chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe chest pain; severe chest pain / pressure on right side; severe chest pain / pressure on right side that woke me from sleep; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 via unspecified route of administration in the arm left, on 03Aug2021 at 17:15 (lot number: fc3180), at the age of 46-years-old, at single dose for COVID-19 immunisation. Medical history included insomnia. Patient was not pregnant at the time of vaccination. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for unspecified indication, and unspecified vitamins. The patient experienced severe chest pain / pressure on right side that woke the patient from sleep, all on 19Aug2021 at 04:00 am. The events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Therapeutic measure was taken in response to the events which included unspecified IV med. Laboratory tests included EKG, Chest X-ray, blood work on unspecified date in Aug2021 with unknown results. Outcome of the event was recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
had shots & got shingles/suspected vaccination failure; shingles/ got shingles again and it was mild case; 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.   The patient's past medical history included shingles (had shingles).   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 shots & got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/ got shingles again and it was mild case). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-Mar-2023 The case was received form the patient via interactive digital media. The patient also had the shots and got the shingles again. The patient stated that it was a mild case. 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.
I awakened with chills and fever, that climbed to 102.8 within a couple of hours.  I had headache, muscle and joint pain, nausea that lasted for 18 hours.  All symptoms slowly remitted, and by early afternoon on 4/28, I felt fine again.
Tender at injection site; Redness at injection site; Swollen arm; Sore arm; Flu-like symptoms; A spontaneous report was received from a dentist concerning a 63 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm, flu-like symptoms, tender at injection site, redness at injection site and a swollen arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch no: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 27 Dec 2020, the patient developed a sore arm. On 02 Jan 2021, she experienced flu-like symptoms. Additionally patient also developed tenderness, redness and swollen arm, which was getting bigger, 4 inch long by 3 inches wide at the injection site. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, sore arm and flu-like symptoms was unknown. The outcome of the events, tender at injection site, redness at injection site and a swollen arm was considered as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
2nd dose on the evening of vaccine, low grade fever 101.9. I seemed okay, had fatigue and sore arm and that was it. The next day, midday upper arm and face were hot and tight, swollen. Fever, headache, and fatigue. Fever at that time was 102.9. 3PM-6AM all of the following symptoms from 4/3-4/4: Pain at the injection site, hot tight upper arm and face, fever, headache, fatigue, achy stiff muscles and neck, jaw pain, swollen glands, sore joints, chills, nasal congestion, dizziness almost passing out when I would get up, abdominal pain and reflux very loud gurgling in abdomen, intestinal pain, cramping, nausea, spots in my vision when almost passing out, lower back pain, rapid breathing possibly due to fever as well as elevated heart rate (110BPM), pelvis felt completely bruised and beaten. Couldn't sit, etc. uncomfortable and painful. Under my arm and in my arm pit, huge lump. By noon the next day, fever went down and majority of it was over, especially the pain it resolved around 9am that morning on 4/4. At that point, I was back to being fine. I did not seek medical treatment at that time. Mentioned it to doctor at a later date, and she noted it and moved on. Smaller event with like symptoms a week later, but that disappeared again as well within 4-6 hours in the same day.
Patient experienced itchiness at the site of the injection under her band-aid and PPE. Patient was given oral benadryl and did not complain of the event further when I saw her the remaining 6 hours of work.
Pt. waited approx 10 min. in our office and had no symptoms. But approx 20 minutes later she felt "faint" and passed out while driving.  She required emergency abdominal exploration for bleeding and her injuries included pneumothorax, liver laceration, and vena cava laceration which required R. nephrectomy.  12/20/05 Reviewed medical records. Add accident with injuries.
I was administered a booster dosage of 0.5, which is not the recommended amount. 24 hours after I had a fever and felt worse than I did after my 2nd series. 48 hours after my injection I have pressure/discomfort around the lymph nodes alongside my groin. In general I have not felt my normal-self since my booster shot. (At full dosage amount)
I am experiencing a reoccurrence of Shingles.  The first time I experienced Shingles was in June and the reoccurance started 2 days post vaccination of my 3rd dose.  Site of the Shingles is in the same location.  Based on the advice of my physician he has prescribed Valacyclovir which I will begin taking today.   Dates of my other doses were 12/18/20 and 1/8/21.
pt recvd vax & 6DEC93 & 1wk later pt devel pneumonia; No further details were provided;
(Reddness, Swelling , and pain)- Cellulitis Cephalexin 500 MG tablet 1 tablet by mouth twice daily for 7 days,
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for hx of cerebrovascular accident, t2dm, htn, hyperlipidemia. Per note 4/7, patient was taken to ER with a cc of vomiting and lethargy. Next note was 4/27 which daughter reported that patient was still in the hospital (had 2 surgeries) and inquiring about home health. Patient discharged on 4/29 and deceased 9 hours later. Lack of information available regarding hospital visit and death.
Initial report received from the patient's parent on 01 August 2007.  A 14-year-old female with a history of seasonal allergies had received vaccinations with Menactra (Lot number U2227AA), varicella (manufactured by Merck, Lot number 0606U), and Gardasil (manufactured by Merck, Lot number not provided) on 12 July 2007 and two days later developed white spots on her throat.  The patient had no illness at the time of vaccination and the only reported concomitant medication was Zyrtec, taken daily.  The patient was seen in the hospital emergency room and was given Nystatin and unspecified antibiotics.  Blood work, throat cultures and an HIV test were performed.  Diagnosis was "thrush".  Patient outcome was not reported.  No additional information had been provided at the time of this report.  Follow-up information received on 21 September 2007 from a health care professional, the patient's treating physician; Menactra was given intramuscular, into the left arm.  Varicella was given subcutaneous into the left arm and Gardasil (lot #0525U) was given intramuscular into the right arm.  The final diagnosis was candidal pharyngitis (thrush).  Extensive work-up performed in the emergency room (ER) (on 17 July 2007) with multiple cultures.  The patient was given 1 dose of IM Ceftriaxone.  Then results of bacterial cultures came back all negative.  The only positive culture was fungal culture positive for candida.  Further evaluation for immunodeficiency performed as out patient.  All labs were okay, including negative HIV.  No etiology determined for candidal pharyngitis, which, per reporter was unusual in immunocompetent adolescents.  As of last contact with the parent, the patient was still using Nystatin, which was the final treatment.  Concomitant medications (per patient's records) included also Flonase.  Current status was unknown.  Documents held by the sender: ER and office visits and labs.
Patient received incorrect vaccine. Intended was janssen booster 0.5 ml, patient received pfizer 5-11 yo 0.2 ml dose.
After, about 3 days it got very red and itchy on my entire inside arm. Nothing seemed to help except ice pack. It would fade and then come back for almost 2 weeks.
Tinnitus started occurring on April 12 which is roughtly about 1 1/2 week after vaccine.  Went to doctor who prescribed azithromycin assuming it was an ear infection but problem did not resolve.  Went to see ENT who mentioned it could be Eustachian Tube Dysfunction and prescribed Fluticasone Propianate for a month which also did not resolve the tinnitus.   Also around this time frame been having a shoulder issue that also has not resolve on the left side where I had the 2nd shot.
Flumist was administered to patient over the age of 49.  Followed up with patient who reported mild malaise the following day but felt normal the day after that.
10:00 am Patient sweating and pale. Cool packs to neck.  Layed down, Elevated feet. 10:15am Complaints of left arm pain and chest discomfort.  10:17 Oxygen administered via nasal canula.  10:17 Ambulance contacted and client transported to the hospital.
A little more than 3 weeks after the 4th dose I came down with shingles. No idea if there is any relation to the booster. I have not had the shingles vaccine.
4x3 inch reaction of redness with 1inch of vesicles. Follow up with progress and recheck if not improving.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No Adverse Event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Patient didn't had any known allergies.     On 22-Sep-2022 at 5:57 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 22-Sep-2022 at 5:57 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant drug information was provided.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. It was unknown if the patient had ever tested positive or been diagnosed with COVID-19.  It was reported that the vaccines had undergone several temperature excursions in August 2022.  Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation.  No adverse reactions were reported for any of the patients at the time of the report.   No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654158, US-MODERNATX, INC.-MOD-2022-654537 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654158:same reporter US-MODERNATX, INC.-MOD-2022-654537:same reporter
Patient received vaccination at 2:00 pm on 9/1/17; at 8:00 am on 9/2/17, patient started with symptoms of dizziness/headache.
Verbatim per incident report: "Administered Menveo and Hep A #1 in left deltoid and HPV #1 in right deltoid. Assisted client from exam table to chair. While observing sibling receiving immunizations, patient's head leaned back against the wall, eyes rolled back, face went pale, upper and lower extremities with movement lasting 5 seconds. Awoke unaware of what had happened. Laid (patient) down on table with cold rag on forehead, knees bent. He did not eat breakfast this morning. Gave cereal bar and sunny delight. Color returned to face, lips pink. Bp 90/60, Pulse 72, Resp 24. Reccomended to follow up w/ pediatrician. Dr. contacted and notified, ok to finish vaccine series. Schedule well child visit and can discuss further with them (parents). Mom aware.
Fever, full body measle like rash, lethargic, cranky. Starting at day 7 and worsening on day 10. Was told to watch and make sure she doesn't have a high fever or stiffening of joints.
Initial information received on 10-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 18 months old male patient who was vaccinated with 0.5 ml one time dose of ADACEL (Batch number U5702AA, expiry date 20 June 2019, dose in series, route and site of administration were not reported) on 22-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
pt extremely irritable w/high pitched cry from 10PM-1AM per mom; temp 101; mom giveing APAP encouraged mom to call pvt MD & make them aware & to call back to hlth dept; if any other problems arise;
swollen tender inflamed inject site lasting 3 days; 2 days p/inject began w/malaise, poss fever, green sputum;
patient had the first dose of Pfizer's COVID vaccine in December and got COVID; patient had the first dose of Pfizer's COVID vaccine in December and got COVID; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on dec2020 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She got COVID. She was asking if she would be able to get the second dose next week. The events got COVID and drug ineffective were assessed as medical significant with outcome unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Based on the information currently available, lack of efficacy of the vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. The case will be reevaluated should additional information become available.
Having episodes of  deep depression and suicidal thoughts.  Lack of motivation. No interest in everyday events or happenings.
my heart started pounding fast and hard; my upper left head area above eyebrow hurt and pounded; Could not sleep first 2 days; feel heavy and water-bloated throughout my whole body; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration in upper right arm on 10Jul2021 at 15:00 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. There was no patient's other medical history reported. There were no known allergies reported. The patient's concomitant medications were not reported. No other vaccine was received by the patient within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and post vaccination, the patient had not been tested for COVID-19. A couple of hours after the vaccination on 10Jul2021 at 18:00, the patient's heart started pounding fast and hard and upper left head area above the eyebrow was hurt and pounded. The patient could not sleep for the first 2 days, pounded hard and fast on and off during the day for 8 days and the patient feels heavy and water-bloated throughout her whole body and went in to an emergency room (ER) for a few blood tests but showed up nothing. Patient was still concerned about her events. No treatment was received by the patient for these events. The outcome of insomnia was recovered on 12Jul2021 while the other events was not recovered at the time of report.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Immediate pain and limited range of motion following shot, continued for 48 hours. Severity improved over the next week, however at 2 weeks post-shot, I still experience pain and stiffness in my left shoulder.
Fluid in the pericardium; Heart skips a beat; Out of breath; Heart pound when sedentary; A spontaneous report was received from a consumer who was also a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fluid in the pericardium (pericardial efflusion), heart skips a beat (heart rate irregular) when out of breath (dyspnoea), and heart pounds when sedentary (palpitations).  The patient's medical history included irregular heartbeat. Relevant concomitant medications taken within two weeks prior to the events were not provided.   On 05 Jan 2021 at 12: 30 pm, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 02 Feb 2021, at 12:30 pm, the patient received their second of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On an undisclosed date, the patient developed fluid in the pericardium, and her heart skipped a beat when out of breath. It would happen when she was sedentary, and her heart would pound when not walking. She had irregular heartbeat before and was prescribed a concomitant medicine which was a nasal steroid.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   The outcome of the events, fluid in the pericardium, heart skips a beat when out of breath and heart pound when sedentary, were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time in this case of serious unlisted event of pericardial effusion and non-serious unlisted events of heart rate irregular, dyspnea, and palpitations. However, patient's medical history of irregular heartbeat is a confounding factor that may play a contributory role providing an alternative explanation. Further information has been requested.
Within about a minute after receiving dose 1 of the Pfizer COVID-19 vaccine, patient vomited (once on 12/21/2021) and felt lightheaded. He was kept for observation for a total of 30 minutes. He left the office in stable condition.
Information has been received from a physician and a school nurse concerning an 8-year-old male who on 22-DED-1997 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy that day included a dose of MMR. It was also noted that the patient was vaccinated with a dose of MMR on 03-APR-2001. A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005, the child developed a "more severe case" of chickenpox, noted to be breakthrough with 50 to 250 lesions. Unspecified medical attention was sought. The outcome was recovered. A product quality complaint was not involved.  No additional information is expected.