chrisvoncsefalvay/vaers-outcomes huggingface dataset:
autism; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an male patient (pt) (age not provided). The pt's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 29-FEB-2000, the pt received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dosage information, lot # and expiration date were not provided) for its intended purpose: prophylaxis. On unspecified date, after the receipt of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), the patient was diagnosed with autism. As a result of the vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) the patient was caused and/or in the future will be caused to suffer severe personal injuries, pain, disability, and suffering. At the time of the report, the patient had not recovered from the event. The reporter considered the event to be related to the suspect therapy.   Upon internal review, the event of autism was considered medically significant. The reporter considered the event to be disabling.   This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2205USA002241:
Fell asleep around 9:00 pm with slight fever and stuffy nose. then i woke around 1:30 am with a slight headache and patches hives from shoulder to my thigh. I took a benadryl and went back to sleep. Awoke on 4/22/2021 with none of the above symptoms or hives.
04-06-04 given DTaP and IPV left thigh. 4-7-04 left thigh 9 cm x 11 cm redness and swelling given Motrin and Cephalexin 250 mg/ml 3/4 tsp. 4-8-04 13 x 11 cm redness and swelling. Prescription Rocephin 1 gm IM. 4-12-04 redness & swelling resolved.
Admitted to the hospital on 10/11/15 with fever of 104, chills, headache, sore throat, nausea, vomiting, extreme achiness, flare up of asthmatic symptoms. Discharged on 10/13/15.
Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. Information concerning medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (lot#, expiration date, dose and route not provided), which had been improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Next day was just fatigued all day. Felt so good to just sit down and not move. Not as tired the next day and then pretty much normal the next day after
Muscle aches, fatigue, headache, swollen glands, upset stomach, fever 102.4 at the highest. Symptoms started approximately 5 1/2 to 6 hours after vaccine. And lasted 60 hours. My heart has some irregular beating and some hard beating this morning and yesterday.   I did have Covid over 90 days ago. Was treated with monoclonal antibodies. Recovered at home. The symptoms I had over the weekend felt very much like Covid symptoms. I sincerely was concerned that I had Covid again. Although obviously not from the vaccine itself. I did an at home rapid test which was negative. And this morning since my fever broke at 7 AM I have felt much better. The only lingering symptom I currently have is a headache some slight fatigue and the feeling that my heart is not quite right. I do have a heart murmur anyway, but this feels like additional heart arrhythmia.  I have messaged my doctor.
Pt arrived at pharmacy on 5/11/18 displaying redness, swelling and irritation at site of injection and surrounding area. Area was about 2 inches wide by 4 inches long, and pt said area was warm to the touch on the left arm.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 15 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
After each vaccine: Fever, chills, upset stomach, fatigue, swelling and pain 2-3 inches radius. surrounding injector site, hot to the touch.
experienced some itching at the injection site in left arm; This is a spontaneous report from a contactable consumer (patient).  A 81-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included memory impairment ongoing from an unknown date. The patient's concomitant medications were not reported.  The patient experienced some itching at the injection site in left arm on an unspecified date. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Irregular menstruation after 2nd dose/The following day after I received the 2nd shot I started to bleed heavily; This is a spontaneous report received from a contactable consumer (Patient). A 42-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6200 and expiration date not provided) via an unspecified route of administration, administered in right arm on 24Mar2021 02:00 PM as SINGLE DOSE for COVID-19 immunization. The patient's medical history was not provided. The patient's historical vaccine included first dose of BNT162B2 (Solution for injection, lot number EN6203 and expiration date not provided) via an unspecified route of administration, administered in right arm as SINGLE DOSE on 03Mar2021 2:00 PM for COVID-19 immunization. There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25 Mar 2021, the patient had irregular menstruation after 2nd dose and it was reported that, following day after the patient received the 2nd shot and she started to bleed heavily. Heavy bleeding consisted for 5 days. On the 6th day it stopped. The patient assessed the events as non-serious.cThe adverse event resulted in emergency room. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On 31 Mar2021, the event was resolved.   Information on the lot/batch number has been requested.
Pt had flu shot in right deltoid on 10/19/20.  That night she started getting swelling, redness around the area.  On 10/20 MOC have Benadryl, then again 10/21 and it is getting better.  No associated fever, no associated pain and no limitation of movement.  Pt has received flu vaccine before without reaction.
Following the first dose, I was referred for an EKG by my primary physician. My heartbeat was irregular and the doctors said it was probably from the vaccination. I had severe arm pain and flu-like symptoms. Dose 2, I had intense lymph node swelling and pain of vaccination site, a three-day continuous fever between 99 and 102 degrees, no sleep and horrible body/head pain.
stomach pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "recovered", described as "stomach pain".  Additional information: It was reported that the event was experienced about 40 hours after receiving the COVID-19 injection but was resolved within 2 hours.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia D69.6 - Thrombocytopenia, unspecified
Pt experienced redness and soreness of the arm at injection site. Several days later she experienced a "slight headache" for four days. A week after the vaccination, she experienced body aches, hot and cold feeling and a fever of 102. She also has frothy sputum when she cough up phlegm.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Vaccine administered past its 30-days Expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered past its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Feb-2022 at 2:10 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered past its 30-days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered past its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Vaccines went into 2-8 degree Celsius thaw state on or about 20-Dec-2021  No treatment medication information provided.
In January 2020 I received immunizations for shingles and flu at Pharmacy. Reactions to shots is that they were painful afterwards which that was expected.Follow up shingles shot in March 2020 was painful afterwards with swelling and itching at site, headache, tired, listlessness.Shortly, days afterwards I started feeling tingling in both hands. Most noticeable in the early morning on rising. As the day progresses the tingling abated more and more until slight by bedtime. This has occurred daily since the immunization on 3-16-2020. Less for a few days following the shot, then growing in intensity the next few days.Have put off reporting this mostly because of the Corona Virus alerts.At first I didnt know what may be the cause and have been trying to recall medical events that may have contributed to this condition.On researching the events and reviewing side effects of medications and procedures I think I have narrowed it down to the SINGRIX shingles immunizations.At this time it seems to be slightly lessening in its intensity as the days progress..I am going to be sending this information to the pharmacy, urologist, and drug manufacture.     SHINGRIX50MCG INJ(IM)SNGL DSE  1VL
Fainting. After the COVID vaccine she was feeling completely normal, however about 23 hours after she woke up lightheaded, nauseous, became dizzy and fainted. (hit her head, elbow, knee, face when she fell) She then was helped up, was confused. When she was being walked to her bed with help she again collapsed in the person's arms. It looked like here eyes were staring, unable to respond, mouth was open, possible facial drooping.
Tinnitus. I first noticed Tinnitus after my first vaccine in the summer. Didn't think anything of it. Got my second dose. It got worse.  Noticed both these changes within days od vaccine. Went to an audiologist. They said some people report experiencing it after vaccine but hard to tell. I just got my booster, tinnitus is much worse. I'll never be getting a covid shot again. 3 times work 3 profound upticks the the span of a week is enough data for me. And it has never gone away after the 1st 2 shots so I'm sure this is my new normal. Thanks Pfizer since this is completely incurable.
GUILLAIN BARRE SYNDROME; This spontaneous report received from a consumer via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series was 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced guillain barre syndrome. Consumer reported that a coworker contracted Guillain barre syndrome from the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain barre syndrome was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211240145.; Sender's Comments: V0-  20211240501- covid-19 vaccine ad26.cov2.s   Guillain-Barre Syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
Diarrhea; Dizziness; weakness; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (weakness) and DIARRHOEA (Diarrhea) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included AMLODIPINE for Blood pressure high, ATORVASTATIN for Cholesterol, IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (Dizziness) and ASTHENIA (weakness). On 12-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) and ASTHENIA (weakness) outcome was unknown and DIARRHOEA (Diarrhea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated he takes Advil when he has a headache and drinks lots of water.
I had the shingles shot / got shingles/Suspected Vaccination failure; I had the shingles shot / got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included radiation therapy. Concurrent medical conditions included cancer and decreased immune responsiveness.   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 reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had shingles shot but had radiation for cancer so his or her system went down and as a result he or she got shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and TOPIRAMATE (TOPAMAX) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced TACHYCARDIA (Severe Tachycardia/ Still very tachycardia) and FEELING ABNORMAL (Felt a little weird). On 03-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), FATIGUE (Could not get up), ASTHMA (Asthma) and ASTHENIA (Could not get up). On 04-Feb-2021, the patient experienced CONTUSION (Bruise on her right and left leg) and VACCINATION COMPLICATION (Had a reaction to the vaccine). On 01-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg) (seriousness criterion medically significant). On an unknown date, the patient experienced HAEMOGLOBIN DECREASED (Hemoglobin decreased) and RED BLOOD CELL COUNT DECREASED (Red blood cells are low). At the time of the report, DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg), TACHYCARDIA (Severe Tachycardia/ Still very tachycardia), DYSPNOEA (Difficulty breathing), FEELING ABNORMAL (Felt a little weird), FATIGUE (Could not get up), ASTHMA (Asthma), CONTUSION (Bruise on her right and left leg), ASTHENIA (Could not get up), VACCINATION COMPLICATION (Had a reaction to the vaccine), HAEMOGLOBIN DECREASED (Hemoglobin decreased) and RED BLOOD CELL COUNT DECREASED (Red blood cells are low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Haemoglobin: low gram per litre (Low) LOW. In March 2021, Red blood cell count: low cells per microlitre (Low) LOW.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment informations reported were Levalbuterol tartrate  and Rivaroxaba 20 mg   This case was linked to MOD-2021-059897 (Patient Link).
Within 48 hours of second dose of vaccine I had severe difficulty breathing. I was using accessory muscles to try to get a satisfying breath. I also developed a painful, hot rash ('COVID arm') within 48 hours of final vaccination. Three days (1/24/2021) after the vaccine I went to Urgent Care for breathing difficulty. A home SpO2 monitor showed O2 sats 93-98 and HR 80-120 upon minimal exertion. I continued to have breathing difficulty and contacted my PCP for further guidance on 1/28/2021. I did take a short burst of prednisone starting 1/24/2021 (40 mg X 5 days), Bactrim DS X 7 days, and began scheduling 6 puffs of albuterol HFA every 4 hours (per guidance from my physician) without relief. The rash on my arm cleared up within 2 days of starting prednisone. I stopped using the albuterol inhaler in February as it was not improving my symptoms. As time progresses I continue to have difficulty breathing but it has been slowly improving. I feel the difficulty breathing is due to an overreaction of my immune system from the second COVID-19 vaccination.
Extreme fatigue, couldn?t keep eyes open for days. Caffeine nothing helped. Trouble focusing and remembering, can?t complete analytical work for my job. Also had second dose on 4/19/21 and symptoms worsened. Continued symptoms include fatigue, memory loss/brain fog, difficulty concentrating on detailed task, confusion.
I got my second Pfizer COVID-19 vaccine shot on 5/5 at 1:30PM and woke up on 05/08 at 04:30AM in extreme abdominal pain.  I was nauseous, had hot and cold flashes, and vomited.  The pain eventually moved to my lower right abdominal quadrant and I decided to go the ER at around 11:00AM. I was diagnosed with acute appendicitis and had my appendix removed at about 4PM that same day.  I was sent home Sunday at around 11:00AM.
COVID pna, multiple falls at NH and declining mental status. Subdural hemotoma. Rocephin, cefepime, flagyl. Per documentation COVID pna was dx 4 weeks prior. Fully vaccinated. Remained unresponsive and was not improving Transferred to hospice. Date/Time of death declaration:  8/30/2021 9:23 AM
pt recvd vax; cry constantly for 4 hrs w/ fever of 101-102; contacted MD, stated to wait 2 more hrs, if cont, to take to er;pt did not cont to cry; did not see LMD;
Woke up with chills; Severe body aches; Joint pain; Headache; Fever; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 13Sep2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to sulfa drugs and injection dyes. Prior to 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 medication included paracetamol (TYLENOL) for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 22Aug2021 at 17:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 14Sep2021 at 04:00, the patient woke up with chills, severe body aches, joint pain, headache and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, severe body aches, joint pain, headache and fever was resolved on an unknown date in Sep2021.   No follow-up attempts are possible. No further information is expected.