chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started 2 days ago (9/18/16) with swelling, warmth and itching to Right arm Treated w/10 day course antibiotic.
low grade fever 99.8 F, slight nausea, over feeling not well, fatigue
Heavy breathing , felt like something heavy was on my Chest , coughing so much . Diagnosed with bronchitis, given a steroid , and an inhaler
Expired vial was initially stored in the refrigerator on 20-Sep-2022; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 20-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator on 20-Sep-2022).    Concomitant product use was not provided by the reporter.  The information was unknown whether the patient had ever been diagnosed with or tested positive with COVID-19.  The information of acute illness at the time of vaccination and up to one month before was unknown.  Expired Moderna vaccine was given to the patient. The vial was taken out of the freezer recently.  The vial size was 5.5 ml.  The vial was initially stored in the refrigerator on 20-Sep-2022.  The vial did not undergo temperature excursion.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-648572 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow-up information received included updated reporters address.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648572:Master case
The day after the 2nd dose, I woke up at around 1350 est.  I was dizzy/lightheaded, and felt odd as if I was going to pass out.  This lasted for about 4-5 hours.  In addition, I have a large knot on my arm at the injection site and my heart /left side of chest feels tight.  I had to lay on the right side of my body last night, because laying on the left side hurts.
Information has been received from the physician concerning a now 20 years old female patient who was vaccinated with two series of RECOMBIVAX HB - three doses of first series were given on 26-Oct-1992 (dose, route and lot # not provided), 09-DEC-1992 (late) and 15-MAY-1993 (late) respectively. Physician reported that the patient had "low immunity" to the first series of RECOMBIVAX HB, so a second series of was given. Three doses of second series were given on 10-AUG-2010 (lot # 666187/1484Y), 24-NOV-2010 (lot # 666029/1456Y) and 28-JAN-2011 (lot # "AHBLOVB868CE", not valid for the vaccine) respectively. All expiration dates were not provided. Physician reported that after receiving the second series, the patient's immunity was "low at 0.26". The patient had blood work, result was not provided. The patient saw the physician to seek medical attention. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. The patients did not seek medical attention. Follow up information has been received from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 27-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
back pain; neck pain; Shoulder pain, Hip pain, joint pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), NECK PAIN (neck pain) and ARTHRALGIA (Shoulder pain, Hip pain, joint pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced BACK PAIN (back pain), NECK PAIN (neck pain) and ARTHRALGIA (Shoulder pain, Hip pain, joint pain). At the time of the report, BACK PAIN (back pain), NECK PAIN (neck pain) and ARTHRALGIA (Shoulder pain, Hip pain, joint pain) outcome was unknown.            Concomitant medications were not reported. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-230245, MOD-2021-230245 (Patient Link).
Hives on chin approximately 1 hr after injections were given. Fever developed within 24 hrs.
Information has been received from a nurse practitioner NP concerning a 12 month old male patient who was vaccinated with a dose of measles virus vaccine live (enders Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (upgrade process). Subsequently, on approximately on 4/7/2006, the patient experienced a maculopapular rash from head to toe. It was reported that at the time of rash onset, the patient was also taking amoxicillin. Unspecified medical attention was sought. No outcome was reported there was no product quality complaint. Additional information has been requested.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar adverse events for three patients. This is the second of three reports. An adolescent female patient of unspecified race/ethnicity received on an unknown date a single dose of TRUMENBA for immunization. Medical history and concomitant medications were not reported. Next day after vaccination, the patient experienced chills. Outcome was unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018031111 Same reporter/product/event, different patient. US-PFIZER INC-2018031093 Same reporter/product/event, different patient.
17OCT91 neck down covered w/red blotches bumpy rash to touch; To MD dx w/hives; 18OCT91 dx w/erythema multiform;
Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion; Facility had a temperature excursion in the freezer; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) and NO ADVERSE EVENT (No Adverse Event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) 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 (Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer).    No concomitant medications were reported.  The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures. At the time of the excursion, the vaccine was in frozen storage. The vaccines were in broken cartons with vial size of 2.5 ml and 5.5 ml. Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer. The visual inspection showed the vaccine state as still frozen. The vial underwent temperature excursion for the first time.  No treatment information was provided by the reporter.
At 2am 4/30/21 woke up with a terrible headache that hurt so bad my molars hurt, chills, full body muscle aches, fatigue.  This lasted the entire day and through the next night and morning on 5/2/21 around 10am chills subsided, aches subsided  and I was able to finally get out of bed.  headache gradually went away throughout the day.  On 5/3/21, just felt fatigued all day. Then have been feeling back to normal since 5/4/21.
Day 12 after Varivax #1 given, developed erythema, increased warmth, pain, swelling 4 X 4.5 cm area left deltoid, & with tenderness left axilla. No nodes. Prescribed with Claritin 10 mg 1 day & ice pack. Reaction increased to 5 X 5 cm 1 day later. Prescribed with 10 mg Claritin 1 day. Reaction decreased over next week.
fatigue, achy, sore arm, rash (which appeared almost a week after the injection)
Per mom noticed swelling around the vaccine site the same day. Today noticed some redness around the area and slightly itchy. Denies fever, SOB, cough, vomiting or fainting. Otherwise baby acting normal (provider's notes).
Fever; Chills; Pain in the muscle and joints; Pain in the muscle and joints; Had continued fatigue for the two following weeks; This is a spontaneous report from a contactable consumer. A 34-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 05May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. On 05May2021, 12 hours after injection of the second dose of the vaccine, the patient experienced fever and chills, along with pain in the muscle and joints. He took paracetamol (TYLENOL) to reduce the fever. The patient had continued fatigue for the two following weeks. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of fever which included treatment with paracetamol (TYLENOL) (self-administered) to reduce the fever. The outcome of the events was recovered on an unspecified date of May2021.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
pt states a few days after getting the 2nd covid dose he had severe joint pains in both shoulders, both hips, and both thighs.  He has a lot of pain moving around felt like he had somebody punching him in both arms.  He went to his Ortho Dr. where he was given a shot of cortisone in his right arm.  This helped for about 3 days and then the pain came back.  He went to the doctor.  He had lab work with normal results.  He went to another doctor on 5/13/21.  He prescribed steroids.  This medicine seemed to help but after finishing the medicine his pain returned. On 5/29/2021 he went to Medical ER.  He had blood work and was prescribed more steroids.  He states his blood pressure has gone from 130/78 and now is 191/78.  He says his pain is better at this time while he is still on the steroid medication but thinks the pain will return once he completes it.
I felt like I had the cold symptoms; I have a cough and I was wheezing; I had a headache but it was mild and I felt tired but not too tired
This spontaneous report as received from a physician refers an unspecified number of patients of unknown age and gender. On an unspecified dates since 21-FEB-2015, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (dose, route, lot #, therapy type and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented at Urgent Care on 4/18 at approximately 1:15 pm.  Reports left arm pain, headache, chest pressure, chills, nausea, vomit 3x since Covid vaccine on 4/16. Reports feet turned red and swelled on Friday night, hands mildly swollen. Reports headache as 10/10.  Patient received a Torodol injection (60 mg); Promethazine injection (50 mg).  Performed Veritor Antigen Covid-19 Test - Negative. Prescribed Mobic 7.5 mg (1 PO BID) (qty 14); Prescribed Promethazine  25 mg (1 PO QID PRN) (qty 14).
fever, chills, headache, aches in every imaginable joint.  Tylenol taken three times in first 24 hours, then nothing to "burn out the fever."   48 hours total.  Fever 101 throughout the 48 period.
pt recv vax 15AUG94 & OCT94 pt exp a rash over the trunk of body;ER or MD visit was required;
Patient reports bumps and raised lesions on both sides of trunk along with down the length of the arms. The "rash" appeared about 24-48 hours after receving vaccination. The rashes began to go away after about 1 week. Patient also had swelling and redness at sight of injection.
Patient presented to the pharmacy after leaving the hospital stating he was experiencing shoulder pain after receiving a shot on 12/18/22. Patient said he ha seen the doctor and went to the hospital.
Information has been received from a health professional concerning a 6 year old male pt who was vaccinated 04/20/1998 with a dose of varicella virus vaccine, live. Subsequently, on approximately  02/20/2004, the pt developed breakthrough chicken pox with less than 50 lesions. Follow up information indicated that "there was not a single report of an adverse reaction following varicella vaccination". The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox ( WAES # 0405USA02615, 0405USA00572,  0405USA00573,  0405USA00574,  0405USA00575,  0405USA00576,  0405USA00577,  0405USA00578,  0405USA00579,  0405USA00580, 0405USA00581, 0405USA00582, 0405USA00583, 0405USA00584, 0405USA00585, 0405USA00586, 0405USA00587, 0405USA00588, 0405USA00589, 0405USA00590, 0405USA00591,  0405USA00592, 0405USA00593,  0405USA00594,  0405USA00595,  0405USA00596, 0405USA00597, 0405USA00598,  0405USA00599,  0405USA00600,0405USA00601, 0405USA00602,0405USA00603, 0405USA00604, 0405USA00605, 0405USA00606, 0405USA00607, 0405USA00608, 0405USA00609, 0405USA00610,0405USA00611, 0405USA00612, 0405USA00613, 0405USA00614, 0405USA00615, 0405USA00616, 0405USA00617, 0405USA00618, and 0405USA00619).
pt recvd vax; pt exp abdo pain, headache, pain; pt devel also itchy, swollen eyes;
patient fainted. was only unconscious for a few seconds, came to, and was fine afterwards. pt admitted afterwards that he has a fear of needles and was nervous.
No additional AE info; TE evaluation of refrigerated products; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.   On 19-APR-2022, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot #1780867, expiration date: 08-AUG-2023 (strength, dose and route of administration were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  On an unknown date, before the vaccination, the sample of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) underwent a temperature excursion at 58.5 Fahrenheit degrees (F) for 4 hours and 2 minutes. No previous temperature excursions were reported.
Onset 7/21/05 fever 102.5F. Dx: URI-7/25/05. Rash from neck down. Dx: Rubella reaction to MMR shot.
13FEB93 fever 103, aching; 26FEB93 swelling all joints, severe pain; 27FEB93 went to ER, hands, legs, feet extremely swollen & painful;
The patient presented to the office, under the accompanyment of her mother, for administration of the third Gardasil vaccine. They denied any previous reactions to the vaccine and reviewed the VIS sheet. The patient was administer Gardasil IM in her left deltoid and the Havrix IM in her right deltoid while sitting on the exam table by LPN. While she turned around to dispose of the used needles, the patient fell face first off of the table onto a laminate tile floor. LPN immediately alerted myself, and MD to the patient falling. We came into the room and found the patient lying on the floor with her head turned to the side. LPN reported that the patient had been unconscious for a few seconds prior to us coming into the room. The patient was turned to a supine position and allowed to rest on the floor for a few minutes, then helped onto the table to lie down. She was then examined by myself and found to have normal vitals, contusions to her nose and forehead, and slight bleeding of the upper gum. LPN stayed in the room with the patient to monitor her until about 3:15. Then I checked on the patient periodically (approx Q5-10 minitues) for the next hour. The patient was discharged from the office in the care of her mother and father, and was advised to get a facial xray done that day to rule out facial fractures and to follow up with a concussion specialist and a dentist the next day to rule out concussion and any dental damage. The patient was found to have a concussion and is being followed by MD. One of her teeth was found to be loose and she is being followed by her private dentist.
Information has been received from a registered nurse concerning a male who on 06-AUG-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On an unspecified date the patient developed varicella. At the time of reporting the patient's status was unknown. It was also reported the patient's sibling had an adverse experience WAES # 0710USA02657. Follow-up information received on 26-FEB-2008 indicated the reporter could not not identify the patient in their records from the information that was provided. Additional information is not expected.
This study case was received from the investigator on 27 August 2012. A male subject with a medical history of Lasik and use of topical steroids to treat an eye problem/disease in November 2006, had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced chest pressure on 03 May 2010 (also with a reported date of 05 May 2010). Treatment (other than medication) was provided to the subject. On 05 May 2010, the subject had a rapid Troponin I level that was within normal limits (negative) and central laboratory Troponin I levels of <0.10 ng/ml. On 05 May 2010, the subject had ECG reading of "Abnormal: NCS." On 05 May 2010, the subject experienced non-serious events of nausea, feeling light-headed, and feeling clammy. There was no other reported visit. 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 chest pressure was possibly related to vaccination with ACAM2000, and was considered to be an Other Important Medical Event. 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.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
stiffness; feeling foggy; tiredness; body aches; headache; Chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), FEELING ABNORMAL (feeling foggy), SOMNOLENCE (tiredness), PAIN (body aches) and HEADACHE (headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CELECOXIB (CELEXA [CELECOXIB]), ERGOCALCIFEROL (DRISDOL), GABAPENTIN, QUETIAPINE FUMARATE (SEROQUEL) and AMLODIPINE for an unknown indication.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), FEELING ABNORMAL (feeling foggy), SOMNOLENCE (tiredness), PAIN (body aches), HEADACHE (headache), CHILLS (Chills) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness), FEELING ABNORMAL (feeling foggy), SOMNOLENCE (tiredness), PAIN (body aches), HEADACHE (headache), CHILLS (Chills) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Severe fatigue, severe body aches, fever up to 103, chills, headache, brain fog
Reactions started a couple days post vaccination. Fever (101.5), body aches, malaise, headache (10/10), chills, brain fog, paresthesia on both sides/back and left fingertips.  All basically resolved by Thursday September 17th EXCEPT for paresthesia, brain fog, malaise and extreme fatigue.  Was seen by ER on September 17th and follow up with Primary Care on September 20th.  Infectious Disease phone consult on September 23rd who have referred me to Neurology.