chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got reinfected with COVID; Extra dose administered; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I got reinfected with COVID) and EXTRA DOSE ADMINISTERED (Extra dose administered) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 treatment.     Concurrent medical conditions included Crohn's disease, Hashimoto's disease, Drug allergy (Sulf), Penicillin allergy and Drug allergy (Remicade). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), BUPROPION HYDROCHLORIDE (WELLBUTRIN), DULOXETINE HYDROCHLORIDE (CYMBALTA), VITAMIN D [VITAMIN D NOS] and VITAMIN B12 NOS for an unknown indication.   On 26-Feb-2021 at 12:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021 at 12:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-2022, received sixth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 26-Jun-2022, the patient experienced COVID-19 (I got reinfected with COVID). At the time of the report, COVID-19 (I got reinfected with COVID) was resolving and EXTRA DOSE ADMINISTERED (Extra dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient historical condition included Lupus.  Patient concurrent medication included Plaquenil, Pepcid, P.  Patient had no hospitalization prolonged.  Patient had not taken treatment for the adverse reaction. Device Date : 29Jun2022  Company Comment: This spontaneous case concerns a 69-year-old female patient, with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 (I got reinfected with COVID) unspecified 13 days after receiving a dose of mRNA-1273 vaccine. Extra dose administered was noted in this case. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old female patient, with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 (I got reinfected with COVID) unspecified 13 days after receiving a dose of mRNA-1273 vaccine. Extra dose administered was noted in this case. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
whole left arm feeling sore; feeling foggy and out of it; threw up; both legs feels sore and achy; tired; Diarrhea; hot and sweaty; nauseous; This is a spontaneous report from a Contactable consumer. A 27 years-old female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Lot number: not reported: Expiration date: not reported) via intramuscular route of administration in the left arm on 01Feb2021 at 10:20 AM as a single dose for COVID-19 immunisation (age at vaccination was 27 years). Patient's medical history includes Bipolar disorder from 2014 to unspecified stop date, ADHD (Attention deficit hyperactivity disorder) from unspecified start date and stop date. The patient's concomitant medication includes Vyvance (LISDEXAMFETAMINE MESILATE) 40mg, once a day, orally for ADHD (Attention deficit hyperactivity disorder), LAMOTRIGINE 200mg, once a day, orally for Bipolar disorder, Rexulti (BREXPIPRAZOLE) 2mg, once a day, orally for bipolar anxiety depression, Lithium 900mg, once a day, orally for Bipolar disorder. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Feb2021 patient received vaccine at 10:20AM and sat down for 10 minutes and felt good. Her whole left arm was feeling sore, the same arm where she received the injection. She got up to walk back to her car and she felt so out of it, she felt so foggy, not dizzy. She went back to the parking garage and she felt hot, sweaty, and nauseous. She threw up once about 45 minutes after the injection. Patient reported that she still feels kind of foggy and that started about 40 minutes after she got the shot. She does not know if this is normal or what she should do. Patient was advised to contact hcp. The patient reported foggy was improved with sitting down, if she is walking around it become worse. Fogginess was improved when she decided to start driving. She felt like she could not drive, and she did not drive till about an hour after. Reports both her legs felt sore and achy. She also feels tired. She had diarrhoea right before her call was answered. The outcome of the events vomiting, diarrhea, nausea, hot and sweaty was unknown, for the events whole left arm feeling sore, feeling foggy and out of it was recovering and for the event both legs feels sore and achy was not recovered.   Information on the Batch/Lot number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Information has been received from a healthcare worker concerning an 18 year old female with no medical history and allergies, who on 18-JUN-2008 was vaccinated with a first dose of GARDASIL.  There was no concomitant medication.  On 18-DEC-2008 the patient received a partial dose of GARDASIL (lot # 661530/0575X), intramuscularly, the patient pulled away saying "ouch, ouch, ouch."  She did not get another dose yet.  The outcome is unknown.  The outcome is unknown.  The patient sought medical attention through an office visit.  Additional information has been requested.
Low grade fever; muscle and joint pain; muscle and joint pain; mild chills; This is a spontaneous report from a non-contactable physician (patient). A 60-year-old male patient receive first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration in left arm on 04Jan2021 14:00 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history included none. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced low grade fever, muscle and joint pain, mild chills on 05Jan2021 09:00. This case was non-serious. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.
body aches, headache, fever, sore arm, night sweats, dizziness, weakness, chills
Initially, arm was sore and inflamed for about 4 days. I did not notice condition afterwards because pain had subsided. Approximately 8 days after shot, arm started to itch and I examined further. It was still very red and inflamed with knots under the skin. An area approximately 2" x6". I started to keep a closer eye on it and when it was not better the next day, I contacted my doctors office in the building where I received the shot. The nurse who responded had me photograph it and continue to monitor until the doctor could look at it on Monday (this being Friday afternoon). Friday evening I outlined the affected area with marker to see if it was worsening or maintaining the same level. By Saturday morning it had grown outside the marked line by about an inch, was warm to the touch, and was starting to hurt. I decided to not wait until Monday and called an urgent care to go doctor to look at. They examined and read temperature (head was 97.2, arm was 99.5). After consideration the doctor advised me to take benadryl that evening to see if it had any effect. If not I was presribed Cefdinir 300mg antibiotic to take in the morning. Benadryl did nothing so I started taking the antibiotic and noticed marked improvement by day 2. Site is mostly gone now (4 days into 10 day antibiotic cycle).
10 days after the vaccine I felt pain on the side of my fibroid cyst and it started to get bigger so I went to the ER because I couldn't get to my PCP.
Woke up the next morning with intense body aching from head, neck, shoulders, arm, spine; lightheaded, fatigued, and weak all day, no fever, took ibuprofen that evening (day after vaccine), and symptoms resolved by the next morning.
ITCHING ON R ARM IN THE MIDDLE OF THE NIGHT. NOTICED RED RAISED BUMPS ON R ARM 4 DAYS LATER.  THESE RED RAISED BUMPS TURNED INTO PUSTULES AND ARE ON BOTH ARMS AND A FEW ON MY BODY LEGS, TORSO. TODAY I PUT LOTION ON AND THEN THEY BECAME MUCH MORE NOTICABLE.  THEY FEEL HEAVY AND COULD POSSIBLY BECOME ITCHY IF I STARTED TO ITCH.
swelling, redness, itching, inc warmth, tightness of skin in 14 x 16 cm area surrounding inject site-swelling 1st noted w/in 8 hrs;
PT presented to pharmacy with his right arm below deltoid muscle and above the elbow which was red. But not hot.
I also developed this very very nasty taste in my mouth and I still have that taste; I started breaking out; I get these funny weird headache off and on and I still have the funny weird headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Lot number: ER8736) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure measurement" (ongoing), notes: Verbatim: Blood pressure; "Allergy" (unspecified if ongoing), notes: Verbatim: Allergy. Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement; CETIRIZINE. Vaccination history included: Bnt162b2 (First dose, Event: I got really gassy and it kind of messed up my bowel movement a little bit), administration date: 07Apr2021, for COVID-19 Immunization, reaction(s): "Bowel movement irregularity". The following information was reported: FEELING ABNORMAL (non-serious) with onset 05May2021, outcome "unknown", described as "I started breaking out"; TASTE DISORDER (non-serious) with onset 06May2021, outcome "not recovered", described as "I also developed this very very nasty taste in my mouth and I still have that taste"; HEADACHE (non-serious) with onset May2021, outcome "not recovered", described as "I get these funny weird headache off and on and I still have the funny weird headache".  Additional information: The patient was taking allergy medicines.  No follow-up attempts are possible. No further information is expected.
Pt reported arm soreness at first and being unble to lift after a certain point.  Also reports certain expected side effects like fatigue, slight fever and malaise. Pt stated she felt "just yucky all over and really drained".  Pt reported still having arm soreness and arm achiness a week later.
Migraine started about a minute after the shot; Immediate tension to neck; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 14:15 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medications within two weeks of vaccination. On 23Mar2021 at 14:15, the patient had immediate tension to her neck and about a minute after the shot, the patient experienced migraine. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any treatment for the reported events. The clinical outcome of the events immediate tension to neck and migraine was recovered on an unknown date in 2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 14:15 (at the age of 22-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
did develop COVID that week probably symptoms in general by 25Dec/probably infected whenever got the vaccine; did develop COVID that week probably symptoms in general by 25Dec/probably infected whenever got the vaccine/I don't feel very well right now; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received 1st vaccine on 21Dec2020. The patient did develop COVID that week probably symptoms in general by 25Dec2020. She was probably infected whenever she got the vaccine and the patient was scheduled to have second vaccine on 11Jan2021 which was next Monday and the patient was still sick, should the patient delayed that. The patient also did not feel very well on an unknown date ("right now"). The outcome of the events was not recovered.
Itchy Rash (small pumps) around injection side - continues to expand - darker red around edges than in center currently (2.22,21) about 5 inches long and 3.5 inches wide
Pain and swelling in the shot area Muscle pain all over the body, headache, fatigue, difficulty focusing, light-headed, fever
I could not eat; I'm really hot; yesterday, it was worse than today; I felt like throwing up; I got a little dizzy; Fatigue; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (I could not eat), FEELING HOT (I'm really hot; yesterday, it was worse than today), MALAISE (I felt like throwing up), DIZZINESS (I got a little dizzy) and FATIGUE (Fatigue) in a female 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 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced FEEDING DISORDER (I could not eat), FEELING HOT (I'm really hot; yesterday, it was worse than today), MALAISE (I felt like throwing up), DIZZINESS (I got a little dizzy), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, FEEDING DISORDER (I could not eat), FEELING HOT (I'm really hot; yesterday, it was worse than today), MALAISE (I felt like throwing up), DIZZINESS (I got a little dizzy), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow-up received on 26-May-2021 and verbatim events are updated. On 19-Apr-2021: Non-Significant Follow up appended.
Injection at 8:00am. Woke up around 2am the next morning with strong chills, muscle aches, and mild fever. Took 2 ibuprofens which helped the fever, but still had trouble sleeping. Later in the morning 8am, had same symptoms plus had 3 different sudden episodes of dizziness,  nausea, and light headedness. I had to physically sit down as it felt like I might pass out. From 9am-1pm the symptoms steadily decreased until there was just a bit of muscle weakness. I was taking ibuprofen every 6hrs.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 09-AUG-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, lot#, expiration date and route of administration were not reported). There was no adverse effect reported.  Administered doses of vaccines experienced the temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 11 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005855: US-009507513-1708USA007464: US-009507513-1708USA007466: US-009507513-1708USA007463:
2 large clots; heavy bleeding like the first day of a period; The pregnant patient had her FLUZONE QUADRIVALENT vaccine; Initial information received on 22-Oct-2021 regarding an unsolicited valid serious case received from consumer/non-healthcare professional and physician via call center via Global Medical Information (GMI) (Reference number- 00824506) in the United States.  This case involves a 38-year-old female patient who experienced heavy bleeding like the first day of a period (abnormal uterine bleeding), 2 large clots (thrombosis) after received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].   Data regarding this pregnancy were received prospectively, that is before pregnancy outcome was known. The reported events occurred at 15 weeks of pregnancy.  The date of last menstrual period was reported as 16-Jul-2021.  The estimated due date is 15-Jun-2022.  The patient's medical history, medical treatments, vaccinations, concomitant medivation and family history were not provided.  On 14-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) (Dosage text: once) via an intramuscular route at an the left arm for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (same day latency).  On 17-Oct-2021, the patient developed a non-serious heavy bleeding like the first day of a period (abnormal uterine bleeding) and 2 large clots (thrombosis) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Thrombosis event was assessed as medically significant.  Relevant laboratory test results included:  Ultrasound scan - On an unknown date: [the fetus was ok]  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  Information on the batch number was requested for this case.; Sender's Comments: This case concerns a 38-year-old female patient who experienced abnormal uterine bleeding, thrombosis (3 days) and Exposure during pregnancy (same day) after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible. There is no further information regarding patient's medical condition at the time of vaccination was not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
On Thursday, April 2, 2021 client DOB 8/3/1973 received her first dose of Pfizer COVID vaccine (LOT # EW0150, EXP 7/2021) at approximately 9:30am. During assessment of screening questions, client stated she has a history of severe allergic reaction to amoxicillin and was to be observed for 30 minutes in the Observation Area. At 10:00am, 30 minutes after vaccination, client approached EMT with chief complaint of "nausea and feeling light-headed". Vitals were taken on client at 10:08am: BP: 138/90, HR: 76 regular, strong, RR:14, O2 sat: 94%, A&O x4, pupils: PERRLA, skin: warm, pink and dry. Client requested to use the restroom and was accompanied to the restroom door by EMT. Lead was alerted and advised client when she returned to Observation Area to be observed for an additional 30 minutes. Client sat in the zero gravity chair while vitals were retaken. At 10:20am: BP: 142/94, HR: 70 regular and strong, RR: 13, O2 sat: 99%, A&O x4, pupils: PERRLA, skin: warm, pink and dry. Client stated to Lead RN & EMTs she has a history of high blood pressure which she takes medication for. Client also stated three weeks ago she went to the Urgent Care for vertigo. At 10:25am client stated her nausea had subsided and she was no longer feeling dizzy when standing up. Client stated she felt ok to drive herself home. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Client was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client left vaccination site at approximately 10:50 with a steady gait.
Developed itchy red spotty rash behind bilateral knees. Rash spread to lower back. Rash is described as red and raised above skin. At 12 hours after rash started, rash is reported as still spreading. Other symptoms include fatigue. Pt did not take any treatment. Advised at time of VAERS report, to take oral Benadryl. Rash outcome unknown at this time.
fever started 6/13/07, spots started 6/14/07, lethargic, agitated, refusal of food, symtoms peaked 6/16/07, aproxamately 4-6 spots per sq. inch over entire body. red 2-3 mm raised spots no open blisters or crusting. spots are fading but not yet gone as of 6/20/07
This spontaneous report as received from a pharmacist via a company representative refers to a 75 year old female patient. The patient's pertinent medical history included hypertension and high cholesterol. The patient's concomitant medications included multiple unspecified medications. On 03-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX dose, route and site of administration, lot#, expiry date were not reported for prevention of shingles. On an unknown date in 2015, reported as "since receiving the ZOSTAVAX", the patient was diagnosed with bullous pemphigoid. The patient received unspecified prednisone treatment for the bullous pemphigoid. The outcome of pemphigoid was unknown. The patient sought medical attention by going to the physician. The relatedness between the event and the ZOSTAVAX was not reported. Additional information has been requested.
On 1/6/2022 I started coughing a lot. I had so much phlegm I could not breathe well. My joints in my feet and knees hurt so bad I couldn't walk well. I felt very weak. The phlegm lasted about a week. The other symptoms lasted about 3-4 days. About two weeks after I started to feel joint pain again that would make it difficult to sleep. I still feel joint pain to this day. On March 2,2022 I saw a doctor who told me this is common for people who have had COVID- 19. The doctor prescribed an antifungal and a steroid but I can't remember the names.
pt recvd vax 11JUL94 11AM & same day 3PM pt exp inj site redness, induration & pain;the area of redness measured approx the size of a silver dollar;rxn was localized;vax was inadvertently administered intradermally;