chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 67 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Mar2021 as dose 1, single (Lot number: 044A21A), in right arm and on 12Apr2021 as dose 2, single (Lot number: 030B21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Retested positive; negative, notes: testing negative; positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was treated with anti-viral Paxlovid from 04Sep2022 to 09Sep2022. The patient retested positive after testing negative following 7 days of a first Covid 19 infection.
Evening 12/17/07 itchy, red, swollen, and tender. Benadryl 50 q 8 hours. Then Zyrtec 10 q.d. x 7 days.
Chronic cough with mucus, heavy menstruation .  3 courses of antibiotics and stilling coughing
This spontaneous report as received from a nurse refers to a 61 year old female patient. On unknown date in 2016, patient received a dose of FLUZONE and an unspecified time after receiving it, the patient developed a red, hot and swollen injection site. No information regarding the patient's allergies and concomitant therapies was provided. On 02-NOV-2017, the patient was vaccinated with ZOSTAVAX, subcutaneous (dose, site, lot # and expiration date were not reported) for prophylaxis. On 03-NOV-2017 (reported as "the next day"), the patient developed redness and swelling at the injection site the size of a soft ball, which was also hot to the touch and there was one pustule at the injection site. Patient sought medical attention via seeing an unspecified healthcare provider. Adverse events were treated with an unspecified antibiotics. The outcome of events was reported as recovered on an unspecified date in November 2017. The relatedness beetwen events and ZOSTAVAX was unknown.
Pt has been sick since the time after (1-2 days) the vaccination as noted in our record and multiple flu visits after. Only exposure per pt was this vaccine. Pt was given at Urgent Care. Paresthesias to his head and neck.
Day 1 post vaccination of booster : Fatigue , chills Day 2 post vaccination of booster : lymph swelling under armpit about 3 inches in diameter , some itching started irritating  Day 6  post vaccination of booster : lymph swelling under armpit about 1 1/2 inch in diameter still some irritation, will try Benadryl and call on call nurse for more instructions
she was sick; This is a spontaneous report from a contactable consumer (the patient) from a sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 18Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she couldn't get the second one (dose), because she was sick. The second dose was tomorrow. She wanted to know if that was okay. The outcome of sick was not recovered.   Information on the lot/batch number has been requested.
Immunization Rotarix was given. However the child grew out of the recommended age for the first dose of Rotarix. Patient is 16 weeks and was delinquent with their first set of vaccines. Patient asymptomatic and stable while transferring to observation in the patient lobby. Mother educated to wait 15 minutes, post injections due to first set of vaccines. After the 15 minutes observation period ended, mother and patient were not located in the lobby. I called Mom at 15:48 and informed her regarding the medication error. Patient continues to be asymptomatic.  Mom voiced no concerns at that time. Dr. was notified at 15:25 regarding the administration of the vaccine. Provider stated he did not order the vaccine Rotarix due to the CDC recommendation. 15:30 Staff notified of medication error. Notified pharmacy at 15:51, they referred me  to CDC. Contacted CDC 16:05.
fever, chills, headache, muscle spasms, difficulty walking across the room,  dizziness, fatigue, brain fog
C/O constant dizziness started 2 hours after vaccines were given. Observed after shots, no fever, no headache.
Case number PHEH2012US007401 is a spontaneous report initially received from a health care professional on 30 Mar 2012 with a follow-up received on 16 Apr 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were unspecified. It was reported that he was vaccinated intramuscularly only with the MenA lyophilized conjugate of MENVEO (batch number: A10058) reconstituted with a sterile diluent and that he did not receive the MenCYW-135 liquid conjugate vaccine component on an unspecified date. No adverse event was reported following this drug administration error. The Marketing Authorization Holder (MAH) attempted further follow-up but no response received so far from the reporter. Hence the case was closed due to lack of response. Follow up report was received on 16 Apr 2012: Updated information about lost to follow-up. Following an internal review on 18 May 2012 of the data received on 16 Apr 2012 it was observed that the event verbatim "received only Men A lyophilized conjugate component of MENVEO vaccine' was erroneously coded to drug administration error and hence the event was now recoded to inappropriate preparation of medication.
Patient received shot at approx 19:00 on 10/9/13 upon waking morning of 10/10/13, she noticed her heart racing this was about 7:00-7:30 am, face, neck, chest, upper back, rt arm and lower extremity urticaria. Urticaria to face and neck noted 8pm one hour after immunization.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: IMMEDIATELY AFTER VACCINE ADMINISTRATION, PT FAINTED FOR A FEW SECONDS, STARTED JERKY MOVEMENT. WHEN CAME BACK SHE DID NOT REMEMBER ANYTHING. THEN AGAIN SHE FAINTED TURNED EXTREMELY PAIL WITH EXCESSIVE SWEATING AND FEELING HOT, SHE SEEMED STUNNED GAZING TO ONE POINT NOT ABLE TO TALK OR MOVE. RPH ASKED TO CALL 911 IMM. PT TURNED BLUE WITH VERY LOW PULSE AND SHALLOW BREATHING. RPH ADMINISTERED EPIPEN  TO THE UPPER OUTER RIGHT THIGH TO HELP RAISE BP AND PULSE. PUT PT IN SUPINE POS W/ ELEVATED  FEET
Shot was administered into shoulder instead of arm muscle. Intense pain began immediately but I didnt realize it was that bad until I returned home. I cannot lift the arm and there are waves of warm and cold as well as tingling and pain.
Patient stopped by  stated he is planning a  trip  and that his  doctor wants him to get Jansen  vaccine . we  I gave him the shot 20 minutes later he started  showing flushing  and difficulty  talking.
Patient started to develop symptoms of chills, aches, bad headache, fatigue evening of receiving vaccination. Contacted me on 4/15 (10 days after receiving vaccine) and stated most of initial symptoms had resolved, but fatigue (particularly in evenings around 7 pm), lightheadedness persisted in addition to body aches and some chills. I spoke with her by phone on 4/15 and then saw her in person on 4/22. On 4/22, she complained of feeling worse the weekend prior to this visit, but when I saw her said she noticed she was having some improvement in her symptoms. Reported persistent night sweats, nausea, some lightheadedness, no chills, no known fevers, no cough, no dyspnea, no chest pain, no sore throat or URI symptoms. Diarrhea that started in the month prior to getting the vaccine and attributed to small bowel intestinal overgrowth had improved. Still feeling tired. Spoke by phone on 5/5 and still night sweats that she can control with Benadryl at bedtime and fatigue. Did not receive second dose of Pfizer vaccine as a result of these symptoms.
AFTER ADMINISTRATION OF VACCINE 0.1ML LEFT IN THE SYRINGE; This spontaneous report received from a patient concerned multiple female patients. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced after administration of vaccine 0.1ml left in the syringe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of after administration of vaccine 0.1ml left in the syringe was not reported. This report was non-serious.
Following immunization today - Patient extreme pain at injection site and leg, redness, edema, hot to touch and constant crying. Fever unknown as he has received doses of Tylenol/Motrin. Reacted a little worse with 1st dose in April - also received PREVNAR in same leg at that time
Muscle aches, joint pain, fatigue the day after.  Redness, heat, pain about 1 inch below injection site.  Muscle pain has resolved, but the redness, heat and pain below the injection site persists.
Pt presented to the ED after falling in the bathroom. He had developed a runny nose and a cough with sore throat. He also had a fever yesterday. Pt was admitted for COVID and generalized weakness.
On 08/28/22 she started having symptoms with a fever of 101F, on 08/29/22 her temperature spiked to 102F and she was lethargic. We went to the doctor on 08/30/22 and had her tested for COVID-19 after I tested positive for COVID-19. We were advised to alternate TYLENOL and ibuprofen to help keep her comfortable and get her temperature down. Her temperature did come down by 09/01/22 and she was more like herself.
Patient observed for a total of 30 minutes. Stated headache and some chest discomfort, back aches as well. stated pain 1/10.  BP 151/86, HR 71 and 98% on room air.  after 30 minutes stated feels achy and slight headache. Denied chest discomfort.  Able to be released to home.
Information has been received from a medical assistant concerning a 15 year old female with no drug allergies and no medical history, who on 15-AUG-2007 was vaccinated in the left arm with a second dose of Gardasil. The first dose was given on 20-JUN-2007. There was no concomitant medication. Shortly after receiving the vaccination at 09:15am the patient felt "queasy." The patient was directed to sit down and the only observation was that the patient was "clammy." The patient reported a short period of "loss of vision", but the healthcare worker stated that she had her eyes closed. The patient never lost consciousness, and after 10 minutes, she was treated with an ice pack and some juice (the patient never ate breakfast) the patient felt fine and left the office. No laboratory diagnostic were performed. On 15-AUG-2007 the patient recovered. No product quality complaint was involved. Additional information is not expected.
Provider d/c note:  Pt is a 89 YO male with a PMHx of pacemaker for afib, HTN, T2 DM, and BPH who presented with sore throat and was diagnosed with acute hypoxic respiratory failure 2/2 COVID-19 pneumonia. Pt finished 5 days of remdesivir and was started on decadron, which he will finish 10-day course at home. Due to elevated procalcitonin and concern for superimposed bacterial infection, Pt was started unasyn and azithromycin (received Zosyn and azithromycin on 9/26) and transitioned to Augmentin. Will take 3 more doses of Augmentin after discharge. Pt initially required up to 6L NC, which were weaned to 2L NC. Pt discharged to home with home O2 in stable condition. "
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 24 years 3 months.  It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had any acute illness at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.  Vaccine Ndc code was reported as 80777-0273-99.  Concomitant medication of the patient was not reported.  The patient did not experience any adverse reactions after the administration of vaccine.  No treatment information was provided by the reporter.
Hives (off and on). C/O hives since 15 month WCC in which she received 4th DTaP and also finished 10 day course of amoxicillin around that time. Parents have not noted any other symptoms. No recent changes in soaps, lotions, detergents, foods, etc.
Pt was given vaccines on 10/27/04. Reported back to office on 10/9/04 with red swollen area at the injection site. He was evaluated and treated with Bactrim and Bactraban. Diagnosis was allergic reaction vs cellulitis.
Mild sensation in left chest area and along left side neck, along with mild shortness of breath starting about 3/20/21   Has since disappeared.  On or about 3/25/21 a hard, painful rash appeared on buttocks and has since healed. A second larger painful rash appeared in a different area on or about 4/5/21 and lasted about 2 weeks.  Along with rash is tenderness of skin in surrendering area of rash, there is pain under breast area which extends to back and persists.
Vaccine was drawn up the day prior on 4/20/23 and was not wasted. By FDA guidelines, the Covid Bivalent Vaccine had expired within the 12 hours of being open on 4/20/23.
Patient experienced tingling in elbow and a little above the elbow on the arm he received the vaccine.
Patient became dizzy and suffered from diaphoresis after vaccination. Reclined patient, gave HiC, vitals taken and stable throughout. After 15 minutes patient was able to walk and leave clinic.
I have had a terrible reaction to this medication.; My arm has been terribly painful; My arm has been terribly painful, hot; arm swollen to the touch still as of today 30Sep2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious) with onset Sep2022, outcome "not recovered", described as "I have had a terrible reaction to this medication."; PAIN IN EXTREMITY (non-serious) with onset Sep2022, outcome "not recovered", described as "My arm has been terribly painful"; ADMINISTRATION SITE WARMTH (non-serious) with onset Sep2022, outcome "not recovered", described as "My arm has been terribly painful, hot"; PERIPHERAL SWELLING (non-serious) with onset Sep2022, outcome "not recovered", described as "arm swollen to the touch still as of today 30Sep2022".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
itching to left arm Benadryl 25mg given  129/80 BP Pulse 88 O2 99%   went home
I had the injections and I also getting the shingles/ suspected vaccination failure; I had the injections and I also getting the shingles.; pain; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient had the injections for the shingles and also got the shingles. The shingles were really painful.  Additional Supportive information: The case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation was not reported.
This was second injection. She did have worse reaction to first shot and was sent to ED and also cleared by her PCP. This time she has tingling of the tongue. She immediately took Benadryl. Issues subsided and sent home with instructions to call PCP or go to ED if symptoms returned.
Patient got  flu shot on 9/28/20 and came to the store on 10/9/20 to say that her shoulder still hurts from the flu shot and that it hurts to lift it all the way. She states she thinks that possibly the shot was given too high and maybe caused bursitis. She states that she has a doctors appointment on 10/14/20 and she will discuss it with her doctor.
Began swelling a couple hours after injection in two spots on left arm, became red as well, swelling and redness went down but has now begun again, 4" by 4" red, swollen, itchy, warm area around injection, painful if pushed on
Unspecified disease of the pericardium. 5-000007  4/28/09 Received vaccine & clinic medical records of 3/20/09. FINAL DX: pericarditis Records reveal patient experienced chest pain which increased w/lying down.  Seen in ER 3/19 & had f/u clinic visit on 3/20.  ER had tx w/NSAID & inhaler.  Pts symptoms relieved.
Horrible Migraine headache for 6 days; fever for 2 days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the left arm on 05Mar2021 at 15:00 (at the age of 41-year-old), as a single dose and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736), via an unspecified route of administration in the right arm on 02Apr2021 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history included migraines but only have 1 headache ever 4 months and last for few hours and cured with medication and the patent had a history of allergy to yellow dye, diacetyl, spice allergy and banana. Concomitant medications included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE) and ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C) from an unknown date for an unknown indication. 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. On 05Mar2021 at 19:00, after the first dose the patient experienced horrible migraine headache for 6 days and fever for 2 days. After the second dose the patient had migraine for two days and fever for one day. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events and included the treatment with Ubervly migraine drug. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event fever for 2 days following first dose was recovered on 07Mar2021. The clinical outcome of the event horrible migraine headache for 6 days following first dose was recovered on 11Mar2021.  No follow-up attempts are needed. No further information is expected.
Arm hurts at the injection site; Chills; Headache; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Aneurysm. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.