chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a sore arm; woke up and was about to fall on the floor; had a mini nerve attack; A spontaneous report  was received from a consumer concerning a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced woke up and was about to fall on the floor, had a mini nerve attack, and sore arm.  The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.  On 18 Jan 2021, approximately same day prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 18 Jan 2021, after receiving mRNA-1273, the patient woke up in the middle of that night experiencing "mini nerve attack". The patient stated "was about to fall on the floor but didn't and sat back down" on bed and was able to go back to sleep. The patient woke up again and was given two Tylenols by the nurse. At 0700am, the patient wasn't feeling normal and had a sore arm. Patient was then given Norco to relieve the pain. Treatment for the events included acetaminophen, Narco was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The events, woke up and was about to fall on the floor, had a mini nerve attack, and sore arm were considered resolved on an unknown date.; 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.
Patient received the following vaccines: Janssen 4/7/21 Moderna #1 9/8/2021 Moderna #2 10/13/2021
Unusual swelling.  Pr referred by PCP to rheumatology and nephrology for elevated ESR and ANA w/ concern for poss vasculitis or nephritis..  While work-up in process,  pt experienced cardiopulmonary arrest.  Hospitalized and ventilator supported.  Remained encephalopathic, presumed anoxic, w/ seizure disorder and shock liver that precluded proceeding w/ planned coronary/cardiac catheterization.  CT chest showed no pulm emb, CT brain showed multiple punctate infarcts suggestive of embolic etiology.  Neurology felt infarcts could not explain his encephalopathy.  Echocardiogram neg.  Family declined trach and PEG and pt was compassionately weaned to comfort from ventilator support, extubated and transitioned to hospice care.  Pt passed 6/22/21.  Autopsy declined.
This case was reported by a healthcare professional (also the subject's aunt), via a sales representative, and described the occurrence of arm pain after injection in a 6-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), MMRV vaccine (non-gsk). On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, unknown route, left arm), unspecified dose of MMRV vaccine (Non-GSK) (unknown route, left arm). Less than one day after vaccination with KINRIX and MMRV vaccine (Non-GSK), "within 24 hours", the subject experienced arm pain after injection, arm red after injection, swelling of arm following injection and skin rash on injection area. The KINRIX and MMRV were administered at different sites in the left arm. Within 24 hours from receiving the vaccines, the subject experienced "severe" pain in left arm, "looks like a diffuse rash from left shoulder to elbow", and redness and swollen from the left shoulder to elbow. The subject was taken to the emergency department and was treated with non-steroidal anti-inflammatory (Nsaid), prednisone and antihistamine. The subject was seen by his pediatrician the next day and the symptoms were improved. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). The subject was treated with non-steroidal and anti-inflammatory (Nsaid), prednisone and antihistamine. At the time of reporting the events were improved.
Adacel was given to a 4 years old male patient/No AE; Initial information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a four years old male patient who received a 0.5 ml fifth dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6401AA, expiry date: 26-Jul-2021 via intramuscular route in the left deltoid on 10-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was administered.   It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Information has been received from a physicians concerning a 16 year old female who in approximately May 2008, about two and a half months ago, was vaccinated with the first dose of GARDASIL. The patient experienced dizziness after vaccination. The patient sat down for a while and was given an "epi pen" just in case of an allergic reaction, but then recovered and was able to leave. The physician also reported that the patient has received the second dose of GARDASIL and no adverse experienced occurred. The patient sought medical attention and saw physician. This is one of several reports from the same source. Additional information has been requested.
2 days after MMR #2: eyes blinking, raising eyebrows and closing eyes. Otherwise normal.
Client report receiving first COVID vaccine on 04-13-2021 about 10:30 am,  adverse reaction began on same day, hours later about 4:30 - 5:00 pm.  Adverse reaction of blurred vision started.  Client wears contacts and glasses, normally without issues.  Blurred vision in both eyes, right eye feels dry.  Client has not reported rubbing eyes, no drainage or redness in either eyes.  Client has also reported symptoms of fatigue, headache and congestions.  Took Tylenol for the headache on 04/14.  No known history of allergies.  Client plan to contact her PCP, regarding adverse reaction.
10.5 x 12 cm tenderness areoun injection site. 6 x 5 cm induration and redness.
On the evening of 8/15/00, temperature increased to 104F until morning. Then she had vomiting and joints ached. Doctor was called and felt it wasn't due to vaccines. She was given Solu-Cortef on 8/16/00 to stabilize her, if she vomits.
About 4mo. after the shot I experienced high levels of anxiety, nausea, & low grade temperature. Took an at home rapid test and a PCR CoVid test with pharmacist (both negative). (08/19/2021) Physical with doctor, probiotic advised and to return if symptoms persist. Diazepam prescribed for anxiety. (10/05/2021) Symptoms did not go away and went to see Doctor again. Battery of test were administered to determine the cause.
Significant rash and swelling at injection site (left arm) approximately 9 days after orange cap dosage for 7 year old
No event; reporting because govt does not recommend pregnant females to receive anthrax; pt knew she was pregnant but did not disclose this to the tech; after the shot her friend returned and told the tech about the pregnancy.
arm a little sore; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient) via social media.  This case involves a female patient (age unknown) whose arm was a little sore (pain in extremity), while she received INFLUENZA VACCINE.  Past vaccination(s) included influenza (20 years ago) for prophylactic vaccination. She developed flu after vaccination  Medical history, medical treatment(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient arm was a little sore (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE for 2 days. She had no flu. She takes flu shot every year.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case
Headache, Myalgia, Fever, fatigue, Left arm tingling sensation on injection site, chills Narrative:
Flu vaccine #2 given  11-12-15 in office pt seen 11-16-15 for fever (103.6 T Max) x 4 days. Began approx 24 hours after shot. Fussy; occasional cough. Had fever x 1 day after Flu #1 was given. Tx with PRN TYLENOL/ IBP. Return if no improved 2-3 D or worsening.
Patient reported having an "itchy" tongue that felt like sandpaper, "tingling" sensation in the arm, and an overall feeling of being "off." She denied any difficulty breathing. Patient was given two doses of Benadryl 25mg tablets - one 15 minutes after the injection, and another one hour after injection. She walked out of the store under her own power and planned to seek further medical attention at urgent care/ ER based on the recommendation of the Fire Rescue team. She declined an ambulance and planned for her husband to drive her.
MIND FOGGY; SHORTNESS OF BREATH; HEART RACING; UNABLE TO MOVE AROUND; CHILL; FATIGUE; FEVER; MUSCLE PAIN; VERY RED VEINS ON RIGHT LEG LOWER PART/RED VEINS ON LEFT ARM LOWER PART BETWEEN WRIST AND ELBOW; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and other pre-existing medical conditions included patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced very red veins on right leg lower part/red veins on left arm lower part between wrist and elbow. On 06-APR-2021, the subject experienced shortness of breath. On 06-APR-2021, the subject experienced heart racing. On 06-APR-2021, the subject experienced unable to move around. On 06-APR-2021, the subject experienced chill. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced muscle pain. Laboratory data included: Pulse rate (NR: not provided) 92 /min. On 16-APR-2021, the subject experienced mind foggy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chill, fatigue, fever, and muscle pain on 08-APR-2021, was recovering from shortness of breath, and unable to move around, and had not recovered from heart racing, mind foggy, and very red veins on right leg lower part/red veins on left arm lower part between wrist and elbow. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
low energy; frequent urination; freezing; loss of appetite; sweating; dry cough; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), POLYURIA (frequent urination), FEELING COLD (freezing), DECREASED APPETITE (loss of appetite) and HYPERHIDROSIS (sweating) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (low energy), POLYURIA (frequent urination), FEELING COLD (freezing), DECREASED APPETITE (loss of appetite), HYPERHIDROSIS (sweating), COUGH (dry cough) and PYREXIA (fever). At the time of the report, ASTHENIA (low energy), POLYURIA (frequent urination), FEELING COLD (freezing), DECREASED APPETITE (loss of appetite), HYPERHIDROSIS (sweating), COUGH (dry cough) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was provided. No treatment information was reported.
Narrative: Required transfer to Emergency Department for observation. Patient was given a 1 L bolus of normal saline.
Itching, not feeling well, sl. tightness in chest-seen at medical center. On arrival, lips swollen, throat and chest tight, wheezy, itching, hive on L arm. Given O2, epinephrine 0.1mg, Benadryl 25mg IM and Albuterol nebulizer treatment. O2 sats increase to 99% pt. better.
I had a large, red, rectangular rash @ injection site. Was swollen + sore. Significant and uncomfortable swelling in lymph node @ left underarm. Still swollen as almost 2 weeks since receiving vaccine. Rash is gone.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Jan2021 as dose 1, single (Lot number: 041L20A), in left arm, on 27Feb2021 as dose 2, single (Lot number: 013A21A), in left arm, on 08Nov2021 as dose 3 (booster), single (Lot number: 017F21A), in left arm and on 31Mar2023 as dose 5 (booster), single (Lot number: 083J21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2022, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative; (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Therapeutic measures were taken with Paxlovid as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271066 same patient, different drug/event;
Patient was scheduled to receive a Primary Pediatric Pfizer 5yrs-11yrs 2nd dose, but was mistakenly given a Pediatric Pifzer Bivalent dose.
suspected vaccination failure; I got the Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles again. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
First symptoms - headache, nausea and muscle aches. On Friday, Nov. 13, 2009, symptoms became worse, with severe pains in neck, arm, back and head. By Saturday, Nov. 14, 2009, the pains started shooting down both arms from the neck, through the arms and to the wrists, and unable to turn neck either way without pain. Nausea continued throughout, with an inability to eat much. Symptoms continued without abating and not responsive to pain killers on Monday, Nov. 16, 2009, resulting in a doctor's appointment.
On day 9 after vaccines was given he had a large raised red hot to the touch bump / nodule on his right thigh at the injection site with a high temp, low fever of 100. Was seen at the ER and was released the same day without treatment diagnosed as febrile illness immunization rxn. On day 10 his fever spiked to 104.6 and we returned to the ER where we ran blood work for illnesses which came back clear. Fever was treated and we were sent home and advised to follow up with his pediatrician. I immediately made an apt for today Monday August 21st. While at school today his teacher noted he was crying all day and was biting himself. This is not like him. We went to his Dr apt and was turned away, they said they could no longer see us. I called our insurance company and was able to be reassigned to another pediatrician in which we have now scheduled a follow up apt with for tomorrow afternoon. We are still monitoring him around the clock and noting everything that seems unusual for him which are as follows, clumsiness, loss of appetite, interrupted sleep, soreness at injection site, redness, itching, low to high fever, biting himself and crying on and off.
Woke 7am 5/20/22, body aches all over, nausea, chills, feeling feverish. Rose to get up and instantly started sweating, stomach cramps...felt the need to vomit, blurry tunnel vision, collapsed to the floor. Had to crawl to bathroom. Diarrhea followed by extremely painful stomach cramps and lower back pain continued for 2-3 minutes. Then diarrhea again, followed by another cycle of extremely painful stomach cramps and lower back pain. In total, about 12-15 mins of this. Applied heat pad to stomach, pain eventually subsided, then able to take 3 motrin with water.  No fever.  Hot bath + Epson salts, ate banana + water, slept 2 hrs.  2pm fever of 99.7, took 3 more motrin. 9pm fever of 99.4, took 3 motrin then to bed.  5/21/22 - woke to red bumpy rash on neck, chest, back, stomach, groin. No fever.
Rash, hives from scalp to legs, itching, used benadryl and zyrtec first 48 hours then high dose steroids for 1 week.
Information has been received from a physician and follow up from a registered nurse concerning a 26 year old female with no known pre-existing allergies or medical conditions, who on 6/9/04 at 10:00 AM was vaccinated SC in the left arm with a 0.5ml first dose of varicella virus vaccine live (lot # 648043/1345N). It was noted that the patient had no known illness at the time of vaccination. Subsequently, 2-2.5 weeks later at 10:00 AM on 6/24/04, the patient presented to the clinic and had developed 8-10 lesions on her arms, legs, and chest, which appeared like chicken pox. Verbal instructions for chicken pox care were given to the patient. She was told to return to the clinic if necessary. There were no signs or symptoms of acute distress. No laboratory tests were performed. It was noted that the patient did not have adverse events following prior vaccination. There was no product quality complaint involved. Unspecified medical attention was sought. No additional information is expected.
Narrative:  74yo with AFIB and other problems: Under care of multiple providers (SCT 20Hearing loss (SCT 15188001) Long-term current use of anticoagulant (Sacral back pain (SCT 61486003) Low back pain (SCT 279039007) History of total replacement of right hip joint (SCT 449141000124100) Artificial knee joint present (SCT 91100Paresthesia of foot (SCT 309087008) Tinnitus (SCT 60862001) Hearing loss (SCT 15188001) Essential hypertension (SCT 59621000) Hyperlipidemia (ICD-9-CM 272.4) Gout (ICD-9-CM 274.9) Gastroesophageal Reflux Disease (ICD-9-CM 530.81) History of repair of dissecting thoracicObese (ICD-9-CM 278.00) Deviated nasal septum (ICD-9-CM 470.) Varicose veins of lower extremity (ICD-9-CM 454.9) Osteoarthritis of Multiple Joints (ICD-9Pain due to knee joint prosthesis (ICD-9-CM 996.77) Benign prostatic hyperplasia (ICD-9-CM 6Proteinuria (ICD-9-CM 791.0) DIED on 9/13/2021. Pt had received covid vaccines on 2/22/21 & 3/22/21. Not able to assess if death is related as no info available about pt's death. Likely this death is not related given pt's age, comorbidities, & length of time between date of vaccines and date of death.
Headache, Fever ranging from 99-101 and achy.  Lasted about 24 hours
About 2 to 3 hours after shot, I felt woozy and then very nauseous. It was strong, came in waves. But I did not throw up.  Ate a little, took some alive (two tablets). Was tired but not overly fatigued. My arm really hurt at injection site, pain traveled up to my neck. Unable to lay on arm at all. Then I just felt buzzing in waves. I went to bed (no chills) but couldn't go to sleep.  Body felt wired and tired. Finally fell asleep at 8:30 am.  Day after shot: Arm still sore but not as much. Still experience nausea but not as strong. Tired but not overly so. Later in evening (around 12:30 pm) developed some chills and had four sneezes in a row causing me to have a stuffy head. Not sure if that is allergies or a cold coming on.
nasal congestion & drainage; itching @ eyes & throat; full feeling in larynx & trachea; chest discomfort; sx responded to Epi & DPH;
Pt reported reactions began with headache progressed to lightheadedness, dizziness, vertigo chills, fatigue, insomnia.
Still tested positive after getting Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Still tested positive after getting Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Still tested positive after getting Moderna vaccine). At the time of the report, COVID-19 (Still tested positive after getting Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.