chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented to observation station 5 mn post vaccination.  C/o lip swelling and throat itching  NP initial evaluation  VS: 132/103, 95, 100%  Heent; moderate edema to lips no intraoral abnormality  Lungs: clear  CV: tachycardic  Benadryl 50 mg po given @ 11:19  11:22 pt noted with facial edema, oropharyngeal edema, and attempts to clear her throat.   ALS ambulance called by EMT  Epi pen injected @ 11:22  VS 143/106, 121, 99%  Mild reduction in angiodema post injection however At 1128 noted with increased angioedema again at this time   Epi pen injected @ 11:29  Care transferred to ALS crew at 11:35  Notified by ALS crew at 11:45 that patient was refusing transport. I along with EMS crew spoke to patient about risks of not transporting.
Developed sudden pain on the left side of my chest and in my left arm on Saturday, 1/08/22 at about 7:45am. At the time I was just standing in my kitchen (about to feed my cat). It was severe enough that I immediately froze, but it quickly got a bit better. I finished my morning routine but then decided to go to Urgent Care to get it checked out. By that time the chest pain was slight. At Urgent Care, they administered an EKG that apparently showed no heart issues, and they released me after about an hour. Blood pressure and other things were also normal, and the doctor and nurses noted that I do not have any risk factors for heart trouble (very physically active, normal weight, no family history, etc.) The doctor concluded that it was musculoskeletal pain (based in part on sensitivity when he pushed on the spot) and also mentioned costochronditis. I continued to have mild chest pain most of that day, but it was entirely gone by the next day and has not returned. I have no idea if this was related to the COVID vaccine booster shot that I received on 12/14/21, but it was very unusual so I wanted to report it. (The doctor did not ask about any recent vaccinations. I thought about bringing it up at the time but did not do so.)
Patient came in and the injection site looked like an allergic reaction. Swollen but not red and slightly warm to the touch. Patient stated some soreness but was not painful. Told patient to contact her doctor the next day if area was not better or was worse.
Large lump/knot in the injection area after the 'student' administered the vaccine by pinching my skin and fat then injecting at a 45-degree angle that caused excessive bleeding on my arm. The lump/knot is painful and I am concerned about my blood possibly clotting.
Patient did not receive the second dose as she forgot to go get the 2nd; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive the second dose as she forgot to go get the 2nd) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive the second dose as she forgot to go get the 2nd) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive the second dose as she forgot to go get the 2nd) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive the second dose as she forgot to go get the 2nd).    No concomitant medications were reported.   Patient  took only the first dose of the Moderna COVID19 vaccine and patient's employer made a request in regards to vaccination process.  No treatment details were reported.
1/31/22 ER visit- diagnosed with TIA, continued to have dizziness and weakness. Admitted to hospital 2/5/22 and diagnosed with COVID pneumonia, discharged to rehab facility 2/18/22 through 3/20/22.
The day after the vaccine (2/11) felt achy and feverish. This resolved after about 5 days, had some sinus symptoms. 3/5 had comp apnel done with many abnormal labs, esp cr 6.2. In 10/20  Cr was  .96
Persistent viscous nasal congestion starting two weeks after shot. Accumulates between the nose and throat. Pattern as after second shot. Flu-like symptoms always for 12-24 hours are physically exerting oneself (light workout).
Vaccine went through excursion in freezer twice and administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went through excursion in freezer twice and administered to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went through excursion in freezer twice and administered to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went through excursion in freezer twice and administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.  She actually called last Thursday to cancel this inquiry. Her pharmacist on duty and she had a miscommunication. The sensor, to her understanding was not in correct position and was not collecting the data of the vaccine temperature. She was originally under the impression that the freezer had not been closed for the entire day.  She had called in last Wednesday about a possible excursion, but  called back Thursday to cancel it when she spoke more to her pharmacist that was on duty the day in question and learned that what she thought had happened did not happen. So sorry for the confusion.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Non Significant Follow up received and checked medication error On 28-Sep-2021: Non Significant follow up received and appended
patient experienced Covid arm 24 hours after vaccination. patient states redness, bump, pain, itchiness with pediatric Pfizer vaccine. patient was told to take Pediatric ibuprofen/Tylenol, Benadryl, and hydrocortisone and cooling compress. Informed patient to notify us if other complications arise
Left side face and hand numbness lasting through out the day on 2/7/2021 starting around 1:00 pm.  Resolved by the following day.   No treatment sought.  Did not lose motor function and no reports of facial drooping.
High fever,  chills, body aches,  sore muscles,  brain fog, mental confusion, can't work,  fatigue, nausea,  new onset of cough. All started at around 2am.  I took ibuprofen around 11am. Brought fever down and I have slightly more energy.  Other symptoms still present.
Patient reports sudden onset of  dizziness and heart palpitations.  Initial vitals BP 224/117, HR 112, RR 28 ,Pox 100% RA (at 1700) Repeat vitals at 1710  BP 217/110, HR 103, RR 32, Pox 97% RA.  Symptoms became progressively worse.  She was given water.  She reports she takes Metoprolol and Nefedipine ( last dose 1/20/21) and HCTZ (last dose 1/19/21.    She also began to report feeling weakness as well.  Due to persistent symptoms she was transported to the ER at 1715 via wheelchair.
I took the first dose of vaccine (lot number EW0196) on 06/16/2021, and I took the second dose of the vaccine (lot number FA6780) on 07/08/2021, The injection site started to swell and be very painful, I also had tiredness and a headache, and I don't really get headaches. The whole left arm was also very painful. This lasted for two and a half days.
3 days after injection I experienced confusion, lightheadedness and difficulty walking (it felt like there were weights on my feet).  The next day I was advised to go to the ER and after being admitted to the hospital, where many tests were performed , I was diagnosed with having had a stroke.  Fortunately it was a light stroke & I was sent home after 24 Hrs with a prescription for Plavix & a follow up with neurologist.
pt recvd vax for prophylaxis & exp thrombocytopenia p/ 3rd dose;
exhausted, sore all over his body,  feels sick to stomach but has not vomited, left side of body behind breast is extremely sore
Local reaction on left arm, redness, warm to touch, slight swelling. A week later rash on top of both feet, raised and itchy.
3-7-08 pt noticed left eyelid drooping. 3-8-08 pt noticed left side of mouth drooping. 3-9-08 to ER - prednisone given.  5/16/08 Reviewed ER & clinic medical records. FINAL ER DX: acute Bell's palsy. ER records of 3/9/08 reveal patient experienced left facial droop, left facial weakness, unable to close left eye or wrinkle left forehead, increased tearing left eye, left eyelid puffy x 2 days.  Tx w/steroids, antivirals & eye ointment/patching.  D/C to home.  PCP f/u on 3/17/08 showed improvement but still w/left facial droop & upper back/neck pain.  Tx w/continued meds.  Was to see ophthal.  Returned to PCP on 4/17/08 improved but had continued significant left facial droop, left upper eyelid droop.
Larger red spot in the IS; Very Itchy; red spot in the IS; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Larger red spot in the IS), PRURITUS (Very Itchy) and VACCINATION SITE ERYTHEMA (red spot in the IS) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot in the IS). On 21-Feb-2021, the patient experienced RASH MACULAR (Larger red spot in the IS) and PRURITUS (Very Itchy). On 20-Feb-2021, VACCINATION SITE ERYTHEMA (red spot in the IS) had resolved. At the time of the report, RASH MACULAR (Larger red spot in the IS) and PRURITUS (Very Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Bad headache, body aches, chills, fatigue, injection site pain, malaise, new joint and muscle pain
Pt experienced (L) arm pn @ injection site with approximately 1 cm surrounding ecchymosis, arm has erythema/induration heat approximately 115x10 cm total.  Quite warm to touch.  No tx @ this time.
is not sure if this because of nerve pain or shingles; last 48 hours and 4 weeks after booster she is suddenly experiencing leg pain on left side interior leg pain every 2 hours intermittently/whole night she had pain but now she has no pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (is not sure if this because of nerve pain or shingles), PAIN IN EXTREMITY (last 48 hours and 4 weeks after booster she is suddenly experiencing leg pain on left side interior leg pain every 2 hours intermittently/whole night she had pain but now she has no pain) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced PYREXIA (fever). On 05-Dec-2021, the patient experienced PAIN IN EXTREMITY (last 48 hours and 4 weeks after booster she is suddenly experiencing leg pain on left side interior leg pain every 2 hours intermittently/whole night she had pain but now she has no pain). On an unknown date, the patient experienced NEURALGIA (is not sure if this because of nerve pain or shingles). In November 2021, PYREXIA (fever) had resolved. On 06-Dec-2021, PAIN IN EXTREMITY (last 48 hours and 4 weeks after booster she is suddenly experiencing leg pain on left side interior leg pain every 2 hours intermittently/whole night she had pain but now she has no pain) had resolved. At the time of the report, NEURALGIA (is not sure if this because of nerve pain or shingles) outcome was unknown.            Concomitant medications details were not reported by the reporter. It was reported that patient was not sure if the pain because of nerve pain or shingles. As she had shingles after second dose. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-405235 (Patient Link).
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 3:17 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 3:17 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 29.70. Concomitant products were not provided.  On 29-Apr-2021, Excursion time was 10 AM, temperature was 33, total doses given for the day was 201, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021. 05 vials were sent to clinic. Vaccine BUD date was 19-May-2021. On 29-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 PM: 45, 1PM: 45, 2 PM: 44, 3 PM: 45, and 4 PM: 44. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
About 6 ? 7 days w/ side effects ? Significant  Malaise, tiredness.  Unable to function or concentrate.  Likely a "self inflicted" situation by unknowingly sitting in chair in a daze ultimately developing blood clots (pulmonary edema), blood clots in legs, leading to mild heart attack, hospitalization.  I believe there may be a direct connection to a medical procedure (vedolizumab (Entyvio) 300 mg intravenously infusion) that preceded the vaccination on the previous Friday (2/19/21).
swollen lt deltoid area, pain lt arm, shoulder, axilla, swollen upper lt chest & axilla; painful to touch; guarded movements;
loss of taste, still persists Noticed when I woke up the next morning after receving the vaccine and my coffee tasted like hot water.
This spontaneous report as received from a licensed practical nurse refers to a male patient of unknown age. The patient had no pertinent medical history nor drug reactions or allergies. On 30-DEC-2014 the patient was vaccinated with PNEUMOVAX 23 lot # reported as 018528, expiration date 14-APR-2016 (strength, dose and route not provided). There was no concomitant medication. On 31-DEC-2014 the patient experienced cellulitis and swollen arm. Patient sought medical attention and unspecified antibiotics were given as a treatment by the physician. The outcome of the events was unknown. Additional information has been requested.
This is a literature report. A 18 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: PERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "patient developed pericarditis 2 weeks after COVID mRNA vaccine"; CARDIAC TAMPONADE (hospitalization, medically significant), outcome "unknown", described as "tamponade". We report the first case of incessant pericarditis and tamponade associated with the Pfizer- BioNTech vaccine. Case: An 18 year-old male presented with positional chest pain 2 weeks after the first dose of the BNT162b2 mRNA vaccine. CRP was elevated and ECG showed diffuse ST segment elevations. Troponin, BNP, and transthoracic echocardiogram were normal. He was discharged with ibuprofen and colchicine. Two weeks later, he returned with chest pain and a large pericardial effusion with tamponade. Pericardiocentesis was performed with placement of a pericardial drain. Cultures and cytology were negative. 4 days after drain removal, he developed recurrent chest pain. Decision-making: Our patient developed pericarditis 2 weeks after COVID mRNA vaccine with no other etiology identified. Despite appropriate initial therapy, he developed incessant pericarditis and tamponade. Treatment success was ultimately obtained with prednisone and rilonacept. Conclusion(s): Pericarditis is a rare adverse effect associated with the mRNA COVID-19 vaccine, however this is the first description of a pericardial effusion resulting in cardiac tamponade associated with the vaccine in the literature. In patients with incessant pericarditis, the use of rilonacept has been associated with marked reduction in recurrence. Rilonacept may serve as a therapeutic strategy for severe refractory cases of pericarditis secondary to mRNA vaccines. The patient underwent the following laboratory tests and procedures: brain natriuretic peptide: normal; c-reactive protein: elevated; culture: negative; cytology: negative; echocardiogram: normal; electrocardiogram: diffuse ST segment elevations; troponin: normal. Therapeutic measures were taken as a result of pericarditis, cardiac tamponade. Sender's Comments: As there is limited information in the case provided, the causal association between the event pericarditis and Cardiac tamponade  and the suspect drug cannot be excluded. This is literature- spontaneous case. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
achey; This case was reported by a other health professional via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient received Shingrix at different facility. The patient felt better after taking tylenol. The reporter decline to provide more information. The reporter did not consent to follow up.
2:30pm chills and nausea 4:30pm body aches 6:30pm took tylenol 9:00pm nausea ended Excessive night sweats, chills, body aches. Symptoms lasted until approximately 3:00pm 3/14/21.
hu This spontaneous case was reported by a patient and describes the occurrence of PAIN (hurting very much/had aches), INSOMNIA (could not sleep), FEELING ABNORMAL (thinks that there was something that got a hold of him badly and made him ill.), PAIN IN EXTREMITY (shooting pain on his legs, arms all day and all night long) and BACK PAIN (shooting pain on his back all day and all night long) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.          On 26-Nov-2021, Received 1st booster dose of moderna and lot number was 019F21A, 2nd booster dose on  22-Jun-2022 and no lot number.  Patient had the omicron vaccine and that night he had fever and was hurting very much. He had aches and shooting pain on his legs, arms and back all day and all night long. He could not sleep. He thought he was going to be put in a hospital and thinks that there was something that got a hold of him badly and made him ill. He took Tylenol Extra Strength from, but it did not help at all. His symptoms resolved around midday of 21-Nov-2022.
Rapid pulse - resting baseline 60-70 bpm, measured up to 127 at rest ~24 hours after the shot.
Client informed RN that when she received Dose Moderna client experienced chest pain for three days, starting with the same night of vaccination on 4/20/21. Client didn?t seek emergency care or spoke to her primary care provider. RN submitted a medical consult to clinical lead  for approval. Pfizer booster was approved for client by MD. Client was vaccinated with Pfizer Booster Lot#FK9896  Client reported no symptoms while in observation area.