISTRESS.