chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case received from Health Authorities under reference-745497. This case involves a 37 years old male patient who experienced arthus reaction, warmth, induration and consisting of pain, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 11-Apr-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On 13-Apr-2018, 2 days (also reported as 12 hours) after the vaccination the patient experienced arthus reaction (type iii immune complex mediated reaction), feeling hot, induration and pain. Arthus reaction was assessed as medically significant. (Other relevant tests included no lab data.) Final diagnosis was arthus reaction, feeling hot, induration and pain. It was not reported if the patient received a corrective treatment.  The outcome of the events was reported as unknown for all events. List of documents held by sender: none. Amendment: 01-Apr-2019 Upon second medical examination of the case during internal review, a significant correction was performed on 01-Apr-2019 to correct the case seriousness which was upgraded due to IME convention (type III immune complex mediated reaction); Sender's Comments: This case involves a 37 years old patient who developed Arthus reaction consisting of pain, warmth, and induration 12 hours post vaccination with ADACEL Time to onset is compatible with the role of vaccine. More details regarding patient's condition at the time of vaccination, immune status, previous vaccination history, etiological workup and investigation reports to identify alternative etiology particularly infectious are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Fever, chills, extreme nausea. Went to bathroom to vomit but could not. Next thing I know I wake up on the floor about an hour later soaking wet.  When I washed my hair a day later I found a sore bump on my head at the site where I would have hit the tiles from a sitting position by the toilet. I have no memory of hitting my head.
Patient received an needlestick injury/exposure at work.  Case was discussed with hotline through the CDC regarding initiation of postexposure treatment for HIV.  Risk and benefit of starting HIV postexposure prophylaxis was discussed with patient and he is declining initiation of treatment at this time.  Patient reports that he is up-to-date on his tetanus shot.  Patient believes that he received hepatitis B vaccination series in the past either as a child or before working in correctional facility, however, unable to confirm at this time.  Hepatitis titers ordered, but results pending.  Given inability to confirm vaccination status/unknown vaccination status of patient and unknown hepatitis B status of the source patient, patient was provided with a dose of the hepatitis B vaccination series while in the ED.  However, after patient was discharged, it was noted that he received the pediatric dose of the vaccine.  Spoke with pharmacy who stated that to err on the side of caution, it would likely be most beneficial for patient to come back to the ED and receive the additional dose of the adult hepatitis B vaccine.  Patient was called and advised to return to the ED, but states that he has a follow-up appointment scheduled for tomorrow and he would rather follow-up with them for additional vaccination as needed.  Discussed that the protocol regarding this is unknown and that it is possible that given the inadequate dose provided in the ED for the initial vaccine of the series, it is possible that it would not have the same efficacy.  Discussed that it is unknown whether or not occupational health/PCP would provide additional vaccination dose as well.  Patient reported understanding and stated that he would still rather follow-up with them tomorrow. Patient advised to bring a copy of his vaccination records to his appointment tomorrow. Strict ED return precautions were discussed and patient reported understanding.  Patient returned the next day 10/10/2023 and received the adult Heplisav B Vaccine.
I tested positive for Covid; I tested positive for Covid; This is a spontaneous report received from a contactable consumer (patient).  A patient of unspecified age and gender received second dose and first dose of BNT162B2 on unspecified date approx 6 months prior to the time of report at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Yesterday (03Jun2021) patient tested positive for Covid, patient had many symptoms. Fever, chills, sore throat, headache, fatigue, runny nose and cough. The doctors patient have seen say they have never seen a case like mine before. Patient would like to be tested by you to figure out why I am having breakthrough symptoms. Patient have no underlying conditions. The outcome of the event was unknown.  Information about lot/batch number has been requested.
chills; pressure on her chest; she was not able to breath when walking; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2, via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 (she contracted the infection on December). When she had the infection the first time she presented no symptoms but found out that she was infected because she had a positive PCR lab test, after that she developed sever tiredness and shortness of breath. Patient also had pressure on her chest. The patient's concomitant medications were not reported. The patient wanted to know if she should receive the second dose of the Pfizer COVID-19 vaccine taking into consideration her reaction to the first dose, she received the first dose on 06Apr2021, 5 days later she started to develop chills (on 11Apr2021) that lasted for about 8 days, she also presented pressure on her chest similar to when she had COVID-19 and shortness of breath (she was not able to breath when walking), her physician indicated that the reaction that she was presenting could be due to her previous COVID-19 diagnose. Patient had presented these side effects for more than 12 days, patient had taken ibuprofen and acetaminophen to treat the chills, thanked to that the chills stopped on Sunday and she was able to go to work. When the chills were present the sensation was so bad that she could not get warm during the day or night even having 3 blanquettes on top. Outcome of event chills was resolved, and of other events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Patient required hospitalization due to breakthrough infection. She received Pfizer vaccine (2nd dose in series) on 03/26/21. Hospitalized from 08/04/21 - 08/10/21. Below is copied from discharge summary:   Patient presented to the ED in somnolent condition, complaining of peripheral weakness and paresthesias. Patient was noted to be in mild rhabdomyolysis with elevated CK, LFT, and hematuria, and was treated with IVF hydration. She was additionally given narcan which resulted in improvement in her somnolence. She was found to be COVID-19 positive, but remained asymptomatic, able to saturate normally on room air, and without respiratory distress. On further discussion with patient, it was discovered that the patient had obtained methadone and had been passed out for some unspecified period of time prior to coming to the ED. Over the course of her stay, the patient's lab abnormalities normalized, she remained hemodynamically stable with VS WNL, afebrile, and medically at her baseline. She is discharged at this time to the COVID hotel in stable condition.
I have a large misshapen circle around my vaccination site on my left arm. The ring is red and the area including the red ring and inside of the ring is raised. I have not received treatment for it.
Pt devel edema from elbow to shoulder, erythema, inflammation & warmth @ inject site p/receiving TTox for a needle-stick; Also devel fever of 102; tx Duricef;
I had a heart attack two days after Injection. I was just n vacation. I was transported by ambulance to hospital. I?m 33 year old male, exercise daily. Local cardiologist declared conditions was acute myocarditis. Infarction ruled out after arterial catheterization..
NJ CDRSS Case ID: 7303827  J&J Breakthrough Case  Case was scheduled to go into a surgery, but tested positive and was having severe symptoms including: Runny Nose (Rhinorrhea) / Sinus Congestion, Sore Throat, Loss of smell / taste, Headache, Fatiguen, Cough, Wheezing, Shortness of Breath (dyspnea)
Vaccine was administered in deltoid muscles, one each side.  On the day following the vaccinations, both sides of jaw were noted by spouse to be swollen; confirmed by patient and complains of pain upon opening mouth widely.  Also general malaise and fever.  Consulted personal MD office by phone and was advised to seek emergency care if symptoms worsened.  Symptoms seemed to subside toward evening, but returned the next day.  Went to personal physician - diagnosis vaccine reaction; Rx rest, oral fluids, aspirin prn pain or discomfort; expect complete recovery in several days.
She woke up Sat with headache, body aches and muscle aches. Around 10:30 pm night she was became dizzy passed out fell down the stairs.  I took her to the ER she required stitches (chin) and had some test to rule of chest pain.
Product storage error; no adverse event; reported excursion on 14Feb2023; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) in a 20-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jan-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023) and PRODUCT STORAGE ERROR (Product storage error).    Concomitant product use was not provided by the reporter.  One of the medical assistants reported excursion on 14-Feb-2023 previously. Now they are following up to see if the 6 doses administered to children during this time need to be revaccinated or not.   Maximum temperature was 1.8 C. Storage at time of excursion was freezer. Excursion duration was unknown for each day starting on 01-Feb-2023 and continued until 14-Feb-2023. HCP can confirm it was not out of range the entire day.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712044 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Feb-2023: Live Followup recived included non significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712044:
the patient is a 15 month old female who presents for evaluation following an "episode." Around 645, the patients mother went to check on her to wake her up from a nap. She is sleeping on her stomach, but doing well. Approximately 10 minutes later, father went to get her up, and found her on her back, with glazed eyes. When he tried to pick her up, he found her to be completely floppy. He called down to his wife, who came upstairs and noticed that her lips were purple (dad is colorblind). That time they decide to call 911. Mother initially states that patient was not breathing, however after further questioning it seems that she was making gurgling, choking, "aspiration" noises. During this time, the patient did bite down on her father's finger, but they are under the impression that it was more of a reflex than a purposeful behavior. the episode lasted approximately 5-8 minutes, suddenly the patient took a big breath like a sigh, and came back around. Her breathing pattern normalized. After that, mother and father state that she is not acting her normal self, that she is slightly fussier than normal. EMS arrived and checked her glucose (118), recommended transport, but mother and father decided to bring her via private vehicle. She does have a history of developmental delay, but otherwise does not have any chronic medical problems. Last year, she was having some jerking episodes which was thought potentially to the due to seizures, however were found not to be the case. She does have a fever here. Mother and father state that she had not been exhibiting any signs or symptoms of infection. No coughing, congestion, runny nose. She often pulls at her ears and does have ear tubes in place. No nausea, vomiting, or diarrhea. No rashes.
THEY HAD ME WAIT 15MIN AND I SEEMED FINE SO THEY LET ME LEAVE. I DROVE 3-4MILES TO MY OFFICE, WHEN I GOT THERE MY STOMACH FELT SICK AND I FELT DIZZY A LITTLE, AND THEN I JUST ALL OF A SUDDEN GOT A HEADACHE. BY THAT TIME IT WAS TIME TO GO HOME SO I RODE HOME AND GOT HOME FEELING TIRED AND DRAINED. I LAID DOWN AND WHEN I WOKE UP I COULDN'T MOVE MY ARM AND I HAD HIVES ALL OVER MY ARM AND MY BLOOD PRESSURE WAS UP AND MY HEADACHE WAS EXTREMLY WORSE. I COULD BARELY STAND SO I CALLED MY DOCTOR AND SHE WAS TRYING TO GET ME TO COME IN AND I WAS EXPLAINING EVERYTHING TO HER AND SHE WAS TELLING ME TO CALM DOWN AND TOLD ME TO TAKE IBUPROHEN OR ASPRIN SOMETHING TO SUBSIDE THE HEADACHE. I TOOK 2 ASPRIN AND LAID DOWN. THE NEXT WEEKS I FELT SO TIRED. I DIDN'T EVEN GET TO SPEAK TO A SPECIALIST BECAUSE THEY NEVER CALLED BACK, AND BY THE TIME THEY CALLED BACK I RELOCATED BECAUSE I WAS LAID OFF. I WENT TO MY DOCTOR IN BETWEEN THE PROCESS OF LEAVING , SHE CHECKED MY BLOOD PRESSURE AND SHE SAID IT WAS FINE AND WAIT TO SEE THE SPECIALIST, BUT I WAS WEAK. MY ENERGY LEVEL NEVER CAME BACK TO WHERE IT WAS BEFORE THE SHOT. IF I WALK UP A PAIR OF STEPS, I'M EXHAUSED AND IT FEELS LIKE I WALKED 4-5 BLOCKS AND I NEED TO LAY DOWN. I JUST WENT TO THE ER AND THEY BRUSHED ME OFF SO I LEFT. THE NEXT DAY I WENT TO ANOTHER HOSPITAL AND THEY LOOKED AT MY BONES AND WHAT WAS GOING ON WITH ME AND SAID SHE COULDN'T DIAGNOIS ME WITH RHEUMATOID ARTHRITIS IN THE ER AND REFERRED ME TO AN ORTHOPEDIC DOCTOR. THIS IS FAST AND PROGRESSIVE, EVERYTIME I WAKE UP THERE IS A BONE THAT'S GOING ANOTHER WAY AND THE PAIN MEDICATION IS NOT HELPING, AND I'M STILL HAVING THE HEADACHES. AND I'VE NEVER HAD THESE ISSUES BEFORE THE VACCINE. NOW MY KNEES ARE BOTH BIG, MY ANKLES ARE BIG, MY FINGERS ARE GOING THE OTHER WAY. THAT'S WHY I'M SO UPSET BECAUSE I'M WAITING TO SEE THE SPECIALIST AND THESE ISSUES HAVEN'T GONE AWAY.
pt recv vax & exp severe redness, soreness & swelling in the arm & joint;no further details were provided;
On 27Jan2021 tested positive for the PCR/She got the rapid and PCR test results back on 29Jan2021 and they were positive for COVID.; This is a spontaneous report from a contactable consumer (patient, self-reported) from sponsored program . A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, into upper left arm below the shoulder, on 19Jan2021, just after noon, around 12:30 or 1:00 PM, as a single dose for COVID-19 immunization. Ongoing medical history included, seasonal allergies, sinus issues, sinus infection and head pressure. Concomitant medications included celecoxib (CELEBREX), azithromycin, from 25Jan2021 for sinus infection and methylprednisolone acetate (MEDROL) from 26Jan2021 to 31Jan2021 and then from Feb2021, for sinus infection and head pressure. It was described as she started treatment for sinus infection on 25Jan2021. He put her on Azithromycin 250mg, six pack, and also Medrol Pack. She started the Medrol pack on the twenty sixth and finished it on 31Jan2021. Then she started her again on Medrol Pack yesterday because she still has head pressure. Clarified Medrol Pack as Methylprednisolone. She is on the second round and will finish it on Tuesday. Caller doesn't have NDC, lot, and expiry for Azithromycin or Medrol Pack. She doesn't have the product but has the paperwork. Patient did not receive any other medications, prior Vaccinations (within 4 weeks). She had her first vaccine on 19Jan2021. Four days later she started getting sick. She thought she had a sinus infection. Then after that patient got sick, Doctor prescribed to take antibiotics and steroids. She went for her annual physical on 21Jan2021. She was in his office two days after the vaccine. The doctor treated her for a sinus infection but thought she should get tested. Clarified that she got sick on 22Jan2021. She didn't get tested until the twenty seventh when she had the PCR test. On 27Jan2021 tested positive for the PCR and on 29Jan2021 tested positive for Rapid Test (She got a rapid on 29Jan2021. She got the rapid and PCR test results back on 29Jan2021 and they were positive for COVID). She was scheduled for the second shot on the 09Feb2021. She would like to be able to get her second shot. She was asking if she could get the second shot of the Pfizer COVID-19 vaccine after she gets well. Outcome of the event was unknown.
Pt was due for Pfizer Bivalent ages 5-11 yr vaccine but was given 3rd dose of Pfizer 5-11yr vaccine.
I am magnetic from injection site arm to upper torso and opposite arm. I noticed this June 1, 2021.
Condition aggravated; Feeling bad; Ache; Skin red; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated), FEELING ABNORMAL (Feeling bad), PAIN (Ache), ERYTHEMA (Skin red) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 01-Mar-2021 to an unknown date for COVID-19 vaccination.   On 01-Jan-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 13-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2022, the patient experienced CONDITION AGGRAVATED (Condition aggravated), FEELING ABNORMAL (Feeling bad), PAIN (Ache), ERYTHEMA (Skin red) and PYREXIA (Fever). At the time of the report, CONDITION AGGRAVATED (Condition aggravated), FEELING ABNORMAL (Feeling bad), PAIN (Ache), ERYTHEMA (Skin red) and PYREXIA (Fever) had not resolved.            On 13 Apr 2022, the patient experienced skin all red and flared up, feeling terrible, fever, severe aches and skin all red. Moderna COVID-19 vaccine (Elasomeran) was also considered suspect.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Treatment medication was unknown.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient said she has rash/itching around the injection site. she started having this rash 3/29. patient received vaccine on 3/24
pt recv vax 3PM on 14APR95; pt went limp for 5 mins & 8PM; MD was called; pt had grand mal sz while mom talking to MD: pt taken to local ER; sz x 3 up to 30 mins duration; hosp tx w/valium & Dilantin; hospitalized;
Severe Chills and shaking Fever maxed out at 99.5 Muscle Aces Severe Headaches Nausea
Swelling and redness at right arm painful no itching or rash no signs infection. Seen 5/17/07
could not raise the right arm and currently still can not/not being able to lift his arm as normal; when moving the arm out from his body it still hurts; arm is sore around the injection area; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (could not raise the right arm and currently still can not/not being able to lift his arm as normal), PAIN IN EXTREMITY (when moving the arm out from his body it still hurts) and VACCINATION SITE PAIN (arm is sore around the injection area) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, CALCIUM, METOPROLOL, OXYBUTYNIN HYDROCHLORIDE (OXIBUTIN), RIFAMPICIN (RIFAMPIN), MINOCYCLINE, AMLODIPINE BESILATE (AMLODIPINE BESYLATE), APIXABAN (ELIQUIS), MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], ACETYLSALICYLIC ACID (ASAPRIN) and MELATONIN for an unknown indication.    On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced LIMB DISCOMFORT (could not raise the right arm and currently still can not/not being able to lift his arm as normal), PAIN IN EXTREMITY (when moving the arm out from his body it still hurts) and VACCINATION SITE PAIN (arm is sore around the injection area). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (could not raise the right arm and currently still can not/not being able to lift his arm as normal), PAIN IN EXTREMITY (when moving the arm out from his body it still hurts) and VACCINATION SITE PAIN (arm is sore around the injection area) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This case involves an unknown age and unknown gender patient who was passing out (loss of consciousness), was sick with flu (influenza) and thought was gonna die after receiving INFLUENZA VACCINE. The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site. On an unknown date the patient developed a serious thought was passing out (loss of consciousness), was sick with flu (influenza) and thought was gonna die (unknown latency) following the administration of INFLUENZA VACCINE. These event were assessed as medically significant. Sick (illness) and flu (influenza)(unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant. On an unknown date the patient developed a non-serious sick (illness), flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Laboratory details were not reported. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome of the event was reported as unknown; Sender's Comments: This case concerns an unknown age and unknown gender patient who experienced loss of consciousness, and influenza (unknown latency) after vaccination with INFLUENZA VACCINE. The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.