chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Aches; General unwell feelings; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 03Mar2021 at 17:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included "MORTON" for an unknown indication from an unknown date and unknown if ongoing. On 05Mar2021 at 09:30, the patient experienced chills, aches, and general unwell feelings. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, aches, and general unwell feelings was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (tingling in face / Tingling feet / Tingling hands) and MUSCLE TWITCHING (twinkling her left side of her face and also her breast) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and CALCIUM for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced MUSCLE TWITCHING (twinkling her left side of her face and also her breast). On an unknown date, the patient experienced PARAESTHESIA (tingling in face / Tingling feet / Tingling hands). The patient was treated with Physical therapy for Paraesthesia. At the time of the report, PARAESTHESIA (tingling in face / Tingling feet / Tingling hands) had not resolved and MUSCLE TWITCHING (twinkling her left side of her face and also her breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: New AER tingling in face/hands/feet added
Extreme tiredness the day after.  I sleep almost around  clock.  I have have fatigue on and off throughout the day since the second injection.  I have random times of moderate anxiety spells that last 2 - 3 hrs.  I also have difficulty concentrating and remembering things I need to accomplish throughout the day.
Presented to ER on 11/26 with Rt Parotitis w/o stone (CT confirmed)
went out of recommended temperature range during delivery; This non-serious case was reported by a pharmacist and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) (batch number 52X45) for prophylaxis.   In AUG-2023, the patient received Menveo. On 11-AUG-2023, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: went out of recommended temperature range during delivery).The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2023 The reporter stated that we would not be able to send back the 60 units of Menveo and currently had 38 units to be returned. We issued an investigation since the product was received in the system and customers were able to place orders (22 units). The feedback needed from Glaxo for investigation. The 22 units of Menveo vaccine temperature excursion on 11th August 2023. The tag alert alarm 2, 3 with 4 black squares. The Menveo vaccine had temperature excursion, which led to incorrect storage of vaccine.
Itching,hives,redness from right waist to right ankle.Started 2/27/2021 ongoing.Cannot take antihistamines due to Sjogrens.Cortisone cream not helping
a minor headache for part; I had soreness in site of injection for a couple days (1st dose); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Oct-2021 and was forwarded to Moderna on 26-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (I had soreness in site of injection for a couple days (1st dose)) and HEADACHE (a minor headache for part) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (I had soreness in site of injection for a couple days (1st dose)) and HEADACHE (a minor headache for part). At the time of the report, VACCINATION SITE PAIN (I had soreness in site of injection for a couple days (1st dose)) and HEADACHE (a minor headache for part) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter.  Patient stated after first dose had soreness in site of injection for a couple days and a minor headache for part of the day   This case was linked to MOD-2021-364550 (Patient Link).
Asthma I don't know the date and time of vaccination and asthma,  This is estimate.
positive PCR test; positive PCR test; This is a spontaneous report from a contactable Nurse. This nurse reported for a 39-year-old patient that:  A 39-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in arm left on 24Mar2021 (Batch/Lot Number: EP6955; Expiration Date: 30Jun2021) as single dose, dose 2 intramuscular, administered in arm left on 15Apr2021 (at the age of 39-year-old) (Batch/Lot Number: EP6955; Expiration Date: 30Jun2021) as single dose, for COVID-19 immunisation, administered at workplace clinic.  The patient medical history and concomitant medications were not reported. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced vaccination failure (medically significant) on 03Sep2021 with outcome of unknown, positive PCR test (medically significant) on 03Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included: Sars-cov-2 test (Nasal Swab): positive on 03Sep2021  Investigational results were received from a Pfizer product quality complaint group for Lot: EP6955. Product-Description: COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Lot: EP6955. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP6955 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Left axillary pain bad enough that arm is difficult to raise.  No masses or LAD.
Localized induration.  Painful and swollen approximately 8cm by 5cm.
AFIB incident . Dr. sent me to ER for cardizem and EKG.  Have been on Metoprolol 25mg twice a day along with Eliquis 5mg twice a day.  Prior to the vaccination had no heart condition.
Patient got less than 0.1mL of the dose; most of it got on her jeans; The seal on the syringe was not good; This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (Patient got less than 0.1mL of the dose; most of it got on her jeans) and DEVICE CONNECTION ISSUE (The seal on the syringe was not good) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Patient got less than 0.1mL of the dose; most of it got on her jeans) and DEVICE CONNECTION ISSUE (The seal on the syringe was not good). At the time of the report, UNDERDOSE (Patient got less than 0.1mL of the dose; most of it got on her jeans) and DEVICE CONNECTION ISSUE (The seal on the syringe was not good) outcome was unknown. Not Provided      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 details were provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up received on 24-May-2021. The pharmacist stated that the patient was fine after receiving the under dose, that patient didn't experience any adverse events and has already received her 2nd dose.
arm (swollen), sharp pain from vax site then arm would go limp (very weak), loss of feeling for a time loss of function intermittently; recently had trouble of life side-neck, leg pain; some numbness, vax site pain-pain in arm;
arm that I got the shot in is reddened and swollen and there is pain; arm that I got the shot in is reddened and swollen and there is pain; tiny little red spots; tiny little bit of aching; a little itchy all over too; arm was really sore and hurting and I noticed it had turned red; my arm is very uncomfortable; This is a spontaneous report from a contactable nurse (patient).  A 58-Year-Old female patient received second dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Aug2021 single dose in left arm for COVID-19 immunisation. Lot number was FA7484. Medical history and concomitant medications were unknown. On 14Jul2021, the patient received first dose of BNT162 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation and she experienced sore in arm (lot number FA6780). On unknown date, the patient received a flu shot for immunization (inflamed, painful). The patient experienced arm that got the shot in was reddened and swollen and there was pain, tiny little red spots; tiny little bit of aching, a little itchy all over too, arm was really sore and hurting and it had turned red, arm was very uncomfortable. Little spots treated with antibiotics cream; the patient also received Benadryl and a Claritin, Ibuprofen 200 milligram. The outcome of the events was unknown.
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 improperly stored doses of PEDVAXHIB (dose and route were not reported, lot # K011077, expiration date 30-MAR-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a medical assistant regarding a 9 months 19 days old infant. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 18-JAN-2018, the patient received the third dose of ROTATEQ lot# N011647 with expiry date of 17-NOV-2018 orally for prophylaxis (Inappropriate schedule of drug administration). No adverse effects were reported.
Weakness, panic attacks, heart palpitations, blurry vision, burning sensation in extremities, balance issues, spasms
Headache, Injection site pain Narrative: Patient continue to experience injection site pain 3 weeks after vaccination
The Flu shot (in right arm) and whooping cough/tetanus shot (left arm) were administered high on the arm. Shot hurt worse than before especially for right arm. That day I could not raise either arm above my head. Saw administering nurse approximately 3 weeks after. Then saw my general practitioner approximately 5 weeks after. She diagnosed me with shoulder bursitis in both shoulders. Right one is the worse one. Treatment included 2 weeks of NSAID (took approximately 4 weeks) & exercises. Pain continues to be present.
pt recvd vax; fainted rt p/ shot; 30 secs later was completely recovered; er Dx as vaso-vagal responsse;
1 day /p vax local allergic rxn @ site of inject & small generalized fungi forms lesions all over the body; 2 days /p vax approx 7pm h/a, completely recovered /p 2 wks.
Pt vaccinated with DTP developed temp 104 rectally. Swollen red leg.
I am an asthmatic.  Fine until 25 mins. after vaccine then tightness in chest that lasted about 45-60 mins.  Next day asthma had started.; I am an asthmatic.  Fine until 25 mins. after vaccine then tightness in chest that lasted about 45-60 mins.  Next day asthma had started.; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: LL3248, expiry date not reported), via an unspecified route of administration at the right arm on 25Jan2021 09:00 at single dose for COVID-19 immunization. Medical history included allergies, chronic asthma, immune deficiency, high blood pressure, allergic to injections and infusions. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. On 25Jan2021 09:00, the patient stated that she was an asthmatic. She was fine until 25 mins. After vaccine, she then experienced tightness in chest that lasted about 45-60 mins. On the next day, asthma had started. She had the vaccine on Monday, and called her physician and requested to come to be checked which she did. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unspecified date. Therapeutic measure was taken for the events that included  Symbicort inhaler. Clinical outcome of the events was recovering.
HEP B SHOT WAS ADMINISTERED IM IN THE PATIENTS LEFT ARM. AFTERWARDS IT WAS RECOGNIZED THE PATIENT HAD AN OBSERVATION NOTED FOR IMMUNITY TO HEP B AND THAT THE SHOT WAS UNNECESSARY.
Immunizations were given at 1607, at 1615 a red rash was noticed around pt's eyes and also forehead and cheeks. Also noticed red rash to arms bilat.  Pt denied that he was short of breath or that his throat itched.  Pt was also afebrile.  Checked pt's 02 saturation and level was at 88% on room air.  Brought pt and guardian over to the clinic to be evaluated by a provider.  Pt was brought back to clinic room by clinic staff to be triaged and evaluated.  Pt was placed on 2L of 02 per nasal cannula by clinic nurse and sats then when up to 93%.
Got shingles within days of their shots / Suspected vaccination failure; Got shingles within days of their shots this year; This 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, 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 Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comments: The case was reported by a patient's family member interactive digital media. The reporter reported that then avoid the shingles shot. The patient (two people in the reporter's family) got shingles within days of their shots this year. This case is linked with US2023AMR025323 same reporter for different patient. Additional Supportive Information:This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR025323:Same reporter
positive COVID-19 via testing.; sick; chills; nasal not right; ache all over in the back; aches all over in the back and up/down the legs; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), CHILLS (chills), BACK PAIN (ache all over in the back), PAIN IN EXTREMITY (aches all over in the back and up/down the legs) and COVID-19 (positive COVID-19 via testing.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0481921A and 039AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN for Cholesterol, CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE (CANDESARTAN HCTZ), METOPROLOL and AMLODIPINE for Hypertension, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for Vitamin C, MULTI VITAMIN & MINERAL and ASCORBIC ACID, ECHINACEA PURPUREA (ECHINACEA + VITAMINA C VITATECH) for Vitamin supplementation, PROBIOTIC 10 and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.   On 06-Mar-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 06-Mar-2021, the patient experienced BACK PAIN (ache all over in the back) and PAIN IN EXTREMITY (aches all over in the back and up/down the legs). On 16-Mar-2021, the patient experienced NASAL DISCOMFORT (nasal not right). On 11-Apr-2021, the patient experienced ILLNESS (sick) and CHILLS (chills). On an unknown date, the patient experienced COVID-19 (positive COVID-19 via testing.). At the time of the report, ILLNESS (sick) had not resolved and CHILLS (chills), BACK PAIN (ache all over in the back), PAIN IN EXTREMITY (aches all over in the back and up/down the legs), COVID-19 (positive COVID-19 via testing.) and NASAL DISCOMFORT (nasal not right) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    This case was linked to US-MODERNATX, INC.-MOD-2021-074925 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074925:
On 10/25/01 at 8:50 AM, returned to clinic with complaints of fever, chills, nausea and diarrhea. Pt also had general muscle aching which started @ midnight. Also complained of right deltoid pain and it appears bruised and slightly swollen @ injection site. CBC was repeated.
3 days splotchy red dot rash appeared on extremities only, none on face that went away with BENADRYL.
Fever, full body muscle aches & joint pain, fatigue, soreness, pain at injection site, nausea, dizziness (each of these started/were most severe the day after vaccine and continued to 2nd day after vaccine)
This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M042170, expiration date 22-JUN-2018; lot # M044397, expiration date 20-JUN-2018 and lot # N009948, expiration date 21-OCT-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 0.8 degrees Celsius for 52 minutes and 10.9 degrees Celsius for 3 hours and 17 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint has been filled. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007137: US-009507513-1709USA007138: US-009507513-1709USA004848.
Received first Moderna Vaccine 4/1/21. Noted generalized erythematous rash within 48 hours of first vaccine. No other symptoms.   Received 2nd Moderna Vaccine 4/30/21. At 1500 5/1/21 developed itchy generalized rash involving trunk, upper and lower extremities. No angioedema. No cough. No hives. No difficulty in breathing. No nausea or vomiting.
I have not had a period in over 2 years.  I received the shot on April 7th.  On April 8th I started to see blood when I went to the bathroom.  On April 11th I had period like symptoms, clotting, big chunks that is still continuing as of today April 30th.  I have been to several doctors to figure out why the bleeding is happening and the doctors can not find anything wrong  and have recommend  hysterectomy.  I was given medroxyprogesterone 10 milligrams to be taken for 10 days starting April 13th for 10 days 3 times a day.  Then reduce down to 1 time a day.  On day 10 I reduced down to 1 a day and the bleeding came back to soaking one extra large pad in less than 30 minuets.  The doctor told me to continue on three a day till the bleeding tampered off.  After I got my 2nd shot on April 28th the bleeding was heavy again and I am back to taking the pills 3 times a day.  I was only on 2 pills a day for 2 days.
Patient noted a history of fainting in past. We discussed staying seated a few minutes after just to make sure. She said she did not feel right so she remained seated. I went to check on her because she did not answer when I asked a few minutes later if she felt better. I walked in front of her and she dropped her phone and slumped. I called her name, no response. My technician brought me an ice pack. I had her call 911. Once I placed the ice pack on her neck, patient responded. She was very sweaty. We gave her a small glass of water, then was able to get some ice water for her. The ambulance arrived and checked her vitals, she was feeling better and did not want to go to the hospital. Family also came to drive her and her car home.
Pt had a sore arm starting in the evening of 9/21/20. Pt went to her providers office on 9/22/20 since her arm "locked up", The provider then sent her to the emergency room.  At the emergency room she had to have her arm cut open to debride the tissue and have fluid removed from her arm . The hospital is doing a culture to see what bacteria the patient has an infection from, the patient is currently still in the hospital.