chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received VZV vaccine 4-11-08 then presented in the office 4-14-08 with redness and swelling at the injection site.  Onset of symptoms was 4-12-08.  Patient has an area of dark pinkish-red erythema and induration measuring 120 x 120 mm.  The site is warm and tender to touch. Movement of the left arm has improved since Saturday and Sunday. Treatment with Ibuprofen and Benadryl, warm or cool compresses were recommended at the 4-14-08 office visit.  Diagnosed by the provider seeing him on 4-14-08 as an allergic reaction to VZV vaccine.
On 5/24/21 I started having shortness of breath and heart palpitations. On 5/25/21 symptoms increased. On 5/26/21 symptoms started getting worse with pressure in my chest. I went to urgent care on 5/25/21 and I received bloodwork, but everything came back normal. The Urgent care also checked for blood clots which was negative. My blood pressure and heart rate were elevated, I had a chest X-ray, but it also came back clear. I was sent home to follow up with my PCP. I still had symptoms for the next few days and started feeling better on 6/3/21, I felt like I was able to do normal activities. I started feeling sick again on 6/14/21, 6/15/21, and has continued ever since. I had another visit with my PCP who suggested a meeting with an allergist to make sure I didn't have an allergic reaction to the vaccine. I saw the allergist on 6/17/21, after testing it didn't appear to be an allergic reaction. I followed up with my PCP again on 6/18/21 for follow up because I was still having increased heart rate. I was referred to cardiology for an evaluation and additional lab work. The cardiologist had me walk while wearing a blood oxygen monitor, while I was walking my oxygen level would drop to about 80%. The cardiologist did another blood clot test and another round of lab work. The blood clot test came back negative and I'm still waiting on results from the lab work. I was sent home on 6/21/21 with a heart monitor for 24hours to be monitored. I am currently waiting on the results from the Holter monitor test. I am still suffering with heart palpations and shortness of breath.
The patient was waiting in the waiting room for her 15 minute reaction time.  Her father gave her a bottled water to drink and she drank a few sips of water, then she bent over to start vomiting.  I ran to her with a garbage can.  Then, she started to faint with her eyes rolled back and all of her limbs became stiff.  We immediately called 911.  We gently placed her on the ground from her chair and raised her legs.  Her body began to have tremors like a seizure and her neck bent backwards, then we offered an epi pen injection, but her father refused.  She started talking again and we took her blood pressure.  It was elevated.  Then, the paramedics arrived and they started to treat her and monitor her vitals.  After their assessment and cleared her to go home, they offered to take her to the ER, but she refused to go to the hospital.  Her father told me that she fainted with her first dose of Janssen back in April at a different pharmacy and along with other vaccines; however, the patient lied on the pre-screening questions about reactions to vaccines and did not inform the immunizer.  She only stated that she is afraid of needles.  The patient decided to go home and the paramedics released her as their patient.
I had no period after I finished my birth control round and I ALWAYS have one. I also tested to see if I was pregnant and I?m not.
States started with lump at site Rt. upper arm. Approx 3 days ago notice large red area. Measures 17.5 cm x 11.5 cm red, not raised.
2 hours after receiving vaccines stomach starting itching. Woke up next morning with whole body itching.
similar symptoms to COVID; unstable in walking; headache; chills; low grade temperature; very tired; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (similar symptoms to COVID), GAIT DISTURBANCE (unstable in walking), HEADACHE (headache), CHILLS (chills) and PYREXIA (low grade temperature) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020. Concurrent medical conditions included Parkinson's disease.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced SUSPECTED COVID-19 (similar symptoms to COVID), GAIT DISTURBANCE (unstable in walking), HEADACHE (headache), CHILLS (chills), PYREXIA (low grade temperature) and FATIGUE (very tired). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date for Headache, at an unspecified dose and frequency. On 04-Feb-2021, SUSPECTED COVID-19 (similar symptoms to COVID), GAIT DISTURBANCE (unstable in walking), HEADACHE (headache), CHILLS (chills), PYREXIA (low grade temperature) and FATIGUE (very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Non-Significant follow up received: contact information updated
RAISED SPOT OF PLAQUE and FATIGUE; RAISED SPOT OF PLAQUE and FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (RAISED SPOT OF PLAQUE and FATIGUE) and FATIGUE (RAISED SPOT OF PLAQUE and FATIGUE) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.  No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN PLAQUE (RAISED SPOT OF PLAQUE and FATIGUE) and FATIGUE (RAISED SPOT OF PLAQUE and FATIGUE). At the time of the report, SKIN PLAQUE (RAISED SPOT OF PLAQUE and FATIGUE) had not resolved and FATIGUE (RAISED SPOT OF PLAQUE and FATIGUE) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.  No concomitant medication information was provided.  The patient had raised spot of plaque that did not itch on her head. When she took her covid vaccine all she experienced was some fatigue for a day. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No treatment medication was provided.
I had vaginal bleeding after a week of vaccination; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 24-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07May2021 10:30 (at the age of 24 years), (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at clinic. Medical history included no from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 16:00 the patient experienced, had vaginal bleeding after a week of vaccination. The patient did not receive any treatment for the adverse event. The clinical outcome of the event was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history or concomitant medications were not reported. In December 2016 (reported as about four weeks ago), the patient was inadvertently administered a dose of VARIVAX and PROQUAD at the same time (dose, route of administration and lot number not reported). On an unknown date, the patient developed vesicular/pustular area about 6 inches from where the VARIVAX was administered and a more localized reaction at the site that the PROQUAD was administered.     The outcome of the events was unknown. The relationship between vaccination with VARIVAX; PROQUAD and the events was not reported. Additional information has been requested.
(L) upper thigh with 3cm x 1cm hard induration and erythema - visible puncture mark.
Dizziness, Myalgia, Fever & Diarrhea Narrative:
Covid vaccine was given beyond use of date. Last day to use vaccine was 9/30/2021, vaccine given on 10/2/2021. Patient notified. No adverse events or outcome.
Mild fever, chills night of the shot.  Spent the next day in bed, lethargy.  Sore arm for a couple of days.
3-17-21 6:20PM PT C/O 'SEVERE HEADACHE'.  NO NEURO DEFICIT NOTED. A/O, PINK, W/D, RESP REG WITH EASE. 6:28PM PT STATES SHE IS 'FEELING BETTER' HUSBAND HERE TO DRIVE PT HOME. PT AMBULATORY - GAIT BRISK/STEADY. NO ACUTE OR OBVIOUS DISTRESS NOTED.
Developed dizziness and fever the morning following vaccination followed by chest pain around 48 hours after vaccination. Presented to outside urgent care where pt noted to have elevated troponin >10, prompting transfer to ED. and admission for myocarditis. Symptoms improved over next several days and chest pain was well controlled with ibuprofen and tylenol.
Felt achy morning after; A little warm but no fever; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8N6208) via an unspecified route of administration in the left arm on 03Mar2021 at 11:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications was not reported. On an unknown date in Mar2021, the patient felt achy morning after and a little warm but had no fever. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt achy morning after and a little warm but had no fever was unknown at the time of the report.   No follow-up attempts are possible. No further information is expected.
Patient devleoped rash on left clavicle, left side of throat, and 2 papules on left cheek on 11/21/21.  mother treated with benadryl and hydrocortisone.  experienced itchiness.  at time of office call (11/22) symptoms were still present
24 hours post injection patient had 6x8 cm erythema L deltoid to elbow. 48 hours post injection patient had L shoulder, knee pain, fatigue, irregular heart beat.
felt bad; shot site hah a rash and warmth.; shot site hah a rash; vaccination site erythema; Muscle pain; Chills; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt bad), VACCINATION SITE WARMTH (shot site hah a rash and warmth.), VACCINATION SITE RASH (shot site hah a rash), VACCINATION SITE ERYTHEMA (vaccination site erythema) and MYALGIA (Muscle pain) in a  patient of an unknown age and gender 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt bad), VACCINATION SITE WARMTH (shot site hah a rash and warmth.), VACCINATION SITE RASH (shot site hah a rash), VACCINATION SITE ERYTHEMA (vaccination site erythema), MYALGIA (Muscle pain), CHILLS (Chills) and VACCINATION SITE PAIN (vaccination site pain). At the time of the report, MALAISE (felt bad), VACCINATION SITE WARMTH (shot site hah a rash and warmth.), VACCINATION SITE RASH (shot site hah a rash), VACCINATION SITE ERYTHEMA (vaccination site erythema), MYALGIA (Muscle pain), CHILLS (Chills) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.            No concomitant medications was included. No treatment drug details was provided.   I had an adverse reaction after my second dose and a week later had a relapse with a reaction at the injection site and I had pain at the injection site and chills and redness at the injection site. I felt as bad a week after as I did the 2nd day after my 2nd injection. This is information that should be shared with patients. I had to call my doctor.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up information received, event vaccination site erythema added.
A 15 yr old female adolescent came in for second dose COVID vaccine, after failing to appear for appointment on 07/01/2021 where she was suppose to recieve second dose of Pfizer. The patient stated she was here for a second dose of Moderna on 07/06/2021, and was mistakenly administered  the Moderna dose. Patient should have recieved second dose of Pfizer.
A report was received from a health care professional on 10/21/02 concerning a 38 year old female vaccinee who developed a welt over the deltoid region of her arm which was described as red, swollen, hot and painful after receiving 0.5 ml Fluvirin on 10/15/02. On 10/15/2002 the vaccinee received 0.5 ml Fluvirin intramuscularly. On 10/16/02 she had developed a welt over the deltoid region of her arm, which was also described as red, swollen, hand and painful. The vaccinee was reported as recovered since 10/18/02. There was insufficient information to determine the reporter's causality assessment. Ref: PJP200200596, PJP200200601, PJP200200602 and PJP200200598.
R57.0 CARDIOGENIC SHOCK 9/5/2022 GANGRENE OF LEFT TOE
Information has been received from an licensed practical nurse concerning a 12 month old female who on 19 Apr 2006 was vaccinated SC in the right upper thigh with a first dose of Varivax (lot # 652452/1016R). Concomitant vaccination on the same day included an IM Fourth dose in the left upper thigh of ActHIB (lot # UE788AA). On 27 Apr 2006, the patient developed vaccine site inflammation. She was started on Keflex (400/5mL 6cc TID x 7 days), warm compresses, and Motrin as needed for pain. No further information is expected.
Pt noticed (L) arm becoming edematous approx 6 hours after PNEUMOVAX23 injection was administered. Today pt presents with (L) arm red, edematous, warm to touch below injection site-primarily over biceps muscles (L) arm is 1 1/2 in larger in diameter than (R). 8 in in width for redness/edema; 7 in in length. Instructed warm compress et TYLENOL every 4 hours - if no better to PMD.
Swelling that has "gone underneath the skin, at the right arm pit"/I have swelling under my armpit; My arm that I got it in is really sore; I am facing swelling; My arm is really stuck; I am experiencing some swelling in my arm that I got in which; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP8731, Expiration date: unknown) via an unspecified route of administration, administered in arm on 05May2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in arm on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization and she didn't have any problem just sore throat from the first one for a couple of days and experienced some swelling in her arm that she got in which. The patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine last Wednesday, 05May2021. On an unspecified date, the patient experienced some swelling that had "gone underneath the skin, at the right arm pit", little swelling under her armpit. Her arm that she got it in was really sore and she was facing swelling under her armpit. She experienced some swelling in her arm that she got in which. She knew it was normal because she had it with her first one but this time she had swelling under her armpit. Not more than the swelling under her armpit. Her arm was really stuck and it concerned her when she saw swelling under her armpit. On an unspecified date, the patient had facing swelling. She asked if that was normal. She asked for information on this possible side effect. The patient received the response stating that the Pfizer-BioNTech COVID-19 mentioned no information found on swelling that has "gone underneath the skin, at the right arm pit", and referred to HCP for guidance. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (strength, dose, frequency and route were unknown, lot # L002866, expiration date 10-NOV-2017) (Incorrect product storage). No symptoms were reported. This is one of several reports from the same reporter. Additional information is not expected as the reporter asked not to be contacted.
fever up to 104.2 began 2 hrs p/vax c/o abdo pain, vomiting, h/a; seen by MD 18 hrs p/vax pale, t103.2, mildly red throat & inc bowel sounds; BP 78/38;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 0.5ml(lot # L007531, expiration date 04-NOV-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 8, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report received from a patient concerned a patient of unspecified age, sex, race, and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient got covid-19, omicron (suspected covid-19 infection) and was quite symptomatic. The patient also experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine was not applicable. The outcome of the suspected covid-19 infection (omicron) and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211211.; Sender's Comments: V0; 20220118479-COVID-19 VACCINE suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Patient was fully vaccinated with the Pfizer vaccine.  She came into get her second Shingrix vaccination but was given a Moderna Covid vaccine in error.    Patient reports feeling bad, running temp, excessive sleepiness for most of Saturday and Sunday following the immunization. Pt also complained of nausea, blurred vision, hurting teeth, ligaments in wrist extending with the skin blue around these area and thumb pads.    She has seen a Physician and the Dr. ordered labs.  She is waiting the results.
I started feeling dizzy, head pressure, head pain, headaches, unwell...  On Monday March 21st at 9:05PM i dropped a bowl and felt lightheaded.  Started slurring my speech, I was talking but words weren't coming out.  I felt disconnected and sat down.  Husband said I wasn't moving my lips and the right side of my face was frozen.  I went to the ER, they did a CT scan and couldn't find anything.  Still feel crappy and dizzy off and on today.  Doctor has tried different treatments.
Chest pain; Acute Myocarditis; Fever; A spontaneous report was received from a healthcare professional concerning a 35-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed chest pain, myocarditis, and fever.   The patient's medical history included COVID-19 in Oct of 2020.  No relevant concomitant medications were reported.   On 29 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (lot number or batch number not provided) intramuscularly (in the left arm) for prophylaxis of COVID-19 infection.   On an unknown date after receiving vaccine the patient developed a fever and chest pain.  On 31 Dec 2020 the patient was admitted to the hospital where a heart catheterization was done-negative results.  The patient was diagnosed with myocarditis.  He was scheduled to receive his second dose of vaccine on 03 Feb 2021.    No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events chest pain, myocarditis, and fever were not reported.; Reporter's Comments: This case concerns a 35-year-old, male patient with a medical history of COVID-19, who experienced a serious unexpected event of chest pain, myocarditis and an expected event of pyrexia. The events of chest pain and pyrexia occurred on an unspecified date and the event of myocarditis occurred 3 days after the first dose of mRNA-1273. A heart catheterization was done-negative results.Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.
Patient c/o lightheadedness with rapid Heart Rate. Handoff to parametics with nurse observing patient. Remained alert and oriented x3, clear speech, without rash/hives. BP 190/118 HR 120 O2 98%.Lungs clear. Continued monitoring patient and at 0655 BP 140/80 HR 85 O2 95%.Family called to pick patient up. Will not be returning to work today.