chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient received BNT162b2 (BNT162B2), on 06Jul2022 as dose 5 (booster), single (Lot number: FM7553) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 27Jul2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Negative; (29Jul2022) Positive, notes: Testing positive again on 07/29. Runny nose is main symptom. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. The patient was started on anti viral drug Paxlovid from start date: 19Jul2022 to treatment stop date: 23Jul2022.  Clinical information: The patient had no known allergies. The patient had Rebound symptoms beginning 27Jul2022. Tested negative on 23Jul2022. Testing Positive again on 29Jul2022). Runny nose was main symptom.
Received the vaccine on a Thursday evening. 9 hours after I received the vaccine I woke up with chills, fever, headache, body aches, and a sore arm around the injection site. These symptoms lasted a full day (all of Friday) with the body aches being the most intense. When I woke up Saturday, these symptoms were gone with the exception of the sore arm which took another two days before getting back to normal. I took one 500 mg Acetaminophen on Friday to relieve the symptoms which didn't seem to help.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient had previously fainted with both does of COVID vaccine (given elsewhere).  Patient fainted approximately 30 seconds after administration, caught and laid on floor by pharmacist administering vaccine and patient's mother.  Patient regained consciousness approximately 15 seconds after being laid on floor and legs raised.  Blood pressure was monitored over the next 15 minutes while patient was slowly moved from laying down to sitting to standing and walking.  No further issues.
Three days after first vaccine injection, experienced vertigo. Dizziness diminished over next 4 weeks. Three days after second vaccine, big increase in dizziness, vertigo. On 3/30/2021 diagnosed with left peripheral vestibular hypofunction. Dizziness continues to diminish.
02/22/2023 I felt like I was getting a cold I had nasal congestion and drip. 02/23/2023 continued Head and Nasal congestion 02/24/2023 I tested positive for COVID-19. I contacted the Telehealth Nurse service and was not a candidate for Paxlovid due to HBP issues. I took xlovod was not prescribed because of my other medications. Coricidin as needed x 5 days.
Patient reports itchy rash that went halfway down her arm.  The rash appeared a week later after the shot and slowly resolved on its own
Within 5 minutes of second injection had headache 8/10 and sensation of feet being hot. No other symptoms reported. She was given Benadryl at her request. Symptoms improved in about 15 minutes. She left with her spouse and did not need any additional care.
Fever above 102. Chills, aches, shortness of breath, severe nausea, misery plus! Symptoms began to slowly reside after 12 hours.
Swelling and redness in arm where Fluvirin and Pneumovax were administered. Patient also reports some swelling in throat. Advised to take diphenhydramine qid and seek MD today. Patient states her daughter will take her to MD today.
Patient of refugee status presented to clinic 6/6/11 complaining of upper Right arm pain since immunized 5/3/11. Physical exam normal - see progress notes from date. 8/5/11 patient returned still complaining Right arm pain see progress notes from date. He denies ever having swelling, redness or rash from site. Shot record enclosed. Patient did not have/bring shot record from other state.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 06-FEB-2018, the patient was vaccinated with an improperly stored dose of PROQUAD with lot # reported as N042500 (expiration date unknown) (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis, reconstituted with sterile diluent (MERCK) that was properly stored. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 6°F to 14°F degrees Fahrenheit for 158 hours 39 minutes and 15°F to 46°F degrees Fahrenheit for 343 hours 29 minutes. There was a digital data logger involved, but there was no previous temperature excursion. This is one of several reports received from the same reporter. Lot number N042500 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live; Sender's Comments: US-009507513-1803USA006483.
Gave vaccine to a 16 year old; A spontaneous report was received from a pharmacist concerning a 16-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event,  gave vaccine to a 16-year-old.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, a pharmacist gave the mRNA-1273 vaccine to a 16-year-old patient. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event, gave vaccine to a 16-year-old was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age specification product use for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product administered to patient of inappropriate age.
This is a spontaneous report from a contactable nurse and a physician via a sales representative. An 8-month-old patient of an unspecified ethnicity and gender received PREVNAR 13, (lot # N34935) at single dose, and PENTACEL, both via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had some vomiting, fever, lot# had been reported back on 12Oct2016 as being bad. No treatment was received for vomiting and fever. The outcome of the events was unknown. The mom had said that she had something on mind, there was something wrong with the Lot. Nurse was just trying to find out that if there was something with the Lot.  A Product Complaint was filed. Course of events: A physician had received a call from a mother in the middle of the night and said that there was a severe reaction, that is the child had fever and one episode of vomiting after receiving Pentacel and Prevnar 13 vaccine Lot# N34935 but the mother did not mention about what type of severe reaction. The mother told the doctor that how does the doctor did not know that Prevnar 13 had a bad Lot # out there and the doctor gave it to the mother's patient. The mother who had reported the incident to the physician said that this Lot# had been reported back on 12Oct2016 as being bad. The doctor said that he/she had looked at several websites and did not see anything and was assuming that it was a baseless claim and they wanted to make sure that the doctor was not missing something. The physician had sent the email to all the providers and the nurse had forwarded it to her. The nurse said that the doctor did not say anything about it but it was the mother who thought that the severe reaction was because the Prevnar 13 Lot# was reported on 12Oct2016.
Myalgia, Arthralgia, chills and weakness Narrative:  Other Relevant History:
Difficulty swallowing  Diaphoretic Chest tightness  Increased heart rate
This is a spontaneous report from a contactable consumer (patient). A 60-year-old (age at vaccination) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 04Nov2021 09:54 (Batch/Lot Number: FF2593; Expiration Date: 31Dec2021) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included diabetes, COPD, rheumatoid arthritis, breathing issues and shrunk from unknown dates. There were no concomitant medications. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 59-years-old on 04Feb2021 (Batch/Lot number: EN531B) which may have received in left arm for covid-19 immunisation and experienced no side effects, second dose at the age of 59-years-old on 25Feb2021 (Batch/Lot number: EN531B) which may have received in left arm for covid-19 immunisation and experienced slight headache for about a week. The patient received a flu shot 34 days before the 3rd booster dose for immunization.  On 08Nov2021, the patient experienced itching and cold sweat. She has not gotten cold sweats before, but after getting the vaccine. The patient stated that it is not listed among the side effects. She further reported that she has had all 3 doses. She had the booster on the 4th, last Thursday. On Monday, during the day, she started itching. States that she didn't think any of it until the evening. It kept her up until the following day when she took 2 Benadryl and then it finally went away. The patient clarifies that she took 2 Benadryl on Monday night and 1 more Benadryl on Tuesday during the day, and now the itching is gone. She is calling to report this, but she also has a question. She has also noticed having cold sweats, out of nowhere; she has never had cold sweats before. States that it has been happening for a couple of days. The paper doesn't say this is one of the common side effects, so she wants to know if it could still be a side effect of the vaccine. She had a hard time remembering the doctor's phone number; stated she got a brain freeze and had to look the phone number up in her phone. She thinks she has shrunk. States that it goes with age. Verified that this occurred prior to getting the vaccines. The patient reported that she may have received the vaccine in the left arm. States that the injection site doesn't hurt anymore so she really doesn't remember which arm it was. Therapeutic measures were taken as a result of itching which included treatment with Benadryl. The patient recovered from itching on 10Nov2021, did not recover from cold sweat while the outcome of the other events was unknown.
Our son was given a Tdap shot on Friday, November 25th at approximately 3:15 p.m. during a physical he was undergoing. He seemed okay that night except for his injection site (right deltoid) which was quite sore. That appointment was at the clinic with CNP. The next day (Saturday, 11/26/16) he slept late and felt achy and generally under the weather. On Sunday (11/27/16) he was feverish along with body aches. His temperature was 102.0 at 4:22 a.m. He had 600 mg Ibuprofen at 9 a.m. just for comfort. He is a college student and had finals coming up. The highest fever we recorded that day was at 10:40 p.m. when it was 102.2. We didn't medicate at that point. Monday (11/28/16) he had a low-grade fever of 99.6 at 9:12 a.m. He took Ibuprofen 600 mg about an hour-and-a-half later so he could function at school. Tuesday (11/29/16) around midnight patient was taking his temperature-it was 99.2. (He had 600 mg Ibuprofen and one TUMS tablet at this time.) He was feeling chest pain that caused him to breathe shallowly. He also had injection site pain that radiated down his right arm, a flat red spot an inch or two below that site (about 3/4" in diameter), a headache (front, back and other areas), sinus pain, all his teeth hurt, joint pain (especially his knees and ankles), neck and back pain. This lasted more than 2 hours. At 2:00 a.m. he said it was about a "5 out of 10" and he was very sweaty. At 3:00 a.m. he said he was "fine" and was still very sweaty. He had another episode lasting probably 30 minutes around 7:00 p.m. that night-similar to above. Wednesday (11/30/16) morning around 7:00 a.m. he had another episode with the same symptoms. We decided to go in to the walk-in clinic. The symptoms had subsided by then. Around 9:30 a.m. we went there: He had a chest x-ray, EKG and blood work done there. Since the Troponin level was high they sent him to the hospital as a direct admission. He had more blood work, a heart monitor, echocardiogram, angiogram. He spent the night for observation and tests. Thursday (12/1/16) early afternoon he was discharged. Wednesday (12/7/16) he was seen post-hospitalization by CNP at clinic.
Rash since she got the vaccine in 2021 the rash name is Lichen planus rash; This spontaneous case was reported by a patient and describes the occurrence of LICHEN PLANUS (Rash since she got the vaccine in 2021 the rash name is Lichen planus rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LICHEN PLANUS (Rash since she got the vaccine in 2021 the rash name is Lichen planus rash). At the time of the report, LICHEN PLANUS (Rash since she got the vaccine in 2021 the rash name is Lichen planus rash) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. It was reported that the rash comes and goes. Patient was seeing skin doctor and was on medication.
The patient came into the pharmacy and talked with me. She stated that about 20 minutes after receiving the vaccine, her arm began to hurt. The next morning it was so painful that she couldn't move it and the pain persisted for about 5-6 days. She stated that she takes hydrocodone/APAP for her rheumatoid arthritis and was taking it more that usual to help with this pain, although it didn't help much. She stated she had never had a bad reaction from a vaccine before. She felt as though the person giving her the vaccine gave it too high up in her arm and that she felt it hit her bone and thought that might be why she had such pain. She did not seek medical treatment.
Fussy later in afternoon day of visit. Given Tylenol. Next day not quite herself. Forceful vomiting 30hrs after shots after eating. 6-10x. Whimpering. ? Lethargic. Taken to ER. Tolerated Pedialyte there and d/c to home. One BM since shots hard and sticky.
vomit profusely; low-grade temperature; This spontaneous report was received from a company employee referring to the employee's daughter, a female patient of unknown age. The patient's concomitant drugs included ondansetron (ZOFRAN). The patient's medical history, historical drugs, past drug reactions or allergies, and concurrent conditions were unknown.   On 14-JUN-2023, the patient received her second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not provided) for prophylaxis.  Within a few short hours of receiving the vaccine on 14-JUN-2023, the patient began to vomit profusely. On 16-JUN-2023, the patient's pediatrician sent her to the emergency room. The patient was prescribed ondansetron (ZOFRAN) for her symptom. On an unknown date in June 2023, the patient started to have low-grade temperature. The outcome of the events above was unknown. The patient was advised to return to the emergency room if the illness continued. The causal relationship between vomit and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was reported as related. The causal relationship between the pyrexia and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was unknown.
6 months after receiving the shot I developed blood clots in my left arm after having a IV to administer pain medication.  The clots started out superficial, as of 8/5 and have now as of 08/09/2021 they are DVT.  This has been going on since the first ER visit on 7/29.
Erythematous rash consistent with Erythema Multiforme Minor, swelling and pain of hands and feet. Seen by MD on 6/18/2010 at 10:00am. Started on Orapred and Zyrtec and Ibuprofen.
Returned to the dr two days after receiving the first COVID vaccine dose and doctor found elevated blood pressure.  Blood pressure has always been normal and healthy, as I have always been thin and athletic an in excellent health,   and no history whatsoever of a single  high blood pressure regarding prior to being administered the COVID vaccine. Dr advised me to monitor my blood pressure at home so I purchased a monitoring machine.  Blood pressure  steadily rose over the next two weeks.  Went to ER on 8/14/21 and determined to have blood pressure spike of 220/136.  Admitted to hospital for treatment.
received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     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 INCORRECT DOSE ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine).    Concomitant product use was not provided by the reporter.  The nurse stated that it happened because of the monovalent vaccine with the purple border was labeled booster doses.  Treatment information was not provided.
Patient received vaccine,  was ok for a few minutes and then fainted.  Patient urinated, and then regained consciousness a few minutes later.  He was groggy, and refused medical attention from paramedics when they arrived.  He eventually left with a family member.
Pain at injection site and worsening pain over ~2wk period.  Pain radiating from shoulder to wrist and limited shoulder range of motion. Patient denies numbness or tingling.
the patient did not experience any other AE; the patient received PEDVAX HIB after it experienced a temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 23-NOV-2021, the patient was vaccinated with haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose (lot #T037648, expiration date: 20-JUL-2023; strength and route of administration were not provided) for prophylaxis after a temperature excursion of 8.5 degrees Celsius (C) for 30 minutes (product storage error). No previous temperature excursion. The patient did not experience any other adverse event (AE).   This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA008367: US-009507513-2112USA008430:
Cellulitis, upper left arm; painful,red, hot, swollen shoulder to elbow; Treated with Keflex
passed out; Dizziness; This spontaneous report was received from a 43-year-old male patient via other company Pfizer (2021855371). The patient's medical history and concomitant medications were not reported. It was reported that the patient was nervous about the vaccinations.  On an unknown date in August 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. The patient had dizziness and he passed out when he got the vaccinations. The patient thought that this happened because "he was nervous about it".  The action taken with the suspect vaccines, the outcome of the events and the relatedness between the events and the suspect vaccines were not reported.  Upon internal review, the event of passed out was determined to be medically significant.
fever, chills, extreme muscle pain/aches, headache, brain fog. felt like i had taken a couple of pills. felt drowsy
pt recvd vax; began crying & screaming about 4:30-5pm; would take no liquids; t almost 103;to er 8pm; no tx given; pt fussy but sleeping ok; took milk 16nov in am;
Pt. described slight tenderness & redness about baseball size. Does not really bothered but concerned about rxn.
10 1/2 yr. with 36 hours of getting vaccine.  Injection site swollen to size of softball, resolved w/ in 48 hours.  No redness.
Fever (low grade fever) 8-9 hours after receiving vaccines on 1-31-12.
Quadracel was administered to a 7 year old patient; a 7 year old patient was given Quadracel, the patient was supposed to have had Ipol and Daptacel; Initial information received on 28-Jun-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 7 years old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and reported that Quadracel was administered to a 7 year old patient and a 7 year old patient was given Quadracel, the patient was supposed to have had Ipol and Daptacel.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 24-Jun-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5497AA and expiry date: 17-Jul-2020 via intramuscular route in left upper arm.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  It was unknown if the patient had any adverse event.  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.  List of documents held by sender: none.