chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had COVID after taking Pfizer vaccine and booster; patient had COVID after taking Pfizer vaccine and booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "patient had COVID after taking Pfizer vaccine and booster". Clinical course: A 64 (age unit unknown) male patient had COVID after taking Pfizer vaccine and booster, so the patient doesn't need any more vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 2 days after receiving SHINGRIX, the patient experienced muscle pain, lethargy, malaise, activities of daily living impaired and pain upon movement. On an unknown date, the outcome of the muscle pain, lethargy, malaise, activities of daily living impaired and pain upon movement were recovered/resolved. It was unknown if the reporter considered the muscle pain, lethargy, malaise, activities of daily living impaired and pain upon movement to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced extraordinary muscle aches and pain as well as lethargy and malaise after getting SHINGRIX about 3 months ago from the date of reporting, she lost a week of her life because it was too painful for her to move due to muscle aches all over her body. After a week the patient woke up and the symptoms had resolved.
patient reports arm and shoulder pain since time of vaccination in the right arm. she has not seen her doctor yet, but has plans to see her physcian in the future
I started to get hives approximately two hours after I got the shot.  I ran a fever that night.  This was two weeks ago and I am still getting the hives.  The only thing that helps is taking a Benadryl.  I take Allegra during the day so I can function, but it is not as effective.  The hives itch and are red blotches on my body.  I did not eat or drink anything from the time between the shot and the reaction.  I notified the nurse who gave me Benadryl.  She is now suggesting I get a dose pack since the hives are not going away.
Patient diagnosed with dural sinus thrombosis, our stroke team believes this to be an incidental finding, as this was ordered for initial work-up of new onset headache. However, symptoms had resolved completely by time of COVID vaccination on 3/14/21.
Pt had symptoms of cellulitis (redness, swelling, pain and heat at site of injection) that started the day after the injection. She waited a couple days and then went to the urgent care and got diagnosed with cellulitis. She recieved KEFLEX, BACTRIM and some ibuprofen.
Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore left arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (Sore left arm). At the time of the report, MYALGIA (Sore left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported.   This case was linked to MOD-2021-356258, MOD-2021-356046 (Patient Link).
weakness in his legs; Myositis; The weakness progressed to his arms and then to the point where he couldn't walk.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 58 years 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: MUSCULAR WEAKNESS (non-serious) with onset 2022, outcome "not recovered", described as "weakness in his legs"; MYOSITIS (non-serious) with onset 2022, outcome "not recovered", described as "Myositis"; GAIT INABILITY (non-serious) with onset 2022, outcome "not recovered", described as "The weakness progressed to his arms and then to the point where he couldn't walk.". The events "weakness in his legs", "myositis" and "the weakness progressed to his arms and then to the point where he couldn't walk." were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscular weakness, myositis, gait inability.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (07Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Patient came in complaining of chest pain, difficulty breathing and light headedness. Patient evacuated to emergency room. Had similar reactions with first doses but less severe, not reported.
Information has been received from a medical assistant concerning a 6 year old female patient who on 16-NOV-2000 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Breakthrough case admission after two vaccines Janssen 3/14/21 Lot# 1805020;  Janssen 11/10/21 Lot# 1855194
pt recv vax 23DEC96 & 4 days p/vax pt exp a rash & hives;tx w/DPH;
10:50 RIGHT ARM AT SIDE, SORE. ENCOURAGED TO MOVE ARM FREQUENTLY. STATES SITE ITCHING. ICE APPLIED. 11:05 PATIENT SAYS THAT ITCHING HAS STOPPED. NO MORE ITCHING OR OTHER SYMPTOMS PER PATIENT.
Case became light-headed, dizzy and unsteady on feet. BP dropped to 76/40. Case was extremely diaphoretic. Diaphoresis and dizziness lasted approx. 10-15 minutes. AP 48 initially. Case given crackers, juice and H2O due to not eating lunch. BP after 20 minutes was 104/76; AP-56. Rechecked after another 10 minutes and BP 118/80 and AP-56. Case then stated fells fine and left office. Case called me about 1 hour later at 14:00 and stated he was fine.
pt recv vax & 2wk p/vax pt exp a serum sickness-like rxn;pt also devel a maculopapular, erythematous rash;pt also exp low grade fever 99-100 & some diffuse joint pain;
Patient was given Moderna vaccine and patient is only 17 years old. No signs and symptoms of adverse event to the vaccine.
Client was to receive Pfizer Bivalent Booster. Client was instead administered Pfizer monovalent shot. Client had no symptoms or adverse effects while being self-monitored in the waiting lounge for 15-25 minutes. Client was called on the listed phone number on 1/5/23 @ 1106. Talked to father. Father stated that client is sleeping at the time and will let her know. Client father stated that client had initial arm soreness that dissipated after 24-48 hours. Client father was shared the vaccine administration difference and educated. Was offered Bivalent administration in 8 weeks from date. Client father stated no further needs or concern at this time.
Rash/hives started at 3:45 pm, Gave 100 mg IM of diphenhydramine at Left Deltoid at 3:47 pm  patient complained of heaviness in chest at 3:51 pm, called 911  patient reported Dizziness at 3:59 pm, BP was 179/128 HR 105 Paramedics arrived at 4:01 pm, patient was reporting feeling better, BP 177/127 HR 100
patient got booster dose of moderna on Saturday. Monday began experiencing redness, swelling, pain shooting to fingertips, hot to touch at the injection site. she was advised to see her physician by us. She had appointment and was confirmed cellulitis. patient was given antibiotic
Rash/redness left arm 3 days after imms. Pain at site night of and next day. All Sx resolved 3-12-17.
Left arm tender to touch and sore from shortly after time of injection until present. Flu-like symptoms starting from approximately 1:00 PM 4/9/19 (day of injection), extending until bedtime same day and each day following until 4/11/19, partially relieved by ibuprofen.
Approximately 3 months after vaccine, I began experiencing tremors in hands, unsteady balance, began running into walls and furniture, and frequent falls. Doctor prescribed B12 and symptoms have improved.
Pt. fainted after a couple minutes past shot. Breathing slowed, went pale but color would return. Called 911 they provided oxygen, and took patient away.
24 hours after the vaccine had red spots on both legs and leg/abdomen cramping started.  48 hours after vaccine started a menstrual cycle after being in menopause for 19 months.  Extremely heavy bleeding with severe leg and abdomen cramps lasted 4 days.   Once the bleeding stopped, abdomen cramps continued but slowly subsided after a couple of weeks.  Leg pain and red spots continued.    I contacted my health insurance , but they weren't able to provide any good information.  My primary physician retired, so the only doctor appt I was able to get was my OB/GYN on April 26th.    On approx April 11/12th I noticed a large bruise on the back of my right calf, but had not hit it on anything .  I also felt a large lump under where the bruise was.  A few days later, on April 24th  my calf was extremely swollen, and was still experiencing pain in both legs.  This was Saturday evening so I reached out again to the ask a nurse and the reply was "this should not be vaccine related, it's been too many weeks".  I had my OB/GYN appt the following Monday, and she took pictures of my leg and also measured my calf, but the swelling had gone down quite a bit.      Bruise and leg pain eventually went away within a few weeks.  No confirmation but suspicions of a blood clot
pt recv vax 10DEC96 & pt father reported pt exp tremors of arms/legs & sweating alot;denied inc temp;reported high pitch cry x several mins-quietens then begins again;sent to ER-hosp 24hr for observation;
Pt stated initially she was dizzy w/ a h/A. After observation pt came back c/o chest pain mid substernal.
ACUTE KIDNEY INJURY; SEPTIC SHOCK; This spontaneous report was received from literature: This report concerned a 64 year old male. The objective of this study was to describe fatal and non-fatal possible AEs after COVID-19 vaccine administration. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, type 2 diabetes mellitus, lymphoma, and obstructive sleep apnea. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced acute kidney injury, and septic shock. On an unspecified date, the patient died from septic shock, and acute kidney injury. It was unspecified if an autopsy was performed. The action taken with COVID-19 vaccine AD26.CoV2. was not applicable. The authors concluded that Although reported AEs are not necessarily caused by the vaccination, this study provides further information about possible AEs after COVID-19 immunization, especially those requiring hospital admission. This study also supports prior data that serious AEs post vaccination are much lower than primary COVID-19 infections. Further studies are needed to investigate causalities between vaccines and reported AEs across all age groups. This report was serious (Death). This case, from Same Literature article is linked to 20211045466 and 20211048130.; Sender's Comments: V0- 20211060043 covid-19 vaccine ad26.cov2.s- Acute kidney injury, Septic shock. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: SEPTIC SHOCK; ACUTE KIDNEY INJURY
Moderna rec'd last Thursday, the injection was pushed in deep and by the evening the pain at the injection site was unbearable, she injected pretty high in my arm and it started to sting.  After 4 hours the pain was unbearable and my range of motion was limited and the it feels very hot.  I cant sleep because of the pain and have to take Motrin to even function.
Vomiting, fever and a 7 x 4 1/4 cm red,swollen, warm to touch area on the R posterior upper arm. Patient was alreaday on Doxycycline for ear cellulitis.
developed new rash over back and arms, started after cholecalciferol and hydroxyzine started.  continue to worsen after medications stopped
fever of 102F; soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102F) and PAIN IN EXTREMITY (soreness in his arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm). On 21-Feb-2021, the patient experienced PYREXIA (fever of 102F). At the time of the report, PYREXIA (fever of 102F) was resolving and PAIN IN EXTREMITY (soreness in his arm) outcome was unknown.            No concomitants and treatment medications were not reported.
really tired; no energy; pain in her shoulder where she got the vaccine was reported as worsened/it's worse today; her arm was sore; has shoulder pain at the injection site; feeling really terrible; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 17:30 (Batch/Lot number: unknown) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sleep" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE taken for sleep disorder. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Mar2021, outcome "not recovered", described as "has shoulder pain at the injection site"; FEELING ABNORMAL (non-serious) with onset 04Mar2021, outcome "not recovered", described as "feeling really terrible"; FATIGUE (non-serious) with onset 05Mar2021, outcome "not recovered", described as "really tired"; PAIN IN EXTREMITY (non-serious) with onset 04Mar2021, outcome "not recovered", described as "her arm was sore"; ASTHENIA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "no energy"; CONDITION AGGRAVATED (non-serious) with onset 05Mar2021, outcome "not recovered", described as "pain in her shoulder where she got the vaccine was reported as worsened/it's worse today". Therapeutic measures were taken as a result of vaccination site pain, feeling abnormal, fatigue, pain in extremity, asthenia, condition aggravated.  Additional information: The reporter mentioned that she had her 1st COVID shot yesterday (04Mar2021) and is feeling really terrible, really tired, and has shoulder pain at the injection site. She is calling while laying in bed and is asking how long should these side effects last. The patient received the vaccine and right shoulder. She took Tylenol for the shoulder pain; her arm was sore yesterday but it's worse today. She took Tylenol last night and maybe about a half hour ago today. When querying medications and medical history, she states she has medications but she doesn't feel like reporting them. Vaccine not Administered at Military Facility. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and no additional Administered Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect. AE(s) did not require a visit to Emergency Room and Physician Office. No prior Vaccinations (within 4 weeks) and regarding AE(s) following prior vaccinations a long time ago when she found out she had sulfa (as reported), but that was a long time ago it was probably about 30 years. No relevant Tests. Other Products: Unknown, Patient History: Unknown, Investigation Assessment: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Woke with a 99.5 fever, nausea, headache, sore arm, aches and tiredness. Symptoms worsened as day progressed. Temperature was steady at 99.1 all day/night with increased severe aches and tiredness and chills. Also developed swollen lymph node in left side of neck. This happened after both the first and second shots except were on the right side instead of the left (this coincides with arm in which I received the vaccine). lasted 2 days after the first two vaccines.
?numbness on the left side of my face for 10 days ?headache for 2 weeks ?very sore arm for 4 days
I started experiencing upper abdominal pain on my left side Monday,  November 22, 2021, three days after my booster (3rd) Pfizer vaccine.  On Thursday, November 25, 2021, I went to the Emergency Room at the Hospital on Thursday, November 25, 2021, where I was diagnosed with Pancreatitis.
Approximately 18 hours after receiving the vaccine, I developed a fever ranging from 101-102.4.   I had muscle aches and for a short time, blurred vision.  After resting for approximately 12 hours, taking Tylenol and drinking water, my symptoms subsided.
This was my booster shot. Previously I received J&J March 2021 and has a headache for 8 hours.  With the booster I had swollen lymph nodes the next day under my left armpit, I could not lift my arm for 3 days. 2 days after I noticed I had an elevated heart rate and started having chest pains. These are still occurring after day 5. It?s possible it trigged a thyroid flare up for me as my Graves? disease has been under control.
Broke out in rash starting 11-19-02. Seen PAC on 11-22-02 with diffuse rash covering face, neck, abdomen and shoulders. Spotty on legs. Rx: Tapering dose Redi-Pred. 11-27-02 almost gone.
My child became very sleepy, and slept for five hours straight. She has also become very fussy cranky and has also been crying for no reason.
Patient claims that she started having headaches the day after she received the vaccine (received on 11/30/21).  She claims that she has been having headaches since then and has since been diagnosed with migraine headaches which she says she may have as many as 4/day.  She claims that she has had imaging done which showed no evidence of blood clots in her brain and she has been referred to a neurologist.
4 days after dose 2, hives all over body, itchy/swelling/red
flu symptoms ; tiredness ,headache , muscle and join paint ,slight fever , cough , running nose ,  feeling unwell  these symptoms start second day of the vaccination on 1/15 2021 , and I'm still sick today is my 4 th days after vaccination .
My right eye began swelling shortly after the shot. Turned red, painful, watery, worsening of double vision. Diagnosed with episcleritis 5/12/2022. Also, the morning after the vaccination I was "seeing stars" and feeling faint.
3-4 hour after vaccination, child had inconsolable cry w/body shaking per mom. TYLENOL given and symptoms resolved about 2-3 h after.
ACUTE RESPIRATORY FAILURE 4/12/2023 LUMBAR VERTEBRAL PATHOLOGICAL FX, INIT ACUTE RESPIRATORY FAILURE 4/12/2023 NEUTROPENIC FEVER, UNSPECIFIED
No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-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. On 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant medication information was provided.  The vial was thawed on 10Jun2023.  No treatment drug information was provided.  The case corresponds to 16th out of 30 patient as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow-up received, updated suspect drug start date and I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
I administered patient's first shingrix vaccine of the 2 dose series and she stated she was fine until she got up to leave and stated that she felt funny (dizzy, lightheaded, "off" is how she described it to me at the time).  She sat back farther in her chair, starting to sweat and was slightly slumped over in the chair.  I immediately put an ice pack on her neck and within a few minutes she asked how it got there.  She stated that she has never had a reaction to a vaccine before and that she remembers feeling fine up until she was ready to stand up & then all of a sudden not feeling ok.  She sat in our immunization area for ~20-25 minutes and at that point stated that she was feeling better (no sweatiness, dizziness, light-headedness)... and felt well enough to leave.
Fever up to 102.0F, severe headache, severe muscle aches, dizziness, nausea, exhaustion and possibly "brain-fog."