chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arthralgia, SkinRash, Fatigue, arm soreness, redness/rash and swelling at injection site Narrative:
Patient received Zostavax (0981f) on 10/11/2006. she developed typical chicken pox lesions over her trunk arms and legs on 11/3/2006. Patient was treated with Valtrex 500 tid starting on 11/03/2006. Her lesions are improving as of 11/6/2006.
Pt.'s sister states that after receiving the 2nd dose of Phizer 06/24/2021, Pt. passed away suddenly 08/21/2021. Unknown Autopsy preformed.
arm sore; left non-dominate arm was itchy; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm sore) and VACCINATION SITE PRURITUS (left non-dominate arm was itchy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Balance disorder (Condition gotten better prior to vaccine.) since October 2020 and Dizziness (Condition gotten better prior to vaccine.) since October 2020. Concomitant products included INSULIN for Diabetes, MECLIZINE HCL, TOPIRAMATE and ONDANSETRON for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore) and VACCINATION SITE PRURITUS (left non-dominate arm was itchy). On 21-Feb-2021, PAIN IN EXTREMITY (arm sore) and VACCINATION SITE PRURITUS (left non-dominate arm was itchy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-054916 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054916:patient link 2nd dose
Pt with Moderna booster 10/5/22 (5th in series).  Approx 2 weeks later developed left-sided chest pressure (around 10/19/22).  Started having SOB and DOE approx 3 weeks from booster (~10/26/22).  Diagnosed with segmental and subsegmental RUL PE 11/11/22.
Erythema, pain and warmth spreading in upper left deltoid area is indurated and painful to palpation. Started 12-24 hours after injection and worsened despite ice and BENADRYL. Treated with Cephalexin 250/5ml 10 ml PO BID x 10 day., MD. F/U call 10/4/16 decreased swelling decreased redness no pain, LPN.
Starting 1/2/22 (day of vaccination) patient reported to spouse a headache and nausea/upset stomach. On 1/3/22 spouse called the pharmacy around noon to report patient called him at work to come home, he had a rash at injection site, nausea, and was having memory problems and does not remember things. When spouse got home, patient told him he  didn't know how he got where he was and didn't remember who people were. Spouse reports rash was red blotches limited to the area near the injection. Denied any swelling of lips, tongue, throat, or trouble breathing.  Spouse was advised to call the patient's physician for evaluation and guidance, but they are currently out of town. Then spouse was advised to take patient to urgent care as the memory issues are not expected and very concerning and need to be evaluated by a doctor.
Swollen arm at site of vaccination; This is a spontaneous report from a contactable consumer. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 13Mar2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamins (MANUFACTURER UNKNOWN) from an unknown date, for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 20:00, the patient experienced swollen arm at site of vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen arm at site of vaccination was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Minor Allergic reaction:  Swelling below the injection site, hot, red hard and itching.  This occurred around 8pm the following day (Saturday).  I took  one Benadryl capsule that night and took 2 Zrytec Sunday morning and another Benadryl.  On Monday morning it was better, but a red ring was forming around my arm and it still itched.  I sought care at Urgent Care.  The nurse practioner administered a steriod injection, Dex.  It helped, but the itching and redness continued for several days, but was improving each day.  I believe my reaction was caused by the Prevnar injection.  Rite Aid stacked my injections in the left arm,  the top injection was the senior flu vaccine, followed by the Covid injection and lastly by Prevnar.  The swelling and redness occurrred below the prevnar injection.
Thrombocytopenia 21JUL92 responded to daily dose IVGG x 2 days;
Patient was given a dose of Janssen vaccine that was stored at room temp longer than 2 hours.  (less than 6 hours)  Manufacture was contacted and they had no stability data on this vaccine for this window of time at room temperature and suggested we use our clinical expertise.  Patient was notified of error. Patient was revaccinated about 1 month later.    Patient reported that original vaccine hurt and stung with administration and that they had a sore arm for a few days later but otherwise felt fine.  After revaccination with valid dose patient still reported that the vaccine stung with administration . No other side effects.
Patient presented with a red and swollen arm. It reached all the way to his elbow. It was sore and tender to touch. There was also warmth to it. It began 2 hours after he received the vaccination and was still occurring this afternoon, more than 24 hours later.
This spontaneous report was received from the patient's father and refers to a 4 day old male patient. The patient's medical history, concurrent condition, concomitant medication and drug allergies/reactions were unknown. It was reported that on 26-JUN-2017, the physician's office accidentally gave the patient VAQTA (dose, frequency, lot#, route of administration and indication were not provided) instead of the RECOMBIVAX HB. Afterward (on an unknown date in 2017), the patient seem "more tired" and was not interested in eating. No treatment was provided. The patient sought medical attention and visited physician office. The outcome of fatigue, wrong drug administered and decreased appetite were unknown. Causality assessment for the events fatigue and decreased appetite were not provided. No Product Quality Complaint (PQC) was involved. No further AE information provided. Additional informational is not expected as no contact details have been provided.
Immunized on 10/03/06. parent called on 10/06/06 stated child had about 6-8 pimple like pustules on stomach and back, 10/09/06 parent called stated child covered with pox, 10/10/06 MD confirmed chicken pox. 10/11/06 pox dried and crusted over.
Booster; pain at the site of injection plus redness; pain at the site of injection plus redness; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 09Oct2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), administered in deltoid right, administration date 09Oct2021 (Batch/Lot number: unknown) as dose 2, single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization; Bnt162b2 (Dose Number: 2), for COVID-19 immunization; Pcv13 (Dose number: 1, It was years ago). The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Oct2021, outcome "unknown" and all described as "pain at the site of injection plus redness"; HEADACHE (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Headache". Therapeutic measures were taken as a result of headache.  Additional information :She reported that on 09Oct2021 She had an appointment at withheld (store location: withheld at around 5pm. She went there to get her covid-19 booster (she turned 65 recently) and she was also looking to get pneumovax as she already had PCV13 (she didn't recall the exact year in which she was vaccinated with PCV13 but she mentioned that it was years ago at the withheld office as part of a health fair). The pharmacist instructed her to get PCV13 as she just turned 65 recently and not pneumovax despite that she mentioned to the pharmacists that she already had PCV13. She ended getting her third covid-19 dose (comirnaty) plus PCV13 (2nd dose for her). She get comirnaty in her left shoulder and pcv13 in the right shoulder. In regards to adverse events she mentioned that she had pain at the site of injection plus redness, she referred that she had headache that resolved after taking panadol bid the next day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
my teeth are hurting so bad; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 61-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "I had the tooth problem"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "I had the tooth problem". The following information was reported: TOOTHACHE (non-serious), outcome "unknown", described as "my teeth are hurting so bad". The event "my teeth are hurting so bad" required physician office visit. Therapeutic measures were taken as a result of toothache.  Additional information: It was also reported that the first two time patient had the tooth problem, he/she thought it was dental related, he/she really did not pay much attention, just went to the dentist, they gave him/her the pain medicine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine given on 8/27/21 at 1:40pm. Vaccine was drawn up at 9:00am on 8/26/21. Vaccine only viable for 6 hours after reconstitution. Vaccine given over 24 hours after reconstitution. No adverse effects noted.
Within 1 hour the pt broke out in hives. No respiratory problems. Treated with prednisone and antihistamines. discharged home.
ED on 11/19/2021:   CArdiology follow up on 12/8/2021 I saw patient today for cardiac evaluation post hospital discharge. He was hunting and while resting in the cabin developed severe chest and back pain. His symptom waxed and waned in the following morning there were no better. He went to the local ER and underwent a cardiac catheterization which revealed normal coronary arteries. His serum troponin levels were in the 2500 range according to the patient. His echo revealed anterolateral wall motion abnormalities with an EF 45%. His symptoms occurred 2 weeks post COVID-19 booster injection. Since discharge he has been asymptomatic and has resume normal activities avoiding strenuous activities. His 12 lead EKG today revealed a sinus rhythm with marked T-wave abnormalities in the anterior lateral precordial leads. These are similar to his hospital tracings. There were no old tracings for comparison. Active medical problems Takotsubo Cardiomyopathy ( possibly Covid Booster related )  COPD HLD PLAN     1. Acute cardiomyopathy, coronary arteries normal. Possible acute takotsubo cardiomyopathy possibly related to COVID-19 booster injection. Continue with current meds and re-evaluate in 4 weeks with a limited echo and repeat EKG. If no improvement will schedule for cardiac MRI. In the meantime begin cardiac rehab. 2. Hyperlipidemia on Crestor 10 mg daily 3. History of COPD
Vx exposed at 72°F  more than 7 days; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2023, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 1-Feb-2023 Reporter's comment: The pharmacist called to check stability on a Engerix-B that was administered to the patient but they suspect that the vaccine was exposed to highest temperature of 72 degree fahrenheit  for probably more than 7 days. Lot number was not available at the moment of the call.  The reporter consented to follow-up. Additional supportive information: The patient received Engerix-B after temperature excursion, which led to incorrect storage of drug.
Right eye swollen, pain on top right side of teeth, similar symptoms to a sinus infection.  Went to facility, saw medic, took Benadryl and Tylenol with no relief.  Symptoms resolved 1 week later.
Very hot to touch - sore. 3rd day very painful. MD gave KEFLEX 7-Days later getting better.
Very achy muscles, profuse sweating, and chills.  It started about 5pm on Wednesday , June 10th, 2021 and subsided by 5am on Friday, June 11th, 2021
very bad migraine headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (very bad migraine headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced MIGRAINE (very bad migraine headache). At the time of the report, MIGRAINE (very bad migraine headache) outcome was unknown.            No Concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Pt has cellulitis (L) LE. 16 x 16 cm erythema.
4/27- 22 Hours after immunization, had 99.0F temp- progressed though out the day to 101.0 F with chills. 4/28 - Woke in am with raised, red itchy rash on chest and neck. Seen at Clinic on Call 4/28 - 7:00PM. As of 4/30- AM- Temp 99.0 F, scattered  raised, red, itchy rash on back and abdomen continue. Pt. has returned to work.
I had what felt like I was coming down with a cold on May 26, 2022. I did not have a cough or a fever. My husband and I took a home test on May 28, 2022, we both tested positive. I felt better than my husband, we did not want to eat or drink anything. Although I have recovered I am now having trouble with my heart. I have had an echocardiogram and wore a heart monitor to determine what is causing my heart to race. Neither showed A-fib.
Patient admitted after ground level fall.  His wife tested detected for COVID after visiting and patient was subsequently tested for COVID which resulted ""detected"" for COVID.  Provider d/c note:  ""Patient was initially admitted to ICU for BP control and neuromonitoring. Workup from traums surgery was negative for any fractures or other injuries that would warrant trauma to follow, so neurosurgery became primary for patient's care. He was transferred to the floor shortly after ICU stay under stable condition. During his time on the floor he was evaluated by PT/OT who felt he was a good candidate for rehab at discharge. Due to his likely spinal cord injury our physiatrist felt he would be better suited at a facility that was better suited for treating spinal cord injuries as patient had developed urinary and bowel retention. His cervical spine CT was negative for any fractures, but he was quite tender to the cervical spine, so we will plan on keeping his Aspen collar on whenever he is out of bed performing therapy, but as long as he is in bed or in a chair he can remove the collar. This will continue until we can clear her cervical spine at outpatient follow up. He was accepted to Bed rehab and is scheduled for transport there today.    Of note, on 8/11 patient was noted to have a run of Vtach on telemetry and cardiology was consulted. He was started on Metoprolol and has not had this event occur again since. He was cleared from telemetry monitoring per cardiology on 8/17. Patient's wife tested positive for COVID-19 during his admission and he tested negative on 8/14, but then developed fever and sinus congestion on 8/16 and tested positive at that time. Overall he has felt minimal symptoms from this outside of congestion.  At this stage he is cleared from a medical standpoint for discharge to MFB today. "
Information has been received from a physician concerning unidentified children who were vaccinated with varicella virus vaccine live. The physician indicated that his ER colleagues feel that they are seeing more cases of zoster in the vaccine recipients. Unspecified medical attention was sought. Additional information has been requested.
Used a vial that was expired yesterday to administer 7 employees, today; 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 EXPIRED PRODUCT ADMINISTERED (Used a vial that was expired yesterday to administer 7 employees, today) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Used a vial that was expired yesterday to administer 7 employees, today). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Used a vial that was expired yesterday to administer 7 employees, today) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Redness, swelling at site of injection that spread almost to elbow (all upper arm).
Vaccinee rec'd a 1st dose of vax 22AUG90; Events occurred w/in 24 hrs of inject; Recovered fully w/in days, w/out treatment; Pt was due for a second dose on 14SEP90;
Headache x 24 hrs onset 12 hrs after shot, chills, body aches, lightheaded for 2 days and still present.
erythema & induration 24hr p/vax; 3x4 inches in size;
Information has been received from a health professional concerning an adult female who was vaccinated with a first, second, third and fourth (SC, 0.5mL) dose of varicella virus vaccine live. It was reported that the pt was vaccinated with the first two doses of varicella virus vaccine live and much later she became pregnant and her varicella antibody titer came back negative. After the pt delivered the baby, she later received another 2 dose series and she still had no varicella antibody titer. Unspecified medical attention was sought. It was reported that the pt had 4 siblings who had chickenpox as children, but she never contracted them. There was no product quality complaint involved. Additional information has been requested.
less than 6 months from the second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 6 months from the second dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 6 months from the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 6 months from the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
I got the vaccine on Sunday 10/24/2021, and I was okay. The Thursday following that I started to feel sore, it was painful to swallow, and I had flu like symptoms. On 10/29/2021 I went to the ER. They took a COVID-19 and flu test that both came out negative. The doctor said I had a virus that I would have for about 10 days, and then I should be fine after that. They sent me OTC medication for Advil.  I ended up going out of town with my family, and I had felt worse. I took some Tylenol. I returned on Monday and called my doctor to send more medications for my coughs. Now I still feel a sore throat but nothing else. I feel like I am getting a little better. I don't feel like this is related to the vaccine.
Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient left, but daughter came back in to report her father was complaining of left arm numbess and tingling that started within minutes of booster injection & had not resolved after 20min.  Patient himself left pharmacy without reporting to vaccine adminstrator or staff but did report to his daughter.  She is going to monitor him and report event to MD if it continues.  Daughter
7/1/15 routine vaccines-adult Hep A given in error. 7/2/15 wellness check revealed rash on torso. Diphenhydramine given. F/U scheduled. 7/3/15 seen at F/U appt. Afebrile; no rash, resolved. 7/4/15 no fever no site reaction. 7/5/15 asymptomatic. 7/6/15 no systemic issues noted.