chrisvoncsefalvay/vaers-outcomes huggingface dataset:
42 Patients received bivalent booster with 38 having improvement of symptoms; No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID-19.     No Medical History information was reported.    In 2023, 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. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome 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 assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).      Concomitant product use was not provided by the reporter.  Reporter called in to report success of non-indicated use of vaccine to treat long-haul COVID symptoms and asking to connect with research team. Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of "long-haul COVID" and had seen 88-90% success rate in resolving the symptoms of long-haul COVID.   Vaccine was given to the patients for long COVID between March 2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms and 50 % or more.  Vaccine was given within current guidelines except seven were under 65.   Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved.   No adverse reactions occurred.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:
This spontaneous report was received from an unspecified healthcare professional concerning an unspecified number of patients of unknown age and gender. Since an unknown date between September 2012 and November 2012, patients were vaccinated with the doses of improperly stored (exposed for 28 hours and 30 Fahrenheit) PEDVAXHIB (lot number and expiry date reported as 0692AA and 13-AUG-2013 respectively. dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Several weeks after the vaccine he started having SOB episodes at hockey practice. He has played hockey since he was 7 and the last three years at a very high level.  He is well conditioned and in shape and started having SOB episodes and racing pulse. The episodes were sporadic but became more frequent. He would rest when this happened. He has not had covid to our knowledge, One day when lifting weights (which he does daily) he got a sudden extreme headache and almost passed out. He has since been diagnosed with hypertrophic cardiac myopathy as of December 3rd. the only thing that changed on this time period was the vaccine.
Lightheadedness up the back of neck and scalp Narrative:  Started feeling light headed up back of neck and scalp. B/P 119/84, P 76, R 16, O2 Sat 98%. Left walking fine and stated she was ok.
3/26/21 Chest pain 1 day after vaccine then shortness of breath with exertion and fatigue.  Symptoms worsened when at work 3/29/21 so went to ER.   Saw PCP 3/30/21 and tests ordered.  No change in symptoms.  Saw Cardiologist next week 4/6/21 and admitted to hospital for heart catheterization 4/7/21.  Cath was negative so was discharged from hospital.   Symptoms continued so saw Cardiologist NP 4/28/21 and tests ordered EGD done 5/10/21 and was negative Echocardiogram and AAA sonogram done 5/13/21 and were negative as well Was released to go back to work 5/18/21 Continue to have rare chest pain with exertion that is not as severe now.  Shortness of breath and fatigue daily with moderate  exertion now
Per Patient "Last evening I developed a mild rash, mostly on my arms and torso. Pink, splotchy and itchy.  Also a headache. I called the nurse advisor to discuss.  Because I was scheduled for a bone density this morning I didn't take any benedryl as it contains calcium, but used topical Cortisone 10.  This morning the rash as almost entirely gone.  The nurse advisor suggested that I advise you since it was possibly a reaction to the pneumonia shot.  I had eaten shrimp for dinner but have never had any reactions to shellfish in the past.  Nurse advisor couldn't find any connection between the vaccine and shellfish. I still have a mild headache but otherwise okay."
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 24-OCT-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # N010495 with expiration date 31-MAR-2019 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Weak, Dizzy, Fatigue, Muscle ache vomited X 1 this lasted for 4 days.
numbness in let hand, nausea, tremor in left hand Narrative:  77 yo male with PMH of COPD, arthritis, allergic rhinitis and  hyperlipidemia was found to have numbness in left hand along with brief second  of syncope on 2/11/2021 (1 day after his second dose of covid19 Moderna  vaccine on 2/10/2021). Patient did not react to the first one covid19 vaccine. His  wife called triage line right away and was recommended to seek local ED. Per local ED record on 2/11/2021 @10:28am, patient also reported fatigue, chills,  sore arms right after the vaccine. The nausea, syncope and numbness/tremor in left  arm occurred the next day. Pt denied chest pain, palpitations or any seizure like activities. Pt was tested for negative at the ED, result was NEGATIVE. Patient has  stable lab work (CBC, Chem 12, cardiac enzymes, EKG). Pt was given fluid, he felt well after and asked to go home. Provider diagnosed patient with non-critical reaction to covid19 immunization (vasovagal reaction). They recommend increase fluids and normal nutrition support, avoiding climbing and strenuous activities.
Initial report was received from a health care professional on 18 October 2010. A report of "several" unidentified patients with no reported past medical histories, had received FLUZONE HIGH-DOSE (lot number, date, route and site of administration not reported) and an unspecified amount of time later, experienced fever, chills and "other side effects". No further information was available at the time of the report. The patients' outcomes were not reported. The reporter for this case is the same as for 2010-06068. Documents held by sender: none.
bodyache; headache; Nausea; This is a spontaneous report from a contactable health care professional, as a patient. A 43-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) as a first dose on an unspecified date and as a second dose (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) intramuscularly on 15Mar2021 at 11.30 am in the right arm for COVID-19 vaccination. Medical history and concomitant medications were not provided. Patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was at a public health clinic. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 at 12:00 am, the patient developed nausea, headache and bodyache. The patient did not receive treatment for adverse events. The outcome of the events was not reported. Information about lot/batch number cannot be obtained. No further information is expected.
UTI after 2nd dose; Nausea; Vomiting; Diarrhea; Dizziness; This non-serious case was reported by a consumer via call center representative and described the occurrence of urinary tract infection in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of urinary tract infection (received 1st dose on 12th January 2023 and also experienced nausea, vomiting diarrhea and dizziness, refer case US2023051919).   On 27-MAR-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid) .5 ml. In MAR-2023, 3 days after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), vomiting (Verbatim: Vomiting), diarrhea (Verbatim: Diarrhea) and dizziness (Verbatim: Dizziness). On an unknown date, the patient experienced urinary tract infection (Verbatim: UTI after 2nd dose). The patient was treated with macrobid (nos) (Macrobid). Rechallenge with Shingrix was positive. The outcome of the urinary tract infection, nausea, vomiting, diarrhea and dizziness were resolved.   It was unknown if the reporter considered the urinary tract infection, nausea, vomiting, diarrhea and dizziness to be related to Shingrix.     It was unknown if the company considered the urinary tract infection, nausea, vomiting, diarrhea and dizziness to be related to Shingrix.   Linked case(s) involving the same patient: US2023051919   Additional Information: GSK Receipt Date: 10-APR-2023 The case was self-reported by the patient. The patient reported that she had not experienced an UTI in over 10 years, so she felt this be reported. The patient received second dose of Shingrix into left arm and experienced urinary tract infection and 3 days later had nausea, vomiting, diarrhea and dizziness. The reporter reported that her healthcare professional prescribed Macrobid for 5 days for both UTI's. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023051919:Same reporter.
Left thigh swollen midthigh to knee, erythema tones, not hot to touch, mildly tender, walks well. 15cm long, 12cm wide redness.
Patient could not get up and could not move from the waist up; bruised arm; the patient felt sick; lightheaded and dizzy; tired; Patient felt like jello, very weak; fell; peeling back the skin; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via The agency (Reference number- 00313403) and transmitted to Sanofi on 13-Oct-2020.  This case involves a 72 years old female patient who could not get up and could not move from the waist up (dyskinesia), felt like jello, very weak (asthenia), sick (illness), lightheaded/dizzy (dizziness), tired (fatigue), fell and bruised arm peeling back the skin (fall, contusion and skin exfoliation), while she received INFLUENZA VACCINE.  Patient had a history getting sick from a spider bite on her foot in Dec-2019 that caused her not to be able to be able to walk. She stated that had to use a wheelchair for long distances. At the time of event patient had ongoing Diabetes mellitus. Medical treatment, vaccination, family history and concomitant medication were not provided.  On 10-Oct-2020, 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  the left arm for prophylactic vaccination.  On 11-Oct-2020, the patient could not get up and could not move from the waist up (dyskinesia), felt like jello, very weak (asthenia), sick (illness), lightheaded/dizzy (dizziness), tired (fatigue), fell and bruised arm peeling back the skin (fall, contusion and skin exfoliation) 1 day following the administration of INFLUENZA VACCINE. Relevant laboratory test results included: X-ray - On an unknown date: The x rays were clear  Final diagnosis was peeling back the skin, fell, patient felt like jello, very weak, tired, lightheaded and dizzy, the patient felt sick, bruised arm and patient could not get up and could not move from the waist up.   The patient was prescribed a treatment of an antibiotic cream and a Vitamin D shot.  At the time of reporting event outcome was not reported.  There will be no information on the batch number to be requested for this case.
Injection itself was much more painful than in the past. I immediately had pain in my shoulder muscle that radiates to my elbow and up to my neck. Aggravates with movement. Very painful to lift arm above head or to put arm behind back. (most notably while pulling on or taking off a shirt.) No pain at site of injection which seems to have been too high on the shoulder and close to the joint. Level of pain has not lessened since injection.
It was reported that a pt (8 of 9) received a Tripedia vaccination the week of 3/23/01. Reportedly, sometime after the vaccination (date not specified), the pt developed a large local reaction at the injection site. From additional correspondence received on 5/16/01, it was reported, "unable to locate pt name".
diagnosed with Covid; Diagnosed with Covid; This is a spontaneous report from a contactable consumer who reported for a female patient (reporter's wife). A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as single dose and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient  diagnosed with COVID on 07Oct2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: diagnosed with COVID on 07Oct2021.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
25-year-old male with a history of exercise-induced asthma who presents with headache, myalgias, nausea, vomiting as well as sudden onset chest pain with diarrhea in the setting of recent Covid-19 vaccination. He was found to have diffuse ST elevations and PR depressions on EKG with downtrending troponins from 0.15 ng/mL and admitted for myopericarditis.
Sleepy after the first dose, low grade fever, headache. Second vaccine my joints felt numbness and my hands kept falling asleep as well as my feet. My hands shake occasionally. Up till now I still have the same symptoms.
doses administered after excursion; No adverse event; received vaccine from vaccine that underwent a temperature excursion in the Freezer; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, 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 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medication was provided.  The pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The excursion was found out in an audit.   No adverse events were reported.   Treatment medication was not provided by the reporter.
Per patient he received his second Covid vaccine 3 days prior to arrival and immediately following developed myalgias, subjective fevers and " viral symptoms" which she managed with ibuprofen 2 tabs q6h some improvement.  On the day prior to arrival he developed increasing shortness of breath particularly with talking and with ambulation.  He also describes chest tightness with deep inspiration, the tightness radiates to back, no radiation to left arm or jaw.  Chest tightness is non-positional, but does feel worse immediately after he lies down from ambulation and then slowly dissipates.  His last subjective fever was yesterday evening.  He has never had a reaction to the vaccine before.  He has no allergies.  No prior medical conditions he is aware of, and takes no medications.  He did not experience any of the symptoms following the first vaccine. He has h/o asymptomatic COVID infection in November 2020. Cardiology consulted for concern of pericarditis post COVID-19 vaccine. He does not have significant ST elevation or PR depression.  He also does not have evidence of significant pericardial effusion at this point.  The high sensitivity troponins are mildly elevated.  He does have viral syndrome.  Is unclear if Covid vaccination was causally related to his symptoms.  We would like to improve his medications for better chest pain control and to prevent recurrent pericarditis in the future.
I got my booster shot of Moderna Covid-19 vaccine on Jan 4, 2022 and started coughing after a few hours of getting it. And I am still coughing until today 2/15/2022, it has been six weeks. I also got other side effects such as headache and fever, body ache, but they all disappeared after 48-72 hours, but my cough still exists. I got the same side effects after I got second shot last year 2/22/2021.  I?m going to see pulmonologist due to this side effect to get a thorough exam.  Moderna  should pay all the cost.
c/o headache, lightheadedness, stomach cramping, nausea, low back pain beginning 4 hrs p/vax; no specific signs; afebrile;
After getting the 2nd  dose of the Pfizer vaccine at 1:45pm in his left arm, around 9pm,  started to get a headache. He went to sleep but felt cold at night and then started to get a cough. In the morning on Thursday July 22 his chest started to hurt in the upper area. He was feeling body aches. At 12:55pm he had a fever of 101.4  I gave him  2 Tylenol tablets. At 2:22 pm fever went down to 100.4 At 4:48pm his temperature was at 98.9.  At 4:30pm he was complaining that his chest hurts, achy legs, headache. I call 911 and they tell me that he will need an ambulance to go to the hospital.
a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION COMPLICATION (a reaction). At the time of the report, VACCINATION COMPLICATION (a reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Possible mild rhabdomyolysis following fever/rigors and diffuse myalgias. Dark urine resolved with PO hydration, no other symptoms. Visited urgent care 10/27/22: UA 3+ blood, trace protein. CMP WNL except Calcium 8.6.  CBC WNL except platelet count 133x10e3/uL, CRP 32.  CPK pending.