chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in neck; Pain in shoulder; Shaking that he cannot control, uncontrollable shaking and Tremors; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking that he cannot control, uncontrollable shaking and Tremors), NECK PAIN (Pain in neck), CHILLS (Chills) and ARTHRALGIA (Pain in shoulder) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced TREMOR (Shaking that he cannot control, uncontrollable shaking and Tremors) and CHILLS (Chills). On 04-Apr-2021 at 2:30 AM, the patient experienced NECK PAIN (Pain in neck) and ARTHRALGIA (Pain in shoulder). At the time of the report, TREMOR (Shaking that he cannot control, uncontrollable shaking and Tremors), NECK PAIN (Pain in neck), CHILLS (Chills) and ARTHRALGIA (Pain in shoulder) outcome was unknown.            No concomitant medications were provided. Treatment medications were not provided. This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking that he cannot control, uncontrollable shaking and Tremors), NECK PAIN (Pain in neck), CHILLS (Chills) and ARTHRALGIA (Pain in shoulder) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced TREMOR (Shaking that he cannot control, uncontrollable shaking and Tremors) and CHILLS (Chills). On 04-Apr-2021 at 2:30 AM, the patient experienced NECK PAIN (Pain in neck) and ARTHRALGIA (Pain in shoulder). At the time of the report, TREMOR (Shaking that he cannot control, uncontrollable shaking and Tremors), NECK PAIN (Pain in neck), CHILLS (Chills) and ARTHRALGIA (Pain in shoulder) outcome was unknown.            No concomitant medications were provided. Treatment medications were not provided.
Resident had previously received 2 Moderna Covid vaccines in January and March 2021. There was no documentation in his chart stating he had previously received them. He was previously asked if he had received them and he stated he had not. He consented and received a Pfizer vaccine on 7/14/21. The administering entity did not inform us until 4-5 hours after administration when they were entering the data in the system that he had previously received 2 vaccines.
Patient is fully vaccinated.  COVID + on 12/27/2021 at ED visit.  41-year-old female with no significant past medical history presents to the emergency Department with complaints of cough, fever, chills, body aches and shortness of breath. Patient states she has had symptoms since she was at a party with coworkers. O2 sat 94% RA. tacycardia (121). CXR:  Patchy opacities noted bilaterally mainly at the lung bases, can be seen with COVID-19. Toradol given.  We'll refer patient to infusion center as she qualifies for further treatment due to her BMI. Patient discharged, recommend Motrin for body aches.
Menstrual period lasted more than 6 days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Oct2021 12:30 (Lot number: Ff2589) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Route of Administration: Intramuscular), administration date: Jan2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1), administration date: Dec2020, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 02Nov2021, outcome "not recovered", described as "Menstrual period lasted more than 6 days". Therapeutic measures were not taken as a result of oligomenorrhoea.  Additional Information: The patient did not have any known allergies. The patient did not receive any other vaccine in 4 weeks. The patient did not have COVID prior to vaccination. The patient was not tested positive post vaccination. Menstraul period lasted more than 6 days. Before the booster shot, usually the period stopped at day 4. Now, by day 6, the flow is still medium. I need to change 4-5 pads per day.  Follow-up attempts are completed. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 at 13:00 as dose 1, single (Lot number: EL9266), in right arm, on 05Mar2021 at 12:15 as dose 2, single (Lot number: EN6204), in right arm, on 25Sep2021 at 10:30 as dose 3 (booster), single (Lot number: 301358A), in right arm and on 30Mar2022 at 10:00 as dose 4 (booster), single (Lot number: FK9896) at the age of 71 years, in right arm for covid-19 immunisation. The patient 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 "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment for covid-19. Treatment started on 20May2022 and stop on 24May2022. Patient did not receive other medication in 2weeks.  No follow-up attempts are possible. No further information is expected.
1133-vaccine given 1140-Layed person done with legs raised. Epi given due to dizziness, nausea and hypotensive. Cool rag placed.  1142- BP 80/60, P 69, spo2-93% 1146-110/58, 97 pulse, spo2-79% 1151-118/62, 98%, 95 pulse 1153 EMS called 1155-142/60, 99 %, 99 pulse 1158-132/70, 99 %, 97 pulse Patient had blood sugar taken by EMS, 212. Patient refused to go with EMS, She was willing to take a Uber to her place of employment. She was able to sit up while EMS was still here. She left the observation area at 1210 and was able to walk downstairs on her own power.  She did tell me that she gets faint when she listens to things about venipunctures or anything about needles. I was talking to her about what the z track method was, then she got faint.
had the shot too but still got it/suspected vaccination failure; had the shot too but still got it; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shot too but still got it/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had the shot too but still got it) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-MAR-2023 The case was received from the patient via interactive digital media. The patient stated that he or she hope that's right for you but did not count on it, it was not 100 percent. The patient had the shot too but still got them, not assess bad but was still very painful. The patient wish well. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient noticed "chickenpox-like" rash started in hairline then spread behind ear and down neck. Has swollen lymph nodes. Lesions are itchy and painful. 3/30/10 ordered Valtrex 1000mg tid x 7 days and Vicoden 5/520 T-TT q 6 h PRN pain.
Having skipped heart beats, PAC, PVC. on and off for 1 week. ER visit, EKG done, no medication 72 hrs monitor done no results yet
Fingers and joints hurt, eye issues, tired, severe headache, vomiting. 11/20/09 Medical records received from dates 9/16/09, 9/25/09 to 10/2/09. DX: acute demyelinating encephalomyelitis, HA.  Pt presents w/ c/o HA x3days. Pt. had h/o migraine HA. Pt. parent states this HA is different from previous HA. Pt. states pain is throbbing, pressure, N/V, weight loss, body aches, fatigue. Assessment: WNL. On 9/25 pt. seen in ER for c/o cont. HA. Pt states neck stiffness, fever, tremors. Pt recently had flu vax.
The evening of the vaccine: I had fever, severe headache & chills for approx. 6 hrs.The next day (day 2), arm sore as expected, chills, severe headache (in a different area of my head than my usual migraines), fever again, lethargic, shortness of breath, diarrhea & body aches. I also went in & out of AFB RVR all day (some bouts lasting 4 hrs, others two hrs, some only minutes).  Finally being out of Afib RVR in the PM. Next day (3rd) more AFib, but not as aggressive. I have not been in Afib like these episodes since my last Heart Ablation; W/O a doubt, I contribute these episodes to the covid vaccine triggering Afib RVR. Summary: After the vaccine, the best way I can describe how I felt, was exactly like when I had covid 19 this past January. On Sept. 13, 2021, I tested negative for the C19 Antibodies (I had previously tested positive for 2xs), therefore opted for the vaccine.  I waited out the side effects, did not see a doctor. As of today, I feel good, except for a headache, some mild confusion and being tired.
tested positive with Covid symptoms (omicron was mostly in area); tested positive with Covid symptoms (omicron was mostly in area); hyperthyroidism; heart rate elevated; elevated white cell blood count; elevated iron; her heartrate elevated along with bp; Hypothyroid; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 46 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hashimoto" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: controlled with meds for years. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome "unknown" and all described as "tested positive with Covid symptoms (omicron was mostly in area)"; HYPOTHYROIDISM (medically significant) with onset 2021, outcome "unknown", described as "Hypothyroid"; HYPERTHYROIDISM (medically significant) with onset May2021, outcome "unknown", described as "hyperthyroidism"; HEART RATE INCREASED (non-serious) with onset May2021, outcome "unknown", described as "heart rate elevated"; WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 2021, outcome "unknown", described as "elevated white cell blood count"; BLOOD IRON INCREASED (non-serious) with onset 2021, outcome "unknown", described as "elevated iron"; BLOOD PRESSURE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "her heartrate elevated along with bp".The patient underwent the following laboratory tests and procedures: blood iron: (unspecified date) elevated; blood pressure measurement: (unspecified date) elevated; heart rate: (unspecified date) elevated; investigation: (unspecified date) hypothyroid; sars-cov-2 test: (20Dec2021) positive; white blood cell count: (unspecified date) elevated. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered drug ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration and based on the current available limited information in the case provided, the causal association between the events Hypothyroidism, Hyperthyroidism, Heart rate increased, White blood cell count increased, Blood iron increased, Blood pressure increased and the use of suspect product BNT162B2 cannot be fully excluded  The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and Investigators, as appropriate.
Weak feeling; Lightheadedness; Diarrhea; Shivers; Sore arm; Red patch; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and skin red. On 30th July 2020, the patient experienced shivers. On 2nd August 2020, the patient experienced weakness, light headedness and diarrhea. On an unknown date, the outcome of the weakness, light headedness and diarrhea were not recovered/not resolved and the outcome of the shivers, pain in arm and skin red were recovered/resolved.   It was unknown if the reporter considered the weakness, light headedness, diarrhea, shivers, pain in arm and skin red to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a red patch and sore arm that has since resolved.  The following day the patient came down with shivers that also has since resolved. The patient had experiencing diarrhea, lightheadedness, and a weak feeling that was unknown if related to Shingrix vaccine.  These symptoms were still ongoing. The reporter did not consent to follow up. The reporter did not consent to HCP follow up and stated she would follow up on her own.
4/18/2022- Presents to ED c/o chest pain and c/o of n/v with coffee ground emesis. EKG showed no changes, H&H stabe, trop was negative. Covid - on admission. Upper GI Endo-large hiatal hernia present 4/19/2022-Hiatal hernia, conservative tx due to cardiac concerns. PPI. 4/20/2022- New onset A fib with RVR, HR elevated (107-150) BP 92/60. Placed on 3.5 L NC. Chest pain resolved Trop - x 3. Toprol changed to Lopressor and Digoxin. Amlodipine d/c.  4/21/2022- BP stable, sinus rhythm with HR in 80's. temp-100.9, on empiric antibiotics for possible aspiration pneumonia due to vomiting.  4/23/2022-Temp wnl. BC, show no growth. Currently 98% o2 on 3 L NC.  4/24/2022-Covid + bebtelovimab given. Supplemental o2 at 2 L.  4/25/2022- Started Remdesivir. D/C ceftriaxone and Doxy, start Zosyn. VSS. 4/26/2022- D dimer 970 4/29/2022 - Repeat CXR- no acute disease. Currently satting 93-97% on 2L.  5/6/2022- segmental/subsegmental emboli, right upper and right lower lobe pulmonary arteries. D Dimer 1,946.Heparin Started.  5/10/2022- Chest pain and coffee ground emesis resolved.  Stable H & H, started on eliquis. D/C to Home.
18 hours after the injection i got a 101 fever. Body aches and headache as well as fever lasted 12 hours. Took tylanol. Today 42 hours later big itchy redness over the vaccine site.
Pt is a 04M 02D year old female patient that presents for Allergic reaction.  Mom brought baby in - was in the clinic this morning for a health check and had PENTACEL and PREVNAR.  Dr. had also evaluated for some small bumps on the babies skin.  Baby was at daycare and was noted to have hives on abdomen.  Mom brought baby back in - red raised rash to abdomen and a few speckles on arms.  Nothing noted on back or legs.  Baby was playful, no signs of difficulty breathing.  Mom was instructed to continue to monitor and bring baby to the ER for any difficulty breathing.  She will give BENADRYL every 6 hours PRN and continue to monitor the rash.  She will let us know if further problems or questions.  Dr was not available in the clinic, I did discuss with him on the phone. RN.  14:15 - Mom called back - pts right leg is swollen very large - This is the side the PENTACEL was given in.  She will try and give a dose of BENDARYL.  If it gets worse she will take her to the ER.  RN.
I changed my son into pajamas and at that time noticed his upper arm had swollen and turned red around the injection site. There is approximately a 4 inch by 3 inch round area very swollen, red, raised, and firm. No white discoloration is showing in his arm (it doesn't look like a hive). The swelling is obviously related to the injection as the injection puncture site is in the exact middle of the swollen, red, area. His upper left arm is disproportionately larger than the other arm. I gave patient 5mL Hydroxyzine syrup at approximately 1:45 AM in case it was an allergic reaction. It is approximately 50 minutes later and there is no sign of improvement.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic lymphocytic leukemia (inactive) and allergic reaction to antibiotics. On 7th July 2018, the patient received the 1st dose of SHINGRIX. On 7th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 8th July 2018, the patient experienced erythema of extremities and injection site swelling. In July 2018, the patient experienced injection site itching. The patient was treated with Cortisone Cream (non-proprietary). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the erythema of extremities and injection site swelling were recovering/resolving and the outcome of the injection site itching was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, erythema of extremities, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the SHINGRIX on the left arm. The patient stated that, on the day of vaccination, she experienced pain at the injection site. The next day after receiving the SHINGRIX, the patient experienced redness on her left arm and extreme swelling at the injection site. The patient stated that, the redness was located on her left arm from the shoulder to the elbow. She also experienced itching at the injection site, however, she does not remember when the itching started. The patient went back to the pharmacy to let the pharmacist check out her arm. She called her doctor's office, but had not yet seen the doctor. She used 2.5 percent cortisone cream at the site to treat the symptoms. The patient was not sure which physician she would see for these symptoms and was not able to provide healthcare professional information at the time of the call.
She got her vaccine, the morning after the vaccine she awoke and her legs were very weak and she kind of while she was going towards the bathroom,(she has to use a walker), her legs gave out on her and she was on the floor, and she could not push herself back up.  Her husband had a hard time getting her back up.  She was wobbly which she kind of is in the morning.  They called the ambulance and brought her to the hospital and was released about 5 hours later.  She had a small stroke about 2 weeks ago.  They told her in the ER that they could not find any reason for her weakness.  They told the ER that she had had the vaccine the day before and that was kind of shaky the night before.  She got a little better while in the ER and then released her.  She believes that it was from the vaccine itself.  Her son also pointed out that she sort of had a weird reaction to the 2nd vaccine perhaps, but had no other issues with the other vaccines.  She feeling better, still wobbly but believes it was from her original from her autoimmune encephalitis.     She went to local hospital.
Case number PHEH2014US005003, is an initial spontaneous report from a nurse received on 10 Mar 2014, with a follow up received on 02 Apr 2014. This report refers to a 67-year-old female patient. Past medical history included spleen removal and immunocompromised. Concomitant medications were not reported. She was administered incorrectly with only MenA powder component of MENVEO (batch number: M13011) reconstituted with incorrect diluent (unspecified diluent) instead of Men-CWY-135, intramuscularly into the left arm on 20 Feb 2014. On the same day, she also administered PNEUMOVAX 23 (other manufacturer, batch number: H017759) intramuscularly. Also on an undetermined date, she was administered Hib vaccine (manufacturer and batch number: not reported) incorrectly. So the physician requested to administer ACT-HIB (other manufacturer, batch number: UH629AA) intramuscularly on 18 Mar 2014. She did not experience any adverse reactions due to the maladministration (wrong solution used in drug reconstitution and inappropriate age at vaccine administration). Follow up received on 02 Apr 2014: Updated medical history, concomitant medication, vaccination site, new event (wrong solution used in drug reconstitution) and deleted event (inappropriate preparation of medication).
Fever to 102 deg and apnea. The discharge summary received on 2/19/04 states gastroesophageal reflux.
Extreme pain in back and thighs; Extreme pain in back and thighs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 at 12:00 as dose 4 (booster), single (Lot number: F54989) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 14Apr2022, outcome "not recovered" and all described as "Extreme pain in back and thighs". Therapeutic measures were not taken as a result of back pain, pain in extremity. No follow-up attempts are possible. No further information is expected.