chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via a company representative refers to a 60 year old female patient. On 26-APR-2013 the patient was vaccinated with ZOSTAVAX (lot # not reported) (one shot, strength and total daily dose not reported) (in the arm). It was reported that the patient developed an "injection-site reaction" on 26-APR-2013 after receiving ZOSTAVAX. The patient appeared to have a "large ball on her arm" at the injection site on 26-APR-2013 and sought medical attention on 26-APR-2013 at an unspecified emergency room, where she was treated with unspecified antibiotics and then released at an unspecified time on an unspecified date. The patient returned to the unspecified emergency room on 29-APR-2013 and was treated with unspecified intravenous and oral steroids before being released at an unspecified time on an unspecified date. The patient saw the pharmacist on 30-APR-2013 to show him her remaining injection-site reaction. The remaining reaction appeared to be minor and only "a little injection-site reaction" with no cause for concern. The injection-site reaction was reported to "look like cellulitis" on 30-APR-2013. The patient's unspecified medications were evaluated to not have caused any kind of immunosuppressed state. The patient was not yet fully recovered. The outcome was reported as recovering. The causality between the adverse event and ZOSTAVAX was unknown. Additional information has been requested.
Child reported SOB and dizziness after receiving vaccines. Advised to relax against the wall, cool compresses applied to neck and forehead moved fan to blow on pt. Respiration rate 20 with pulse of 96. Pt reported was okay and felt same every 2 minutes up until 0900 at which point she reported increased difficulty breathing. Child advised to move to more of a high Fowlers against wall with feet on bench. Request help from another nurse. Bilateral inspiratory wheezes with ausculataion of lung sounds. 1 dose of Epi prepped in room, administrator called 911 to request transport to ER. Vitals P 120 R. 22 B/P 122/64 At 0910 child reported feeling better, inspiratory wheezes still present but greatly reduced. Child was able to converse throughout entire reaction 0915 child reports feeling better wheezes had resolved, child was advised ambulance was coming to pick her up to take to ER for further evaluation. Child started to cry and increased respirations( 24) at which point ambulance arrived and was taken to EMS.
Very Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 23rd July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-Jul-2022 Reporter's Comments: This case was received from consumer via interactive digital media.  The patient  got my first shingles shot yesterday and had very sore arm but no more symptoms. Get your shot. The follow-up would not possible as no contact details were available. Additional supportive Information: Theas event description event outcome captured as not recovered. The event onset date and TTO were captured with respect to event description and GSK receipt date.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received HAV (Havrix 720) (batch number 2JD3Y, expiry date 4th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th January 2023, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 5th January 2023, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 6-Jan-2023 Reporter's comment: The licensed practical nurse called to inquire any information if administered after expiration or the expiration date changed. The reporter did not consent to follow-up. Additional supportive information: The pediatric patient was inadvertently administered an expired Harvix dose one day before the reporting date, which led to expired vaccine used.
Developed swelling and erythema of L arm ~ 20 hours post immunization. Continue to worsen. Involved area 15cm x 8cm . Tx'd with Motrin, Benadryl and ice.
On Wednesday had sore throat, runny nose and developed into cough.  fever of 100 degrees taking aspirin helped.  Today feeling the worst.
pt reports itching and "sticking" sensation in left deltoid for almost a month after vaccination. not painful, no redness, no swelling, just irritating sensation in arm
Moderna on 2/1 and 3/1. Positive on 12/3
Ache; Chills; sore arm; This is a spontaneous report received from a non-contactable consumer(patient). A 25-year-old female patient received BNT162B2 (solution for injection; lot number- ew0181, expiry date not reported) via an unspecified route of administration into right arm, on 16Aug2021 17:00  at the age of 25-year-old, dose 2, single for covid-19 immunisation in a pharmacy or drug Store. The patient did not have any medical history. Historical vaccine included BNT162B2 (solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on unknown date, dose 1, single for covid-19 immunisation. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. On 17Aug2021 09:00, the patient experienced ache, chills,and sore arm. The patient did not receive treatment in response to the events. The outcome of the events was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Approximately 10 days after the 2nd booster (4th shot) I developed enlarged lymph nodes in my neck followed by severe red, scaly, flat rash. This progressed to lymphadenopathy and an enlarged spleen,. Although it is beginning to resolve (rash went away 6 months after vaccine) many of the symptoms mimicked lymphoma and therefore I underwent extensive testing to determine the cause.
BREAKTHROUGH COVID: FULLY VACINATED COVID POSITIVE 56 y/o M with pmh of HTN who presents with eye swelling and eye discharged for the last 2 days. Pt stated he had uri sx and dyspnea was given abx by PCP (keflex) 2 days ago but stopped d/t his eye swelling. He denies any previous rxn. He complained of weakness, dyspnea and cough. He denied chest pain n/v/d denies fever but had some chills. CTA reported right lower lobe pneumonia. Started COVID treatment with Remsesivir during hospitalization 3/5 days.
Patient felt light headed after second shot, laid head down on table in room.  Complained of feeling "loss of sense of reality".  Respirations normal, blood pressure 112/77, heart rate 83.  Cold, clammy skin.  Asked for water and asked me to call 911.  Patient was able to respond to questions, but did close eyes and seemed to lose full consciousness for a few seconds.  Patient was checked out by EMS and released.
On 2/7/21 resident complainted of not feeling well, nausea, vomiting and weakness sent to ER passed away.
2 hours after receiving vaccines, patient fell to her knees while at work and everything went black but was still able to hear people talking. Difficulty elevating left arm. The darkness only lasted about 1 minute. Pt. was rushing that day to get to work. Sent to ER for further evaluation.
Admitted w/ COVID-19 PNA on 03/03/21 on HFNC 50L. Now w/ superimposed HAP.
Flu like symptoms; I was bedridden for 4 days; High fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), BEDRIDDEN (I was bedridden for 4 days) and PYREXIA (High fever) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), BEDRIDDEN (I was bedridden for 4 days) and PYREXIA (High fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), BEDRIDDEN (I was bedridden for 4 days) and PYREXIA (High fever) outcome was unknown.            No concomitant medications were provided.  No treatment information provided.   This case was linked to MOD-2021-015748 (Patient Link).
Approximately two weeks after vaccine administration, developed tightening of the jaw, tongue numbness and ultimately the right side of the face became paralyzed.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 04-MAR-2015, the patient was inadvertently administered a dose of expired ZOSTAVAX, 0.65 ml dose, subcutaneous, lot # J011211 and expiration date on 31-JUL-2014. No adverse effects reported. Additional information has been requested.
Received first vaccine on April 10, more than 28 days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first vaccine on April 10, more than 28 days ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first vaccine on April 10, more than 28 days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first vaccine on April 10, more than 28 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details was not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication was reported in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
At 2:30 pm after being in observation for 30 minutes, patient became concerned about a rash to her left arm.   There was a small area that had a lace modeling appearance.  Patient denied any pain or itchiness to this area and there were no hives.  Patient very anxious and concerned and asked if she could take her own liquid Benadryl which she had on hand.  She was offered  Benadryl from the clinic but refused and really wanted to take her own.  Approval from supervisor obtained and Benadryl was verified.  VS BP 110/60, HR 76 and pulse ox 98% at 2:35 pm.  Patient denied any other signs and symptoms of allergic reaction except anxiety.  VS repeated at 2:55pm and were; BP 110/60, HR 68, Pulse ox 100%.  No change in condition and patient felt good enough to leave.  Patients sister accompanied her to the clinic today and will stay with her tonight.
On 2/7 new bilateral leg weakness and progressive inability to walk x several days. Legs weak and cannot hold her. She fell 2-3 days ago bruising her right chest and left knee. Denies loss of consciousness. At baseline she states she was able to get around within her home.
Patient has had pain since the date of vaccination in the left arm. She states that she has pain when moving her arm. There is no pain when the arm is not in motion. She stated that it hurts at the sight of injection. She has taken tylenol for the pain.
Cold symptoms, headache  and tired since 3.21.21 3.24.21 injection site red raised and hot to the touch
Change is menstral cycle. Heavier, longer mensis with blood clots; Change is menstral cycle. Heavier, longer mensis with blood clots; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: Er8737) at the age of 39 years as dose 2, single and intramuscular, administered in arm left, administration date 2021 (Lot number: Ep7534) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 01Apr2021, outcome "not recovered" and all described as "Change is menstral cycle. Heavier, longer mensis with blood clots". The event "change is menstral cycle. heavier, longer mensis with blood clots" and "change is menstral cycle. heavier, longer mensis with blood clots" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding. Additional Information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. No known allergy reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Presented with fever, N/V, headache, myalgias; +covid in ED; CXR without infiltrate; CT abd/pelvis with possible enterocolitis; Labs: D-dimer 0.84, CRP  9.27, Ferritin  436.7 Tx: Decadron, Femdesivir, Rocephin, Maxipime, Vit C, vit D3, Lovenox, Singulair, Zinc; No supplemental O2 needed; remained on Room air during stay
Subsequently - a doctor discovered numerous blood clots in that leg; then a blood clot in one of her lungs; her left leg (she was inoculated on the left side) swelled up; it was painful; She is being treated but the lymphadenopathy has not subsided in her leg; she is now unable to walk without a cane; This is a spontaneous report from a contactable consumer.  A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number not reported) on an unspecified date in 2021 at single dose (inoculated on the left side) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the vaccine few weeks ago, in 2021, and within 3 hours, she recounted her left leg (she was inoculated on the left side) swelled up dramatically it was painful. Subsequently a doctor discovered numerous blood clots in that leg, then a blood clot in one of her lungs. She is being treated but the lymphadenopathy has not subsided in her leg and she was now unable to walk without a cane. The outcome of lymphadenopathy and unable to walk without a cane events was not recovered; outcome of the other events was unknown.Reporter asked if there were reports of blood clots that have been validated as a result of the Pfizer shot. Information on the lot/batch number has been requested.
7.20.21 LEFT ACHILLES TENDON PAIN - PATIENT SEEN IN OFFICE 2 DAYS AFTER INJECTION AND GIVEN A WALKING BOOT TO WEAR. PATIENT WORE IT FOR 5 DAYS UNTIL ALL PAIN WAS RESOLVED
Tested positive for COVID on 4/21.....well after the full vaccination series was completed on 1/7/21. Mild symptoms including loss of taste and small dry cough
menstrual cycle was impacted following 1st (2/11/21) and 2nd (3/11/21) doses of the Moderna Covid-19 vaccine.  Specifically, I had not had a period since approximately May 2018 following IUD insertion for contraception.   Following the vaccination, I began having active periods again.  This change lasted from March 2021 until September 2022, at which time the periods have again stopped.
Heart palpitations (PVCs). I first noticed an occasional unfamiliar feeling in my chest (pressure then big heartbeat) in the late afternoon/early evening, and the frequency increased over the next few hours. I went to the hospital around 11pm on 12/13 under the advisement of my PCP's office because the palpitations were occurring >3 times per minute. EKG at the hospital revealed that they were PVCs. At the peak (around midnight-2am?) they were occurring every 3-5 seconds. They have been decreasing in frequency over the past few days, but are still happening every minute or so. I do not have any history of heart palpitations, and as far as I know, this is the first time they have ever occurred. I also had a headache for 3-4  days (starting in the afternoon on 12/13) and a low-grade fever on 12/14 (mid-99s F).
Had the shot and it didn't help; it didn't help; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that he/she had the shingles shot experienced shingles. It was reported that vaccine did not help. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Information has been received from a physician concerning a 6 year old female who on an unspecified date in May 2002, was vaccinated with a single first dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed a C4, 5, 6 shingles rash on her left arm. She had no documented case of breakthrough. Medical attention was sought by the patient who had the rash for 5 days. The physician prescribed acyclovir and Tylenol with Codeine. She is on no other medications. No further information was provided. Additional information has been requested.
This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since 14-DEC-2015, the patients were vaccinated with an improperly stored doses of (Oka-Merck) PROQUAD (dose and route were not reported, lot # L042817, expiration date 26-APR-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Weakness; Flu symptoms.; Dizzy standing up; Muscle still hurts.; Chills; Fatigue; Headache; Pink patches the size of a nickel close to the injection site; Arm also hurt/Painful arm of injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), Flu symptoms, Dizzy standing up, MYALGIA (Muscle hurts), and CHILLS in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ROSUVASTATIN and LEVOTHYROXINE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced ASTHENIA (Weakness), Flu symptoms, Dizzy standing up, MYALGIA (Muscle hurts), CHILLS, FATIGUE, HEADACHE, INJECTION SITE RASH (Pink patches the size of a nickel close to the injection site), and VACCINATION SITE PAIN (Arm also hurt/Painful arm of injection site). At the time of the report, ASTHENIA (Weakness), Flu symptoms, Dizzy standing up, MYALGIA (Muscle still hurts), CHILLS, FATIGUE, HEADACHE, INJECTION SITE RASH (Pink patches the size of a nickel close to the injection site), and VACCINATION SITE PAIN (Arm also hurt/Painful arm of injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ASTHENIA (Weakness), Flu symptoms, Dizzy standing up, MYALGIA (Muscle hurts), CHILLS, FATIGUE, HEADACHE, and VACCINATION SITE PAIN (Arm also hurt/Painful arm of injection site) to be related. No further causality assessment was provided for INJECTION SITE RASH (Pink patches the size of a nickel close to the injection site).    Treatment medication included cold compress for pain. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Upon in internal review on 04-Aug-2021, the age was corrected to 71 years.   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2021: facility Information updated.
8 days after the injection, I started feeling a slight itch at the injection site.  Then 2 small red dots appeared and over the last couple of days, the 2 red dots have swelled to about a 2 inch rectangle across the top of my arm.  The whelp is slightly warm but not hot.  I have taken benedryl at night for 2 nights and used Sarna on the whelp.  It keeps spreading and not going away.