chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arthric pain in joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Arthric pain in joints) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Arthric pain in joints). At the time of the report, ARTHRALGIA (Arthric pain in joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
the patient had no symptoms or adverse events following administration; nurse who reports administration of vaccines following temperature excursion.; This spontaneous report has been received from a nurse referring to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, and previous drug allergies or reactions were not provided.  On 29-JUN-2022, the patient was vaccinated with an improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) at a dose of 0.5 milliliter once, lot number T032918 was determined to be valid for vial formulation for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date: 12-NOV-2022 (vaccination scheme, and route of administration were not provided), and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally at a dose of  2ml once, lot number U038864, expiration date: 22-APR-2023 (vaccination scheme was not provided), as prophylaxis following a temperature excursion of minus 0.8 degrees Celsius (C) for 1 hour 10 minutes (product storage error), there was stated that no previous temperature excursion occurred. The patient had no symptoms or adverse events following administration of the vaccine.  This is one of several cases from the same reporter.
Muscle soreness and weakness, severe swelling, hot to touch, itching, diarrhea.
Right hand hurt after first dose; Aches after 1st dose; Slight headache after 1st dose; Fever after 1st dose; Joints hurt after 1st dose; Chills after first dose; Nausea after first dose; Diarrhea after first dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea after first dose), PAIN IN EXTREMITY (Right hand hurt after first dose), PAIN (Aches after 1st dose), HEADACHE (Slight headache after 1st dose) and PYREXIA (Fever after 1st dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007m21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Diabetes mellitus non-insulin-dependent. Concomitant products included IBUPROFEN for Arthritis, METFORMIN and LISINOPRIL for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea after first dose), PAIN IN EXTREMITY (Right hand hurt after first dose), PAIN (Aches after 1st dose), HEADACHE (Slight headache after 1st dose), PYREXIA (Fever after 1st dose), ARTHRALGIA (Joints hurt after 1st dose), CHILLS (Chills after first dose) and NAUSEA (Nausea after first dose). At the time of the report, DIARRHOEA (Diarrhea after first dose), PAIN IN EXTREMITY (Right hand hurt after first dose), PAIN (Aches after 1st dose), HEADACHE (Slight headache after 1st dose), PYREXIA (Fever after 1st dose), ARTHRALGIA (Joints hurt after 1st dose) and CHILLS (Chills after first dose) had resolved and NAUSEA (Nausea after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included pain killers and fever reducers.   This case was linked to US-MODERNATX, INC.-MOD-2021-073210 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Added past medical history, event outcome and about vaccine second dose details.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073210:
I had Covid 19 vaccine. Right after 5 min, I had a heavy arm. I mentioned that to the monitoring nurse and she kept me extra 8 min minutes before releasing me home. An hour later, the left arm had been swollen to a weak, red, itching. It is about 2 and 1/2 inches long and 1 and 1/2 inches wide. The red colored has been fade but the itching come and go and still having. Last itching is this morning
Patient previously received 2 doses of the Moderna vaccine. We incorrectly administered the Pfizer vaccine for the 3rd shot. No adverse reactions to report.
COVID-19; COVID-19; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 with nirmatrelvir/ritonavir (PAXLOVID) from 31Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
+ rapid Ag/Test: Home Ag Result: Positive; + rapid Ag/Test: Home Ag Result: Positive; Allergies; dizziness; cramping; bones ached; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL3247), on 25Feb2021 as dose 2, single (Lot number: EL3247) and on 12Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. If patient had Covid prior to vaccination was unknown. If Covid tested post vaccination was yes. The following information was reported: MULTIPLE ALLERGIES (non-serious) with onset 10May2022, outcome "unknown", described as "Allergies"; BONE PAIN (non-serious) with onset 10May2022, outcome "unknown", described as "bones ached"; MUSCLE SPASMS (non-serious) with onset 10May2022, outcome "unknown", described as "cramping"; DIZZINESS (non-serious) with onset 10May2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "unknown" and all described as "+ rapid Ag/Test: Home Ag Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (11May2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.  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.
No adverse event happened. Patient was ineligible for vaccine at the time of vaccine administration. We were informed by an outside source that we vaccinated a child who was not eligible at the time.
Information has been received from a licensed practical nurse concerning an approximately 20 year old female with unknown pertinent medical history and unknown drug reactions/allergies, who was vaccinated as a child with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live Wistar RA 27/3). There was no concomitant medication. Subsequently, the patient developed shingles some time later. The nurse stated that the patient's college did not require her to get a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) because of this "reaction." The outcome is reported as recovered, date unspecified. No other details. There was no product quality complaint. Additional information has been requested.
received an expired Quadracel/no AE; Initial information received on 09-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years 11 month old male patient who received an expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Nov-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to Expired vaccine used.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim.
Received Td, MMR, Hep B vaccines on 12/16/02.  On the morning of 12/18/02, I woke up feeling dizzy.  Every morning now I am dizzy, and when I am in certain positions (looking up, head tilted backwards to rinse shampoo out of hair, bendign over to pick something up,etc) have a dizzy sensation for a few seconds.
Information was received from a pharmacist regarding an patient of unknown age and gender who received a dose of pneumococcal vaccine (unspecified manufacturer) on an unspecified date (lot and expiration were not reported). The pharmacist reported that the patient's 'hands swelled up' after receiving pneumococcal vaccine. Causality and outcome were not reported. Additional information has been requested.
patient complains of pain the arm since she has gotten the vaccine, so painful that she says she cannot raise her hand over her head, she went to her doctor who gave her muscle relaxers and pain medication,  doctor is still trying to assess what is specifically causing the pain
This case was retrieved via a search of scientific literature on 14 November 2011. This reporter also reported other adverse events, which were captured in case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11221, 2011-11223, 2011-11224, 2011-11225, 2011-11226, 2011-11227, 2011-11228, 2011-11229, 2011-11230, 2011-11231, 2011-11232, 2011-11233, and 2011-11234. Verbatim from the abstract: "Background: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Methods: Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. Results: CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". A 6-month old infant (sex not reported) received an injection on an unknown date (route, site, manufacturer and lot number not reported) of DTaP. The patient had no medical history. On an unknown date the patient developed brachial neuritis 7 days after the vaccine. The causality was reported as probable. The outcome was not reported. Documents held by sender: None.
Initial report was received from a healthcare professional on 17 November 2011. A 45-year-old female patients had received an intramuscular (IM) injection of ADACEL; lot number U4090BA (sanofi pasteur Ltd. lot number C3961) in the right deltoid on 17 November 2011. On the same day of the injection, the patient developed a "7x6 cm" dark (pigmented skin), swollen and warm distal from the injection site (10 cm below the injection site). The reporter stated that it looks like a sterile abscess. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Follow-up information was received from a health care professional on 22 March 2012. The patient was vaccinated on 17 November 2011 and on 21 November 2011 she was re-examined. The patient had noted swelling about 8 hours after immunization. On 20 February 2012, the patient noted no residual pain and no scarring. The injection reaction resolved over a 3 weeks period. No antibiotics were needed. The patient's outcome was recovered. Documents held by sender: None.
Within 24 hours, developed fever 101 degrees and body aches that lasted for 3 days. I was unable to get up and move around due to body aches and fever, even while taking my ibuprofen prescription (600 mg) every six hours.  I missed 3 days of work. On the 4th day, fever subsided but migraine persisted for 3 more days. This migraine was unresponsive to my migraine medicines (Triptans ) I have never had side effects from any vaccine before (other than a sore arm).
Patient fainted about 1 min and 30 seconds after injection. Pt. regained consciousness about 10-15 seconds later. She was sent to the ER due to injuries sustained by the fall.
Information has been received from a female in a physicians office concerning a 4 or 5 year old male who in approximately 2000 at one year of age was vaccianted with a dose of varicella virus vaccine live. On approximately 5/9/2005 the patient was seen in the physicians office with 100 lesions all over his trunk, neck, and face. It was reported that he had no fever or other symptoms. As of 5/16/2005, the patients recovery status was unknown. No product quality complaint was involved. Additional information has been requested.
Patient has a history of chronic  panic attack . Present with signs and symptoms of anxiety. Patient reports feeling light headedness and dizziness after vaccine. Vitals all in normal limits . After being asked patient reports feeling better.  Patient walk.
A month after getting my second  Moderna vaccine, I had a large lump (size of Large cherry tomato) that appeared under my left  armpit, the same arm as my vaccine. It appeared over night and was a bit tender.  I went to an appointment with Dr. He did an ultra sound , and in talking I mentioned it was the same arm as my Moderna vaccine. Dr. stopped right there and said they have been seeing lymph node swelling on some people that had the vaccine. He wanted to wait a month and see what happens. My follow up appt is Tuesday and the lump cannot be found.
Patient said the morning after immunization his arm was swollen, hot, sore.  He came to pharmacy on 09/27/2011 at 8:30 pm and reported the side effects to me.  He stated that it was no longer sore but this arm was still swollen, hot and red.  I called his MD on 09/28 and reported incident.  The patient was seen on 09/29 and given antibiotic and MD says patient had local reaction.
Patient reported warm, painful red area at site of ZOSTAVAX injection on Sunday, 7-24-16. She saw doctor on Monday 7-25-16 and was destroyed with cellulitis and prescribed antibiotic.
About an hour after receiving the vaccine I started getting pins and needles in my face/jaw.  About 2 hours later my blood pressure was high - 150/90  (checked on a home monitoring machine) and then I started with heart palpitations which lasted throughout the night - did not sleep more than an hour or two.  Next day around noon had diarrhea a few times - tired and weak.  Slight headache for about 4 days.  Nausea for about 3 or 4 days.
Glaring menstrual changes. My cycle for years has typically been 31-35 days. Since getting the second dose of the covid vaccine, my cycle has shortened to 25 days with spotting around days 20-23. I haven't had consistent spotting since I was 13 years old...I'm now 33 and all of sudden it has started again. I think the vaccine caused this.
Dizziness / dizzy; Muscle weakness / weak in his muscle; Felt nauseated / stomach is nauseous; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "Dizziness / dizzy"; MUSCULAR WEAKNESS (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "Muscle weakness / weak in his muscle"; NAUSEA (non-serious) with onset 24Mar2021, outcome "unknown", described as "Felt nauseated / stomach is nauseous"; FATIGUE (non-serious) with onset 24Mar2021, outcome "unknown", described as "Tired".  Additional information: The events dizziness / dizzy and muscle weakness / weak in his muscle lasted for 3 hours, as reported.  No follow-up attempts are possible. No further information is expected.
Hives on both arms and face but resolving.  No SOB.  O2-98;  HR-94; BP 174/103
Tested positive for COVID-19.  Symptoms: started with night sore throat (minor), followed by slight fever and runny nose. Prescribed Paxlovid one day after symptoms. Took Paxlovid, isolated 5 days. Symptoms gone in 2 days. No rebound. No short or long term effects. Very mild.
3 days p/vax pt c/o h/a, chills, fever & nausea;went to MD given phenergan suppository & APAP;pt still feeling bad;pt adm to hosp for test;did spinal tap poss infect; 60 day follow-up received on 08/14/00 provided no additional data. 60 day follow-up provided no additional data.
25th Jan-body aches, fatigue, HA, nausea 26th Jan 2021-Body aches, fatigue, HA, N/V, Chills, severe low back pain, bilateral arm tingling 27th Jan 2021-Body aches, HA, fatigue 28th Jan 2021-Fatigue
nonradiating chest pain/ Myocarditis; 1 day of fatigue and arm soreness after vaccination; 1 day of fatigue and arm soreness after vaccination; The initial case was missing the following minimum criteria: unspecified suspect product. Upon receipt of follow-up information on 26Nov2021, this case now contains all required information to be considered valid. This is a literature report.  A previously healthy 19-year-old man presented with sudden onset of severe, nonradiating chest pain 3 days after receiving a second dose of a messenger RNA (mRNA) SARS-CoV-2 vaccine. He noted 1 day of fatigue and arm soreness after vaccination, which resolved before the onset of chest pain. There was no associated dyspnea, nausea, or vomiting. Work-up included a negative SARS-CoV-2 polymerase chain reaction test result, electrocardiography with diffuse ST-segment elevation, and high-sensitivity cardiac troponin T level of 1029 pg/mL (reference range, 0 to 19 pg/mL). A transthoracic echocardiogram showed left ventricular systolic function within normal range (ejection fraction of 58%), with no regional wall motion abnormalities and no pericardial effusion. He was admitted and received ibuprofen and colchicine. His pain resolved by the following morning. Troponin T levels peaked the day after presentation at 1273 pg/mL; repeated measure of troponin T level 1 month later was within normal range (10 pg/mL). Echocardiography done 4 days after presentation was normal, with an ejection fraction of 67%. Three months after presentation, the patient was asymptomatic. A 7-day ambulatory rhythm monitor showed 25 isolated ventricular ectopic beats. An exercise stress test was normal. A cardiac magnetic resonance image (MRI) showed a small area of subepicardial late gadolinium enhancement but no definite signs of active myocardial inflammation.; Sender's Comments: Based on the currently available information the possibility of causal association between the event myocarditis and the suspect drug BNT162B2  cannot be ruled out. 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.
Four days after vaccination, patient had 102.4° fever, aches, chills. Five days after vaccinations, 101° fever, aches, fatigue. Six days after vaccination, 99° fever, diarrhea, aches, fatigue.
pt tested positive for COVID; asymptomatic; treated with ABX and steroids; pt continues to remain asymptomatic and requests to dc ABX and steroids; medications dc'd 1/18/22; pt found deceased in his bed on 1/19/22
Event at the park, was given the moderna covid vaccine even though the patient wasn't at least 18 years of age on 03/29/2021.
Painful aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Painful aches and pains) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 16-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (Painful aches and pains). At the time of the report, PAIN (Painful aches and pains) outcome was unknown. Not Provided          The patient's medical history was not provided.  No relevant concomitant medications were reported. The patient did not receive any treatment. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable. Reporter did not allow further contact.